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Thursday, September 9, 2010

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Health Min. assigns DCGI to review provision linking expiry date of APIs with formulations (7/9/10)

Mumbai, 7 Sept: The Ministry of Health and Family Welfare would soon look into a demand from the pharma industry to review a provision in the Drugs and Cosmetics Rules, 1945, limiting the expiry date of the finished dose formulation based on the period of expiry of active ingredients, it is learnt.
According to the industry sources, Ghulam Nabi Azad, Union minister for health and family welfare has agreed to look into the issue by assigning the central drug regulator for further studies. The Drug Controller General of India (DCGI) will moot the issue in the next Drug Consultative Committee (DCC) for the purpose, they added
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As per the Proviso 10.9 in the Schedule M, Part I of the Drugs and Cosmetics Rules, 1945, it must be ensured that the "shelf life of formulation product shall not exceed with that of active raw materials used." However, the industry argued that world wide, the provision is to determine the shelf life of the formulation based on the stability studies on the finished products, and this has to be followed in India too.
"Globally, the procedure is to fix an expiry date of the formulations based on the results of stability tests conducted on the finished formulation and we asked that why it should be different in India when we are following the international regulations more now a days. The minister informed us that the issue will be discussed in the next DCC for further action," said N R Munjal, president, IDMA.
Considering the expiry date of the raw material to determine the expiry of formulations has caused trouble for both the formulations and active pharmaceutical ingredient (API) manufacturers, said sources from the industry.
For instance, a formulations manufacturer who relies on another firm for raw material supplies may face loss due to wastage of material and lower shelf life for its product if the raw material is nearing overage or a consignment is delayed. In such circumstances, the formulation manufacturers are forced to reject the consignment, which may also cause trouble to both the parties, said a senior pharma expert.

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