India plans vaccine storage overhaul

India is planning to overhaul its pharmaceutical storage rules for vaccines and biological products, as gaps in the regulatory framework have frequently led to drugs being stored under improper temperature conditions, potentially compromising their efficacy, according to two government officials and documents reviewed by Mint.

- Priyanka Sharma

The plan is to define and classify these medications into two groups—thermostable or those that can survive high temperatures, and thermolabile, or those that cannot, to ensure medicines, including insulin and vaccines are handled with scientific precision throughout the supply chain. Currently, the Drugs and Cosmetics Act, 1940, lacks these specific classifications.

While Schedule P of the Drugs Rules, 1945 provides general storage instructions such as ‘cold place’ for temperatures not exceeding 8 degrees Celsius, there has been no comprehensive, science-based list to guide manufacturers and drug inspectors. As part of the plan, all drug formulations requiring storage at or below 8 degrees Celsius will be classified as thermolabile drugs.