Saturday, May 14, 2022

FAQs - on Schedule-P (Expiry Date of drugs)
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. Click to download Schedule-P 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 Also read Schedules: Drugs Schedules: Cosmetics Schedules: Medical Devices Schedules: Clinical Trials
https://thehealthmaster.com/2022/05/14/faqs-on-schedule-p-expiry-date-of-drugs/

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