In the wake of prevailing ambiguity over the categorization of thermolabile and thermostable drugs, an expert panel has been constituted by the Drugs Consultative Committee (DCC) to decide which categories of drugs are to be taken as thermolabile or thermostable specifically.

The categorization of thermolabile and thermostable drugs is important as due to the prevailing lack of clarity on the issue and also in the wake of lack of any specific guidelines from higher authorities. Because of this,the state drug control authorities have been finding it difficult to take action regarding drug samples declared 'not of standard quality' in assay in their routine random inspection of drugs in their states.

Several state drug controllers raised the issue during the last DCC meeting, which was chaired by Drugs Controller General of India (DCGI) Dr GN Singh.

In the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act 2008, guidelines were issued by the DCGI for taking action on the samples of drugs declared “Not of Standard” quality. As per guidelines, if the active ingredients of drugs are below 70 per cent in case of  thermolabile drug and below five per cent of the permitted limits for the thermostable drugs they are categorized as grossly sub standard drugs.

Highlighting the lack of clarity on the issue, the state drug controllers informed the DCC that in most of the drug formulations including biological and non-biological formulations, the storage conditions mentioned by the manufacturer on the labels are to be stored in cool place which means temperature below 25° C. In schedule P of the Drugs and Cosmetics Rules,  for most of the antibiotic and vitamins formulations, no specific storage conditions are prescribed and these are to be stored under normal room temperature. In case of schedule P, no storage conditions are prescribed for enzyme preparations. Enzyme are also not listed in Schedule C and C1 and thus are non-biological drugs.

Some drugs like vaccine, sera and insulin injection, etc., which required storage in cold place i.e. temperature below 8° C, are highly thermolabile drugs. As per guidelines, the weapon for prosecution should be used sparingly and judiciously.

After deliberations, the DCC recommended that categorization of  thermolabile and thermostable drugs should be examined by an expert committee consisting of the drug controllers in Maharashtra, Rajasthan, Odisha and with Dr D Roy, deputy drugs controller, North Zone as the convener.