If the bulk drug is manufactured at 1 manufacturing site and then brought to another manufacturing site for addition of flavour/ fragrance. Do i need to register both the manufacturing locations for import registration or only where the last step of the total process has taken place. Pls suggest
According to the Drugs & cosmetics Act 1940 and Rules thereunder 1945 of India (as ammended upto 2016), please note that manufacturing addresses of all the premises must be registered for “Import registration” according to following details,
SCHEDULE D(I)
(See rule 21 (d) and rule 24 A)
Information and undertaking required to be submitted by the manufacturer or his authorized
agent with the Application Form for a Registration Certificate. The format shall be properly
filled in for each application in Form 40. The detailed information, secret in nature, may be
furnished on a Computer Floppy.
Particulars of the manufactured drugs to be registered under Registration Certificate:-
- Undertaking to declare that: -
3.1. We shall comply with all the conditions imposed on the Registration Certificate,
read with rules 74 and 78 of the Drugs and Cosmetics rules, 1945.
3.2 We declare that we are carrying on the manufacture of the drugs mentioned in
this Schedule, at the premises specified above, and we shall from time to time
report any change of premises on which manufacture will be carried on and in
cases where manufacture is carried on in more than one factory any change in
the distribution of functions between the factories.
3.3 We shall comply with the provisions of Part IX of the Drugs and Cosmetics
Rules, 1945.
3.4 Every drug manufactured by us for import under the Registration Certificate
into India shall be as regard strength, quality and purity conforms with the
provisions of Chapter III of Drugs and Cosmetics Act, 1940 and Part IV of the
Drugs and Cosmetics Rules 1945, and their amendments from time to time.
3.5 We shall from time to time report for any change or manufacturing process, or
in packaging, or in labelling, or in testing, or in documentation of any of the
drugs, pertaining to the Registration Certificate, to be granted to us. Where any
change in respect of any of the drugs under the Registration Certificate has
taken place, in respect of any of the above matters, we shall inform the same to
the licensing authority in writing within 30 days from the date of such changes.
In such cases, where there will be any major change/modification in
manufacturing or in processing or in testing, or in documentation, as the case
may be, at the discretion of the licensing authority, we shall obtain necessary
approval within 30 days by submitting a separate application, alongwith the
registration fee as specified in clause (ii) of sub rule (3) of rule 24-A.
FORM 41
Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945
Conditions of the Registration Certificate are as follows,
- The manufacturer or his authorised agent in India shall inform the
licensing authority immediately in writing in the event of any change in the
constitution of the firm and / or address of the registered office / factory premises
operating under this Registration Certificate. Where any such change in the
constitution of the firm and/or address takes place, the current Registration Certificate
shall be deemed to be valid for a maximum period of three months from the date
on which the change has taken place unless, in the meantime, a fresh
Registration Certificate has been taken from the licensing authority in the
name of the firm with the changed constitution of the firm and/or
changed address of the registered office or factory premises.
(The above information is upto date till year 2016. Please confirm for the current scenario of The Drugs & cosmetics Act 1940 and Rules thereunder 1945)
Import License : The applicant has to apply for Import License through online SUGAM portal as per “Guidance Document” document no. IMP / REG / 200711 available at www.cdsco.nic.in CDSCO recieves the application for ImporImport_Process_Annexure3A.pdf (103.0 KB) t License from stakeholders
Actually the question was as follows,
“If the bulk drug is manufactured at 1 manufacturing site and then brought to another manufacturing site for addition of flavour/ fragrance. Do i need to register both the manufacturing locations for import registration or only where the last step of the total process has taken place. Pls suggest”
This is already answered in my previous communication.