Certainly worth the shot

Context:  The ongoing Covid-19 pandemic and the global race to develop a reliable vaccine, with attendant concerns about ‘vaccine nationalism’, have reinforced  the importance of investing in domestic research and development (R&D).

Achievement of Pharmaceutical Sector of India:

• Global Footprint:  Investment in R&D, combined with supportive public policy, has created global pharma players.
• Indian companies supply 60% of vaccines worldwide; accounted for 75% of the world market for HIV-Aids medicines, cost-effective Indian firms have helped save millions of lives around the world, especially in Africa.
• E.g. Indian pharma has also made its presence felt in biotech products and advanced insulin. 

• Skilled labour: India has sufficient manpower for scientific, academic and entrepreneurial talent in the industry.

Steps to improve the Pharmaceutical Sector:

• Regulatory Framework: India needs regulatory policies and institutions in accordance with the time, and sensitive to the needs of both research and business.
• An enabling regulatory environment based on the scientific competence of regulatory institutions.
• Reduce delays: Through streamlining the regulatory and review process, leading to early access to new drugs, while innovators would also benefit from minimal loss of residual patent life.
• Removing administrative hurdles:
•  By eliminating the need of continuous approvals for every phase of clinical trials (limiting the approval to Phase 1 only)
• Atal Innovation Mission should undertake a forensic study of existing administrative processes that inhibit investment in R&D and weed out such constraints.
• Ensuring domain knowledge and learning from industry experience 

• Improved and efficient inter-agency and inter-departmental coordination in the review process can go a long way in ensuring ease of doing R&D

• Creating a separate and competent organisation equipped with domain knowledge for the approval of new chemical and biological entities.
• Some of the approval processes can be outsourced to experts within, and even outside, the country in order to reduce time and cost.

Conclusion: It is incumbent upon government to provide competitive space to Indian Pharmaceutical firms by ensuring efficient regulation that is sensitive to cost and time requirements of firms investing in R&D.