Need long-term policy to support high-value pharma sector, says NITI Aayog
This story was originally published at 18:48 IST on 23 June 2026
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NEW DELHI – India needs a comprehensive long-term policy framework for sustained investment in and scaling-up of high-value pharmaceutical segments, NITI Aayog said Tuesday. India has limited presence in high-value pharmaceutical segments, which limits its global competitiveness, even as the country has strong foundational advantages in the manufacture of generic drugs, the government's top think-tank said.
"With global pharmaceutical demand shifting towards biologics, biosimilars, and precision therapies, aligning India's pharmaceutical ecosystem with these evolving market trends will be critical to enhancing its global market share and moving decisively up the value chain," NITI Aayog said in its quarterly Trade Watch report.
India must also focus on regulatory cooperation in the pharmaceutical sector when negotiating free trade agreements with partner countries, the think-tank said in the report. A standardised pharmaceutical chapter can be drafted to serve as a template for trade talks, it said.
"A model chapter would help ensure greater consistency in negotiations, strengthen market access outcomes, and systematically address non-tariff barriers affecting pharmaceutical trade," NITI Aayog said. The draft chapter will have a focus on regulatory predictability, mutual recognition and reliance mechanisms, product registration, standards harmonisation, intellectual property cooperation, and dispute-resolution frameworks, among others, it said.
"Dedicated regulatory support mechanisms for MSME (micro, small, and medium enterprises) exporters may further improve their ability to comply with complex international requirements," NITI Aayog said.
India's pharmaceutical exports, excluding active pharmaceutical ingredients, reached around $25.8 billion in 2025. The domestic pharmaceutical market, currently estimated at around $60 billion, is projected to expand to nearly $130 billion by 2030, according to the report, citing commerce ministry data.
The body also suggested restricting pre-grant oppositions to a defined period such as 6–12 months from publication while prescribing clear timelines for admissibility decisions and disposing of oppositions. "This would reduce delays in patent grants, improve predictability in the IP (intellectual property) regime, strengthen investor confidence, and encourage long-term R&D (research and development) investments in innovative drugs and biologics," according to the report.
Meanwhile, India needs improved transparency in the regulatory framework on various aspects such as non-commercial information submitted to the Central Drugs Standard Control Organisation, and state and Union territory food and drug administrations, NITI Aayog said. This will help in monitoring competing applications and enable timely legal redress, strengthening the overall innovation ecosystem, it added. End
US$1 = INR 94.73
Reported by Shweta and Shubham Rana
Edited by Rajeev Pai
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