If closer to expiry API is used in finished product with 3 years , how that product 's potency will remain intact for three years. Is there any guideline for the use of near expiry API. Because expiry can be of different stages ( 50%,or further down)
For any drug product to be sold in the international market, there is no such requirement to co-relate the shelf life (expiry date) of an API with the drug product in which it is incorporated. However, the stability of that drug product should be established for this purpose.
For the Indian domestic market under the Drugs and Cosmetics Act 1940 and Rules thereunder 1945, see Schedule M (Clause ), as per this the shelf of API should be more than the drug product in which it is added. See below text from the Schedule M,
10 RAW MATERIALS
10.9 Only raw materials which have been released by the Quality Control Department and which are within their shelf-life shall be used. It shall be ensured that shelf-life of formulation product shall not exceed with that of active raw materials used.*
However, in the recently published Revised Schedule M (Dec 2023) there is no such requirement to co-relate the shelf life (expiry date) of an API with the drug product in which it is incorporated.
The relevant text of revised Schedule M is reproduced below,
14 MATERIALS:
14.14. Only raw materials which have been released by the QC Department and which are within their shelf life shall be used.
14.17. Only starting materials released by the QC Department and within their shelf-life shall be used.
Hope the matter is clarified.
2 Likes