Weekly Current Affairs (8th to 14th August 2023) Part - 1 | Current Affairs & Hindu Analysis: Daily, Weekly & Monthly - UPSC PDF Download

Revised Good Manufacturing Practices Standards

Context: Recently, the government of India has directed all pharmaceutical companies to implement the Revised Good Manufacturing Practices (GMP), bringing their processes at par with Global Standards.

• Larger companies with a turnover of over Rs 250 crore have been asked to implement the changes within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore have been asked to do so within a year.

What are Good Manufacturing Practices (GMP)?

About:

• GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
• It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

The Main Risks:

• Unexpected contamination of products
• Causing damage to health or even death
• Incorrect labels on containers, which could mean that patients receive the wrong medicine
• Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
• WHO (World Health Organization) has established detailed guidelines for GMP. Many countries have formulated their own requirements for GMP based on WHO GMP.
• Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
• The GMP system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was done in June 2005. WHO-GMP standards are now part of the revised Schedule M.

What are the Major Changes in Revised GMP Guidelines?

Pharmaceutical Quality System and Risk Management:

• The new guidelines introduce a pharmaceutical quality system, which emphasizes the establishment of a comprehensive quality management system throughout the manufacturing process.
• Companies are now required to implement quality risk management practices to identify potential risks to the quality of their products and take appropriate preventive measures, also regular quality reviews of all products are mandated to ensure consistency in quality and processes.

Stability Studies:

• Companies are now required to conduct stability studies based on climate conditions. This involves maintaining drugs in stability chambers at specified temperatures and humidity levels to assess their stability over time. Additionally, accelerated stability tests may be conducted to assess the product's stability under accelerated conditions.

GMP-Related Computerized Systems:

• The new guidelines emphasize the use of computerized systems to manage GMP-related processes.
• These systems are designed to prevent data tampering, unauthorized access, and omission of data. They also automatically record all steps and checks to ensure adherence to processes without any tampering.

Investigational Products for Clinical Trials:

• The new schedule M also lists out the requirements for additional types of products, including biological products, agents with radioactive ingredients, or plant-derived products.
• The new guidelines lay out requirements for investigational products being manufactured for clinical trials. This ensures that the products used in clinical trials meet the necessary quality and safety standards.

What is the Need for Revised GMP Guidelines?

Alignment with Global Standards:

• Implementation of the new norms will bring the Indian industry on par with global standards.

Incidents of Contamination:

• There have been a string of incidents where other countries have reported alleged contamination in India-manufactured syrups, eye-drops, and eye ointments.
• The deaths of 70 children in the Gambia, 18 children in Uzbekistan, three persons in the United States, and six deaths in Cameroon have been linked to these products.

Deficiencies in Current Practices:

• Risk-based inspection found numerous deficiencies in 162 manufacturing units in India.
• Deficiencies include inadequate testing of raw materials, lack of product quality review, infrastructure issues, and missing qualified professionals.
• There are only 2,000 of the 10,500 drug manufacturing units in India at present that meet global standards, being WHO-GMP certified.
• The improved standards will ensure that pharmaceutical companies follow standard processes, quality control measures, and do not cut corners, improving the quality of medicines available in India as well as sold in the global market.

Confidence to Regulators from Other Countries:

• Instituting the same quality across the industry will give confidence to regulators from other countries.
• In addition, it will improve the quality of drugs in the domestic markets. Most of the 8,500 manufacturing units that are not WHO-GMP certified supply medicine within India.

Way Forward

• India's move to implement revised GMP guidelines signifies a significant step toward achieving global quality standards in the pharmaceutical industry.
• The revised standards aim to enhance quality control measures, proper documentation, and IT support, thus ensuring the production of high-quality medicines in India and for the global market.

Genetic Diversity in the Indian Population

Context: Recently, a study by Institute for Human Genetics, University of California, has found stark genetic differences between people from different regions of the Indian subcontinent.

What is the Methodology of the Study?

• The researchers collected DNA (Deoxyribonucleic Acid) from around 5,000 individuals, mainly people from across India, Pakistan, and Bangladesh. This cohort also contained DNA from some Malay, Tibetan, and other South-Asian communities.
• They performed Whole-Genome Sequencing to identify all the instances where the DNA either showed a change, was missing, or had additional base-pairs, or ‘letters’.

What are the Key Findings of the Study?

Endogamous Practices:

• There is little mixing between individuals from different communities in the Indian subcontinent.
• Endogamous practices, such as caste-based, region-based, and consanguineous (Closed Relatives) marriages, contributed to conserved genetic patterns at the community level.
• In an ideal scenario, there would have been random mating in a population, leading to greater genetic diversity and lower frequency of variants, which are linked to disorders.

Regional Trend:

• Compared to a relatively outbred population, like that of Taiwan, the South Asian cohort – and within it, the South-Indian and Pakistani subgroups – showed a higher frequency of homozygous genotypes, possibly due to cultural factors.
• Humans typically have two copies of each gene. When an individual has two copies of the same variant, it is called a Homozygous Genotype.
• Most genetic variants linked to major disorders are recessive in nature and exert their effect only when present in two copies. (Having different variants – i.e. being heterozygous – is usually protective.)
• The South-Indian and Pakistani subgroups were estimated to have a high degree of inbreeding while the Bengali subgroup showed significantly lower inbreeding.
• Not only did the South Asian cohort have a higher number of variants that could disrupt the functioning of genes, there were also unique variants that were not found in European individuals.

Risk of Higher Frequency of Homozygous Variants :

• The presence of rare homozygous variants increased the risk of disorders like cardiovascular diseases, diabetes, cancers, and mental disorders.

What are the Other Studies on Genetic DIversity?

• In 2009, a study in Nature Genetics by the group of Kumarasamy Thangaraj, at the Centre for Cellular and Molecular Biology, Hyderabad, revealed that a small group of Indians are prone to cardiac failure at relatively young ages.
• The DNA of such individuals lacked 25 base-pairs in a gene crucial for the rhythmic beating of the heart (scientists call it a 25-base-pair deletion).
• This deletion was unique to the Indian population and, barring a few groups in Southeast Asia, was not found elsewhere.
• This deletion arose around 30,000 years ago, shortly after people began settling in the subcontinent, and affects roughly 4% of the Indian population today.
• Identifying such genetic novelties helps understand population-specific health risks and vulnerabilities.

What is the Significance of Such Studies on Genetic Diversity?

• Studies have shown that specific genetic novelties are linked to the health of India's populace. Understanding these genetic variations can lead to better interventions for major health concerns.
• Conducting genetic studies within the country can protect vulnerable communities from potential exploitation by multinational companies and foreign research organizations.

What is the Importance of a Detailed Map of the Indian Genome?

• India's incredible diversity necessitates a detailed Map of the Indian Genome for various reasons, including economic, matrimonial, and geographical factors.
• Such a map can aid in understanding the genetic basis of health disparities and guide population health interventions.

Organ Donation in India

Context: Recently, the critical shortage of organ donations, particularly deceased donations, has led to a dire situation in India, with thousands of patients waiting for transplants and a significant number losing their lives daily.

• The Ministry of Health and Family Welfare has earlier modified National Organ Transplantation Guidelines, allowing those above 65 years of age to receive an organ for transplantation from deceased donors.
• In India, the Transplantation of Human Organs Act, 1994 provides various regulations for the removal of human organs and their storage. It also regulates the transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs.

What is the Status of Organ Donation in India?

Growing Demand and Persistent Shortage:

• Over 300,000 patients are on the waiting list for organ donations in India.
• The supply of organ donors has not kept up with the increasing demand.
• Approximately 20 individuals die daily while awaiting organ transplants due to the shortage.

Slow Growth in Donor Numbers:

• Donor numbers, including both living and deceased, have shown slow growth over the years.
• From 6,916 donors in 2014, the count increased to about 16,041 in 2022, indicating a modest rise.
• The deceased organ donation rate in India has remained consistently below one donor per million population for a decade.

Deceased Organ Donation Rate:

• Urgent efforts are required to raise the deceased organ donation rate to address the shortage.
• Countries like Spain and the United States have achieved significantly higher donation rates, ranging from 30 to 50 donors per million population.

Prevalence of Living Donors:

• Living donors constitute the majority, accounting for 85% of all donors in India.
• However, deceased organ donations, especially for kidneys, liver, and heart, remain considerably low.

Regional Disparities:

• Disparities in organ donation rates exist among different states in India.
• Telangana, Tamil Nadu, Karnataka, Gujarat, and Maharashtra have reported the highest number of deceased organ donors.
• Delhi-NCR, Tamil Nadu, Kerala, Maharashtra, and West Bengal are prominent regions with a high number of living donors.

Kidney Transplants:

• Kidney transplantation in India faces a significant disparity between demand and supply.
• Annual demand for 200,000 kidney transplants is met with only around 10,000 transplants each year, creating a substantial gap.

What are the Challenges Regarding Organ Donation?

Lack of Awareness and Education:

• Limited awareness among the general public about organ donation and its impact.
• Insufficient education among medical professionals to identify potential donors and counsel families effectively.

Family Consent and Decision-Making:

• Family reluctance to give consent for organ donation, even when the deceased individual had expressed a willingness to donate.
• Emotional and ethical dilemmas that families face when making decisions about organ donation.

Organ Trafficking and Black Market:

• Illegal organ trafficking and the existence of a black market for organs.
• Criminal activities exploiting the demand for organs and undermining legitimate donation processes.

Medical Eligibility and Compatibility:

• Matching suitable donors and recipients based on medical compatibility and organ availability.
• Limited availability of compatible organs, leading to prolonged waiting periods for patients.

Donor Incentives and Compensation:

• Debates over the ethical implications of offering financial incentives or compensation to organ donors.
• Balancing the need for increasing donation rates with ensuring ethical practices.

Infrastructure and Logistics:

• Inadequate infrastructure and resources for organ retrieval, preservation, and transplantation.
• Challenges in the timely transportation of organs from donors to recipients, especially across different regions.

What are the Highlights of the New National Organ Transplantation Guidelines?

Removed Age Cap:

• Age limit for organ recipients eliminated due to improved life expectancy.
• NOTTO (National Organ and Tissue Transplant Organization) guidelines previously prohibited end-stage organ failure patients above 65 years from registering for organ transplants.

No Domicile Requirement:

• Domicile requirement waived for organ recipient registration.
• 'One Nation, One Policy' approach allows patients to register for organ transplants in any state.

No Registration Fees:

• Removal of registration fees for organ recipient registration.
• States, including Gujarat, Telangana, Maharashtra, and Kerala, no longer charge fees for patient registration.

Note:

• NOTTO is set up under the Directorate General of Health Services, Ministry of Health and Family Welfare, located in New Delhi.
• National Network division of NOTTO functions as the apex centre for all Indian activities for procurement, distribution and registry of organs and tissues donation and transplantation in the country.

Way Forward

• Partner with artists, influencers, and celebrities to create impactful campaigns highlighting organ donation's significance.
• Organize seminars for medical professionals, employing interactive simulations and case studies for donor identification and family counseling.
• Collaborate with educational institutions to raise awareness among students about organ donation through workshops and talks.
• Host community-driven events that showcase the success stories of organ recipients and donors.
• Engage religious leaders to debunk myths and misconceptions about organ donation, emphasizing its compassionate aspect.
• Introduce a program to honour donors and their families, recognizing their selfless contribution through plaques and certificates.
• Foster collaborations between healthcare institutions to optimize organ transplantation processes for efficient outcomes.
• Promote the idea of organ donation as a selfless act of compassion and empathy.

Co-Firing Biomass Pellets in Thermal Power Plants

Context: Recently, the Union Minister for Power and New & Renewable Energy provided valuable insights into the Revised Biomass Policy and 47 Thermal Power Plants that have successfully incorporated the co-firing of coal with biomass pellets derived from agro residues during a written reply in the Rajya Sabha.

• According to Ministry of Power, approximately 1,64,976 Metric Tonnes of agri residues-based biomass has been co-fired in 47 coal based thermal power plants till May 2023

What is the Revised Biomass Policy?

About:

• The Ministry of Power and Ministry of New & Renewable Energy (MNRE) have taken significant steps towards integrating agro residue-based biomass pellets into the operations of Thermal Power Plants (TPPs).
• This marks a crucial step towards transitioning the energy sector to a more sustainable and environmentally friendly direction.

Revised Policy:

• On June 16, 2023, the Ministry of Power issued a modification to the biomass policy dated October 8, 2021.
• The revised policy mandates a 5% biomass co-firing in Thermal Power Plants (TPPs) starting from the fiscal year 2024-25.
• The biomass co-firing obligation will further increase to 7% from the fiscal year 2025-26.

What are the Government Interventions Related to Biomass Co-firing?

Financial Assistance:

• The MNRE and Central Pollution Control Board (CPCB) have introduced Finance Assistance Schemes to support biomass pellet manufacturing units.
• The Reserve Bank of India (RBI) has approved 'Biomass pellet manufacturing' as an eligible activity under Priority Sector Lending (PSL), fostering financial viability for such endeavors.

Procurement and Supply Chain:

• A dedicated Procurement Provision of Biomass Category has been established on the Government e-Marketplace (GeM) portal.
• Ministry of Power has introduced a Revised Model Long-Term Contract for Biomass Supply, ensuring a consistent supply chain.
• The provision of Udyam Aadhaar on the National Single Window System streamlines administrative processes for biomass-related projects.
• The Udyam Aadhaar registration process is based on the concept of self-declaration, enabling MSMEs to register themselves for free and obtain the Udyam Aadhaar number.

What is Biomass Co-Firing?

About:

• Biomass co-firing is a process in which biomass-based fuels are combusted together with traditional fossil fuels (such as coal, oil, or natural gas) in the same power plant or industrial boiler to generate energy.

Advantages of Co-firing Coal with Biomass Pellets:

• Carbon Emission Reduction: The concept behind biomass co-firing is to reduce the environmental impact of energy generation by substituting a portion of the fossil fuel with biomass, which is considered carbon-neutral over its lifecycle.
  • Substituting 5-7 % of coal with biomass in coal-based power plants can save 38 million tonnes of carbon dioxide emissions.
• Renewable Energy Integration: Co-firing helps in integrating renewable energy sources (biomass) with conventional energy sources (coal), aiding in the transition to a cleaner energy mix.
• Economic and Regulatory Benefits: Co-firing can help power plants meet environmental regulations and carbon reduction targets without requiring significant infrastructure changes.
• Utilization of Biomass Waste: Co-firing provides a valuable use for agricultural and forestry residues that might otherwise go to waste.

Agro Residues for Biomass Pellet Production: The Ministry of Power has identified various surplus agro residues that can be utilized for biomass pellet production. These include:

• Crop Residues: Agro-residues from crops such as Paddy, Soya, Arhar, Gwar, Cotton, Gram, Jawar, Bajra, Moong, Mustard, Sesame, Til, Maize, Sunflower, Jute, Coffee, etc.
• Shell Waste: Waste products like Groundnut Shell, Coconut Shell, Castor Seed Shell, etc.
• Additional Biomass Sources: Bamboo and its by-products, horticulture waste, and other biomass materials like Pine Cone/Needle, Elephant Grass, Sarkanda, etc.