Concerned over the recent reports of India becoming a major source of counterfeit drugs in the world market, the Pharmaceutical Export Promotion Council (Pharmexcil) has asked the central government to tighten the procedure at the ports and airports of the country from where the products are exported to other countries.

In a letter to the Director General of Foreign Trade (DGFT) RS Gujral, Pharmexcil chairman DB Modi said exports of fake and counterfeit drugs are a threatening menace to the exports. As the issue is serious which affects the human lives, Modi said that there is an urgent need to tighten the procedure at the port and airports of shipment.

Modi has suggested that the documents presented to the assistant drug controller at the ports should include invoice from the manufacturers to ensure that the products have been procured from them and certificate of analysis from the manufacturers. Besides, there should be documents like the copy of the registration certificate if applicable in the importing country and central excise invoice and ARE-1 of the manufacturers. Another document is the NOC from the original manufacturers of the product.

Pharmexcil has also suggested that the label should also include country code along with the license as this will avoid India being blamed for products entering through any other country. This should also become a part of FTP, the letter said.

Modi has also suggested that the ICDs, which are currently serving the exporters, should also have assistant drug controller to monitor the pharma exports.

The Pharmexcil's concern stems from the fact that the European Commission in its recent report had said that India is the biggest source of the 2.7 million spurious drugs seized by the customs department of European Union states in 2006. The seizure of 2.7 million is a substantial jump from the previous year's five lakh. India, UAE and China account for 80 per cent of the counterfeit medicines, the Commission report said.

The report has created a flutter among the pharmaceutical exporters in the country as it will further spoil the image of Indian drugs abroad which had already earned a bad name. Besides, the pharma industry here fears that the report will further give a fillip to the foreign competitors to prevent the Indian companies from expanding in their countries.