The Central Drugs Standard Control Organization (CDSCO) has issued a set of new rules to the pharma exporters in the country to be adhered to by them while doing international trade. The new rules, which contains 17 points to be strictly followed by the exporters, have been issued to the industry and are effective from January 1, 2010.

In Karnataka too, CDSCO office of the Assistant Drugs Controller (ADC), Sub Zone Bangalore has in a circular No. ADC/TECH/BSZ dated January 1, 2010 highlighted 17 points to be followed by the exporters in the state. The circular now calls for documents to obtain no objection certificate (NOC) from the ADC for export of drugs and cosmetics.

The order mandates the companies to provide a shipping bill along with custom report marked for the ADC NOC. The original copy of the invoice in duplicate should be signed by the authorized authority. A sample of the drugs from the consignment sealed or signed by the customs officer should be submitted. The labels in the case of bulk drugs should be duly signed and stamped by the head of Quality Control or Quality Assurance department. The same practice needs to be followed for outer cartons of subsequent packs.

Among the submissions to be made are certificate of analysis, current Good Manufacturing Practices (cGMP), certified copy of permission for production of the drugs and cosmetics in the list approved by the Central FDA or state drugs controller, separate permission from the DCGI or state drugs control authority in the case of new drugs and approval should also be sought from the DCGI in case of drugs exclusively for export purpose.

Export authorization should be sought from the Commissioner of Narcotics Bureau, Gwalior and import authorization from the government of the importing country in case of narcotics and psychotropic substances. In the case of neutral label, a code allotment letter from the DCGI or state licensing authority should be sought. Companies should also provide details of Certificate of Pharmaceutical Products (CoPP)

For export of vaccines and biologicals, companies should provide batch release certificate from Central Research Institute, Kasauli or the National Chemical Laboratory, Pune. In the case of export of finished formulations to Nigeria, a QCS certificate or ARIL inspection report should be made available. The Merchant Exporters should submit purchase invoice of each drug, wholesale license, DCGI permission in the case of new drugs, neutral code certification from manufacturers for supply of drugs for export and English translation for labels of foreign language certified by the authorized authority.

The CDCSO has also insisted on custom or excise sealed samples would be accepted for clearance of consignment through CFS or foreign post offices. In addition to these documents, other requirements would depend on a case-to-case basis to ascertain the authenticity of the consignment. The order has also called for signing of the documents by the head of the company identified according to the rules under Section 34 of the Drugs & Cosmetics Act 1940.

The CDCO would not accept photocopies or fax versions of the certificates but insists on notary attested documents.