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

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. This assumes significance for India's $12 billion biopharmaceutical market, with India supplying 60% of vaccines to over 200 countries.

A sub-committee was constituted in 2023 by the Drugs Consultative Committee (DCC), a statutory body under the Drugs and Cosmetics Act. The sub-committee, comprising experts from several organisations, including the National Institute of Pharmaceutical Education and Research (NIPER) and CDSCO, was tasked with addressing the lack of legal definitions for thermostability under the Drugs and Cosmetics Act by preparing a science-based indicative list of “Thermostable” and “Thermolabile” drugs to ensure uniform storage and drug efficacy.

The panel, in its report submitted to the goverment and reviewed by Mint, said that “the drugs formulations which require storage at temperature not exceeding 8°C as per the Drugs & Cosmetics Act & Rules as well as Indian Pharmacopoeia can be clearly considered as 'Thermolabile Drugs'".

All other medications would be classified as thermostable drugs, which remain stable without losing their efficacy under normal room temperature not exceeding 30 degree Celsius.

Queries sent to the Union health ministry, Drugs Controller General of India, key vaccine makers Serum Institute and Bharat Biotech and biopharmaceutical firm Biocon did not elicit any response.

“At Panacea Biotec, all vaccines and other thermolabile products are stored strictly as per their approved label claim and defined storage conditions. Validated cold chain systems ensure that specific materials such as drug product, bulk drug substances, cell banks and certain raw materials are stored at appropriately qualified temperature ranges with automatic alarms, including refrigerated, ultra-low, or controlled room temperature conditions as defined in our Site Master File and applicable SOPs,” the spokesperson of Panacea Biotec said in an email response.

The panel also recommended a revision of Schedule P of the Drugs Rules, 1945 and emphasized that this list must remain “dynamic", allowing regulators to update storage requirements as new medical technologies and formulations emerge.

The National Cold Chain and Vaccine Management Resource Centre (NCCVMRC), managed under the Union health ministry, ensures safe storage and transport for the universal immunization program through more than 28,000 cold-chain points with a network of walk-in freezers/coolers and ice-lined refrigerators for storing vaccines at recommended temperatures.