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The US Biosecure Act: An Impetus to Strengthen India’s Pharma Sector
Context:
The United States is poised to pass the Biosecure Act, which will significantly impact the global biotechnology and pharmaceutical sectors. This legislation could position India to take a leading role in these industries.
More on News:
- This legislative push comes after US intelligence allegations that WuXi AppTec shared sensitive US client data without authorisation.
- The company’s links to Chinese entities involved in technological and military advancements were seen as a potential national security threat.
US Biosecure Act Overview
- It will prohibit US federal agencies from contracting with or procuring services and equipment from “biotechnology companies of concern.”
- Including major Chinese firms like BGI, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics.
- The Act extends to companies that use or source equipment or services from these listed entities and aims to address concerns about national security risks associated with these companies.
- The Biotechnology Innovation Organisation (BIO the world’s largest biotechnology advocacy group) supports the Act.
- Although it won’t be fully operational until 2032, US companies are already exploring alternatives to diversify their supply chains.
Key Highlights:
- China’s contract development and manufacturing organisations (CDMOs) hold 8% of the global market share, while Indian CDMOs have only 2.7%.
- The Biosecure Act could disrupt US supply chains, affecting clinical trials and drug manufacturing.
- WuXi AppTec’s removal from the US market, involved in a quarter of US drugs, could impact R&D, clinical trials, and drug production.
Opportunities for Indian CDMOs and Regulatory Concerns:
- India supplies 40-50% of generic drugs to the US, has a skilled workforce, and relatively low manufacturing costs.
- India’s CDMO market is projected to grow from $22.51 billion to $44.63 billion by 2029, with a CAGR of nearly 15%.
- Drug quality issues have emerged, including the death of children in The Gambia, Cameroon, and Uzbekistan due to toxic cough syrups from Indian manufacturers.
- India’s Drug Controller General has revoked the licenses of 18 companies for spurious drug production and increased pharma inspections.
- Despite this USFDA has flagged 13% of Indian facilities for non-compliance with current good manufacturing practices (cGMP).
Path Forward for India:
- Self-Sufficiency: India needs to reduce dependency on Chinese pharmaceutical imports, which constituted 43.45% of its pharma products, including APIs, in 2023-2024.
- Regulatory Improvement: Enhance compliance by fostering a robust internal culture of quality, improving training, and promoting transparency.
- Cooperation with USFDA: Increase engagement with the USFDA, including unannounced inspections and addressing language barriers.
Government Initiatives:
- India is investing in domestic API production through Performance Linked Incentive (PLI) schemes, with INR 15,000 crore allocated for six years starting in 2021.
- Increased funding for USFDA inspections and a pilot program for unannounced inspections in India are underway.
