Siddha and Unani drugs, as the case may be.

(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. List of equipment recommended is given below: CHEMISTRY SECTION: 1. Alcohol determination apparatus complete set. 2. volatile oil determination apparatus. 3. Boiling point determination apparatus. 4. Melting point determination apparatus. 5. Refractometer. 6. Polarimeter. 7. Viscometer (Ostwalds, Redwood Viscometer). 8. Tablet disintegration apparatus. 9. Moisture determination apparatus (IC filtrator). 10. U.V.Spectro-photometer. 11. Muffle furnace. 12. Electronic Balance. 13. Hot air oven(s) different range of temperature/vacuum oven. 14. Refrigerator. 15. Glass distillation apparatus/plant. 16. Water supply demineralised exchange equipment/distillation equipment. 17. Air conditioner. 18. LPG Gas cylinder with burners. 19. Water bath (temperature controlled). 20. Heating mantle(4) or as required. 21. TLC apparatus with all accessories. 22. Sieves 10 to 120 with sieve shaker. 23. Centrifuge machine. 24. Dehumidifier. 25. pH meter. 26. G.L.C. with F.I. detector. 27. Silica crucible. 28. Tablet friability tester. 29. Tablet dissolution tester. 30. Other related equipment, reagents, glasswares etc. PHARMACOGNOSY SECTION: 1. Microscope binocular. 2. Dissecting Microscope. 3. Microtome. 4. Chemical balance. 5. Microslide cabinet. 6. Aluminium slide trays. 7. Hot air oven. 8. Occular Micrometer. 9. Stage Micrometer. 10. Camera Lucida Prism type and mirror type. 11. Hot plates. 12. Refrigerator. 13. LPG Cylinder with burners. 14. Other related equipments, reagents, glasswares etc. Note: Instuments like HPLC, HPTLC, Atomic Absorption spectrophotometer could be arranged by tie up with other laboratories. MICROBIOLOGY SECTION: 1. Laminar air flow bench (L.A.F.) 2. B.O.D. Incubator. 3. Plain Incubator. 4. Serological water bath. 5. Oven. 6. Autoclave/sterilizer. 7. Microscope (high power). 8. Colony counter. 9. Other related equipment and reagents. (3). The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of Ayurvedic, Siddha and Unani drugs intended to be tested which shall be adequate in the opinion of the approving authority. (4) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity, purity, quality and strength shall be carried out under the active direction of one of the experts stated in clause (b) of sub-rule (2) who shall be the person-in-charge of testing and shall be held responsible for the reports of test issued by the applicant. (5) The testing of Ayurvedic, Siddha and Unani drugs, 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 as stated in clause (b) of sub-rule (2). (6) The applicant shall provide books of standards 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. (7) The applicant shall provide list of standard Ayurvedic, Siddha and Unani drugs (Reference samples) recognized under the provisions of the Act and rules made thereunder and such reference samples kept in the laboratory may be required in connection with the testing or analysis of the products of which approval is applied for.