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INDIA'S GENERICS DRUGS: ENSURING GLOBAL HEALTH SECURITY

India's pharmaceutical industry, known as the 'pharmacy of the world', has transformed affordable generic medicines into a global public good. By leveraging unique intellectual property laws and cost-effective manufacturing, India has broken monopolies on life-saving drugs like HIV/AIDS and COVID-19, redefining global health equity.

Description

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Picture Courtesy:  THE HINDU

Context

India's pharmaceutical sector, known as the "Pharmacy of the World," faces challenges in bilateral trade agreement negotiations with the US due to tariffs. To strengthen its negotiating power and address global health needs, India must strategically position its generics as a global public good.

What is Generic Medicine?

It is a pharmaceutical product that contains the same active ingredient, strength, safety, quality, and intended use as its branded counterpart.

Generic medicines, unlike branded drugs, can be manufactured and sold by multiple companies after the original patent expires, making them more affordable due to lower research, development, and marketing costs. 

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, regulates and approves all drugs in India, including generics.

India’s Role in Global Generic Medicine Supply

India dominates the global generic medicine market, supplying affordable drugs to over 200 countries.  

Global Leader in Generics: India accounts for 20% of global generic drug exports by volume, providing 40% of generics used in the U.S. and 50% in Africa. (PIB)

Vaccine Powerhouse: India supplies 60% of global vaccines, including those for HIV, tuberculosis, and malaria, supporting programs by WHO and UNICEF.  

Export Growth: India’s pharmaceutical exports reached $27.82 billion in FY24, with the U.S. accounting for 31.35% of the total.

India’s generics are vital for affordable healthcare, particularly in the Global South, making them a critical global public good.

Strategic Opportunities for India

Promote Generics as Global Public Good

Emphasize India’s role in supplying affordable medicines to the Global South and developed nations. For example, Indian generics constitute 90% of U.S. prescriptions for diabetes, anxiety, depression, and cancer. (The Hindu)

Advocate TRIPS Flexibilities

Push for a comprehensive review of the TRIPS Agreement to protect public health, maintaining India’s stance on compulsory licensing and the Patents Act.

Propose Joint Ventures

Encourage joint ventures with U.S. and Global South pharmaceutical industries to promote technology transfer and collaborative R&D, enhancing India’s bargaining power.

Diversify Markets

Expand exports to West Asia, Central Asia, Africa, and South America, where demand for generics is growing.  

Key Issues Facing India’s Pharmaceutical Sector

API Dependency

India imports 70-80% of Active Pharmaceutical Ingredients (APIs) from China, creating supply chain vulnerabilities.

Low R&D Investment

Indian firms invest low revenue in R&D, limiting innovation in biologics and specialty drugs.  

Environmental Concerns

Pharmaceutical waste contributes to biomedical waste, raising sustainability issues.

Trade Protectionism

U.S. tariffs and potential EU restrictions threaten India’s export growth.

Way Forward to Strengthen India’s Pharmaceutical Sector

Boost Domestic API Production

Expand the Production-Linked Incentive (PLI) scheme for API manufacturing, to reduce reliance on China.

Enhance Regulatory Compliance

Strengthen the Central Drugs Standard Control Organization (CDSCO) and align with WHO GMP (Good Manufacturing Practices) standards to reduce U.S. and EU rejection.

Increase R&D Investment

Offer tax incentives for R&D, to develop biosimilars and innovative therapies.  

Adopt Sustainable Practices

Implement zero-waste technologies and renewable energy in manufacturing to meet global sustainability standards.  

Promote Public-Private Partnerships

Collaborate with academia and global firms to advance biotechnology and digital health, supporting initiatives like the India-US TRUST framework.  

Expand Jan Aushadhi Scheme

Scale up the Pradhan Mantri Bhartiya Janaushadhi Pariyojana Kendras, to ensure affordable generics in other countries, backing India’s global image. Eg. India’s first overseas Jan Aushadi Kendra inaugurated in Mauritius.

Conclusion

The Indian pharmaceutical sector must strategically position its generics as a global public good in trade negotiations with the U.S. By advocating TRIPS flexibilities, proposing joint ventures, and diversifying markets, India can counter U.S. tariffs and IP pressures while promoting public health.  

Source: THE HINDU

PRACTICE QUESTION

Q. Examine the role of India's pharmaceutical industry in its soft power diplomacy. 150 words

Frequently Asked Questions (FAQs)

India is the largest supplier of generic drugs globally, providing over 20% of the world's generic medicines by volume.

A generic medicine is a copy of a branded drug with the same active ingredients, dosage, and quality, but sold at a much lower price after the original patent expires.

It's a provision under the Indian Patents Act and the TRIPS Agreement that allows the government to authorize a third party to produce a patented drug without the consent of the patent holder under specific conditions, primarily for public health emergencies. 

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