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)
1 Like
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
Dear All,
I need to your help to address below question.
The specific requirement regarding the shelf life of the formulation product not exceeding that of the active raw materials used has been removed in the updated Schedule M (Dec 2023).
The deletion of such a statement would mean that there is more flexibility assigning shelf life of drug product.
I would like to know whether for the domestic market, pharma companies can assign the expiry date of drug product based on the release testing of drug substance, even though drug substance is near expiry. Is it accepted by the state regulatory authority?
Thank you!!!
Hello Nirav Ji,
Please note that although 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, however, you can not assign any shelf life to the drug product unless it has been confirmed by the stability studies in the final container closure system in which that drug product is marketed and the stability studies should be carried out as per ICH guidelines. Also, there is a maximum limit to assign the shelf life of generally stable drug products as per the Indian Drug Rules (NMT 36 months). Of course, for other categories of drug products like vitamins, antibiotics, hormones, and thermolabile products it will be much less than 36 months depending upon its stability.
Considering the above facts there is no flexibility in assigning the shelf life to the drug products.
State regulatory authorities must be aware of these facts and rules.
This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.