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FAQs – on Drug Permission in Brand or Generic Name
Q1: The permission to manufacture drug in generic or in brand by the State Licensing Authority (SLA)?
Ans: The permission of drug will be issued in generic name only by the SLA.
Q2: From when the SLA start giving permission of drug in generic name only?
Ans: As per the directions issued by Ministry of Health dated 01.10.2012, SLA will issue permission of drug in generic name only.
To download the directions dated 01-10-2012, click here
Q3: Is any further directions has been issued by the Govt. regarding circulation dated 01.10.2012?
Ans: Yes, on dated 09.11.2012 directions has been issued by the Govt. regarding circular dated 01.10.2012, in which it is said that this direction has prospective effect only.
To download the directions dated 09-11-2012, click here
Q4: What is the status for issuance of permission for Cosmetics?
Ans: SLA can issue permission of cosmetics in both generic and brand name.
Q5: What is the status for issuance of permission for Medical Devices?
Ans: SLA can issue permission for Medical devices in both generic and brand name.
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Q6: What is the status for issuance of permission for Homeopathic Drugs?
Ans: SLA can issue permission for homeopathic drugs in both generic and brand name.
Q7: What are the other exemptions given in the said circular?
Ans: It is not applicable for import of drugs, COPP, GMP, Free Sale Certificate
Q8: Is any notification issued by the Govt. regarding permission of drug formulation containing single ingredient in proper name?
Ans: Yes, Govt. has issued notification No. GSR 570(E) dated 27.08.2014, in which Govt. has made amendment in Rule 71 of the Act for permission of drug formulation containing single ingredient in proper name only
To download the notification dated 27-08-2014, click here
Q9: Is there any notification regarding submission of Form-51 by the manufacturer in case he intended to market the drug in brand name?
Ans: Yes, Govt. has issued notification no. GSR 828(E) dated 06.11.2019 that if a manufacturer intended to market a drug in brand name then he has to submit Form 51 to the Licensing Authority
To download the notification dated 06-11-2019, click here
Q10: What is the parameter for granting permission of multi vitamins containing multi ingredients?
Ans: As per the above said circular dated 01-10-2012 permission can be granted under the category of product i.e. multi vitamin capsule/tablet/syrup etc.
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