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Analysis for Implementation of notification: GSR 828(E) dated 06.11.2019 on Submission of Undertaking on Brand Names
To download the notification, click here
Background of Notification:
Earlier the Drug Formulation approvals were granted by the competent Licensing Authorities mostly State Licensing Authorities with Brand Names/Trade Names as applied by the applicants i.e. manufacturers. However this word ‘manufacturer’ is not defined under Drug Rules and process ‘manufacture’ is defined under Rule 3(f) of Drugs Rules and therefore who so ever is performing/doing manufacturing of drugs is considered to be manufacturer of that drug.
Following questions were raised number of times by stakeholders:-
- Whether approval for applicant is required with Brand Name?
- Whether State or Central Licensing Authorities are competent to issue approvals with Brand names?
As per Rules prevailing under Drug Rules, there are various provisions for this purpose:-
Rule 96(1)(i)-A: Which prescribes labeling provisions and states as under:-
“For this purpose, the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name”
Rule 65(11)-A: Conditions of license for Retail/Wholesale on Forms 20, 20-A, 20-B, 20-F, 20-G, 21 & 21-B prescribed as under:-
“No person dispensing a prescription containing substances specified in [Schedule H and Schedule H1] or X], may supply any other preparation, whether containing the same substance or not, in lieu thereof.”
Rule 65: “Name of drug” is mentioned in Rule 65(3), 65(5)(3) etc. which includes both “Brand name/Trade name and Generic Formulae” and Rule 65(II)-A further substantiate the requirement of “Brand Name” of Drug.
Section 17-B(e): Defines the Spurious Drugs as under:
“If it purports to be the product of a manufacturer of whom it is not truly a product.”
This provision not only prescribes protection against counterfeit drugs but also protect the “Brand Names” of the drugs.”
Section 27(c): For companies contravening this provision of Act was punishable under Section 27(c) which is as under:
“Any drug deemed to be spurious under section 17-B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall 6[not be less than seven years but which may extend to imprisonment for life and with fine which shall not be less than three lakh rupees or three times the value of the drugs confiscated, whichever is more]:
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of 7[less than seven years but not less than three years and of fine of less than one lakh rupees]”
This stringent punishment provisions were sufficient to protect “Brand Names” and also LA/SLA to check Look Alike Sound Alike (LASA) drugs coming in purview of Section 17-B(e).
But directions issued by the Govt. of India u/s 33(P) of Drugs & Cosmetics Act, 1940 for grant/renewal of manufacturing licenses of Drug Formulations in Proper or Generic names only vide notice dated 01.10.2012 which made above mentioned provisions of Section 17-B(e) for spurious drugs, Rule 96(1)(i)-A and Rule 65-II-A redundant. Vide this order under Section 33-P, Govt. of India directed the State Govt. that
“The grant of Drugs Manufacturing License under a Trade or Brand name is not in accordance to the spirit of legislation, therefore, Manufacturing License for drug formulations should be granted in Proper/Generic names only.”
After the directions issued by Govt. of India under Section 33-P of Drugs Act to State Govt., now manufacturers were to apply and take Drug Formulation approvals only in Proper/Generic name without any Brand Name and the manufacturers are free to manufacture one(01) approved formulation with Generic/Proper name under any number of Brand Name(s). Intention of Govt. was to promote the Generic Drugs but it has rather started an era of uncontrolled Branded Generics. Since present regulations’ definition of “Generic Drugs” is not included in Drugs Rules, this added in the extent of problem of uncontrolled Branded Generics. This notification was not applicable in case of approvals of drug formulations for ‘Export Only’.
In a case titled as “Radley Pharma Vs Curewell” in Delhi High Court, Hon’ble High Court made the observation on this uncontrolled era of Brand Names as after directions under section 33-P of Drugs Act, Drug Authorities were not having any control over the Brand Names assigned by the manufacturers and Trade Mark Authorities not having infrastructure available to act and they can act in civil case manner only after getting complaint from Brand Name/Trade Mark owners.
Hon’ble Delhi High Court directed all competent authorities to come with solutions/legislative provisions for protection of Brand Names and/or Brand Name infringement/violation. This was entrusted with Drug Regulators being competent Licensing Authorities for approval of Drug Formulations and only after this a draft notification was issued vide GSR 152(E) dated 26.02.2019 and now final notification GSR 828(E) dated 06.11.2019 has been issued but perusal of this notification for its harmonious implementation and to achieve the desired goal of controlling Branded Generic Drugs, LASA Brands and preparing database of available branded drugs, following queries need to be discussed:-
- How this notification will be implemented through SUGAM portal to make a database of all available Brand Name/Trade Name of drug formulations.
- Generic Drugs and Branded Drugs need to be defined under Drug Rules and these definitions can be taken/imported from Drugs Price Control Order.
- Word “Marketer” is not defined under provisions of Drug Rules, however a draft was issued but final notification yet to be issued.
- Marketers are generally a Marketing Company and may or may not be holding Wholesale Drug License and now how marketer will become applicant especially when these Rules are included in conditions of license under Rule 71, 71-A, 71-B, 76 and 76-A and only a manufacturer can become applicant for this purpose.
- In Form-51 “Licensing Authority for Marketing” is mentioned but when term marketing is not defined and no rules made to regulate marketer, how any authority can be designated as “Licensing Authority for Marketing”.
- Form-51 is an undertaking by applicant (here presenting manufacturer) but it is not clear that how a Licensing Authority can grant approval with Brand Name or to keep this undertaking in records and what action can be taken on this application with this undertaking.
- How database of already existing Brand Names will be prepared as these Amended Rules will be effective from the date of its notification and will not be effective retrospectively.
Disclaimer: This is personal opinion of the writer and anyone may have a different opinion about this article and will not attract any legal implication.