2[(1)] The licensee shali not manufacture the drug save from materials which he is lawfully entitled to possess.
3[(2) The licencee shall not manufactrure the drug without allotment of quota for that drug under sub-rule (2) of rule 67E].
I. Subs. by G.S.R. 359(E), dated 5th May, 2015, for rule 39 (w.e.f. 5-5-2015). Earlier rule 39 was amended by 5.0. 166(E), dated 12th July, 2010 (w.e.f. 13-7-2010). Rule 39, before substitution, stood as under:
"39. CondiHonsfor issue of licences.-(1} No licence shall be issued under rule 37 for under the proviso to rule 35 unless the applicant therefore has-
(i) produced to the issuing authority licences granted to him under (a) the Drugs and Cosmetics Act, 1940 (23 of 1940) for the manufacture of the drug, and (b) the rules framed under section 10 of the Act by State Government of the State in which he has his place of business, for the possession, sale and distribution of the drugs; and
(ii) made a deposit of Rs. 5,000.00 as security in the manner specified by the issuing authority for the due observance of the conditions of the licence and has furnished proof to the satisfaction of the issuing authority that he is equipped as to the land, building and other paraphernalia to properly carry on the business described in the application and is of good financial standing.
(2) Licence referred to in sub-rule (2A) of rule 36 and rule 36A shall be issued subject to the condition that before commencing of the manufacture, the licensee shall obtain the licences required as per the Drugs and Cosmetics Act, 1940 (23 of 1940) from the authority in-charge of drug control in the State and the licence issued by the State Government under section 10 of the Act, or any other licence required under any other law for the time being in force.".
2. Rule 40 re-numbered as sub-rule (1) thereof by G.S.R. 359(E), dated 5th May, 2015 (w.e.f.
5-5-2015).
3. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. 5-5-2015).
Rule 45A] The Narcotic Drugs and Psychotropic Substances Ru/os, 1985 73