74B. Conditions of licence in Form 25A

1. The licence in Form 25A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25 whose manufacturing facilities have been availed of by the licensee is cancelled or suspended as the case may be, under these rules.
2. The licensee shall comply with the provisions of the Act and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
3. The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed.
4. The licensee shall either—
   • provide and maintain to the satisfaction of the licensing authority adequate staff and adequate laboratory facilities for carrying out tests of strength, quality and purity of the substances manufactured by him; or
   • make arrangements with some institution approved by the licensing authority under Part XV(A) of these rules for such tests to be regularly carried out on his behalf by the institution.
5. The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.
6. The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
7. No advertisement of the drugs specified in Schedule H, Schedule HI or Schedule X shall be made except with the previous sanction of the Central Government.
8. the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a licence of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.