FAQs – On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) dated 06.11.2019) etc.

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FAQs
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Lalit Kr. Goel
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Q1:   Who will issue license for manufacturing of Narcotic drugs?

Ans:  Excise and Taxation department will issue Narcotic license to the manufacturer on Form 24 on the recommendation of State Drugs Controller.

Q2:   Who will issue sale license to the chemist shops for sale of Narcotic drugs?

Ans:  Excise and Taxation department will issue Narcotic license to the chemist shop on Form 25 on the recommendation of State Drugs Controller.

Q3:   Whether the nursing homes required license for stocking Narcotic drugs?

Ans:  Yes, in the form of RMI (Registered Medical Institute) certificate issued by State Drugs Controller in which six drugs has been notified which come under this certificate.

Q4:   What are the new guidelines regarding Brand Name permissions to the manufacture for allopathic drugs?

Ans:  As per Govt. notification no. 828(E) dated 06.11.2019, the allopathic drug manufacturer if wants to manufacture drugs by brand name then he should submit Form-51 to the concerned State Drug Controller.

To download the notification, click here

Q5:   Is any fee/challan form required for taking permission?

Ans:  No. If the firm is already having permission of the drug in generic then there is no need of extra fee.

Q6:   What is the status of Tramadol salt?

Ans:  This drug comes under NDPS Act as psychotropic substances on dated 26.04.2018.

Q7:   What is status of combination of Buprenorphine+Naloxone sublingual tablets?

Ans:  These tablets are covered under NDPS Act, official in USP 2018. This preparation can be supplied to psychiatric clinics and hospitals in addition to de-addiction centres as per latest DCG(I)’s letter dated 28.03.2019.


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