In order to ensure that the drug formulations marketed in the country are stable till the end of the shelf life, the union health ministry will soon amend the Drugs and Cosmetics Rules, 1945 to make provisions for providing evidence and data about the stability of the drug products by the manufacturers.

A proposal by the ministry to this effect was discussed by the Drugs Technical Advisory Board (DTAB), the highest decision-making body in the union health ministry on technical matters, in its meeting held on November 25 this year.

The DTAB after deliberations agreed that the condition for stability of the products as condition of license may be incorporated in rule 71, 71-B & 76 and wherever consider necessary. In respect of amendment of Schedule Y, it recommended that WHO may be further consulted and if required more data to be generated for further consideration of the matter.

In the DTAB meeting, drugs controller general of India Dr GN Singh, who is the member secretary of the Board, explained to the members that in order to ensure that the drug formulations marketed in the country are stable till the end of the shelf life, it was necessary that the requirement of stability studies should be brought under the condition of license (s) for manufacture drugs especially in rule 71, 71-B in rule 76 etc. It was therefore proposed that the following condition should be incorporated under the rule 71, 71-B, 76 or wherever consider necessary.

“The applicant shall, while applying for license to manufacture drugs, furnish to the Licensing Authority evidence and data justifying that the drugs are stable for proposed shelf life under the condition of storage recommended. The data shall be generated as per Appendix IX of Schedule Y”.

He further stated that WHO in his publication TRS 937, Guidelines on long term stability conditions for India, has put India in Zone IV b and the long term stability studies are required at 30ºC at 70 per cent RH or 30ºC at 75 ± 5 per cent RH instead of 30ºC ± 2ºC / 65 per cent RH ± 5 per cent RH for 12 months. In view of this Appendix IX of Schedule Y relating to Stability Testing of New Drugs where long term study conditions for drug substances and formulations intended to be stored under general conditions is mentioned as 30ºC ± 2ºC / 65 per cent RH ± 5 per cent RH for 12 months is required to be amended to read as 30ºC ± 2/ 70 per cent RH OR 30ºC ± 2/ 75 ± 5 per cent RH for 12 months.

The proposals were also considered in the 46th DCC meeting held on November 12 & 13, 2013 and it had recommended the proposed amendments.