Bare ActsThe DRUGS AND COSMETICS ACT AND RULES

Section 160B

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Form in which approval to be granted for carrying out tests on Ayurvedic, Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and Unani drugs and conditions for grant or renewal of such approval.-- (1) Approval for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48. (2) Before approval in Form 48 is granted or renewed, the following conditions shall be complied with by the applicants, namely: - (i) The premises where the tests are carried out shall be well lighted and properly ventilated except where the nature of tests of any Ayurvedic, Siddha and Unani drug warrants otherwise. Wherever 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 and microbiological tests. (ii) (a) The applicant shall provide adequate space having regard to the nature and number of samples of drugs proposed to be tested: Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate: Provided further that separate section shall be provided for (i) Chemistry, (ii) Pharmacognosy, (iii) Ayurveda, Siddha and Unani, (iv) Microbiology, (v) Sample Room, (vi) Office-cum-Record Room, with proper partitions and minimum required area is 800 sq. ft. (b) The applicant shall provide a list of persons who may be employed with him as experts, such as Chemist, Botanist and expert in Ayurveda/Siddha/Unani or Pharmacist who shall possess a degree in Chemistry, Botany, Ayurveda/Siddha/Unani/Bachelor in Pharmacy from a recognized University or equivalent, with experience for 2 years for carrying out tests or analysis as per the Ayurvedic, Siddha and Unani Pharmacopoeias. (c)The applicant shall provide adequate equipments essesntial for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as per pharmacopoeial standards or other available standards. Drugs and Cosmetics Rules, 1945 168 List of equipment recommended is given below: Chemistry Section

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