Section 160B(2) in The Drugs and Cosmetics Rules, 1945
(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 of 800 square feet.(b)[(i) Expert in Ayurveda or Siddha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act, 1970; [Substituted by G.S.R. 674(E), dated 10.11.2005 (w.e.f. 18.11.2005).](ii)Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University; and(iii)Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University.](c)The applicant shall provide adequate equipments essential for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as per pharmacopoeial standards or other available standards.List of equipment recommended is given below:CHEMISTRY SECTION
