India Pharma: US Bio-secure Act

By - CMG
23-11-24 10:28 AM

Long Term and Short Term impact of ACT on Pharma Companies in India

The US Biosecure Act is a legislative measure aimed at reducing the United States' dependence on Chinese companies for biopharmaceutical manufacturing. It specifically prohibits US federal agencies and companies from contracting with or providing grants to certain "biotechnology companies of concern," primarily targeting prominent Chinese firms such as BGI Genomics, MGI Tech, Complete Genomics, WuXi AppTec, and WuXi Biologics. This act is seen as a response to national security concerns regarding the unauthorized sharing of sensitive data by these companies with Chinese entities  [1], [2], [3].

 

Implications for Indian Pharma Companies

 

Short-Term Implications

1. Limited Immediate Impact: According to industry experts, the effects of the Biosecure Act on Indian pharma companies are expected to be minimal in the short term. Amit Varma from Quadria Capital noted that any significant changes would likely take two to three years to materialize as companies transition their supply chains away from Chinese CDMOs  [4].

 

2. Supply Chain Disruptions: The act may initially lead to disruptions in the supply of drugs and critical raw materials as US companies seek alternatives to Chinese suppliers. This could create temporary challenges for Indian firms that are not yet fully prepared to scale up production or meet increased demand  [5].

 

3. Increased Enquiries: Despite the limited immediate impact, there has been a noticeable increase in inquiries from US firms looking for alternative suppliers, which indicates a potential shift in sourcing strategies  [5].


Long-Term Implications

1. Market Opportunities: In the long run, the Biosecure Act is expected to create significant opportunities for Indian pharmaceutical companies. As US biopharma looks to diversify its sourcing, Indian firms could fill the gap left by exiting Chinese manufacturers. This shift could enhance India's position as a key player in the global pharmaceutical supply chain  [2], [5].

 

2. Regulatory Enhancements Needed: For Indian pharma companies to capitalize on these opportunities, they will need to strengthen their regulatory processes and ensure that their products meet international safety and efficacy standards. This is crucial for maintaining competitiveness against US and European firms  [2].

 

3. Investment in Capabilities: The act presents an impetus for Indian companies to invest in their manufacturing capabilities and expand their service offerings. Firms like Syngene are already seeing traction due to long-term contracts with multinational corporations, indicating a shift in sourcing strategies among Big Pharma  [1].

 

4. Potential Market Growth: The Indian pharmaceutical market is projected to grow at an annual rate of 8-9%, and with the Biosecure Act potentially driving more business towards Indian firms, this growth could accelerate further  [6].

 

5. Strategic Positioning: Companies like Laurus Labs and Piramal Pharma are optimistic about the favorable environment that may develop over time as they adapt their strategies to align with changing market dynamics resulting from the act  [1].

 

In summary, while the US Biosecure Act may not yield immediate benefits for Indian pharma companies, it holds substantial long-term potential by reshaping supply chains and creating new market opportunities as US firms seek reliable alternatives to Chinese suppliers. However, this will require Indian companies to enhance their operational capabilities and regulatory compliance to fully leverage these opportunities.

CMG