Section 94(1) in The Drugs and Cosmetics Rules, 1945
(1)Labels on packages or containers of drugs for export shall be adapted to meet the specific requirements of the law of the country to which the drug is to be exported but the following particulars shall appear in a conspicuous position on the innermost container in which the drug is packed and every other covering in which that container is packed-(a)name of the drug;(b)the name, address of the manufacturer and the number of the license under which the drug has been manufactured;(c)batch or lot number;(d)date of expiry, if any:[Provided that where a drug, not classified under Schedule F, Schedule F(I) and Schedule X, [or blood products defined under rule 122-EA] [Inserted by G.S.R. 676(E), dated 2.6.1988 (w.e.f. 2.6.1988).][is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the licensing authority mentioned in rule 21:] [Inserted by G.S.R. 676(E), dated 2.6.1988 (w.e.f. 2.6.1988).][Provided further that where a drug classified as Narcotic Drug or Psychotropic Substance is to be exported under a code number, the same may be permitted by the said Licensing Authority on the following conditions, namely:-(i)each consignment of export shall be accompanied with requisite import license from the importing country;(ii)the applicant shall obtain a no objection certificate from the Drugs Controller, India for manufacture of such formulations to be exported with code number against each export order along with certificate from the regulatory authority of the importing country controlling Narcotics Drugs and Psychotropic Substances that they do not have any objection for the import of the drug with code number;(iii)the State Licensing Authority shall issue the manufacturing license for these formulations on each export order on the basis of a no objection certificate from Drugs Controller, India;(iv)a no objection certificate shall be obtained from the Drugs Controller, India for export of each consignment; and(v)a no objection certificate shall be obtained from the Narcotic Commissioner of India, Gwalior for export of each consignment of the drug.]
