Scaling Up Vaccine Production

Context: An overview of legal options to scale up vaccine production.

Background Status of vaccine production: According to Observer Research Foundation, till the end of March, India produced 316 million doses of Covishield and Covaxin, two COVID-19 vaccines in use in India.

• Exports: Of this, 64.5 million doses have been exported.
• Challenges: Centralised procurement, distribution, and coordination with different state governments and local authorities.

Legal options to scale up production

• Non-IP-based solutions:
  • Section 2 of Epidemic Diseases Act of 1897: Empowers government, during an outbreak of an epidemic, to take measures that it may deem necessary to prevent an outbreak or its spread.
  • Section 26B of the Drugs and Cosmetics Act, 1940: Empowers the Central government to regulate the sale, manufacture, and distribution of a drug that is essential to meet the requirements of an emergency arising due to an epidemic.
  • Loaning manufacturing capacity: Government can direct pharmaceutical companies to loan their manufacturing capacity to existing COVID-19 manufacturers like Serum Institute of India and Bharat Biotech.
• IP-based solutions
  • Section 100 of Patents Act, 1970: Central government has the power to authorise anyone (such as specific pharmaceutical companies) to use any patents or patent applications for “purposes of government”.
  • Section 92 of the Patents Act: Allows the Central government to issue a compulsory licence.
  • Relax IP rights: For e.g. All COVID-19 vaccine projects that are funded by taxpayer’s money shall not claim IP rights.
  • Role of the public sector: Government needs to explore the production capabilities of pharmaceutical companies in the public sector to build India’s manufacturing competence.