quality control in india essay

Working Paper 5: Assessing Quality of Care in India: Considerations for National Reform

Assessing Quality of Care in India: Considerations for National Reform

By Anuska Kalita*, Liana Woskie*, and Winnie Yip * Joint First Authors December 2022

Even as the availability and affordability of healthcare improve, many countries are not experiencing anticipated gains in health outcomes. One potential driver for stagnating health outcomes is low-quality health services. For example, between 5.7 and 8.4 million deaths are estimated to result from poor-quality healthcare each year in low- and middle-income countries (LMICs). While people may have better access to health services, the quality of those services is highly variable. At best, healthcare can improve health and save lives; but it can also cause physical harm and erode trust. India has recently implemented several major healthcare reforms at national and state levels, yet the nation continues to face significant challenges in achieving better health system performance.

These challenges are particularly daunting in India’s poorer states, like Odisha. While the focus of several past and newer health policies has been to improve access to care and financial risk protection, there have been few initiatives to improve quality of care in the country. Importantly, there is limited data on quality of care, which often impedes an assessment of the extent and scale of the problems, diagnosing the causes behind them, and designing evidence-based solutions to address it. In this context, the Harvard T.H. Chan School of Public Health conducted a comprehensive study in Odisha to assess quality of care. We assessed quality of care along three aspects: clinical effectiveness, patient safety, and patient-centeredness. These three aspects of quality are the major gaps in existing knowledge, but they are the critical components of healthcare linked to patient outcomes. Using an interconnected set of surveys–patients at outpatient and inpatient exit interviews, interviews with primary care providers using clinical vignettes, and interviews with hospital staff, allowed us to assess three aspects of healthcare quality: patient safety, patient-centeredness, and clinical effectiveness.

In this working paper, we present the following: (1) a summary of the key findings on the three aspects of quality: clinical effectiveness, patient safety, and patient- centeredness; (2) a brief diagnosis of possible causes behind our findings; and (3) some recommendations for reforms to improve quality based on global experiences.

Download this Working Paper here .

Ensuring Quality Control in India: Best Practices and Expert Insights

• By: Trinity
• Date: December 2, 2023

Quality control plays a crucial role in ensuring that products and services meet predefined standards and customer expectations . In India , quality control is of utmost importance due to several factors unique to the country. India has a diverse range of industries, including manufacturing, pharmaceuticals, and food, where maintaining quality is essential. Without effective quality control measures, these industries would struggle to meet international standards and compete in the global market.

In the manufacturing industry, quality control helps identify and rectify defects , ensuring that products meet quality criteria and are safe for consumer use. Similarly, in the pharmaceutical industry , rigorous quality control is necessary to ensure the safety and efficacy of drugs. In the food industry , quality control is important to maintain hygiene , prevent contamination, and ensure that food products are safe for consumption.

There are various methods and techniques employed in quality control in India. Statistical Process Control (SPC) allows for continuous monitoring and controlling of production processes to identify and address variations. Six Sigma is a data-driven methodology that aims to minimize defects and improve quality through process improvement. Failure Mode and Effects Analysis (FMEA) helps evaluate potential failure risks and prioritizes corrective actions.

Implementing quality control in India is not without its challenges. A significant hurdle is the lack of awareness and education about quality control practices among industry professionals. Resource constraints, such as limited access to technology and skilled personnel, also pose challenges. ensuring regulatory compliance with quality control standards is essential but can be demanding due to ever-evolving regulations.

Despite these challenges, there have been successful implementations of quality control in India. Several case studies highlight companies that have effectively integrated quality control measures into their operations, resulting in improved product quality, customer satisfaction, and overall business success.

Looking ahead, future trends and innovations in quality control in India hold great promise. With advancements in technology and the increasing adoption of automation and artificial intelligence, quality control processes are expected to become more efficient and precise. The integration of smart sensors, data analytics, and machine learning will revolutionize quality control practices, enabling quicker identification of defects and proactive resolution.

Key takeaways:

• Quality Control improves product and service reliability: Implementing quality control measures ensures that products and services meet customer expectations, increasing reliability and customer satisfaction.
• Quality Control reduces costs and waste: By identifying and addressing quality issues early on, organizations can reduce waste, improve efficiency, and save costs associated with rework and defects.
• Quality Control enhances competitiveness: With global competition increasing, organizations that prioritize quality control can gain a competitive edge by delivering superior products and services that meet international standards.

The Importance of Quality Control

Quality control is of utmost importance in any industry. It ensures that products and services meet the desired standards and customer expectations. Here are a few reasons why quality control is crucial:

• Customer Satisfaction: By consistently delivering high-quality products, businesses can earn the trust and loyalty of their customers.
• Cost Reduction: Implementing quality control measures helps identify and rectify defects early, reducing the costs associated with rework or customer returns.
• Reputation Management: Maintaining a reputation for producing quality products can enhance brand image and attract more customers.
• Compliance with Regulations: Quality control ensures that products comply with industry standards and regulations, avoiding legal consequences.
• Continuous Improvement: Regular quality checks allow businesses to identify areas for improvement and make necessary adjustments.

Why is Quality Control Important in India?

Quality control is crucial in India due to several reasons. It ensures that products meet acceptable quality standards, promoting customer satisfaction and trust in Indian goods. It helps in preventing violations of packing specifications, measurement discrepancies, and visual defects, enhancing overall product quality. Effective quality control programs can boost the reputation of Indian industries domestically and internationally. To further improve quality control in India, it is recommended to establish partnerships between the government and private sector, increase awareness and education, and promote the use of reputable third-party audits for quality assessment. These measures will contribute to the continued growth and success of Indian industries.

The Role of Quality Control in Different Industries

Quality control plays a crucial role in various industries, ensuring the production of high-quality products and services. In the manufacturing industry , quality control guarantees that products meet specified standards and minimize defects. The pharmaceutical industry relies on quality control to ensure the safety and efficacy of drugs. In the food industry, quality control ensures that products are safe for consumption and comply with regulations. Different methods and techniques, such as Statistical Process Control and Six Sigma, are employed to maintain quality standards. Implementing quality control in India faces challenges such as a lack of awareness, resource constraints, and regulatory compliance. Successful case studies highlight the importance of a strong quality control presence in industries.

Quality Control in Manufacturing Industry

Quality Control in the manufacturing industry is of utmost importance. It ensures that products meet specific standards and customer expectations. Here are some key aspects to focus on:

• Implementing standardized quality control processes that monitor and assess product quality at every stage of the manufacturing process.
• Conducting regular inspections and tests to identify and correct any defects or deviations from quality standards.
• Using statistical process control techniques, like Six Sigma and Failure Mode and Effects Analysis , for analyzing and improving manufacturing processes.
• Ensuring compliance with mandatory regulations and contractual specifications to prevent any violations.
• Collaborating with reputable third-party audit and inspection companies to provide an objective assessment of product quality.

An illustrative example showcasing the significance of quality control in the manufacturing industry is the case of a car manufacturer that implemented a comprehensive quality control program . By consistently monitoring and enhancing their manufacturing processes, they managed to significantly minimize defects and customer complaints. Consequently, this led to heightened customer satisfaction and a remarkable boost in sales.

Quality Control in Pharmaceutical Industry

In the pharmaceutical industry, quality control is essential to ensure the safety, efficacy, and reliability of drugs . It involves rigorous testing and monitoring at every stage of the production process. Below is a table summarizing key aspects of quality control in the pharmaceutical industry:

By implementing effective quality control measures, the pharmaceutical industry can ensure the production of safe and effective medications that meet regulatory standards .

Quality Control in Food Industry

Ensuring quality control in the food industry is of utmost importance in order to protect consumer health and uphold the reputation of food businesses . Adhering to regulatory standards , certifying processes , and conducting regular inspections are all essential for maintaining high quality standards . It is crucial to incorporate standard operating procedures , perform comprehensive quality checks at each stage of the production process , and promptly address any issues that arise. Additionally, accurate labeling , proper storage and transportation practices , and strict adherence to hygiene and sanitation protocols are necessary. The food industry has a vital role in providing safe and nutritious food to consumers , and strong quality control measures are imperative in meeting customer expectations and regulatory requirements .

The implementation of quality control measures in the food industry has a long history, dating back to the early 20th century , in response to major food safety crises . The Pure Food and Drug Act of 1906 in the United States and the subsequent establishment of the Food and Drug Administration (FDA) were significant milestones in the regulation of food quality and safety . These initiatives were designed to address public health concerns and ensure the protection of consumers from harmful products . Over time, quality control practices in the food industry have evolved to incorporate proactive measures and emphasize prevention rather than solely focusing on detection and correction .

Methods and Techniques of Quality Control in India

Methods and Techniques of Quality Control in India play a pivotal role in ensuring the production of top-notch products across various industries. These industries employ several common methods such as statistical process control , Six Sigma , and failure mode and effects analysis . These techniques effectively monitor and control the production process, identify and eliminate defects, and enhance overall product quality. The Quality Council of India , an autonomous body under the Government of India , actively promotes and implements quality control standards pan India. By utilizing these methods and techniques, India consistently strives to maintain high-quality standards in both its domestic and international markets.

Statistical Process Control

Statistical Process Control ( SPC ) is a powerful tool utilized in quality control to monitor and analyze production processes. It effectively helps in detecting and preventing defects by identifying variations in process parameters. By employing statistical methods to analyze data collected during production, businesses can obtain valuable insights to make informed decisions and initiate corrective actions. SPC charts, notably control charts, visually represent process data and promptly identify any out-of-control conditions. Implementing Statistical Process Control in India’s industries holds tremendous potential to significantly enhance product quality, minimize waste, and improve customer satisfaction levels. To ensure successful implementation, companies should prioritize investing in employee training, leveraging advanced software for data analysis, and consistently monitoring and improving their processes.

Six Sigma is a methodology that focuses on improving business processes by reducing defects and minimizing variations. It follows a structured approach using statistical analysis and data-driven techniques. Here are some key points about Six Sigma:

• Six Sigma aims for a high level of quality through the identification and elimination of errors.
• It uses a set of tools and methods, such as DMAIC (Define, Measure, Analyze, Improve, Control), to achieve process improvement.
• Six Sigma projects are driven by trained and certified professionals called Six Sigma Black Belts and Six Sigma Green Belts .
• This methodology has been successfully implemented in various industries, including manufacturing , pharmaceuticals , and healthcare .
• Companies that have implemented Six Sigma have reported significant cost savings, increased customer satisfaction, and improved operational efficiency.

Did you know that Motorola and General Electric are among the companies that popularized Six Sigma and achieved remarkable success through its implementation?

Failure Mode and Effects Analysis

Failure Mode and Effects Analysis (FMEA) is a systematic approach used to identify and prevent potential failures and their effects on a product, process, or system . It involves analyzing failure modes, their causes, and the potential impact on overall performance. By conducting Failure Mode and Effects Analysis (FMEA), organizations can proactively identify and mitigate risks , improve quality, and enhance customer satisfaction . Failure Mode and Effects Analysis (FMEA) is widely used in various industries, including manufacturing, pharmaceuticals, and food . It helps companies optimize their production processes, reduce costs , and ensure compliance with quality standards and regulations. Implementing Failure Mode and Effects Analysis (FMEA) can be challenging, but the benefits of a robust quality control program make it worthwhile.

The Challenges of Implementing Quality Control in India

Implementing quality control in India comes with unique challenges that need to be addressed. From a lack of awareness and education to resource constraints and the burden of regulatory compliance, these sub-sections will shed light on the obstacles faced in ensuring quality standards. With reliable data and insights, we can better understand the uphill battle that companies and industries in India face in maintaining and improving quality control measures.

Lack of Awareness and Education

Lack of awareness and education is a significant hindrance in the successful implementation of quality control in India. Numerous individuals and organizations in the country are not fully cognizant of the significance and advantages of adopting quality control measures. Consequently, there is a lack of investment and resources dedicated to establishing effective quality control programs. The Indian government plays a pivotal role in addressing this challenge by actively promoting awareness and education initiatives , such as the Quality Council of India . Through these endeavors, the objective is to enhance understanding and knowledge concerning quality control standards and practices across various industries. By tackling the issue of inadequate awareness and education , India has the potential to elevate overall quality standards and enhance competitiveness in both domestic and international markets.

Resource Constraints

One of the major challenges faced in quality control in India is resource constraints. Limited funding , inadequate infrastructure , lack of skilled personnel , insufficient technology , and time constraints hinder the effective implementation of quality control programs. These constraints affect various industries, including manufacturing , pharmaceutical , and food sectors. Despite these challenges, there have been success stories where organizations have managed to overcome resource constraints and implement effective quality control practices. One such example is a textile powerhouse in India that partnered with a reputable third-party audit and inspection company to ensure quality standards in their production process. This collaboration helped them overcome resource limitations and promote quality standards in their industry.

Regulatory Compliance

Regulatory compliance is crucial for businesses operating in India to ensure adherence to laws and regulations. It involves implementing processes and systems to meet legal requirements, quality standards, and safety regulations. Here is a table that highlights the importance of regulatory compliance in different industries in India:

To maintain regulatory compliance, businesses should invest in training, regular inspections, and audits. Developing a consistent and transparent system is essential. Collaboration between the government, industry associations, and independent regulatory bodies promotes effective compliance measures. It is crucial to stay updated with changing regulations and best practices. A proactive approach to regulatory compliance not only ensures legal adherence but also gains consumer trust and enhances overall business reputation.

Case Studies of Successful Quality Control Implementation in India

India has witnessed numerous case studies of successful quality control implementation across various sectors. Take, for instance, the automotive industry, where Tata Motors stands out for its stringent quality control measures, which have resulted in the improved reliability of their products and increased customer satisfaction. Similarly, in the healthcare sector, Apollo Hospitals has taken proactive steps to implement quality control protocols, ensuring both patient safety and accurate diagnoses. Hindustan Unilever , in the manufacturing sector, has made quality control a top priority to maintain consistent product standards. With successful implementation of quality control in India, businesses have experienced enhanced productivity, reduced defects, and heightened customer trust. To achieve comparable success, organizations should focus on continuous improvement, invest in thorough employee training, and establish robust quality control systems.

Future Trends and Innovations in Quality Control in India

Future trends and innovations in quality control in India have the potential to greatly improve various industries and enhance overall productivity. These advancements include the integration of AI and automation technologies in quality control processes, which will streamline operations, reduce human error, and increase efficiency. Leveraging big data analytics will enable businesses to gain valuable insights from large volumes of data, helping them identify patterns, make data-driven decisions, and optimize quality control practices. Additionally, the Internet of Things (IoT) will enable real-time monitoring and data collection, allowing for better quality control and preventive maintenance by connecting devices and systems. The adoption of robotics and machine vision systems will enhance precision and accuracy in quality control inspections, ensuring consistent and reliable product quality. Lastly, implementing blockchain technology in quality control will improve transparency and traceability across supply chains, ensuring the authenticity of products and preventing counterfeiting.

Now, let’s delve into a true history related to quality control in India. In 1986 , the Indian government launched the Quality Control Order (QCO) for various products with the aim of ensuring compliance with specific quality standards. This initiative played a pivotal role in regulating the quality of goods in the Indian market and safeguarding consumers’ interests. Throughout the years, the QCO has evolved to address emerging quality control challenges and uphold the integrity of products in India.

Some Facts About Quality Control India:

• ✅ India is a major sourcing destination for many brands. (Source: Our Team)
• ✅ QIMA offers vetting of suppliers and on-the-ground experts to ensure products are manufactured to specifications. (Source: Our Team)
• ✅ Almost 30% of products inspected in India last year were found to be beyond acceptable quality limits. (Source: Our Team)
• ✅ Visual defects, measurement discrepancies, and packing violations are the most common reasons for product rejections in India. (Source: Our Team)
• ✅ QIMA conducts supplier audits to ensure quality management, ethical conduct, and environmental protection. (Source: Our Team)

Frequently Asked Questions

What is the role of a third-party agency in quality control in india.

A third-party agency, such as QIMA, plays a crucial role in quality control in India. They offer vetting of suppliers and on-the-ground experts to ensure products are manufactured to specifications, helping brands maintain quality throughout the manufacturing process.

Which major Indian production hubs benefit from the presence of quality control agencies?

Quality control agencies like QIMA benefit major Indian production hubs where numerous brands source their products. These hubs include sectors such as healthcare, industries, institutions, and professionals.

How does the Quality Council of India operate in the country?

The Quality Council of India (QCI) is an independent autonomous body that operates under the direction of its Governing Body, which includes representatives from the government, industry, and industry associations. QCI follows a public-private partnership model, ensuring collaboration from various spheres of economic and social activities in India.

Where is the headquarters of the Quality Council of India located?

The headquarters of the Quality Council of India is located in New Delhi, Delhi.

Who are the current Chairman and Secretary General of the Quality Council of India?

The current Chairman of the Quality Council of India is Mr. Jaxay Shah, and the Secretary General is Dr. Ravi P. Singh.

What is the significance of having a reputable third-party audit and quality control presence in India?

Having a reputable third-party audit and quality control presence in India, such as QIMA, is essential for brands as it helps ensure products are manufactured to specifications and meet quality standards. This is particularly important due to the challenges of product quality, transparency, and ethical compliance India faces in its manufacturing sector.

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Quality Infrastructure of India and Its Importance for Inclusive National Growth

• Feature Article
• Published: 30 May 2020
• Volume 35 , pages 139–150, ( 2020 )

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• D. K. Aswal 1  

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In this feature article, the quality infrastructure (QI) of India is discussed. A national QI is comprised of internationally recognized metrology, standards and accreditation. The QI built on a technical hierarchy to ensure the accuracy and precision of measurements traceable to SI units, is basic enabling system for providing the conformity assessment (calibration and testing, certification and inspection). The QI is an invisible force that binds the four helices, namely government, university, S&T institutions, civil society & media and enterprises, which are responsible for the growth of economy and quality of life. The existing apex capabilities of National Physical Laboratory, India—the National Metrology Institute of the country, National Accreditation Board for Testing and Calibration Laboratories and the Bureau of Indian Standards, are described. The mechanisms of enhancing the individual capabilities of these QI institutions and to boost synergy amongst them are presented. The need of a robust QI facility by various stakeholders in the areas of implementation of regulations, industrial growth, international trade, food safety, environmental monitoring, sustainable energy, affordable health, attraction of foreign investments, etc. is highlighted.

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Quality Measurements and Relevant Indian Infrastructure

The UKQI: Status and Importance for National Growth

Avoid common mistakes on your manuscript.

1 Introduction of Quality Infrastructure

For the year 2019, the International Monetary Fund (IMF) has listed India as the fifth largest economy of the world with gross domestic product (GDP) of $ 2.93 trillion. USA ($ 21.43 trillion), China ($14.14 trillion) Japan ($5.15 trillion) and Germany ($3.86 trillion) are ahead of India [ 1 ]. India is aiming a goal of becoming a $5 trillion economy by 2024 [ 2 ], which is a must to cater the livelihood of its large current population of 1.32 billion and that is expected to grow to 1.54 billion by 2035 [ 3 ]. This implies an exponential-like growth is needed for all the sectors contributing to the GDP, i.e. agriculture, service and industry. In addition, the export growth rate should be significantly high. Two recent books have aspiringly predicted that by harnessing technology and with a collaborative political, regulatory and business, the economy of India can surpass $20 trillion by 2035–2040 [ 4 , 5 ]. It is well known that India is a country of magnificent paradoxes, and therefore, to enhance its economy and quality of life, a synergy between the government and business, demographics and democracy, culture and modernity, traditional knowledge and modern Science & Technology, etc. needs to be made stronger. Unfortunately, the end of December 2019 witnessed the beginning of the new coronavirus (nCov19) pandemic that has infected more than four million people and killed > 280,000 worldwide till date (May 10, 2020). It is good news that > 1.44 million people have also recovered [ 6 ]. The virus causing coronavirus-induced disease (COVID-19) is transmitted through droplets released during the exhales, coughs or sneezes of an infected person. To avoid the spread of pandemic, most of the governments across the world imposed a complete lockdown for month together [ 7 ]. This has resulted in halting all the economic activities worldwide, which has resulted in the loss of employment and prompted mass return of migrants to their native places [ 8 ]. This will pose a great difficulty in reviving the economy, and therefore, a new thinking will need to be evolved to achieve the set targets of the economy.

Quadruple helix (QH) model of Carayannis and Campbell is widely used to understand how economies improve through the interactions amongst government, university/science & technology (S&T), industries and civil society & media [ 9 ]. A schematic of QH model along with the responsibilities of each of the helices is depicted in Fig.  1 . QH model essentially is an extension of triple helix (TH) model of Etzkowitz and Leydesdorff that deals with dynamics and evolution of university (S&T)–industry–government relations and their impact on global economy and other challenges, including unemployment, low economic growth, healthcare needs, environment and uncoordinated regulatory systems [ 10 , 11 , 12 ]. The civil society and media were added in the QH model so that the innovation can effectively be communicated to the masses. In developed nations, the interactions amongst the four helices of QH are very strong and work in all directions, i.e. top down, bottom up, sideways and criss-cross. These strong interactions are facilitated through an invisible but robust quality infrastructure (QI), which ensures conformity assessment through well-established institutions of metrology, accreditation and standards. The QI in developed nations, e.g. USA, is well established and, therefore, has the strongest S&T and industrial policies resulting in their high GDP [ 13 ].

Well-functioned quadruple helix (QH) comprising government–university/S&T institutes–industry–civil society & media is needed to achieve a high economy and high quality of life. A robust quality infrastructure (QI) is essential for facilitating the strong interactions amongst the helices of QH

United Nations Industrial Development Organization (UNIDO) has extensively been working to strengthen the industrial growth of developing nations [ 14 , 15 , 16 ]. UNIDO defines the QI as: “ the system comprising the organizations (public and private) together with the policies, relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes. The quality infrastructure is required for the effective operation of domestic markets, and its international recognition is important to enable access to foreign markets. It is a critical element in promoting and sustaining economic development, as well as environmental and social wellbeing. It relies on metrology, standardization, accreditation, conformity assessment, and market surveillance ”. In a country, as depicted in Fig. 2 . the quality infrastructure institutions, i.e. metrology, accreditation and standards, are usually formulated under national quality policy to ensure the QI services of conformity assessment through calibration, testing, certification and inspection.

Strong Quality Infrastructure (QI) institutions in a country are essential for the conformity assessment of international level to support government policies and regulations, for innovation in the S&T institutions through precise and accurate measurements, for industries to produce internationally competitive high-quality products and their international trade, and high-quality of life for common citizens

Metrology is the science of measurement (physical, chemical and biological properties), embracing both experimental and theoretical determinations at any level of uncertainty in any field of science and technology [ 17 ]. Metrology is often classified into scientific metrology, industrial metrology and legal metrology. Scientific metrology deals with research and development of new measurement standards as well as their maintenance and dissemination. This is performed by National Metrology Institutes (NMI) of the country. Industrial metrology deals with the application of metrology to industrial processes and ensures the correctness of measurement instruments through their calibration. Precise and accurate measurements improve the quality of the product and, therefore, their market. The strength of industrial metrology, therefore, governs the economic and industrial development of a country. Legal Metrology deals with the statutory requirements concerning measurements as well as the law enforcement on measurements. These statutory requirements arise from a need for the protection of public health and safety, consumers rights, enabling taxation, the environment, and fair trade are performed by competent bodies. Accreditation is a process by which an authorized body officially recognizes (i.e. third-party attestation) that the person or organization is competent to carry out specific tasks with a level of internationally accepted competence. Standardization involves development of technical standards and their implementation to ensure the quality, compatibility, interoperability and safety. Therefore, QI is the basic enabling system of a nation for providing the conformity assessment (compliance with standards and technical regulations) of products and processes with international acceptance through calibration and testing (the determination of the characteristics of a product), certification (a formal and written confirmation that a product, service, organization, system or individual complies with a given set of specifications and/or standards) and inspection (the determination whether products meet the requirements of a given standard) [ 18 ].

QI in nutshell is a complete package for all-round growth of a nation as it: (1) contributes to the formulation of government policies and regulations for S&T, industrial development and competitive international trade; (2) supports enterprises for production of international competitive products and apprises them new trade standards; (3) assists S&T institutions for scientific discoveries and innovation through accurate and precise measurements; and (4) addresses the needs of the consumers in terms of quality products and services at par with international standards, food and health safety, environment and climate change, and efficient use of natural and human resources. The QI also acts a foundation for achieving the sustainable development goals, envisaged by UN to ensure the inclusive economic growth and prosperity, dignified livings of people and the protection of the earth. The International Network of Quality Infrastructure (INetQI) [ 19 ]—a consortium of twelve international organizations—promotes the significances of QI and its effective global implementation, particularly in developing nations with ensured metrological traceability to SI units. These twelve international organizations include International Bureau of Weights and Measures (BIPM), International Accreditation Forum (IAF), International Electrotechnical Commission (IEC), International Laboratory Accreditation Forum (ILAC), International Standards Organization (ISO), International Trade Centre (ITC), International Telecommunication Union (ITU), International Organizations of Legal Metrology (OIML), United Nations Economic Cooperation for Europe (UNECE), World Bank Group (WBG), World Trade Organization (WTO) and UNIDO.

2 India’s Quality Infrastructure and Its International Recognition

Figure  3 summarizes the international QI organizations along with the QI institutions of India and a comparison with that of USA—one of the best QI in the world. India has the desired QI system, and all of its three components, namely metrology, accreditation and standards, have well-established international affiliations. However, despite international affiliations, the QI strength of different countries can be widely dissimilar. The strength of QI system of a nation mainly depends upon (1) overall measurable capabilities of international equivalence available with apex QI institutions and (2) the dissemination mechanism of the available QI capabilities to all the stakeholders across the country. In USA, as shown in Fig.  3 , the National Institute of Standard and Technology (NIST) has multiple responsibilities, i.e. scientific metrology, Legal metrology (ILMG/NIST), accreditation (NVLAP/NIST) and standards [ 20 ]. Multiple roles of NIST’s for measurements, standards and legal metrology allow them to ensure measurement traceability for quality assurance as well as in harmonizing the documentary standards and regulatory notifications. For accreditation and standards, USA has multiple organizations (as listed in Fig.  3 ). On the other hand, the components of India’s QI system belong to independent organizations. The metrology is looked after by National Physical Laboratory of India (NPLI) [ 21 ] with Bhabha Atomic Research Centre (BARC) as the designated Institute for the ionization radiation [ 22 ], legal metrology comes under Ministry of Consumer Affairs [ 23 ], accreditation is the responsibility of Quality Council of India (QCI) [ 24 ] having five independent boards, namely NABCB, NABET, NBQP, NABH and NABL, and Bureau of Indian Standards (BIS) [ 25 ] is the body for Indian standards.

Components of international quality infrastructure and corresponding QIs of USA and India

2.1 Metrology in India

The NPLI is the NMI of the country since 1956 formed by an Act of Parliament, Legal Metrology, Government of India. NPLI deals with all the seven basic SI units and their derivates, except the ionization radiation for which Bhabha Atomic Research Centre (BARC), Mumbai, was made designated institute (DI) in 2003. NPLI is a member of BIPM, signatory of International Committee of Weights and Measures—Mutual Recognition Agreement (CIPM MRA) [ 26 ] and founding member of the Asia Pacific Metrology Program (APMP) [ 27 ]—one of the six Regional Metrology Organizations (RMO). The key roles of BIPM and RMOs are to homogenize the accurate and precise measurement capabilities across the world through NMIs. The Joint Committee of the Regional Metrology Organizations and the BIPM (JCRB CIPM) analyse the calibration and measurement capabilities (CMCs) of NMIs and place the information in the website of Key Comparison Database of BIPM (KCDB-BIPM) [ 28 ]. CMCs are the highest level of calibration and measurements, guaranteed by an institute to customers of its metrological services, in the form of the value of expanded uncertainty of measurement results.

Under the CIPM MRA, NPLI has adopted working quality management (QM) system according to ISO/IEC 17025 as well as ISO 17034 for certified reference material. NPLI like any other NMI of the world has three major tasks: (1) To contribute in the definition of internationally accepted units of measurements. (2) The realization of primary/national measurement standards using well-established procedures of CMCs. (3) To provide measurement traceability through either calibration and/or certified reference materials to all the stakeholders in the country. These responsibilities of NPLI have been depicted using a 3D pyramid installed in the NPLI campus, see Fig.  4 . The NPLI has voted for the redefinition of SI units based on the fundamental constants in the 26th CGPM held in France in 2018 and got it implemented in India on World Metrology Day on 20 May 2019 [ 29 , 30 ]. As can be seen from the KCDB-BIPM, NPL, India has 236 CMCs which is much lower as compared to 1889 CMCs of NIST, USA. Tables  1 and 2 summarize the 236 CMCs and 130 key/supplementary comparisons of NPL-India that covers several metrology areas related to physico-mechanical, electrical and electronics, time and frequency, chemistry, etc. In addition, the BARC has 52 key/supplementary comparisons, as listed in Table  3 , in the area of ionization radiation. The interlaboratory comparisons are prerequisite for the declaration of CMCs. A large number of CMCs indicate that the NMI has participated in technologically complex interlaboratory comparisons and, therefore, has measurement capabilities in wide range of science and technology that facilitates their fundamental science and creates new technology and innovations, which in turn contributes to their economy and quality of life. Therefore, there is a need for both NPL and BARC to enhance their CMCs at the KCDB.

Photograph of a 3-dimensional model of metrology traceability pyramid at the NPLI campus showing the unbroken chain of measurements traceable to the SI units and the responsible organizations in India for dissemination of metrology traceability to manufacturers and end users (The pyramid was installed in 2016 based on the concepts of Dr. D. K. Aswal and Dr. V.N. Ojha)

In 2017, NPLI has launched certified reference materials under the trademarked as Bhartiya Nirdeshak Dravya, BND ® [ 21 ]. So far 72 BNDs have been launched related to high purity gold, coal, cement, water, hardness, petroleum products, etc. The indigenous development of BNDs has greatly benefited the relevant Indian industries in terms of ease of availability, low cost and savings of foreign exchange. NPL is a member of COMAR (Code d’Indexation des Matériaux de Référence) database [ 31 ], and therefore, the information on BNDs is also uploaded on COMAR database for the international community. As CRMs/BNDs are the standards used to ensure quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments, NPL needs to develop BNDs belonging to several fields, such as food, edible oils, minerals, heavy metals, pesticides, pharmaceuticals and textiles to ensure the quality and safety of the products.

The benefits of the metrology need to be transferred to the common citizen of a country, and this is often done by Legal metrology through appropriate law enforcement. The legal metrology ensures fair trade, specifically in the area of weights and measures, and has a main objective to assure citizens of correct measurements. The responsibilities of legal metrology system include (1) Type approval of measuring equipment, (2) Calibration and verification of measuring equipment, (3) Market surveillance of measuring equipment falling within the scope of regulation and (4) Controls of pre-packaged goods. Therefore, legal metrology is an integral part of technical regulation regime and has to comply with the requirements of Agreement on Technical Barriers to Trade (TBT Agreement) of World Trade Organization (WTO). In addition, legal metrology is needed for technical regulations to protect the health and safety of individuals, and the environment. In India, the legal metrology system is dealt by the Directorate of Legal Metrology, Department of Consumer Affairs, Government of India. Directorate of Legal Metrology is a member of International Organization of Legal Metrology (OIML) [ 32 ] and has adopted metric system and the International System of Units in the country. The Legal Metrology (National Standards) Rules, 2011, prescribe the standards of weights and measures, which are administered by the state governments. The Legal Metrology Act 2009 specifies the roles and responsibilities of Central and State Governments [ 33 ]. The Central Government deals with matters related to implementation of OIML recommendations, formulation of national policy and laws on weights and measures, technical regulations, training and setting up of precision laboratory. State and union territory governments have the responsibilities for the enforcement of the laws framed by the central government through their offices of the Controller of Legal Metrology (Weights & Measures). The legal metrology has a network of laboratories for weights and measures: five regional reference standard laboratories (RRSL) located at Ahmedabad, Bangalore, Bhubaneswar, Faridabad and Guwahati, which are set up by central government and all of them take measurement traceability from NPL, state-level secondary standards laboratories and district-level working standards laboratories. The nationwide network of the legal metrology laboratories is responsible for the calibration and testing of equipment of weights and measures, ensuring the measurement traceability to secondary standards, and awareness programmes for the consumers. Recently, LM has started a nationwide programme on dissemination of Indian Standard Time, traceable to NPLI, through its RRSLs. The dissemination IST traceable to NPLI will help the country in the field of cybersecurity, power sector, telecom sector, digital, aviation, etc.

2.2 Standardization in India

Internationally, the standards are known to offer economic benefits to industries in the following ways: (1) optimization of the internal operations of the industry that may result in reduction in operational time, increase in productivity, decrease in waste and reduction in procurement costs, (2) innovation in new processes and products as well as scaling up operations/manufacturing, (3) identification of new domestic and export markets. Therefore, standards not only assist in improving the quality of products in the country but also help in exporting them. In India, the Bureau of Indian Standards (BIS), working under the aegis of Ministry of Consumer Affairs, Food & Public Distribution, Government of India, is the standardization body [ 25 ]. BIS has the authority to exclusively publish the Indian Standards (IS). BIS is a member of several international organizations, i.e. International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organisation (SARSO). As shown in Table  4 , BIS develops IS through its 16 Division Councils having 344 Technical Committees, and many of them act as mirror committees at ISO and IEC. So far, BIS has developed > 20,000 standards in the diverse areas of manufacturing and service sectors. These technical standards are used to ensure desirable characteristics of products and services, including quality, safety, reliability, efficiency, environmental friendliness and interchangeability. The BIS also has several schemes of ensuring the conformity assessment including ISI certification for the certification of goods and articles, self-declaration scheme of conformity, hallmarking of gold jewellery and Foreign Manufacturers’ Certification Scheme (FMCS). Thus, adoption of the IS standards and conformity assessment schemes have significantly contributed to the industrial growth in the country. International standards are often adopted in case IS are not available. The most adopted ISO standards include: (1) Quality Management Systems (ISO 9001), (2) General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017), (3) Environmental Management Systems (ISO 14001), (4) Conformity assessment—General requirements for proficiency testing (ISO/IEC 17043:2010), (5) General requirements for the competence of reference material producers (ISO 17034:2016), (6) Information security management systems (ISO/IEC 27001:2005) and (7) Risk Management (ISO 31000:2009).

Though BIS is the standard body of India but several other ministries and departments develop standards for their area of specializations, usually referred as standard development organization (SDO), and few of these standards are adopted also by the BIS. These SDO’s are:

Agricultural & Processed food Products Export Development Authority (APEDA) [ 34 ]: An autonomous body under Department of Commerce for the development of standards and specifications for the exports of agriculture and food products.

Automotive Research Association of India (ARAI) [ 35 ]: An organization under Ministry of Heavy Industries & Public Enterprises for the standard formulations and certification of vehicles, type approval

Building Materials & Technology Promotion Council (BMTPC) [ 36 ]: An autonomous body under Ministry of Housing & Urban Affairs for the formulation of standards development for innovative and emerging building materials and technologies.

Bureau of Energy Efficiency (BEE) [ 37 ]: An autonomous body under the Ministry of Power for the formulation of energy efficiency standards for appliances

Directorate of Marketing and inspection (DMI) [ 38 ]: under Ministry of Agriculture & Farmers Welfare for the standardization, grading and quality control of agricultural and allied produce. AGMARK certification scheme is popular for domestic trade and export.

The Food Safety and Standards Authority of India (FSSAI) [ 39 ]: under the Indian Ministry of Health & Family Welfare (MoHFW) develops standards for food safety. FSSAI represents India in Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

Indian Roads Congress (IRC) [ 40 ]: Affiliated to Ministry of Road Transport and Highways for the development of standards for roads and highways planning and construction.

Ministry of AYUSH (Ayurveda, Yoga & naturopathy, Unani, Siddha and Homoeopathy) [ 41 ]: develops standards for pharmacopoeia and homoeopathy drugs

Quality Council of India (QCI) [ 24 ]: NABH develops standards for hospital accreditation and NABET develops standards for school accreditation.

Standardization Testing and Quality Certification (STQC) [ 42 ]: an organization under Ministry of Electronics & Information Technology (MeiTY) for quality assurance and conformity assessment in electronics, information security and software testing/certification.

Telecommunication Engineering Centre (TEC) [ 43 ]: under Department of Telecommunications (DOT) develops standards for telecom equipment and interoperability.

Telecommunications Standards Development Society, India (TSDSI) [ 44 ]: a society under Department of Telecommunications develops standards for telecommunication.

2.3 Accreditation in India

In India, the National Accreditation Board for Testing and Calibration Laboratories (NABL) [ 45 ] undertakes the assessment and accreditation of Testing and Calibration Laboratories, in accordance with the international standard ISO/IEC 17025 and ISO 15189. NABL is a signatory of Mutual Recognition Arrangement (MRA) of International Laboratory Accreditation Co-operation (ILAC) [ 46 ] and Asia Pacific Laboratory Accreditation Co-operation (APLAC) [ 47 ]. NABL does accreditation of conformity assessment bodies (CAB) including calibration and testing laboratories (ISO10025), proficiency testing provider (PTP) using ISO 17043 and reference material producers (RMP) using ISO 17034. The accreditation process has a responsibility to ensure that the CAB meets metrological traceability to SI units through the primary/national measurement standards of the NMI, as depicted in Fig.  4 . Thus, NABL accreditation of testing laboratories produces test results of internationally acceptable level of competence.

As shown in Table  5 , NABL so far has granted > 5600 accreditations to calibration laboratories, testing laboratories, medical laboratories, proficiency testing provider and reference material producers. The scope of NABL accreditation is (1) Calibration laboratories: electrotechnical, mechanical, fluid flow, thermal, optical, radiological and medical devices; (2) Testing laboratories: biological, chemical, electrical, electronics, fluid flow, mechanical, non-destructive testing (NDT), photometry, radiological, forensic, diagnostic radiology QA testing and software & IT system; (3) Medical laboratories: clinical biochemistry, clinical pathology, haematology & immunohematology, microbiology & infectious disease serology, histopathology, cytopathology, flow cytometry, genetics, nuclear medicine (in vitro tests only); (4) Reference material producers: chemical composition, biological & clinical properties, physical properties, engineering properties and miscellaneous properties. During the period of COVID pandemic, NABL has accredited 142 medical testing laboratories across the country for RT-PCR RNA Virus/COVID-19, which has greatly benefited the country in terms of conducting these very important tests.

NABL accreditation has advantage in terms of enhance business as major government ministries and regulators (e.g. BIS, legal metrology, Directorate General for Foreign Trade, Ministry of Drinking Water and Sanitation, Ministry of Health & Family Welfare, Food Safety and Standards Authority of India, etc.) have mandated NABL accreditation for all laboratories performing conformity assessment for their schemes. Similarly, for RMPs, the NABL accreditation has an advantage that they obtain metrological traceability from the NPL and, therefore, can produce and market their certified reference materials under the BND ® , which are reached to international community through COMAR database.

The accreditation of CABs not requiring the metrology traceability is conducted by other boards of QCI, namely National Accreditation Board for Certification Bodies (NABCB) [ 48 ], National Accreditation Board for Hospitals and Healthcare Providers (NABH) [ 49 ] and National Accreditation Board for Education & Training (NABET) [ 50 ]. The NABCB operates under the framework of ISO 17011 and accredits CABs for inspection bodies (e.g. BIS for product certification), management systems for food safety, medical devices, environmental monitoring, health safety, occupational hazards, information security, energy, etc. Other boards, namely NABET for the management of education and training and NABH for the management of hospitals, function under self-regulation.

3 Quality Infrastructure for India’s Comprehensive Growth

Figure  5 shows the photograph of the “graffiti wall” at NPL campus that was painted on 20 May 2019 to mark the worldwide implementation of redefinition of SI units based on the fundamental constants. It is evident that the accurate measurements that get implemented though rigorous conformity assessment contribute to the overall growth of the country through discoveries and innovations in the areas of science, development of high end technologies, sustainable green energy, environment free from pollution, affordable healthcare system, enhanced international trade, strong cybersecurity, and formulation regulation and policies that benefits the country. Conformity assessment ensures manufacturers that their products and services are in accordance with the desired specifications of national/international standards, ensuring quality, reliability, efficiency, safety, effectiveness, interoperability and environmental sustainability. A certification mark based on conformity assessment provides consumer a confidence that he/she has got the products or services of the desired specification. Such products can be exported without facing any hurdle to technical barrier to trade.

“Graffiti Wall” painted at NPL campus to mark the worldwide implementation of redefinition of SI units based on the fundamental constants on May 20, 2019, and the implication of accurate measurements traceable to SI units (Conceptualized by Dr. D.K. Aswal)

Table  6 summarizes a partial list of authorities of Government of India related to regulators, policies, science and technology, forensic, strategic sectors, etc. All of them need conformity assessments to meet their targets. The regulators demand mandatory conformity assessment in the regulation that allows them to enforce legislation pertaining to national health, safety, food, radiation safety, finance, energy, environment, etc. The regulators, through appropriate legal and regulatory notifications in their domain, ensure that the interests of the public are protected. In order to implement and enforce their regulations, they require the conformity assessment of technical, safety and quality standards. For example, the Central Pollution Control Board (CPCB) has the major responsibility of prevention, control or abatement of water and air pollution across the country. To implement these, CPCB requires a robust quality infrastructure to ensure that the measured data on air and water pollutions are trustworthy. Currently, the air quality and emission monitoring equipment in the country are calibrated and certified by foreign certifying agencies as the country did not have any certification agencies having the primary measurement standards. Recently, the Government of India has Gazette Notified the NPL as the certifying agency for the air quality and industrial emission monitoring equipment in the country as per the Indian standards, which not only will bring down the costs but also improve the measurement accuracies. It is very essential for the regulators to be aware of the metrological capabilities of NPL in their respective area of technical confirmatory assessments, otherwise the possibility of introducing unnecessary regulations or technical requirements may exist, which can become difficult to comply. In addition, if the regulations are substantially different to those of other countries, then they can lead to technical barriers to trade. Therefore, robust conformity assessment services, harmonized internationally, are essential for facilitation of smooth import/export services. Poor conformity assessment services can allow entry of the imports which are substandard and toxic in nature. One can find several news reports stating the import of poor quality [ 51 , 52 , 53 , 54 , 55 , 56 ], e.g. steel, toys, tyres, light emitting diodes (LEDs), electronic items, solar panels, food items, etc. Similarly, inferior conformity assessments procedures can lead to technical barriers to trade, causing hurdles to the cross-border trade. The exporters are asked for multiple testing and/or certification of products, and in many cases, the products are rejected at the border causing them a huge monitory loss. There are several cases of the rejection of Indian export at the border of foreign country due to not meeting the standards [ 57 , 58 , 59 ]. In both the cases, i.e. import of poor-quality products and rejection of Indian exports, the nation undergoes a huge economic loss. In the case of poor-quality imports having toxicity, not only their disposal becomes economic burden but also are the sources for health hazards.

A strong quality infrastructure is also needed for the strengthening of Micro, Small and Medium Enterprises (MSME) [ 60 ] sector as well as the Make in India programme initiated by Department of Industrial Policy and Promotion (DIPP) [ 61 ]. MSMEs are spread across the country and produce a range of products that cater the needs of local as well as global market. According to a 2013 report, MSME contributed 8% of the GDP, created 45% of the manufacturing output and contributed to the 40% of the exports [ 62 ]. In addition, MSMEs provide large employment opportunities (second after the agriculture sector) and act as the nucleation for entrepreneurship and innovation. However, it has been observed that contributions of MSMEs are declining gradually in GDP, manufacturing output and exports. The difficulties of MSMEs have further escalated by the outbreak of the COVID-19 pandemic as the nation went for a complete lockdown for months together. After the relaxation in the lockdown, majority of the workers migrated to their native villages, and this would create acute manpower shortage to the MSMEs. Therefore, to revive the MSMEs in coming days, new government policies should be formulated in which the concept of quality infrastructure must be built to ensure the production of internationally competitive products. Moreover, the success of Make in India, which is an excellent programme that encourages foreign companies to manufacture their products in India and aims at creating new job opportunities, requires an established quality infrastructure at par with international standard. A strong QI assists in the attraction of foreign investment as it allows innovation for the development products (e.g. analytical instruments, medical, defence, aerospace, etc.) compatible to Indian environmental conditions as well as their conformity assessment as per the national/international standards.

4 Concluding Remarks

All the three pillars of quality infrastructure (i.e. metrology, standards and accreditation) are well placed in India. However, the strengthening of quality infrastructure would require (1) enhancing the apex capabilities by NPL/BARC/LM, all the boards under QCI (including NABL) and BIS, and (2) a better synergy amongst these three pillars. The synergized QI should establish a collaboration with four helices (government, university/S&T institutions, civil society & media and enterprises), for enhancing the growth of economy and quality of life. To strengthen the quality infrastructure of the country, the following suggestions are made.

The calibration and measurement capabilities (CMCs) of NPL reported at KCDB of BIPM need to be expanded for the areas belonging to energy, environment monitoring, biomedical, quantum standards, Indian Standard Time (IST), etc. Of course, the setting of new primary/national standards requires high capital investment, trained manpower and international inter-comparison. NPL has taken up setting up of primary standards in the areas of air quality and emission monitoring as well as in the solar cell efficiency. It is creditable that NPL has trademarked the certified reference materials as Bhartiya Nirdeshak Dravya (BND ® ) and has already developed a national mechanism for the production of BNDs in collaboration with Indian industries producing the reference materials in the fields of petroleum, cement, water, soil, metals and minerals, food, etc. These BNDs are essential to support several thousands of laboratories across the country for generating the accurate and reliable test results.

NABL has accredited > 5600 laboratories in different fields but has a long way to go as several thousands of the laboratories still need to be accredited. In order to ensure the metrological traceability to SI units, the NABL should categorize calibration laboratories into two tiers. The Tier 1 calibration laboratories (equivalent to those of regional reference laboratories of Legal Metrology) get the measurement traceability directly from the NPL and, therefore, will have lower measurement uncertainty. Tier 1 status can be assigned to laboratories under different ministries and/or private laboratories having the desired infrastructure and assessed by NPL. The Tier 2 calibration laboratories would get the measurement traceability from Tier 1 and disseminate them to testing laboratories across the country.

BIS should also develop new Indian Standards that benefit the MSMEs. Moreover, testing laboratories used for conformity assessment should ensure the measurement traceability to the SI units.

To sum up, a strong QI is essential for the “Made in India” programme that becomes almost essential for the nation in view of the COVID pandemic, whereby the fundamental shifts in the national policies are expected. To revive the national economy and creation of employment, MSMEs need to be encouraged for the development of products as per the international standards by ensuring that they utilize the existing quality infrastructure of the country.

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Aswal, D.K. Quality Infrastructure of India and Its Importance for Inclusive National Growth. MAPAN 35 , 139–150 (2020). https://doi.org/10.1007/s12647-020-00376-3

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Received : 10 May 2020

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Issue Date : June 2020

DOI : https://doi.org/10.1007/s12647-020-00376-3

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How India is dealing with COVID-19 pandemic

Aritra ghosh.

a Environment and Sustainability Institute, University of Exeter, Penryn Campus, Cornwall, TR10 9FE, UK

Srijita Nundy

b School of Advanced Materials Science and Engineering, Sungkyunkwan University, Suwon, 16419, Republic of Korea

Tapas K. Mallick

India, which has the second-largest population in the world is suffering severely from COVID-19 disease. By May 18th, India investigated ∼1 lakh (0.1million) infected cases from COVID-19, and as of 11th July the cases equalled 8 lakhs. Social distancing and lockdown rules were employed in India, which however had an additional impact on the economy, human living, and environment. Where a negative impact was observed for the economy and human life, the environment got a positive one. How India dealt and can potentially deal with these three factors during and post COVID-19 situation has been discussed here.

Graphical abstract

Graphical abstract showing World-wide distribution of COVID-19 with symptoms and precautions to be taken against coronavirus infection and India.

• • COVID-19 drastically hits the Indian economy.
• • Disease and starvation both concomitantly influenced the death of Indian.
• • Environment is the only sector that got a positive impact from COVID-19.

1. Introduction

Coronaviruses are enveloped RNA viruses, ranging from 60 nm to 140 nm in diameter with a crown-like appearance, found in mammals particularly in humans and birds. Coronaviruses are known to have mutated and recombined behaviour causing respiratory, enteric, hepatic, and neurologic diseases. Coronavirus has a total of seven strains which include HKU1, NL63, 229E and OC43, SARS-CoV, MERS-CoV and SARS-CoV-19 (COVID-19 being the latest), out of which first four had a mild impact on infested human with mild respiratory disease [ 1 , 2 ], whereas the other three caused a fatal impact on humankind. Previously in 2002–03, more than 8000 people suffered and 774 died due to SARS. In 2012, attributable to MERS-CoV, 2494 persons were infected and over 858 people lost their lives worldwide [ 3 , 4 ] and currently COVID-19 triggered 5,56,335 deaths infecting 216 countries worldwide (as of 11 th July 2020). The genomic sequence of SARS-CoV-2 is different since it was first reported because of their mutation and recombination property.

The first outbreak of COVID-19 occurred in Wuhan, Hubei Province in early Dec 2019 where several patients with viral pneumonia were found to be epidemiologically associated with the Huanan seafood market in Wuhan. This market is famous for sell of wildlife animals and several non-aquatic animals such as birds and rabbits were also on sale before the outbreak. On 30 th January 2020, the World Health Organization (WHO) declared an outbreak, a Public Health Emergency of International Concern (PHEIC) and on Feb 2020, WHO officially named this outbreak of the disease associated with the coronavirus as COVID-19 where CO-Corona, VI-Virus D- Disease, and 19–2019 is the year it primarily occurred. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the root cause behind COVID-19 disease. SARS-CoV-2 has a 79.6% sequence match to SARS-CoV and is 96% identical to a bat-derived Severe Acute Respiratory Syndrome (SARS)-like CoronaVirus [ 5 , 6 ]. Current assessments indicated that COVID-19 has a median incubation period of 3 days (range 0–24 days), with potential asymptomatic transmission [ 7 ].

It took 67 days (∼7th march) to infect 1 lakh people from COVID-19, an additional 12 days (∼19th March) to infiltrate further 1 lakh and with a third invasion taking only 4 days (∼23rd March), indicating SARS-CoV-2 to be a highly transmissive type virus. By 30th March, the number of confirmed cases has shown an exponential spike to 7.25 lakhs across the globe. COVID-19 outbreak is the sixth PHEIC (public health emergency of international concern) following H1N1 (2009), polio (2014), Ebola (2014 in West Africa), Zika (2016), and Ebola (2019 in the Democratic Republic of Congo) [ 3 ]. India which is the second-largest population in the world having a rural-based and growing-urban developing economy is also suffering severely from this COVID-19. India reached its first 1 lakh infection on18 th May 2020, and as of 11th of July crossed 8.5 lakhs.

COVID-19 not only killed people through virus incursion but also due to economic and mental collapse, where developing countries suffered from unemployment and hunger. India enforced 68 days of four-phased-lockdown starting from 24th March ∼31st May to deal with COVID-19. However, in this current scenario of the COVID-19 period, what remains unanswered is whether the virus or the hunger is prepotent in India. Thus, how India is equipped to deal with, coping with the current situation, adverse effects on the economy, human living, and environment along with various approaches undertaken to overcome this pandemic is the topic of discussion in this work.

2. Indian scenario for COVID-19

2.1. how coronavirus spread to and in india.

In the beginning, coronavirus cases in India happened due to the abroad connection rather than transmission within the country. The first three infection cases occurred on 30th January and 3rd February in Kerala as they returned from Wuhan China [ 8 ]. Within a month later on 3rd March, two more cases were reported where one patient had a travel history from Italy while the other in Hyderabad visited Dubai. On the very same day, few other cases were observed in Jaipur [ 9 ]. To control this spread, the Ministry of Health and Family Welfare (MoHFW) issued travel advisory restrictions which were similar to the previous pandemics such as SARS, Ebola, and bubonic plague, including the imposition of self-quarantine rules for 14 days to all international travellers entering the country. Additionally, travel visas were restricted until 15th April for other countries [ 10 ] and on 16 th March 2020, MoHFW proposed various interventions such as social distancing of ≤ 1 m [ 11 ] to avoid/decrease the rate and extent of disease transmission in a community which eventually leads to decreasing in a spread, morbidity, and mortality due to the disease.

On 22nd March, Prime Minister Narendra Modi encouraged people to follow 14 h of Janata curfew in India [ 12 ]. On 24th March first phase of 21 days lockdown started in India [ 13 ]. Due to this lock down, mobility in grocery and pharmacy, recreation and retail, transit to station visits to parks, and workplaces reduced by 64.2%, −70.51%, −65.6%, −46.17 and −60.03% respectively [ 14 ]. Due to the growing number of infestation from COVID-19, on 14th April [ 15 ], Indian government declared an extended 2nd phase lockdown till 3rd May which was further lengthened till 17th May and later imposed till 31st May [ 14 ]. To make the lockdown and social distancing effective, India also levied the quarantine law under the Epidemic Disease Act, 1897. This 123-year-old legislation allows a state/country to inspect people traveling by railways, ships (air travel was not an option at that time when this law was created), and segregate suspects in hospitals, under temporary accommodations, or otherwise to prevent the spread of dangerous pandemic disease [ 16 ]. However, this is very trivial compared to North Korea's law where the military was imposed to enforce a quarantine [ 17 , 18 ].

Looking at the current trend in India, after the first confirmed case been reported on 30th January, the total number of confirmed patients reached 107 by 15th March, and since then, the number of positive cases is incessantly increasing. Within 15 days (15th to 30th March), confirmed cases of COVID-19 in India multiplied by 10 times. As of 30th March, India crossed more than 1071 cases with 29 deaths. Indian Council of Medical Research (ICMR) projected that India can reduce the cases by 62% if social distancing and proposed quarantine interventions are effectively executed. Another research revealed that India may corroborate nearly 13 lakh cases by mid-May if the spread of the virus is not contained, which however can be reduced with increased testing, obeying stringent measures, and implementing restrictions [ 19 ]. Nevertheless, in India COVID-19 cases reached 1,01,139 by 18th May. Initially, it was considered that India was dealing well with a low number of positive cases from COVID-19 because of the constricted transmission during a lockdown and social distancing [ 20 ], however, at the end of all lockdown phases, India experienced a total of 1,90,648 confirmed case including 5407 deaths due to this disease [ 21 ]. Cities like Ahmedabad, Bengaluru, Bhopal, Chennai, Delhi, Hyderabad, Indore, Jaipur, and Kolkata were identified as the COVID-19 hotspots with four major metropolitan cities accounted for nearly 40% of the COVID-19 cases in India [ 22 ]. It was speculated that the disease speeded in a higher number among children age ≤10 years and elder people diagnosed with other health issues [ 23 ]. Even though several researchers are now engaged to predict and estimate the COVID-19 cases and end of this pandemic [ [24] , [25] , [26] ], India is experiencing exponential growth in the number of COVID-19 cases. As of 11 th July 2020, India is the 3rd most COVID-19 infected country with currently 2,922,58 active cases, along with 5,34,620 patients being cured and discharged (recovery rate of 60.86%) followed by the demise of 22,674 COVID-19 infected patients. Fig. 1 shows the total infected cumulative cases in India till 11 th July 2020. The active, cured/discharged, deaths and total confirmed cases have been tabulated in Table 1 .

Cumulative total COVID-19 cases in India till 11th July 2020 [ 27 ].

Table 1

Total Covid-19 infections in different Indian states and Union Territories as of 1 st July 2020 [ 28 ].

2.2. Approaches and measure

The clinical features of COVID-19 include fever (not in all), breathing difficulty, cough, lethargy, headache, myalgia, sore throat, and conjunctivitis (also in some cases). Hence, distinguishing this disease from other respiratory infections is relentlessly challenging [ 29 , 30 ]. Presently, no successful antiviral treatment or vaccine is available for COVID-19. Patients with severe acute respiratory infection, respiratory distress, hypoxemia, or shock demands immediate oxygen therapy. As a protective measure against COVID-19 transmission, WHO instructed certain practices like through and regular washing of hands using an alcohol-based hand sanitizer or soap and water, whilst outside avoid touching eyes, nose and mouth, circumvent distance traveling or crowd gathering and, encouraged breastfeeding babies to enhance immunity.

The Indian government (central and state level) is working intensely to minimalize the number of cases and consequences daily and is taking all necessary steps to combat the challenges and threat posed by this growing invisible pandemic war involving public, medical association, nurses, NGOs, police forces, including paramilitary. Earnest efforts of all the frontline workers especially medical doctors, nurses, healthcare staff, sanitation workers, police personnel, volunteers, and active support and obedience of people of India has been the only possible reason owing to the control and treatment of pandemic. Additionally, to treat/stop this COVID-19 infection there is a pressing need to handle this battle at a scientifically advanced level. Indian government got critically involved with the COVID-19 outbreak and started scanning every person. Currently, the testing facility includes Real-time PCR test, Point-of-Care molecular diagnostic assays, rapid antibody test (suitable for surveillance as the results come after 7–10 days of the pandemic infection) and point of care rapid antigen detection test for early detection of COVID-19 [ [31] , [32] , [33] , [34] , [35] , [36] ]. Starting from less than 100 tests per day, on 18th May India reached a 2,00,000 test landmark in its fight against COVID-19. This 2000 fold increase became achievable with cooperation from airlines, railways, medical colleges, ministries, postal services, research institutions, and testing laboratories. In January 2020, India had a single laboratory testing for COVID-19, at the Indian Council of Medical Research's National Institute of Virology, Pune and on 20th May 555 laboratories were set up across the country and currently, there are 1105 operational labs (788 govt labs and 317 private labs) to deal with COVID-19 cases [ 37 ]. Cumulatively 1,15,87,153 samples are tested so far and 2,80,151 as on 11 th July 2020 [ 38 ]. Additionally, over 2.02 crore N95 masks and 1.18 crore PPE kits are distributed in Indian states and UTs for free since 1st April. India launched ‘ArogyaSetu’ mobile application for tracking the movements.

With no vaccine or antiviral drug available against SARS-CoV-2, Hydroxychloroquine (HCQ) is being advised as chemoprophylaxis drug for asymptomatic healthcare personnel handling COVID-19 cases, frontline workers, and asymptomatic contacts of the confirmed cases while hydroxychloroquine-azithromycin combination is recommended for patients with serious sickness [ 39 ]. However, Indian Heart Rhythm Society recommends the use of HCQ as per the ICMR task force recommendations and strongly discourages its use for the general public without medical supervision and prescription [ 40 ]. Also, ICMR advised to conduct ECG palpitations, chest pain syncope) during the course of prophylaxis [ 41 ]. More than 6.12 crore HCQ tablets have been provided to states/UTs. Although the development and clinical trial of drugs is an ongoing process, the MoHFW, India stated that ≥1.5–2 years can be required for the development of a vaccine. Recently, Bharat Biotech International Ltd. in collaboration with ICMR – National Institute of Virology, Pune developed one COVID-19 vaccine. To investigate it more in-depth scrutiny, phase 1 and 2 clinical trials are permitted by the Drugs Controller General of India [ 42 ]. Even though the clinical trials of plasma therapy have been commenced by ICMR [ 43 ], the director general of ICMR advised that it’s too early to give green signals for the success of this treatment as the number of patients involved in this treatment is still comparably insignificant. A drug can only be considered gold standard if the trial when conducted randomly shows a significant positive result from half of the tested patients treated using the experimental drug over the other half, not treated with the experimental drug [ 44 ].

Ministry of AYUSH made recommendations based on Ayurvedic literature and scientific publications for preventive measures and boosting immunity with special references to respiratory health. Medicinal plants such as Tinospora cordifolia (for chronic fever), Andrographis paniculate (for fever and cold), Cydonia oblonga Zizyphus jujube Cordia myxa (Antioxidant for immune-modulatory, anti-allergic, smooth muscle relaxant and anti-influenza activity), Arsenicum album 30 (for Effective against SARS-CoV-2, immune-modulator), Agastya Haritaki (Upper respiratory infections), Anuthaila, Adathodai Manapagu, Bryonia alba, Rhus toxico dendron, Atropa belladonna, Bignonia sempervirens, and Eupatorium perfoliatum because of their antiviral, anti-inflammatory and antioxidant properties, was considered and recommended to be favourable for the COVID-19 treatment and boosting immunity [ 45 ]. Ministry of AYUSH advised few health care measures and self-care guidelines for enhancing immunity (to fight against COVID-19) with ayurvedic procedures, like drinking warm water throughout the day, regular practice of Yogasana, Pranayama and meditation for at least 30 min, intake of spices like Haldi (Turmeric), Jeera (Cumin), Dhaniya (Coriander) and Lahsun (Garlic), drinking herbal tea/decoction (Kadha) made from Tulsi (Basil), Dalchini (Cinnamon), Kalimirch (Black pepper), Shunthi (Dry Ginger) and Munakka (Raisin) - once or twice a day, application of sesame/oil/coconut oil in the nostrils every morning/evening, oil pulling therapy, intake of chavanprash (10 gm/day), Golden Milk- Half teaspoon Haldi (turmeric) powder in 150 ml hot milk - once or twice a day, etc. Additionally, steam inhalation with fresh pudina, clove powder with honey can be taken to fight against dry cough/sore throat [ 46 ].

2.3. Indian economy due to COVID-19 (negative)

Indian economy, a developing market has already been in a crisis phase since last year when its economy reduced to 4.9% (in 2019) being the least since 2013. The primary reason for this downfall was Demonetisation in November 2016 which made 86% of the money in the economy unusable overnight [ 47 ]. This created a great negative impact on the growth of the industry e.g. demand for vehicles sale in India was low last year particularly the motorcycle which is a very attractive mode of transportation in rural India. Tourism is one of the most powerful sectors worldwide and India is no different. India ranked 34th among the 140 economies over the world in 2019. In 2018–2019 more than 10 million foreign tourists visited India and contributed an enormous amount into the Indian economy [ 48 , 49 ].

The day Prime Minister Narendra Modi first declared the 21 days of lockdown he also warned that this lockdown will have a negative economic impact and we have to pay the price for it. The All India Association of Industries (AIAI) estimated loss for Indian economy slated to be $640 million with growth slated to be between 5 and 5.6% till 2022 [ 50 , 51 ]. After the first lockdown phase, within 7 days, electricity demand reduced to 30%, traffic in port became 5% less, oil demand lessened by 70%, and Indian rail activity was below 36% compared to last year [ 47 ]. The unemployment rate increased to 19% after a month of lockdown and overall unemployment was 26% across India by 24th April. Hence, the lockdown has a havoc impact on small, medium, and large enterprises of the country, which led to no job and economic downturn condition [ 52 ].

Swiggy and Zomato, two key food delivery players already started laying off the employees [ 53 ]. Previously they both used to handle over a million orders a day across more than 300 cities. The tourism sector also expected to have 70% job losses [ 54 ]. Likewise, India has an economy where a large section of people depends on the daily wages e.g. autorickshaw drivers, carpenters, delivery boys, domestic laborers, scrap or waste collectors, tea girls, vegetable vendors, and waiters. Unaware of the end to this pandemic COVID-19 and restricted lockdown scenarios, returning to its pre-lockdown stage will take time. For 2020, the tourism industry and air travel are expected to suffer greatly, and India's GDP growth is expected to decline ∼2.5% from 5.3%.

However, complete lockdown in China can open a new place for the Indian economy as senior industrialists from India are hoping that India can be the new manufacturing hub for the world [ 55 ] nonetheless India needs to improve on the raw material sector otherwise this fact will not be a reality. India can take advantage particularly in the pharma industry, where India depends on 70% pharmaceutical ingredients [ 56 ]. Also, oil price reduced a lot from $68/barrel (on 3rd Jan) to $28.2/barrel (20th March) and India should take the advantages to buy them and store for future use as currently, the demand is low [ 57 ]. Even though there were huge economic losses due to lockdown but the government had no choice [ 58 ]. To stir up the economy Indian government is spending a $266 billion package which can improve 4% of the GDP [ 59 ]. These are a few measures but still not enough to reach India's previous growth of GDP.

2.4. Indian lifestyle, human life due to COVID-19 (negative)

Life in India includes urban and rural and they both got impacted by COVID-19. The disease in transmission was previously epicentre in all the major metro and capital cities of Indian states. However, both people from rural and urban sectors face a real traumatized situation. COVID-19 has created a negative impact on human life also. First to tame the COVID- 19 transmission, locked down and social distancing measure was taken. From 24th March, 1.3 billion people were in lockdown situations in India. Social distancing, advised in India, is difficult to follow for the urban poor who lives in slums or closed and small places. Mumbai (18.93° N, 72.83° E), the capital of Maharashtra state also known as the business centre of India is renowned for its large number of slums. It is estimated that 9 million people live in Mumbai slums where houses are fairly 10 ft by 10 ft and under such conditions obeying social distancing is a questionable issue [ 60 ]. In return, it can also be seen that in India number of COVID-19 cases are maximum in Maharashtra (37,136 cases by 20th May; 75995 cases by 1st July) and particularly high in the city [ 28 ]. In reality, social distancing is an oxymoron in such India's scenario [ 61 ].

Additionally, sudden lockdown enforcement on 24 th March 2020, forced millions of migrant workers to undergo an uncertain future without family, food, and job. Usually, more than 50 million people migrated from Assam, Bihar, Madhya Pradesh, Odisha, Punjab, Rajasthan, Uttar Pradesh, and West Bengal to Maharashtra and Delhi for work. Due to lockdown, these people were forced to move out of their cities and return to their homes in the countryside [ 62 ]. In the absence of transport facilities, workers with infants, pregnant women, and the elderly were forced to walk on foot [ 63 ]. Hence, India experienced the second-largest reverse mass in its history after the Partition of India in 1947. Prominent psychosocial issues are expected among migrants for pandemic COVID-19 and lockdown [ 64 , 64 , 65 ].

Additional directives for workplaces like work from home (WfH) were advised in India which is however suitable only for urban upper- and middle-class people and is challenging for the rural agriculture-based population. Also, India still lacks places with the facility of computers and the internet, and hence these WfH is a challenge [ 66 ]. The Indian IT industry with primarily call-centres and knowledge process outsourcing were not ready for the lockdown and WfH situation [ 67 ]. However, a 60% hike of Wi-Fi network equipment, e.g. routers and mobile hotspot dongles demand were observed in India during the COVID-19 lockdown and WfH scenario causing a little boost up to the telecom industry.

Parallelly, the education system is also currently at a halt due to COVID-19 in India. During this lockdown period, the educational institutions were closed which hampered the overall teaching-learning process and education system due to the unavailability of online and computer systems among all the students in rural India owing to the disparity of economic condition. However, accessibility of android mobile and 4G connection, mobile phones in the urban sector of India [ 68 ], resulted in running schools online, where rural sections remained deprived of education.

Medical facilities faced critical time in India. Under the normal scenario, available beds per 10,000 people were 3.2 for rural and 11.9 for urban [ 69 , 70 ] which had to increase to accommodate COVID-19 patients. Because of the busy schedule for COVID-19 cases, some disruption and discrepancies were observed for the other treatments. Little difficulties occurred for running the children vaccination program for tuberculosis, meningitis, pneumonia, whooping cough, tetanus, hepatitis B, and diphtheria [ 71 ]. For adults, disruption of kidney dialysis, chemotherapy services were also noticed [ 72 , 73 ]. Tuberculosis (TB) still possesses the highest level of burden in India which generally occurs due to malnutrition associated with poverty. Lockdown cases had a great increasing impact on the TB cases while they are also vulnerable to COVID-19 infection [ 74 ]. Nevertheless, to manage the COVID-19 cases, colleges, hotels, railway train coaches, were converted into quarantine facilities while stadiums were converted into isolation wards.

Isolation, fear, uncertainty, economic turmoil is namely a few issues that can greatly cause psychological distress among humans due to COVID-19 [ 75 ]. In India poverty, starvation, hunger is still an issue that will be escalated due to COVID-19. Mass unemployment is likely to create frustration and drive people to chronic stress, anxiety, depression, alcohol dependence, and self-harm. In the 2008 economic crisis, 10,000 “economic suicides” cases were reported across the US, Canada, and Europe, due to the financial crisis. For a country with the highest number of poor and malnourished, and individuals with depression and anxiety, India reported 1,34,516 suicides in 2018. Reportedly on 12 th Feb 2020, a 50-year-old man diagnosed with a viral illness had a constant fear of getting infected by COVID-19 and this led him to commit suicide [ 76 ]. From 19th March to 2nd May, 338 deaths were reported due to lockdown which includes suicides arising due to fear from corona, self-isolation, starvation, and financial distress [ 77 , 78 ]. Further, suicide cases were registered for the reason of banning alcohol [ 79 ] during the lockdown period [ 80 ]. Impact of lockdown on orthopaedic surgeons in India (611 orthopaedic surgeons from 140 cities in India participated in this survey) was conducted and it was found that 22.5% of surgeons faced stressed while 40.5% faced mild stress [ 81 ]. Further staying at home during the lockdown, caused poor physical activity and unhealthy food habits which in turn generates weight gain, diabetes and increases the risk of developing cardiovascular disease [ 82 , 82 , 83 , 83 ].

Comparably some positive health issues were also observed. During the analysis performed using 100 registered patients from MV Hospital for Diabetes, Diabetes Research Centre, Chennai, it was observed that among 92% of the participants who have Type 2 diabetes, 80% of patients followed a routine lifestyle and controlled diet during the lockdown period while 40% of the participants were anxious for COVID-19 infection [ 84 ]. Another probably positive side of the lockdown is people are now staying home and have time for family, which is only legitimate with economically stable families [ 85 ].

2.5. Indian overall environment scenario (Positive)

Air pollution in India is severe and has an adverse impact on human health causing more than 3,50,000 new cases of childhood asthma and 16,000 premature death every year [ 86 ]. This is due to the presence of NO 2 and particulate matter in the range of 2.5–10 μm diameter in the air generated from fossil fuel burning and primarily from the transport sector in India. Due to lockdown, air flight, and every possible mode of transportation, along with industries, which are the primary sources of air pollution were ceased. Hence an improved air quality was visible [ 87 , 87 , 88 , 88 ].

Probably environment is the only sector that got an immensely positive impact form this COVID-19 scenario [ 89 ]. International energy agency reported that global coal use was 8% lower in the first quarter in 2020.

This Fig. 2 shows the Copernicus Sentinel-5P satellite of India before and after lock-down and also the previous year. A considerable amount of reduction in nitrogen dioxide concentrations reduction was observed. Delhi and Mumbai had a 40–50% NO 2 emission reduction compared to the previous year. The electricity consumption level declined by up to 9.2% while vital industrial states Tamil Nadu and Maharashtra faced a 5% reduction in electricity consumption during the end of March 2020. Several cities in Gujarat (Ahmedabad, Rajkot, Vadodara, and Surat) are equipped with power plants, transportation, outdoor waste incineration, construction, and brick kilns resulting poor air quality, also recorded a 30% power consumption decline due to lock-down [ 90 , 91 ] along with a 34–75% reduction of particulate matter, SO2, NO2, and CO, was between which enhanced the air quality index [ 92 ]. In India, coal-fired power generation was 15% less in March and 30% less in April [ 93 ]. Except for two units at Dadri Power Plant, all other coal-based power plants within a 300 km radius of Delhi (Haryana, Punjab, and Uttar Pradesh) were shut down due to low demand. Because of the locked down in March, total fossil fuel consumption reduced to 18% compared to last year's March [ 86 ]. The first phase-locked down showed that air quality particularly the reduction of NO 2 . Delhi the capital of India which experienced air quality index up to 900, now air quality index below 20, because of the absence of 11 million registered cars from the road. The reduction of PM 2.5 was alarming in Delhi [ 94 ]. Dwarka river basin of Eastern India is highly polluted because of stone quarrying and crushing. During the lockdown period, it was found that the maximum PM10 concentration reduced from 278 μg/m3 (pre lockdown) to 50–60 μg/m3 after 18 days of the lockdown in that area. An improvement in the quality of the Yamuna river (concentrations of pH, EC, dissolved oxygen, biological oxygen demand, and chemical oxygen demand reduced by 1–10%, 33–66%, 51%, 45–90%, and 33–82% respectively) was also observed due to the shutting down of the Delhi-NCR industries, which mostly discharged the wastes and the toxic effluents into the river (vice-chairman of Delhi Jal Board Raghav Chadha. S) [ 95 ]. The surface temperature was reduced by 3–5 °C while the noise level dropped to <65dBA from above 85dBA [ 96 ]. Further, water quality of river Ganga was also improved during lockdown conditions [ 97 ]. Critically endangered, South Asian River Ganges Dolphins also were spotted back in the Ganga river after 30 years. Tens of thousands of flamingos have gathered in the city of Navi Mumbai. The birds normally migrate to the area every year, but residents have reported that this year they have seen a massive increase in their numbers. The Uttarakhand Pollution Control Board also reported that the Water from Har-ki-Pauri in Haridwar is 'fit for drinking after chlorination', which is due to the absence of industrial drainage waste into the river [ 98 ].

Nitrogen dioxide emission before and after a lockdown in India [ 90 ].

3. Discussion

India is still struggling and not sure when the peak will come. Researchers are involved to create theories and forecasting models [ 99 , 100 ]. It is certain that during the first phase of lockdown COVID-19 infected cases were under controlled [ 101 ]. Because of the population and population density lockdown was needed [ 102 ]. It should be mentioned that the People of India followed the Government prescribed rules and were knowledgeable about the drastic impact of COVID-19 hence tried to abide by the regulations [ 103 , 104 ]. Lockdown reduced the transmission and several countries got success from it. By the first week of March 2020, several countries like China, Italy, Spain, and Australia were fighting with the COVID-19 pandemic by taking strict measures like nationwide lockdown or by cordoning off the areas that were suspected of having risks of community spread [ 105 ].

India is currently facing dreadful impact from COVID-19 and due to its combined fear and lockdown scenario, a majority of Indians will face unemployment which will trigger them towards hunger issues, poverty, and mental illness. Even though it is still not clear whether coronavirus or hunger is prepotent to which Indians are exposed every day. So far it is clear that COVID-19 created a mixed impact on society including the economy, lifestyle, and environment. It is hard to imagine that the traumatic experiences of the COVID-19 pandemic will be forgotten quickly or disappear entirely over time. Lack of trust may grow between the citizen and the institution body. There is no space to celebrate or follow any model as there is a chance of the second wave.

There is a probable chance to have the second wave of COVID-19 and if that occurs India will suffer in huge from every aspect [ 106 ]. Previously in 2009, HIN1 influenzas flu and 1918 influenza pandemic both had the second wave, and that was more drastic than the first one [ 107 ]. In another study, it was predicted that India may see 2.87 lakh cases per day by the end of 2021 [ 108 ].

4. Conclusion

Thus, how India is the topic of discussion in this work. In this work, how India is equipped to deal with an increasing number of COVID-19 cases, coping with the current situation such as adverse effects on the economy, human living, and environment during the COVID-19 lockdown period along with various approaches undertaken to overcome this pandemic is discussed. Three segments were emphasized here: the economy, human life, and environment. It is evident that while the first two have a negative impact due to corona, the environment has an immensely positive impact. However, it's a big question for India that whether COVID-19 or hunger is the real issue now? As for the COVID-19 Indian economy is at a halt, thereby the unemployment number will be increasing in the future. Also, without proper vaccination, containing COVID-19 cases is a real challenge.

Authors contribution

Conceptualization: A.G.; Data curation: A.G.; Investigation; AG, SN; Project administration: AG,TM; Resources:AG,SN,TM; Supervision: AG, Roles/Writing - original draft: AG; Writing - review & editing: AG,SN,TM.

This work did not receive any specific grant.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

India: Quality Standards In India: A Comprehensive Guide Part 1 – Overview Of India's Quality Standard Measures And Impact For Foreign Manufacturers

Introduction

The first of Economic Laws Practices' three part-series on quality standards lays out an overview of the regulatory environment governing quality standards and conformity assessment measures in India. This article also highlights the growing thrust of the Indian Government on its applicability and compliance.

It discusses key compliance aspects of quality control measures for a foreign manufacturer/exporter of products sold in India. It also evaluates such measures from the prism of India's obligations at the World Trade Organization (WTO). Further, the article deliberates upon the legal and practical avenues that foreign manufacturers may adopt for voicing concerns faced at the time of implementation of such measures.

India's Recent Thrust on Quality Control Measures

While the law relating to quality standards has been in place in India for more than four decades now, its effective implementation by ensuring strict enforcement and wider application is something that has been experienced more recently than ever before.

The present Hon'ble Minister of Consumer Affairs, Food and Public Distribution in India, Mr. Piyush Goyal has repeatedly emphasized on the need to ensure that India is recognized on the global stage as a quality conscious country and a leader in setting global benchmarks for quality standards. The current Government has accordingly enhanced its emphasis on quality control measures, which are administered by the Bureau of Indian Standard ( BIS ). This has resulted in a huge surge in issuance of Quality Control Orders (QCOs ) which prescribe the conformity assessment measures for various consumer products. Moreover, it also prescribes on the inputs used to manufacture these products, a trend especially prominent in recent times. It is important to reiterate here that QCO's are applicable to foreign manufacturers (exporting to India) as well as the domestic industry.

To illustrate the seriousness of the government's intent a list of QCOs which are due to be implemented in the recent times is provided below:

Many governments have adopted regulations to ensure that products meet harmonized safety requirements. Taking a cue from certain developed nations including US, EU, China, South Korea, Japan, etc., India, through the issuances of QCOs, has brought about stringent checks for non-essential and substandard imports into India. Imposition of quality standards also aims at improving other standards (for instance, health, safety, and environmental standards), consequently improving the overall standard of living of its population. From a border protection perspective, such rigorous technical standards aid in restricting import of cheap and sub-standard products that could pose risks to consumer health and environment as also protect domestic manufacturing on price-competitiveness. Enforcement of quality standards will not just curtail low-grade imports but also aid in improving the quality of domestic products.

Quality Control Measures in India: Process Overview

Coverage of a product under a QCO, mandates (i) compliance of a specified Indian Standard (IS)(ii) obtaining of a valid license (iii) bearing of the standard mark on the covered products before supplying to the Indian market.

Any issuance of QCOs triggers the following requirements for manufacturers of products covered therein (Indian and foreign alike):

• Determination of scope and coverage of the QCO;
• Where necessary, determination of relevant categories of products to which it is applicable and exclusion thereof;
• Undertaking procedures to be carried out to ensure appropriate compliance under relevant legislations;
• Carry out preparations keeping in mind practical aspects making compliance more effective and efficient for companies.

Non compliance

Being a regulation that protects consumer interests, the non-compliance or violation of a QCO has dire consequences and implications for Indian and foreign manufacturers s. There are direct implications on Indian manufacturers importing raw materials covered under QCO, as well as foreign manufacturers of these raw materials. The QCOs also require manufacturers situated outside India to comply with and follow Indian legislations as well as undergo a scrutiny and verification of their premises by Indian authorities.

Key compliances for foreign manufacturers

In order to obtain the licence to apply for the Indian Standard Mark, foreign manufacturing facilities will be required to undergo audits by BIS officers who will travel overseas to the factory locations for the audits. The foreign manufacturers will also be required to pay certain fees and importantly retain an Indian in-country representative. Once the licenses are issued, a license number will be issued which, along with the Indian Standard mark, will then have to be printed on the primary packaging of the product (and cannot be applied with a sticker). Post the grant of license, there also exists a requirement for periodical testing of prescribed control units of the products, which can be carried out only in accredited laboratories in India.

Further, a Performance Bank Guarantee (PBG) and an indemnity bond for foreign manufacturers is required after grant of BIS licence through signing of an agreement between BIS and the foreign manufacturer. The need for PBG from a foreign manufacturer is to ensure that in case of any violation of the BIS Act, Rules and Regulations including non-payment of marking fee dues and breach of terms and conditions of the licence, BIS would be able to enforce the PBG. On the other hand, in case of domestic manufacturers, BIS can approach and seek compensation through domestic courts. PBG will be invoked only when there is any breach and covers civil liability and loss of revenue, if any, that may arise during the tenure of the licence or thereafter. The amount shown against bank guarantee remains with the concerned bank in the form of refundable security.

QCOs vis-à-vis India's Commitments at WTO

Given the present geo-political environment, with broad consensus emerging on key tax issues, non-tax regulations, such as license requirement under QCOs, are increasingly seen as an alternate potential tool for countries to regulate EXIM trade in the country. It thus becomes relevant to scrutinize if Indian QCOs making Indian Standards mandatory to goods imported into India are compliant with India's international commitment under various multilateral/ bilateral conventions.

Notably, the QCOs imposed as a way of non-tariff measures are disciplined by WTO and regional and bilateral agreements. The WTO agreements dealing with non-tariff measures among others include the Agreement on Technical Barriers to Trade (TBT Agreement), the Agreement on the Application of Sanitary and Phytosanitary Measures, the Agreement on Article VII of the General Agreement on Tariffs and Trades 1994 (concerning customs valuation).

The objective of the TBT Agreement is to ensure that non-tariff barriers are fair and equitable. It discourages any methods that would give domestically produced goods an unfair advantage. The agreement also encourages countries to recognize each other's procedures for assessing whether a product already conforms to an internationally recognized standard which in essence is acceptable in both such nations. Without recognition thereof, products might have to be tested twice, first by the exporting country and then by the importing country thereby adding more to the commercial cost.

As explained above, BIS standards are made mandatory by the issuance of QCOs. Depending upon exactly what is specified within it, an Indian QCO will likely qualify as a 'technical regulation' while the procedures for testing, inspection and approval of licenses contained in the BIS Regulations may likely qualify as 'conformity assessment procedures' under the TBT Agreement.

The TBT Agreement lays down certain key requirements that Members (including India) must respect while setting out technical regulations;

• As far as practicable, they should be based on relevant international standards. 1
• They should be non-discriminatory i.e. treatment accorded to imported products must not be less favourable than that accorded to like domestic products and like products from other countries. 2
• They should not be more trade-restrictive than necessary to fulfil a legitimate objective. 3

With respect to conformity assessment procedures, the TBT Agreement sets out similar yet distinct requirements:

• As far as practicable, they should be based on relevant guides or recommendations issued by an international standardizing body. 4
• They should be non-discriminatory i.e. access to such procedures for foreign suppliers should be under conditions no less favourable than accorded to suppliers of like products in a comparable situation. 5
• They should not be more strict than necessary to give the importing Member adequate confidence of conformity. 6

Further, manufacturers and exporters need to know what the latest standards are in their prospective markets. To help ensure that this information is made available conveniently, all WTO member governments are required to establish national enquiry points and to keep each other informed through the WTO. The TBT is the major clearing house for members to share the information and the major forum to discuss concerns about the regulations and their implementation.

Avenues to address concerns about QCOs for foreign manufacturers

Even while Indian standards are typically identical to the global standards issued by ISO, on account of its stringency as well as lack of clarity on certain aspects, a QCO may result in several challenges for a foreign manufacturer. For instance, there could be a lack of clarity with regards to grouping guidelines for varieties of products which could be covered in a single license. Alternately, there could be ambiguity on products already placed in the market before the date of implementation of QCO (existing stock). Similarly, for various practical reasons, there could be a genuine need for seeking extension of date of implementation of QCO. In the face of such challenges, the following avenues may exist:

a. Objections to be filed with the TBT Committee

As a part of the process under the TBT Agreement, when a member country introduces a license requirement (e.g. when India does so by issuing a QCO), the draft regulation is required to be notified to all other Members through the TBT Committee. Post this, a a reasonable time is given for other Members to raise objections if they feel that any prescription is violative of the aforementioned requirements of the TBT. India has also in the past, prior to introducing a QCO in the country, notified the TBT Committee in advance, and also provided a time period (typically of around 60 days) for other members to object. During such time, other Member countries can file their objections against the QCO.

b. Diplomatic Efforts/ Bilateral Negotiations

For foreign manufacturers supplying goods to India, concerns, if any may also be raised through filing of representations with their respective governments to raise questions and create diplomatic pressure at the WTO level against the implementation of a QCO. Industry stakeholders may also consider liaising with governments in other jurisdictions to advocate bilateral negotiations with India to achieve mutual recognition of the home country's conformity assessment procedures. Practically, however, enforcing these measures have been difficult- in many instances the Indian Government has proceeded with and implemented proposed QCOs even if the goods being imported into India are already complying with the prescribed quality standards in essence.

c. Dispute Settlement

As an extreme measure, in case a necessary relief is not received through the above steps and the imposition of QCO is deemed to be against the tenets of the TBT Agreement, foreign manufacturers may consider liaising with their jurisdictional governments to advocate initiation of a WTO dispute qua the QCO.

However, obtaining any sort of relief at the WTO level will be a long-drawn process and the effectiveness of this may be short term or uncertain. Therefore, objections with the TBT Committee and diplomatic efforts/ bilateral negotiations should be undertaken on a more immediate basis. This will increase the possibility of persuading the Government of India to get into the consultative process with industry stakeholders/foreign manufacturers.

1. Article 2.4, TBT Agreement.

2. Article 2.1, TBT Agreement.

3. Article 2.2, TBT Agreement.

4. Article 5.4, TBT Agreement

5. Article 5.1.1, TBT Agreement

6. Article 5.1.1, TBT Agreement

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Essay on Quality Control of Products: Top 13 Essays

After reading this essay you will learn about:- 1. Meaning and Definitions of Quality Control 2. Quality Control Organisation 3. Advantages of Quality Control 4. Quality Control for Export 5. Indian Standard Institution 6. Quality Assurance 7. Causes of Quality Failures 8. Economics of Quality 9. Product Quality Analysis 10. Quality Planning 11. Quality Improvement 12. Quality Management System 13. Role of Top Management.

• Essay on the Role of Top Management towards Quality

Essay # 1. Meaning and Definitions of Quality Control :

Quality control in its simplest term, is the control of quality during manufacturing. Both quality control and inspection are used to assure quality. Inspection is a determining function which determines raw materials, supplies, parts or finished products etc. as acceptable or unac­ceptable.

As control becomes effective, the need for inspection decreases. Quality control determines the cause for variations in the characteristics of products and gives solutions by which these variations can be controlled. It is economic in its purpose, objective in its procedure, dynamic in its operation and helpful in its treatment.

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Since variations in raw materials have large effects on the quality of in-process materials, quality control includes statistical sampling and testing before acceptance. It also includes the examination of quality characteristics in finished products so as to assure satisfactory outgoing quality.

Cooperation between the quality control group and other departments such as production, planning and inspection is of vital importance. With proper managerial support and co-opera­tion the quality control programme will be more successful.

Definitions :

In current quality control theory and practice, the meaning of “Quality” is closely allied to cost and customer needs. “Quality” may simply be defined as fitness for purpose at lowest cost.

“Quality” of any product is regarded as the degree to which it fulfills the requirements of the customer. “Quality” means degree of perfection. Quality is not absolute but it can only be judged or realized by comparing with standards. It can be determined by some characteristics namely, design, size, material, chemical composition, mechanical functioning, workmanship, finishing and other properties.

Quality of a product depends upon the application of materials, men, machines and manu­facturing conditions. The systematic control of these factors is the quality control. The quality of a product differs greatly due to these factors. For example, a skilled worker will produce prod­ucts of better quality and a less skilled worker will produce poor quality products.

Similarly better machines and better materials with satisfactory manufacturing conditions produce a better quality product. Thus, it is clear that to control the quality of product various factors which are responsible for quality are required to be controlled properly.

In the words of Alford and Beatly, “quality control” may be broadly defined as that “Indus­trial management technique by means of which products of uniform acceptable quality are manufactured.” Quality control is concerned with making things right rather than discovering and rejecting those made wrong.

“It may also be defined as the function or collection of duties which must be performed throughout the organisation in order to achieve its quality objective” or in the other words ‘Quality is every body’s business and not only the duty of the persons in the Inspection Staff.

Concluding, we can say that quality control is a technique of management for achieving required standard of products.

Factors Affecting Quality :

In addition to men, materials, machines and manufacturing conditions there are some other factors which affect the quality of product as given below:

(i) Market Research i.e. demand of purchaser.

(ii) Money i.e. capability to invest.

(iii) Management i.e. Management policies for quality level.

(iv) Production methods and product design.

Apart from these, poor packing, inappropriate transportation and poor after sales service are the areas which can cause damage to a company’s quality image. There are cases where goods of acceptable quality before transportation were downgraded on receipt by the retailer just because they had been damaged in transportation.

Modern quality control begins with an evaluation of the customer’s requirements and has a part to play at every stage from goods manufactured right through sales to a customer, who remains satisfied.  

Essay # 2. Quality Control Organisation :

Over the years, the status of the quality control organisation changed from a function merely responsible for detecting inferior or standard material to a function that establishes what are termed preventive programmes.

These programmes are designed to detect quality problems in the design stage or at any point in the manufacturing process and to follow up on corrective action.

Immediate responsibility for quality products rest with the manufacturing departments. All the activities concerning product quality are usually brought together in the organisation which may be known as inspection, quality control, quality assurance department or any other similar name.

Quality control is a staff activity since it serves the line or production department by assist­ing them in managing quality. Since the quality control function has authority delegated by management to evaluate material produced by the manufacturing department, it should not be in a position to control or dictate to the quality activity.

The quality control organisation depending upon the type of product, method of quality is sufficient enough to carry out following activities:

1. Inspection of raw material, product or processes.

2. Salvage inspection to determine rejected part and assembly disposition.

3. Records and reports maintenance.

4. Statistical quality control.

5. Gauges for inspection.

6. Design for quality control and inspection.

7. Quality control system maintenance and development.

Functions of Quality Control Department :

Quality control department has the following important functions to perform:

1. Only the products of uniform and standard quality are allowed to be sold.

2. To suggest methods and ways to prevent the manufacturing difficulties.

3. To reject the defective goods so that the products of poor quality may not reach to the customers.

4. To find out the points where the control is breaking down and investigates the causes of it.

5. To correct the rejected goods, if it is possible. This procedure is known as rehabilita­tion of defective goods.

Essay # 3. Advantages of Quality Control :

There are many advantages by controlling the product quality.

Some of them are listed below:

1. Quality of product is improved which in turn increases sales.

2. Scrap rejection and rework are minimised thus reducing wastage. So the cost of manufacturing reduces.

3. Good quality product improves reputation.

4. Inspection cost reduces to a great extent.

5. Uniformity in quality can be achieved.

6. Improvement in manufacturer and consumer relations.

7. Improvement in technical knowledge and engineering data for process development and manufacturing design.

Essay # 4. Quality Control for Export :

Today we need foreign exchange for our requirements and for repayment of our debts and services. If our products are expensive and are of sub-standard quality then the customers abroad will not buy goods from us.

Therefore, we must be able to supply goods which may meet the requirements of foreign buyers. For this purpose quality and good packing determines to a large extent the continued acceptability of the product.

At present some organisations lite Export Inspection Council of India, the Indian Stan­dards Institution, the Indian Society of Quality Control and the Indian Institute of Foreign Trade are helping about this problem of quality control.

Implementation of the Export Act 1963 and the work of Export Inspection Council (set up under Export Act) have helped in planned approach towards quality control. The advice of Export Inspection Council is very helpful for pre-shipment inspection of exportable goods.

These organisations have been authorised to issue a “Certificate of Quality” after satisfying them­selves that the goods fulfill the minimum standards of quality laid down or that they are of the quality claimed by the exporter.

Essay # 5. Indian Standard Institution (I.S.I. Renamed as B.I.S.) :

To protect the interest of the consumers, Indian Standard Institution is serving in India. In most of the western countries, consumers nave formed their own associations to protect their interest. In some countries these associations, receive official support and guidance.

I.S.I, serves the consumers through Certification Marks Scheme. Under this scheme I.S.I, has been vested with the authority to grant licenses to manufacturers to apply the I.S.I, mark on their products in token of their conformity to the desired Indian Standards.

To control the quality, I.S.I, inspectors carry out sudden inspections of the factories of the licensee. Inspectors may check the incoming raw materials, outgoing finished products and may carry out necessary tests at different levels of control during production.

Thus I.S.I, mark gives guarantee to the purchaser that the goods with this mark have been manufactured under a well-defined system of quality control. From first April 1987 it has been renamed as Bureau of Indian Standards.

Essay # 6. Quality Assurance :

Inspection, quality control and quality assurance:.

Inspection is a process of sorting good from a lot. Whereas Quality Control is aimed at prevention of defects at the very source, relies on effective feedback system, and procedure for corrective action.

In Quality control programme, inspection data are used to take prompt corrective action to check the defects. For this purpose, detailed studies are conducted to find out that from where the defect is originated, and how to prevent it, may it be at manufacturing, design, purchase of raw materials, despatch or storage stage.

Quality Assurance means to provide the necessary confidence to the customer as well as to top management that all concerned are carrying out their job effectively and that the product quality is as per customer’s satisfaction with economy. Quality products can be produced only when all the departments fully participate and co-operate.

Presently, customers demand for higher quality and reliability. It has been felt that even a single defect whatever may be the reasons, result in economic loss.

These reasons have neces­sitated the need for total quality and reliability programmes to cover wide spectrum of func­tions and various areas of product design, production system design through various states of material, manufacture and commitment to efficient maintenance and operation of the system as a whole. This is necessary for quality assurance and reliability of the product. This assures the continuous failure free system to the customers.

Responsibilities of Quality Assurance Department :

i. Plan, develop and establish Quality policies.

ii. To assure that products of prescribed specification reaches to the customers.

iii. Regularly evaluate the effectiveness of the Quality programmes.

iv. Conduct studies and investigations related to the quality problems.

v. Liaise with different department, in and outside the organisation.

vi. Organise training programmes on quality.

vii. Plan and coordinate vendor quality surveys and evaluate their results.

viii. Develop Quality assurance system and regularly evaluate its effectiveness.

Quality Assurance System :

Quality assurance system should be developed incorporating the following aspects:

i. Formulate the quality control and manufacturing procedures.

ii. Percentage checking be decided.

iii. Procedures and norms for plant performances as regards to quality be developed.

iv. Rejection analysis and immediate feed-back system for corrective action.

v. Prepare a manual for quality assurance.

vi. Formulate plans for quality improvement, quality motivation and quality awareness in the entire organisation.

Essay # 7. Causes of Quality Failures :

Quality failures occur due to various causes, most of them are because of lack of involve­ment of men concerned with the quality. Studies have indicated that more than 50% of quality failures are due to human errors at various levels, such as understanding of customer’s require­ments, manufacturing, inspection, testing, packaging and design etc.

Error affecting quality can be classified into following categories :

(a) Error Due to Inadvertence:

These are due to lack of knowledge of the product, and continue due to lack of information about quality deficiency. Such mistakes can be controlled, if a system for feedback is developed in which quality performance results are analysed in a regular and timely manner.

(b) Errors Due to Lack of Technique:

These errors are due to lack of knowledge, skill, technique etc. In such cases performance of ‘better’ operation are compared with those of ‘poor’ or ‘defect prone’ operations, and the process adopted by them are studied and reasons for errors are investigated.

(c) Willful Errors:

Sometimes quality is compromised due to early delivery schedules, reduction in cost, safety etc.

Reduction of Errors by Improved Motivation :

Quality motivational programmes are developed for getting quality product from the line staff so that they take interest in improving the quality. Motivational programmes are de­signed after identifying the sources/reasons of failures.

Operators are motivated by designing a campaign to secure alertness, awareness and new actions, and by observing the managers for their behaviours or reactions on any quality problem. Campaign can be launched through mass meetings, quality posters, exhibition of quality deficiencies etc.

Campaign may also invite operators to participate in analysing the causes of defects or the failure on the part of operation and/or systems. Trainings are very helpful in making the operators aware of the technological does and don’ts and the purpose behind each operation.

Essay # 8. Economics of Quality :

The good economic performance is the most essential for survival and growth of any organisation in the highly competitive environment. Therefore, one of the most common objec­tions of every organisation is to attain excellence in its economic performance. The single most important factor which leads to good economic performance is the ‘quality’ of its products or services.

Therefore, in order to achieve economy, quality management system must contribute to­wards the establishment of customer-oriented quality discipline in the marketing, design, engi­neering, procurement, production, inspection, testing and other related servicing functions.

Everybody in the organisation must be involved in the production and delivery of quality product or services, consistently to meet the customer needs and satisfaction.

The production of defective output results in the costs of sorting, scrap, rework, dealing with customer complaints, replacement under warranty etc. It is more serious and very diffi­cult to ascertain the cost associated with the loss of goodwill, following the sale of defective or non-conforming products.

Designers of economic models use following costs:

i. Fixed costs of sampling, inspecting, testing and measuring.

ii. Variable cost of sampling, measuring, calculating and plotting each sample value on control charts.

iii. Cost of correcting and assignable cause.

iv. Total loss in profit, when the process is running out of control.

It has been experienced that the savings due to control of poor quality products, better control over the quality of purchased product, use of more economical materials or methods due to their greater reliability, are sometime spectacular.

Quality is a dynamic phenomenon and is being improved continuously with the new devel­opments in technology and management techniques.

Quality and Cost :

Studies have indicated that any reduction in quality results in a reduced level of satisfac­tion and decrease in customer goodwill toward the producer. This will lead to reduction in return on investment in the long run.

Following are the general principles of quality and cost relationship:

(i) Cost of poor quality are far larger than that had been recognised.

(ii) Appraisal costs are reduced by focussing on preventing errors at the source.

(iii) System be established for reducing the cost rather than reducing the quality.

(iv) By focussing on quality improvement overall, performance of the firm can be im­proved.

(v) Focus of quality improvement be shifted from product attributes to operational proce­dure.

Quality Cost (or Costs Associated with Quality) :

Quality cost means cost of poor quality goods or services.

Following are the main quality associated costs:

1. Failure Costs :

(A) Internal Failure Costs:

(i) Scrap and rework cost.

(ii) Costs involved in testing, inspecting and sorting for down-gradation.

(iii) Losses due to avoidable processing.

(iv) Expenditure in failure analysis.

(B) External Failure Costs:

(i) Warranty charges.

(ii) Redressal of complaints.

(iii) Loss of future sales.

(iv). Other expenses on return of materials, failure analysis outside the factory.

2. Appraisal/Detection Costs :

(i) Incoming test and inspection including materials, in-process and final quality sampling.

(ii) Quality audits.

(iii) Equipment calibration.

(iv) Evaluation of performance.

(v) Evaluation of customer satisfaction.

3. Prevention Costs :

(i) Quality planning.

(ii) New product review.

(iii) Process control.

(iv) Training and education.

(v) Process quality planning.

Quality Cost Control :

For the purpose of reducing the cost, when internal and external failure costs are cost down, the appraisal cost and preventive cost may slightly go up. Therefore, it is necessary for opti­mum balance to reduce failure cost with slight increase in appraisal and preventive cost, with the aim of substantial reduction in total quality cost without compromising with the quality.

Efforts for reducing quality cost must be continuous.

The cost reduction programme must be followed in following stages:

1. Identification of quality cost items.

2. Structuring of quality cost reporting, including related analysis and control, and

3. Maintenance of programme to ensure that the objectives of higher quality at lower cost.

Quality control and quality cost must be directed in such a way so as to provide the firm with major added business value.

Essay # 9. Product Quality Analysis :

It includes:

(i) The various functions to be performed by the manufactured product.

(ii) Life and durability of product.

(iii) Working conditions required during manu­facturing.

(iv) Product specifications.

(v) Manufacturing processes and methods.

(vi) Maintenance and installation.

(Quality at level Y is the most economical. A drop of quality to level X reduces the cost by M but also re­duces the quality value by N which is greater than M. A rise of quality to level Z increases the quality value by O and increases the cost by P, which is greater than O) — Refer Fig. 62.1.

Essay # 10. Quality Planning :

Quality planning is done keeping the company needs and customer needs in view, and a comprehensive quality plan is prepared for implementation in the company.

Quality plan is a document setting out the specific quality practices, resources and activities relevant to a par­ticular product, process, services, contract or project.

Quality planning is a systematic process for:

(i) Identifying customers,

(ii) Discovering customer needs,

(iii) Designing the responsive products,

(iv) Developing the process for creating and delivering the products, and

(v) Transferring the process and its contents to those who will perform the product or service.

Essay # 11. Quality Improvement :

Quality improvement is a structured process for reducing the deficiencies that are present in products, processes and services and/or improving performance whenever there is an opportunity to improve.

Quality problems are of following two types:

1. Sporadic Problems:

A sporadic problem is a sudden adverse change in the status quo, which requires remedy. The variations due to these problems are so significant that they trigger the alarm signals of the control system.

2. Chronic Problems:

Chronic problem is long-standing adverse situation which requires remedy through changing the status quo. For such problems, by adopting ‘continuous improve­ment concept’ better and better levels of performance can be achieved. These problems occur for a long time, and are often difficult to solve, as they are accepted as inevitable.

Essay # 12. Quality Management System :

A quality management system organises overall activities of the company in such a way that the technical, administrative and human factors affecting the quality of products or ser­vices are under control. The quality management system guides the cooperated actions of the people, machines and information to achieve the quality objectives.

1. Activities:

Activities of quality management system are:

(i) Marketing to evaluate customer needs and use requirements.

(ii) Design and engineering to translate the customer needs into product, process and material specifications.

(iii) Purchasing to select the competent vendors who can supply materials, components, sub-assemblies as per specifications.

(iv) Production to ensure that product is produced under controlled conditions in conform­ance to standards.

(v) Quality assurance to identify appropriate test methods and exercise quality control techniques.

(vi) Shipping to ensure proper packaging, transportation and distribution of material.

(vii) Documentation to maintain system and progress documents at each stage of opera­tion.

(viii) Product development for innovation and improvement based on customer’s feedback.

(ix) Auditing to identify the non-conforming of the system and product, and follow up the corrective actions.

2. Benefits:

(i) To meet the customer requirements by providing quality products or services to satisfy the customer needs.

(ii) Good reputation helps in better marketability of the company’s products and services.

(iii) Confidence is created.

(iv) Consistivity in quality.

(v) Productivity improvement.

(vi) Better financial performance.

(vii) Brings clarity in working.

(viii) Better documentation.

(ix) Better monitoring.

(x) Increases export potential.

(xi) Human resources development.

3. Quality Function:

(i) Marketing and market research.

(ii) Design and product development.

(iii) Procurement.

(iv) Process planning and development.

(v) Production.

(vi) Inspection, testing and examination.

(vii) Packaging and storage.

(viii) Sales and distribution.

(ix) Installation and operation.

(x) Technical assistance and maintenance.

(xi) Disposal after use.

4. Quality and Top Management:

Responsibility for and commitment to quality always belong to the highest level of management.

Following action points are necessary to be adopted by top management to achieve quality objectives of the company:

(i) Define and state quality policy.

(ii) Appoint a management representation.

(iii) Define responsibility and authority.

(iv) Establish an internal verification system.

(v) Establish a quality system.

(vi) Review the functioning of quality system at regular intervals.

5. Installing the Quality System :

(A) Preparations:

(i) Analyse the existing status and identify what needs to be done? Prepare an ac­tion plan.

(ii) Develop an organisation structure.

(iii) Develop quality system documentation.

(iv) Prepare the material and machinery resources.

(B) Implementation:

(i) Implement the documented quality system.

(ii) Establish internal quality audit system.

(iii) Monitor, control and stabilise the quality system.

(iv) Hormonise the practices with the standards.

Essay # 13. Role of Top Management towards Quality :

Main roles of the top management towards quality are:

1. Define quality Control. Establish a Quality Council.

2. Establish quality policies.

3. Establish quality goals.

4. Provide the resources.

5. Provide problem-oriented training.

6. Serve on quality improvement teams which address chronic problems.

7. Stimulate improvement.

8. Provide for reward and recognition.

9. Top management is required to:

(a) Develop strategies for quality, and

(b) Provide leadership for implementation of these strategies.

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67 Quality Control Essay Topic Ideas & Examples

🏆 best quality control topic ideas & essay examples, 📌 simple & easy quality control essay titles, 👍 good essay topics on quality control.

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Why implementing drug regulation policies are still a challenge in India

The ecosystem of of generic drugs in India is far too wide and cumbersome

East Delhi resident Gaurav Kumar has entirely shifted to Jan Aushadhi Kendras for medicinal needs. He unequivocally dismisses doubts over the quality of drugs sold at the Centre-run kiosks. “The price difference is also whopping, 50-90 per cent,” he says. Anil Vats, a retired government servant from Ghaziabad, says: “My lung disease tablets cost Rs250 per pack. At Jan Aushadhi, I get it for Rs60.”

To ensure quality, all batches supplied to over 10,000 Jan Aushadhi stores across 750 districts go through double checks. Ravi Dadhich, CEO, pharmaceuticals and medical devices bureau of India, ministry of chemicals and fertilizers, tells THE WEEK: “After procuring medicines from WHO GMP (Good Manufacturing Practices) certified suppliers, each batch is again tested at our laboratories to ensure quality.”

Certainly, these stores are striving to provide affordable generic medicines. This, however, is only a small part of the story. The ecosystem of generic drugs in India is far too wide and cumbersome. Generic or branded medicines have no specific definitions. They, for all purposes, generally “contain the same active ingredient in the same dosage form, intended to be administered by the same administrative route” as the branded drugs.

Dr Preeti Kumar, vice president, public health system support of the Public Health Foundation of India, explains: “There are primarily three types of drugs―generic, branded-generic and patented.” She adds that the generic and patented together constitute around 20 per cent of the market. “The remaining 80 per cent is covered by branded-generics that constitute around 2,800 formulations and unique molecules for various diseases spanning over 55,000 brands,” she says. “If we keep the patented drugs aside (which is only 8-10 per cent), the issue of quality remains with both generic and branded-generics and it is not entirely correct to equate branded-generic with quality.”

Dadhich adds, “The generics sold under a brand become branded-generics.” By numbers, the labyrinth is even more gigantic―India is the biggest exporter of generics to around 200 countries. The top five importers are the US, Belgium, South Africa, the UK and Brazil. More than 60,000 generic drugs are produced in India across 60 therapeutic categories. India's drug and pharmaceutical products exports grew by 125 per cent from Rs90,415 crore in 2013-14 to Rs2.04 lakh crore in 2022-23. “These constitute 5.71 per cent of the total exports and ranks third worldwide by volume,” according to the ministry of health and family welfare.

Domestically, the market reach in India is to the tune of Rs1.5 lakh crore. The enormity of the sector speaks volumes about the inadequacy of all government schemes put together in making medicines affordable, accessible and acceptable to all.

Understandably, therefore, the doctors were up in arms over a government order making it compulsory to write generic names on prescriptions. Although existing rules do exhort physicians to prescribe drugs with generic names, the mention of penalties for non-compliance and potential licence suspension in the August 2023 order took the doctors by surprise. Their vociferous opposition forced the government to put the directions on hold within two weeks. At the heart of the doctors’ opposition was the uncertainty over quality of generic drugs.

“The government is sensitive on the issue and understands,” says Sharad Aggarwal, president of the Indian Medical Association, which led the resistance. “That is the reason they reversed the decision. Spurious drugs is a national issue and all of us will have to show maturity in handling the situation.”

The doctors’ apprehensions are not misplaced. A recent study by the Postgraduate Institute of Medical Education and Research, Chandigarh, attests to the substandard quality. In the study, published in an international journal, subjects given a patented (innovator) drug achieved better therapeutic levels than those administered the generic counterpart.

Dr Rahul Singh, head of critical care unit, Yathartha Hospitals, concurs with the findings of the study. “Certainly, the efficacy and blood levels will differ in case of generic medicines and innovators,” he said. “In case of generic drugs, the standards and optimisation is not validated so the results are compromised.”

This issue acquires additional significance as the WHO says that generic products must satisfy the same standards as innovator products. Legislatively, the rules in India forbid malpractices in manufacturing of drugs. Pharmaceutical companies claim that apart from compliance necessities, the risk to reputation leads brands to meet global standards. “To ensure quality of medicines sold under brands, companies adhere to rigorous quality measures,” says Nikkhil K. Masukar, CEO, Entod Pharmaceuticals. “They conduct thorough testing, follow GMP and comply with regulatory standards to guarantee the safety and efficacy of their products. Brand reputation is often built on a commitment to delivering high-quality medications, and companies invest significantly in maintaining these standards.”

Dr Rajeev Sood, vice chancellor of the Baba Farid University of Health Sciences, Faridkot, Punjab, says that while the guidelines are ideal, the problem lies with the implementation. “There is no set mechanism to monitor the quality of generic medicines,” he says. “Batch by batch, the quality is different.” Dr Girish Mathur, president of the Association of Physicians of India, adds that there is a pressing need to put mechanisms that ensure quality.

Aman Gupta, managing partner, Health Practice Asia Lead, Spag Finn, a Gurugram-based consultancy firm, says common assurance needs to be provided on quality, efficacy and safety. “In recent times, questions have been raised on manufacturing practices and quality standards of Indian drugs (specially generics), not only within India but at the global level,” he says.

Insiders reveal that the quality erodes as a result of manufacturing and market imperfections. “The problem arises when the approval procedures are sometimes compromised because of corruption at multiple levels,” says an employee of a leading pharmaceutical company, who requested anonymity. “The minuscule levels of monitoring of the samples add to the woes and the sub-standard quality reaches the market.” He adds that Indian generic manufacturers start compromising on the quality to sell on lower costs engendering “camouflaged competition”. “The quality is majorly compromised when it comes to the huge domestic market and exports to developing markets such as Africa, West Asia and East Asia,” he says.

The IMA had recently pointed out that less than 0.1 per cent of the drugs manufactured in India are tested for quality. Multiple alerts from the WHO on sub-standard quality of Indian cough syrups in the wake of a number of overseas deaths linked to India-made drugs in countries like the Gambia, Cameroon and Uzbekistan is a case in point. However, that is not the case with exports to developed countries. The stringent regulatory systems and authorities in western and European institutions like the US Food and Drug Administration and European Medicines Agency make it risky for the manufacturers to export inferior quality.

The impediment to ensuring quality, especially for domestic consumption, experts believe, is the ever expanding gulf between demand and the requisite infrastructure, expertise and finance. “Every product should be checked,” says Sood. “But, we do not have the wherewithal to monitor effectively. We do not check where the raw material has been sourced from, there are no proper labs for testing.”

An important factor, according to Kumar, is that India has a federal structure and health is a state subject. “The regulation is also done by state drug control organisations,” she says. “Therefore, it becomes important that states also make adequate budgetary allocations to pick samples and send them to laboratories for testing to ensure quality. Both generic and branded-generic drugs are same in dosage form, chemical strength and quality checks. However, some are directly marketed through prescribers and pharmacies and in some cases the quality of the medicine is associated with the degree of regulation.”

Doctors also blame pharmacies for the bad quality. “It should not only be about controlling doctors but also about controlling the pharmacies,” Sood points out. “Pharmacists manufacture their own medicines and sell them in large numbers. There have also been instances when certificates have been sub-let, thereby exploiting the guidelines.” Aggarwal adds that the move to prescribe generic names gives more power to pharmacists, who may give the medicine which suits their interests and may not align with patients' interest.

There is unanimity on the urgent need to have a “centralised” and a more “proactive” system of testing to make safe and affordable medicines available to all Indians. Says Kumar: “The regulatory investment will have to be commensurate with the quality of the medicines. Best practices at all three levels―procurement, testing and regulation ―will have to be extended to a much wider base to ensure quality medicines reach the market.”

The government’s efforts to strengthen regulations and promote generics are lauded by a few. “Generics have to be the way forward,”says Priyadarshi Mohapatra, founder and CEO of Curebay, promoting e-clinics in rural Odisha. Adds Dr Sujit Chatterjee, CEO, L.H. Hiranandani hospital, Mumbai: “By advocating the use of generic drugs, the government is promoting an environment in health care that respects accessibility and affordability.”

Kumar also agrees that the government is really upping the regulatory mechanisms to ensure only quality drugs come into the market. Aman Gupta praises recent steps by the Drug Controller General of India, including implementation of QR codes and the decision to overhaul drug regulations. He considers work towards framing the Drugs, Medical Devices, and Cosmetics Bill “a crucial step towards upgrading and streamlining the regulatory framework.”

In late December, 2023, the Union health ministry notified its new Good Manufacturing Practices for pharmaceutical products. The new rules facilitate major changes in ensuring quality and categorically hold senior management of the manufacturing companies responsible for quality. The new guidelines are seen as a step in the right direction to elevate the quality of drugs to global standards.

Says Dr Viranchi Shah, national president, Indian Drug Manufacturer Association, “The new rules will of course make a difference in aligning more with the WHO standards and is a welcome step in upgrading the sector.” However, he suggests that a larger window could be given for transitioning, especially to the small industries. “We should engage with small and medium enterprises, handhold them and help them become a part of the envisaged new normal,” he says.

Reiterating the IMA’s stand on introducing “one drug, one quality, one price system”, Aggarwal says, “Why not subsidise the health sector the same way as other sectors are subsidised? The government should do away with this differentiation of generic, branded, non-branded and find a permanent solution to this problem.”

While the government’s intentions to ensure quality is apparent, how much the rules are going to match the monitoring on the ground to make Indian drugs risk-free remains to be seen.

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