The report is based on published information in leading journals, papers and patent application filed on the subject. The draft was discussed with leading experts and drugs manufacturers in the country. The present (final) report incorporate their suggestions.
Need of Temperature Sensitive Indicators
In India, considerable quantity of life saving drugs, vaccines and vitamins are produced. The potency of some of these drugs are adversely affected, when exposed to temperature higher than those specified. At present, no simple means are available either to the manufacturer or the customer to check, if the phile containing the drug, vaccine or vitamins has been exposed to higher temperatures, than those recommended, during its passage from manufacturer to customer. The problem is acute in India, where storage of drugs at required temperature at retail outlets, especially, in remote areas, is either not available or effective, for most of the time, due to frequent power cuts and / or failure, more so during summers, when the ambient temperature, in most parts of the country, during major part of the day is more than 300C.
Recommended Storage Temperature
Detailed study of Indian, British and United States Pharmacopoeias showed that they all indicate only the safe recommended storage temperature of drugs, and do not specify the maximum temperature to which a drug can be exposed without significant loss of potency, nor the allowable duration of exposure to higher temperature. Recommended storage temperature as per Indian Pharmacopoeias (JP), are:
- Temperature less than 80C, for vaccines, injectables and other life saving drugs.
- Temperature less than 250C, for formulations, vitamins and other drugs.
- Temperature above 300C, for capsules, tablets and other types of non-temperature sensitive drugs.
Discussions held with the office of Drug Controller of India, New Delhi, indicated that, to the best of their knowledge, none of the pharmacopoeias published by any country, gives any guidelines, on either maximum allowable duration of exposure to higher temperature or modalities of transportation that should be adopted to minimise exposure to higher temperature.
Discussions held with the major manufacturers of drugs, vaccines and vitamins, on the need for temperature sensitive indicators on each phile for their temperature sensitive medicines revealed, that most of them are in favour of a statutory incorporation of such an indicator on each phile containing the temperature sensitive drugs. Statutory incorporation of such an indicator, they feel, will benefit both the customers and drug manufacturers immensely. The specifications of temperature sensitive indicator required by manufacturers can be summarized as under:
- Temperature of operation – 100C and 300C
- Time delays required for operation:
- For antiseras and Allied items - 30 minutes
- Other injectables - 2 hours
- Vitamins and formulation - 3 hours
- Colour change should be markedly visible by naked eye and should be irreversible.
- Should not get affected and/or poisoned by any solvent, aerosol, disinfectant or any other commonly available items.
- Size should be small enough to be fixed on drug philes an ampules.
- Reliability should be 100% (notional).
- Should be available in batch sizes, atleast to operate the automatic labeling machine uninterruptdly atleast for four hours.
- Should be non-toxic and should not pose any pollution problems.
- Cost should be low enough, not to materiality affect the delivered price of drugs.
- Should be freely available indigenously.