Purchaser of drug or cosmetic enabled to obtain test or analysis.

An import licence shall be subject to the following conditions: (i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9; (ii) the licensee shall allow any Inspector authorised by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples; (iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied; (iv) if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate authorising the sale of the batch has been issued to him by or on behalf of the licensing authority; (v) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall the issues already made from that batch; (vi) the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorised in that behalf by the licensing authority: Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely: 1. Name of the Drug, 2. Batch number, 3. Name and address of the manufacturer, 4. Date of transaction, 5. Opening stock on the business day, 6. Quantity of drug received, if any, and the source from which received, 7. Name of the purchaser, his address and licence number, 8. Balance quantity of drug at the end of the business day, 9. Signature of the person under whose supervision the drugs have been supplied. (vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any Rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months’ notice.