India’s Pharmaceutical Industry With Ambitious Growth Plans

India’s pharmaceutical industry is a significant force in the global market, boasting a strong domestic presence and a rapidly growing export sector. This press release was issued on December 17, 2024.

Industry Size and Strength

• Valued at USD 50 billion (FY 2023-24)
• Domestic consumption: USD 23.5 billion
• Exports: USD 26.5 billion
• Ranked 3rd globally by volume and 14th by value of production
• Offers a diverse product base including generic drugs, bulk drugs, OTC medications, vaccines, biosimilars, and biologics.

Focus on Research & Development

National Institutes of Pharmaceutical Education & Research (NIPERs) spearhead research efforts.

The National Policy on Research & Development and Innovation in Pharma-MedTech Sector aims to:

1. Facilitate innovation and research through a supportive regulatory environment.
2. Encourage private and public investment through financial incentives.
3. Build a robust ecosystem for research and development.
4. Scheme for Promotion of Research & Innovation in Pharma Sector (PRIP) offers financial assistance for R&D initiatives.

Regulatory Streamlining

New Drugs and Clinical Trials Rules, 2019 expedite approvals and encourage clinical trials. Provisions for faster approvals for unmet medical needs and rare diseases. Drugs must comply with domestic regulations and those of the importing country.

Intellectual Property

The government has undertaken broader initiatives to strengthen the Intellectual Property regime across all industries. These initiatives include streamlining patent application processes and offering fee rebates for startups and small entities.

The Start-Ups Intellectual Property Protection (SIPP) Scheme facilitates IP protection for startups and innovators.

India’s pharmaceutical industry is poised for continued growth, fueled by a robust domestic market, a strong export sector, and a growing emphasis on research and development. The government’s supportive policies and initiatives are expected to further enhance the industry’s competitiveness and innovation capabilities.