Section 150C in The Drugs and Cosmetics Rules, 1945
150C. Form in which approval to be granted for carrying out tests on drugs/cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] of such approval.
(1)Approval for carrying out such tests of identity, purity, quality and strength of drugs or cosmetics as may be required under the provisions of these rules, on behalf of licensee for manufacture of drugs or cosmetics shall be granted in Form 37.(2)Before approval in Form 37 is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).], the following conditions shall be complied with by the applicant:-(1)The premises where the tests are being carried on shall be well lighted and properly ventilated except where the nature of tests of any drug or cosmetic warrants otherwise. Whenever necessary, the premises shall be air-conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc.(2)The applicant shall provide adequate space having regard to the nature and number of samples of drugs or cosmetics proposed to be tested:Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate.(3)If it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal house and comply with the following requirements:-(a)The animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests shall be kept in an air-conditioned area.(b)The animals shall be suitably housed in hygienic surroundings and necessary provisions made for removal of excreta and foul smell.(c)The applicant shall provide for suitable arrangements for preparation of animal feed.(d)The applicant shall provide for suitable arrangements for quarantining of all animals immediately on their receipt in the institution.(e)The animals shall be periodically examined for their physical fitness.(f)The applicant shall provide for isolation of sick animals as well as animals under test.(g)The applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960).(h)The applicant shall make proper arrangements for the disposal of the carcasses of animals in a manner as not to cause hazard to public health.(4)The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of drugs or cosmetics intended to be tested which shall be adequate in the opinion of the approving authority.(5)The testing of drugs or cosmetics, as the case may be, shall be under the active direction of a person whose qualifications and experience are considered adequate in the opinion of the approving authority and who shall be held responsible for the reports of test or analysis issued by the applicant.(6)The testing of drugs or cosmetics, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualifications and experience of testing are adequate in the opinion of the approving authority.(7)The applicant shall provide books of standard recognized under the provisions of the Act and the rules made thereunder and such books of reference as may be required in connection with the testing or analysis of the products for the testing of which approval is applied for.[150D.Duration of approval. - (1) A licence issued under Form 37shall remain valid if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.(2)The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required for the grant of such licence.(3)If the licence holder fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent. of the licence fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the licence shall be deemed to have been cancelled.]
