A raw material (API) which is near to expire , and if it becomes part of formulation , then how its efficacy/potency remains 100% through out its shelf life ?
If the formulation product is for the Indian domestic market then please follow The Drugs and Cosmetic Act 1940 and Rules 1945 of India. The relevant clause is enclosed here,
[SCHEDULE M]
[See Rules 71, 74, 76 and 78]
GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES,
PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS.
PART 1
GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS.
- 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.
Hope the matter is clarified.
No brother not agreed , shelf life of product containing sterile material i.e, ceftriaxone sodium, in this the the shelf life of the product will not exceed that of API shelf life , but in other formulations the scenario is totally different . API shelf life is not directly correlate to the Product shelf life.
Please note that I have referred to the Drugs and Cosmetics Act 1940 and Rules, 1945 of India. These are not my thoughts. The rules say so in Schedule M.
You may be right. But the rule is different. You may seek clarification from the Drug Authorities of India (CDSCO).
For the international market what you say is correct, I am talking about Indian domestic market. Please check with CDSCO, India. In their new DRAFT Rules (Schedule M) they have deleted this clause. But still it is a DRAFT and not yet finalized.
Please check.
If a pharma receives a fresh APi in 2022 , and suppose shelf life is 2025. If u ll take this API for a formulation in 2024 which hv a shelf life of three years i.e, 2026 , in this case u r saying that the product shelf life ll not exceed 2025 as API having shelf life 2025. But in this case the product shelf life ll exceed to that of API , and shelf life will be 2026.
Please note that the explanation of the co-relation of the shelf life of API and the final product (formulation) which I gave is according to the Indian Drug Rules (Schedule M). This clause was also reproduced here.
For internationally marketed products this does not apply. Moreover, I had also informed that as per my understanding this clause has been deleted from the DRAFT Schedule M. But this is not finalized yet.
I think somebody should seek clarification from the CDSCO-Indian drug authorities about this requirement.
These are not my views.
thanks brother