Study attempts to find out how India made expensive diabetes medicines affordable
2-minute summary
A recent study published in the journal Diabetes Care and led by Chennai-based diabetologists examines how India has made expensive modern diabetes medications—such as GLP-1 receptor agonists, SGLT2 inhibitors, and analogue insulins—relatively more affordable and accessible compared to other low- and middle-income countries (LMICs). The study highlights India's strategic legislative framework, notably its robust intellectual property regime that prevents 'patent evergreening', along with a strong domestic generic and biosimilar manufacturing ecosystem. While foundational medicines like metformin and sulfonylureas are part of the National List of Essential Medicines (NLEM), newer molecules have become more accessible following competitive entry by multiple domestic manufacturers (e.g., dropping prices of semaglutide). However, affordability challenges persist due to low insurance coverage for outpatient drugs and high absolute monthly costs relative to household incomes. The paper underscores valuable lessons for other LMICs, including building local manufacturing capacity, balancing patent governance, leveraging public distribution networks like Jan Aushadi Kendras, and addressing urban-rural healthcare disparities and quality pharmacovigilance.
Why it's in the news
A prominent study published in Diabetes Care by Dr. V. Mohan and other diabetologists examined India's pharmaceutical policies, generic manufacturing strength, and intellectual property safeguards (like preventing patent evergreening) as a model for making expensive modern diabetes medications affordable in low- and middle-income countries.
Background and context
India's emergence as the 'pharmacy of the world' is rooted in the Indian Patents Act of 1970, which abolished product patents for pharmaceutical products and permitted process patents. This policy shift allowed domestic companies to reverse-engineer and manufacture affordable generic versions of essential drugs. Following India's accession to the WTO and the signing of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement in 1995, India amended its patent laws in 2005 to reintroduce product patents. However, India retained critical public health safeguards under Section 3(d) of the Patents Act, which prevents 'patent evergreening' (granting minor tweaks to existing patents to extend exclusivity). Coupled with active government initiatives like the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) and production-linked incentive (PLI) schemes for active pharmaceutical ingredients (APIs), India has sustained its capacity to supply low-cost generic drugs globally and domestically.
Constitutional provisions
- Article 21 — The Right to Health and access to affordable life-saving medicines is implicitly protected under the Right to Life and Personal Liberty guaranteed by Article 21 of the Constitution.
- Article 47 — Directs the State to raise the level of nutrition and the standard of living and to improve public health, serving as a directive principle for ensuring affordable healthcare and medication.
Government schemes
- Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) — Provides quality generic medicines at affordable prices through dedicated kendras, enhancing access and reducing out-of-pocket expenditure.
- Production Linked Incentive (PLI) Scheme for Pharmaceuticals — Aims to enhance India's manufacturing capabilities by increasing export growth and reducing import dependence on critical active pharmaceutical ingredients (APIs) and raw materials.
International organisations
- World Trade Organization (WTO) - TRIPS Agreement — Governs intellectual property rights globally, while permitting flexibilities such as compulsory licensing and patentability criteria (e.g., Section 3(d)) to protect public health in developing nations.
Mains practice: Examine India's role in making essential and modern medicines affordable, and highlight the challenges that remain in ensuring equitable access to diabetes care.
Introduction:
India is widely recognized as the 'pharmacy of the world' due to its robust generic pharmaceutical manufacturing capacity. Recent studies highlight how India's strategic legislative frameworks have successfully driven down the costs of expensive modern therapies, offering critical lessons for other low- and middle-income countries (LMICs).
Body:
• Legislative Safeguards & IPR: India's Patent Act (specifically Section 3(d)) prevents 'patent evergreening', allowing domestic manufacturers to produce generic equivalents of life-saving drugs once patents expire or through strict patent opposition.
• Generic and Biosimilar Ecosystem: Competitive entry by multiple domestic pharmaceutical firms has drastically reduced the prices of advanced therapies (e.g., semaglutide), expanding market penetration and availability.
• Public Infrastructure & Interventions: Government initiatives like Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) and Production-Linked Incentive (PLI) schemes for APIs help lower import dependencies, boost domestic raw material production, and provide low-cost retail options.
• Persistent Challenges:
- Out-of-Pocket Expenditure: Modern therapeutics and advanced diabetes care are largely excluded from comprehensive health insurance coverage, keeping absolute monthly costs high relative to household incomes.
- Disparities and Quality Control: Significant urban-rural divides persist in the distribution of essential medicines, alongside concerns regarding pharmacovigilance and quality variations among generic alternatives.
Conclusion:
While India's intellectual property and generic manufacturing model successfully balances innovation with affordability, long-term clinical accessibility requires integrating advanced therapeutics into essential medicine lists, expanding public health insurance coverage for outpatient care, and strengthening rural distribution networks.
Prelims practice questions
Q1. Consider the following statements regarding India's pharmaceutical sector and patent laws: 1. Section 3(d) of the Indian Patents Act specifically helps prevent 'patent evergreening'. 2. All modern diabetes medications, including GLP-1 receptor agonists and SGLT2 inhibitors, are currently included in India's National List of Essential Medicines (NLEM). Which of the statements given above is/are correct?
- 1 only
- 2 only
- Both 1 and 2
- Neither 1 nor 2
Answer: A. Statement 1 is correct: Section 3(d) of the Indian Patents Act prevents patent evergreening by setting stringent criteria for granting patents on minor modifications of known substances. Statement 2 is incorrect: While older drugs like metformin and sulfonylureas are in the NLEM, newer classes like DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists are not currently included in the NLEM.
Q2. With reference to the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP), consider the following statements: 1. It is implemented by the Ministry of Health and Family Welfare. 2. Its primary objective is to make quality generic medicines available at affordable prices to all. Which of the statements given above is/are correct?
- 1 only
- 2 only
- Both 1 and 2
- Neither 1 nor 2
Answer: B. Statement 1 is incorrect: PMBJP is implemented by the Bureau of Pharma PSUs of India (BPPI) under the administrative control of the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Statement 2 is correct: The scheme aims to provide quality generic medicines at affordable prices through dedicated Janaushadhi Kendras.
Q3. The term 'patent evergreening', frequently seen in news, relates to which of the following?
- A mechanism to extend the patent term of a drug by making minor, non-innovative modifications
- An environmental certification given to pharmaceutical manufacturing units using green energy
- A tax exemption granted to green-field biotechnology research startups
- A policy ensuring lifelong free distribution of patented vaccines in developing nations
Answer: A. Patent evergreening refers to corporate and legal practices used by patent holders (often pharmaceutical companies) to extend patent protection over products just as existing patents expire, typically by making minor, non-transformative modifications to the original drug.
Revision flashcards
- What is the primary objective of Section 3(d) of the Indian Patents Act? To prevent 'patent evergreening' by disallowing patents on mere discoveries of new forms, uses, or properties of known substances without significant enhancement in efficacy.
- Which ministry implements the Production Linked Incentive (PLI) Scheme for Pharmaceuticals in India? Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.
- What are DPP-4 inhibitors, SGLT2i, and GLP-1 RA in the context of health? Modern therapeutic drug classes used in the management of type 2 diabetes and associated cardiovascular and renal outcomes.
- What is the primary function of Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP)? To provide quality generic medicines at affordable prices through dedicated retail outlets (Janaushadhi Kendras) to reduce out-of-pocket healthcare expenses.
- What major global agreement governs intellectual property standards and provides public health flexibilities like compulsory licensing? The WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.