Govt plans revamp of cold chain storage regulations for vaccines, insulin

Subscribe to enjoy similar stories.New Delhi: 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.The plan is to define and classify these medications into two group— 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.“The idea is to have a clear mandate of labelling and storage practices during routine inspections. By strengthening the national cold chain and enforcing strict storage standards, we can ensure that patients consistently receive good quality medicine,” said the first of the two officials cited earlier, both of whom spoke on the condition of anonymity.The Central Drugs Standard Control Organisation (CDSCO), India’s apex drugs regulator, has identified 203 specific formulations including antibiotics, insulin preparations, vaccines, toxoids, human blood products, and plasma, that require this strict check.