FAQs – on Schedule-P (Expiry Date of drugs)

FAQs - on Schedule-P (Expiry Date of drugs)

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Lalit Kr. Goel

Last Updated on May 14, 2022 by The Health Master

Q. 1: How to fix the expiry date of drugs by the manufacturer ?

Ans: Manufacturer can refer Schedule-P of the Drug and Cosmetic Act where expiry for different Drugs are mentioned. Manufacturer must assign “expiry” of their drug on the basis of stability studies.

Q. 2: Can a manufacturer decrease or increase the Expiry of their Drug ?

Ans: The manufacturer can decrease the expiry date of their drug based on the stability data, but  the expiry of the Drug can’t be increased, as Schedule-P prescribe maximum shelf life.

Also read More FAQs, click here

Q. 3: If the expiry date of the Drug is not mentioned in Schedule-P, then what’s the procedure to assign the expiry of the drug ?

Ans: Yes, expiry of drugs can be assigned based on the stability studies carried out, but upto 60 months only.

Q. 4: Storage of Drugs is mentioned in which Schedule?

Ans: Schedule-P only.

Q. 5: What will be the storage conditions for those drugs where storage condition is not mentioned?

Ans: These Drugs can be store at room temperature.

Q. 6: Is there any drug whose storage is not mentioned in Schedule-P ?

Ans: Yes, Adrenaline for injection. For the storage condition of Adrenalin for Injection, it is written in Schedule-P that “As prescribed in Indian Pharmacopoeia”.

To read all FAQs of the author, click here

Schedules: Drugs

Schedules: Cosmetics

Schedules: Medical Devices

Schedules: Clinical Trials

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