India Pharma Outlook Team | Monday, 07 September 2026
.jpg "Why India Needs Global Regulatory Standards to Attract Pharma")
India’s pharma industry is looking beyond generics, but regulatory standards could determine how quickly it attracts global investment in innovation.
Commerce and Industry Minister Piyush Goyal has called for greater alignment with developed markets to make India more attractive for research, clinical trials, and new drug development.
Speaking at the Bharat Health Global Expo 2026, Goyal said India needs an open regulatory system that encourages companies to invest in clinical trials, R&D, patenting, and new product launches. He also urged regulators to study rules followed by developed countries and move toward greater regulatory convergence.
The push comes as India aims to strengthen its position as a global pharmaceutical and biotechnology hub.
Goyal said India needs to create a regulatory environment where innovation becomes attractive for global companies. He also stressed the need to listen to investors and governments looking to work with India.
The minister highlighted several areas that could benefit from stronger policy support:
Goyal said regulatory standards should not become a barrier to innovation. Instead, they should help companies bring new technologies and treatments to the market.
This approach could also help India attract more global pharmaceutical partnerships. The government has previously positioned India as a trusted partner for manufacturing, clinical trials, technology, and innovation.
The call for regulatory convergence comes amid an ongoing debate over regulatory dossier exclusivity in India.
The Organization of Pharmaceutical Producers of India has sought exclusivity periods for new chemical entities and biologics. OPPI has proposed 10 years for new chemical entities and 12 years for biologics.
India currently allows generic manufacturers to use clinical trial data from new drugs to establish bioequivalence for later regulatory submissions. In the US, new chemical entities generally receive five years of regulatory data exclusivity.
Innovator companies argue that stronger protection could improve incentives for research investment. However, concerns remain that longer exclusivity could delay generic competition and increase medicine costs.
The debate highlights the challenge India faces. The country needs to attract innovation while preserving access to affordable medicines.
Also Read: How Biologics and Complex Therapies Are Reshaping CDMO Strategy
Goyal also linked pharma growth with supply chain resilience. He said India should reduce dependence on limited geographies for critical imports.
The country has lost ground to China in areas such as active pharmaceutical ingredients and key starting materials. Goyal stressed that supply chains should have multiple sources to reduce geopolitical risks.
The government is also working on plans for 100 new industrial parks. These parks are expected to offer plug-and-play facilities for manufacturers.
India has signed nine free trade agreements over the past four years. These agreements provide preferential access to 38 developed countries with a combined GDP of about USD 60 trillion. The government is also negotiating eight to nine more trade deals.
For India, the next phase of pharma growth may depend on balancing three priorities: innovation, affordable medicines, and globally aligned regulatory standards.
.jpg)
