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Drugs & Cosmetics Rules, 1945

Conditions of Licence for Testing Laboratories

150-E. Conditions of approval.- An approval in Form 37 shall be subject to the following general conditions :

  1. The institution granted approval under this Part (hereinafter referred to as the approved institution) shall provide and maintain an adequate staff and adequate premises and equipment as specified in Rule 150-C.
  2. The approved institution shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.
  3. The approved institution shall maintain records of tests for identity, purity, quality and strength carried out on all samples of drugs, or cosmetics and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which an expiry date is assigned for a period of two years from the expiry of such date and in the case of other substances for a period of six years.
  4. The approved institution shall allow the Inspector appointed under the Act to enter with or without prior notice the premises where the testing is carried on and to inspect the premises and the equipment used for test and the testing procedures employed. The institution shall allow the Inspectors to inspect the registers and records maintained under these rules and shall supply to such Inspectors such information as they may require for the purpose of ascertaining whether the provisions of the Act and rules made thereunder have been observed.
  5. The approved institution shall from time to time report to the approving authority any changes in the person-in-charge of testing of drugs or cosmetics or in the expert staff responsible for testing as the case may be and any material alterations in the premises or changes in the equipment used for the purpose of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant of renewal of approval.
  6. The approved institution shall furnish reports of the results of tests or analysis in Form 39.
  7. In case any sample of a drug or a cosmetic is found on test to be not of standard quality, the approved institution shall furnish the approving authority and the licensing authority of the State where the manufacturer and/or sender of the drug or cosmetic is located with a copy of the test report on the sample with the protocols of tests applied.
  8. The approved institution shall comply with the provisions of the Act and rules made thereunder and with such further requirements, if any, as may be specified in the rules subsequently made under Chapter IV of the Act of which the approving authority has given the approved institution not less than four months' notice.
  9. The approved institution shall maintain an inspection Book to enable the Inspector to record his impressions or defects noticed.
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