Food and Drugs Administration, Haryana, India. |
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- FAQs – on Schedule-P (Expiry Date of drugs) - May 14, 2022
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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.
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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”.
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