Discuss how WTO's TRIPS Agreement and its flexibilities, particularly Compulsory Licensing and Section 3(d) of India's Patents Act, shape India's pharmaceutical trade policy.

Q. Discuss how WTO's TRIPS Agreement and its flexibilities, particularly Compulsory Licensing and Section 3(d) of India's Patents Act, shape India's pharmaceutical trade policy. (15 marks, 250-350 words)

The TRIPS Agreement (Annex 1C of the Marrakesh Agreement, 1995) obliged India to grant product patents on medicines from 2005, ending the process-patent regime under which its generic industry was built [1]. India's pharmaceutical trade policy since has been an exercise in using TRIPS' in-built flexibilities to reconcile export competitiveness with affordable access.

TRIPS reset the policy baseline - Article 27 requires patents in all fields of technology, so the Patents (Amendment) Act, 2005 restored product patents on drugs, closing the pure reverse-engineering route [1][2]. - India adapted by specialising in off-patent generics, becoming the third-largest producer by volume, with roughly half of its ~$50 billion output exported [4].

Compulsory Licensing as public-health leverage - The Doha Declaration on TRIPS and Public Health (2001) affirmed members' right to use flexibilities to protect public health — a position India helped shape [3]. - Section 84, Patents Act permits a licence after three years where the drug is unaffordable, unavailable, or the patent is not worked in India [2]. Its landmark use was the 2012 licence to Natco for Bayer's anti-cancer drug sorafenib. - India has invoked it sparingly, signalling restraint to preserve investment confidence and avoid trade friction, while retaining it as negotiating leverage.

Section 3(d) as an anti-evergreening filter - It bars patents on new forms of known substances absent significantly enhanced efficacy [2], upheld by the Supreme Court in Novartis v. Union of India (2013) on imatinib. - This keeps molecules in the generic pool early, sustaining India's low-cost export model and its role as supplier of affordable medicines to developing countries.

Thus TRIPS compliance and TRIPS flexibilities together define India's dual identity — a rule-abiding trading partner and the "pharmacy of the Global South." Going forward, India should pair this legal architecture with value-chain upgrading through the PLI schemes for bulk drugs (₹6,940 crore) and pharmaceuticals (₹15,000 crore) [4], moving from volume-based generics towards biosimilars and patented products — securing export resilience while advancing SDG-3 on affordable medicines.

(~320 words)

Sources: 1. TRIPS Agreement text, WTO — product patents in all fields of technology; TRIPS as Annex 1C 2. The Patents Act, 1970 (as amended), India Code — Section 3(d) anti-evergreening; Section 84 compulsory licensing grounds; 2005 amendment 3. TRIPS and public health / Doha Declaration, WTO — right to use flexibilities for public health 4. Government measures to encourage domestic manufacturing in the pharmaceutical sector, PIB — industry size, third-largest by volume, export share, PLI outlays