An expert committee formed at the behest of Indian Drug Manufacturers' Association (IDMA) has come out with a country specific stability test guideline for biologicals. The committee is planning to circulate the final draft among the scientific community in the vaccine-manufacturing sector and R&D institutions for a consensus. The guideline would then be submitted before the Drugs Controller General of India (DCGI) for converting it into an official guideline.
According to sources associated with the committee, the preparation of guidelines was difficult in the absence of a proper comparative document. While the only international guideline, the ICH guideline is known not to be exhaustive, the effort of WHO to prepare a draft guideline is yet to fructify.
Though the committee had earlier planned to wait for the completion of WHO document, they feel that the country specific guidelines could now be finalized after receiving the opinion from the vaccine manufacturers. They point out that the existing ICH guidelines need to be updated. "ICH guidelines talks about the testing guidelines when one apply for a new drug. It is not an exclusive guideline for vaccines. We needed to frame our own guidelines as our requirement is different", they explained.
Indian guidelines would see that there are proper methods to be followed if someone wants to extend the shelf life of an existing product, or its temperature / humidity / conditions for exposure. "ICH guidelines are not practical in Indian situations. Our guidelines not only cover vaccines but also consider anti-sera and we have common standards for both of them. This is not the case with ICH guidelines" sources said.
It was in 2002, the IDMA requested six experts to be part of a committee for undertaking this project. The proposal came during a Pharmaceutical Analysts Committee meet organized by the association. Dr A K Tahalan, director, Central Drugs Laboratory was the chairman of the committee.
The IDMA request came after it was noticed that there are no guidelines existing in the country for the methods and parameters to be adopted while testing the stability of the biological products. Hence, the association wanted to help both the regulatory authorities as well as manufacturers to assure the maximum period of lifetime for the products and also to specify the most appropriate storage conditions to suite the temperature and humidity conditions in the country.