Manufacture on more than one set of premises

Section 68 of the Drugs and Cosmetics Act and Rules deals with manufacture on more than one set of premises. If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises.

If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 2[68-A. Grant or Renewal of Licences by the Central Licence Approving Authority .- (1) Notwithstanding anything contained in this Part, on and from the commencement of the Drugs and Cosmetics (Amendment) Rules, 1992, a licence for the manufacture for sale or distribution of drugs as specified from time to time by the Central Government by notification in the Official Gazette, for the purpose of this rule, shall be granted or renewed, as the case may be, by the Central Licence Approving Authority (appointed by the Central Government):

Provided that the application for the grant or renewal of such licence shall be made to the Licensing Authority.

(2) On receipt of the application for grant or renewal of a licence, the licensing authority shall,- (i) verify the statement made in the application form; n (ii) cause the manufacturing and testing establishment to be inspected in accordance with the provisions of rule 79; and (iii) in case the application is for the renewal of licence, call for the information(s) of the past performance of the licensee.

(3) If the licensing authority is satisfied that the applicant is in a position to fulfil the requirements laid down as in these Rules, he shall prepare a report to that effect and forward it along with the application 3[and the licence (in triplicate) to be granted and renewed, duly completed] to the Central Licence Approving Authority:

Provided that if the licensing authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these Rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence, as the case may be.

(4) If on receipt of the application and the report of the licensing authority referred to in sub-rule (3) and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, with or without an expert in the concerned field if deemed necessary, the Central 1. Subs. by G.S.R 788 (E), dt. 10-10-1985. 2. Ins. by G.S.R 923 (E), dt. 14-12-1992. 3. Subs. by G.S.R 89 (E), dt. 14-2-1996. Licence Approving Authority, is satisfied that the applicant is in a position to fulfil the requirements laid down in these Rules, he may grant or renew the licence, as the case may be:

Provided that if the Central Licence Approving Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules, he may, notwithstanding the report of the licensing authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of licence, as the case may be.

Section 68, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).