Application for licence to manufacture drugs other than those specified in

(1) Application for grant or renewal of licence to manufacture for sale or for distribution of drugs, other than those specified in Schedules C and C (1) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made—

(a) in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in, Form 24-B;

(b) in the case of manufacture of drugs included in Schedule X, in Form 24-F;

(c) in any other case, in Form 24.

(2)(a) Every application in Form 24-B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of Rs. 500 plus and an inspection fee of Rs. 200 for every inspection or for the purpose of renewal of the licence. (b) Every application in Form 24B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of Rs. 6,000 and an inspection fee of Rs. 1,500 for every subsequent inspection or for the purpose of renewal of licence. (c) Every application in Form 24 shall be made up to ten items for each category of drugs catogarised in Schedule M and Schedule M-III and shall be accompanied by a licence fee of Rs. 6,000 and an inspection fee of Rs. 1,500 for every inspection or for the purpose of renewal of the licence.

(3) If a person applies for the renewal of a licence after the expiry thereof but within six months of such expiry the fee payable for the renewal of such licence shall be— (i) in the case of Form 24-B a licence fee of Rs. 500 plus an additional fee at the rate of Rs. 250 per month or part thereof in addition to an inspection fee of Rs. 200; (ii) in the case of Form 24-F a licence fee of Rs. 6,000 plus an additional fee at the rate of Rs. 1,000 per month or part thereof in addition to an inspection fee of Rs. 1,000; (iii) in the case of Form 24 a licence fee of Rs. 6,000 plus an additional fee at the rate of Rs. 1,000 per month or part thereof in addition to an inspection fee of Rs. 1,500.

(4) A fee Rs. 1,000 shall be paid for a duplicate copy of the licence issued under clause (a), clause (b) or clause (c) of sub-Rule (1) if the original is defaced, damaged or lost.

(5) Applications by licensees to manufacture additional items of drugs shall, in the case of a licence to manufacture for sale and distribution for repacking and other than those specified in Schedule C and Schedule C (I), be made to the Licensing Authority. Such applications shall, if the additional items of drugs applied for belong to categories which are not already included in the licence, be accompanied by an additional fee at the rate of Rs. 100 for each additional item of drug for repacking and Rs. 300 per additional item of drugs categorised in Schedule M and Schedule M-III.

(6) Where an application under this Rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122-E, such application shall also be accompanied with approval, in writing in favour of the applicant, from the licensing authority as defined in clause (b) of rule 21.

Explanation.— For the purpose of these Rules, the term ‘repacking’ means the process of breaking up any drug from a bulk container into small packages and the labelling of each such package with a view to its sale and distribution, but does not include the compounding or dispensing or the packing of any drug in the ordinary course of the retail business.