Conditions of approval

Section 160D of the Drugs and Cosmetics Act and Rules deals with conditions of approval. An approval in Form 48 shall be subject to the following conditions, namely: - I.

An approval in Form 48 shall be subject to the following conditions, namely: - I. The Institution granted approval under this Part (hereinafter referred to as the approved laboratory) shall provide and maintain adequate staff and adequate premises and equipment as specified in rule 160-B. II. The approved laboratory shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it. III. The approved laboratory shall maintain records of tests for identity, purity, quality and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs 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 date of expiry is assigned; for a period of two years from such date of expiry and in the case of other substances, for a period of three years. IV. The approved laboratory shall allow the Inspector appointed under this Act to enter with or without prior notice the premises where testing is carried out and to inspect the premises and the equipment used for test and the testing procedures employed. The laboratory 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. V. The approved laboratory shall from time to time report to the approving authority any changes in the person-in-charge of testing of Ayurvedic, Siddha and Unani drugs or 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 purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval. VI. The approved laboratory shall furnish reports of the results of tests or analysis in Form 50. VII. In case any sample of Ayurvedic, Siddha and Unani drug is found on test to be not of standard quality, the approved laboratory shall furnish to the approving authority and the licensing authority of the State where the manufacturer and/or sender of the Ayurvedic, Siddha and Unani drugs is located, a copy of the test report of the sample with the protocols of tests applied. VIII. The approved laboratory 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 made from time to time under Chapter IV-A of the Act of which the approving authority has given the approved laboratory not less than four months' notice. IX. The approved laboratory shall maintain an inspection book to enable the Inspector to record his impression or defects noticed. 160-E. Inspection before grant of approval .- Before an approval in Form 48 is granted, the approving authority shall cause the laboratory at which the testing of Ayurvedic, Siddha and Unani drugs, as the case may be, is proposed to be carried out to be inspected jointly by the Inspectors appointed or designated by the Central Government and State Government for this purpose, who shall examine the premises and the equipment intended to be used for testing of drugs and verify into the professional qualifications of the expert staff who are or may be employed by the laboratory.

Section 160D, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).