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

According to the new rules, the companies to provide a shipping bill along with custom report marked for the ADC NOC. The authorized authority should sign the original copy of the invoice in duplicate. 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.

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.

Due to a recent Govt. directive, the value- added re-export of medicines are affected. The domestic bulk drug exporters have objection regarding this move. The government has fixed 15 per cent value addition as the minimum requirement for duty-free import of raw materials. However, the manufacturing of such medicines is highly dependent on the import of crucial ingredients from countries like China. The companies convert imported ingredients into bulk drugs and re-export them. Since there are no packaging costs involved, the maximum value-addition that occurs during the process is3-4 percent.

The Bulk Drugs Manufacturers Association said the value of affected products could not be assessed immediately as the issue pertained to specific products only. Indian bulk drug exports account for a fourth of the Rs 39,000-crore medicine exports, industry sources point out. According to earlier criteria, the government had not fixed a value-addition percentage, but only insisted on a revenue-positive value addition.

The industry is also finding it difficult to fulfill the export obligation of 98 per cent yield on formulations or medicines in the ready-to-administer form, which are made using imported raw materials. Exporters say the wastage is often more than 2 per cent and, hence, difficult to fulfill the export criteria. India's drug export promotion agency, the Pharmaceutical Export Promotion Council, is taking up the issue with the commerce ministry.

China has agreed to initiate the process of opening up the pharmaceutical market for Indian companies. It has also promised to enhance buying to correct the trade imbalance caused by low Indian exports.

Chinese leaders including premier Wen Jiabao indicated to visiting Indian commerce minister Anand Sharma that Beijing was prepared to revise its overall approach to trade with India.

Indian pharmaceutical companies have been complaining of non-tariff barriers making it difficult for them to distribute medicine products in China. The Indian side Chinese industry enjoyed a huge amount of free access to Indian markets and have profited in terms of major contracts for machinery and project installation.