In an effort to address the increasing presence of counterfeit drugs of Indian origin in foreign markets the Pharmaceuticals Export Promotion Council (Pharmexcil) has suggested the Ministry of Commerce and Industry to include specific provisions in the new Exim policy.

The council suggested that the merchant exporters might be asked to present various documents to the Assistant Drugs Controller at the port of shipment. The list of documents should include Invoice from manufacturers that the products have been purchased from them, certificate of analysis, registration certificate (if it is applicable in the importing country).

The merchant exporters should also present central excise gate pass and No Objection Certificate (NOC) from the manufacturers from whom the products are purchased to get a clearance certificate. The Council insists that the documentation should become a part of Foreign Trade Policy as soon as possible.

In a letter to Rajeev Kher, joint secretary, Ministry of Commerce and Industry, the Pharmexcil chairman D B Mody suggested that imports should not be permitted from Inland Container Depots (ICDs) where Assistant Drugs Controller (ADC) has not been posted.

The recent move to ban import of drugs through some of the ICDs including New Delhi has resulted in such a suggestion to curb exports of drugs from ICDs without a drug control official. The council also noted a circular of Central Board of Excise and Customs (CBEC), under reference number F.No.450/08/2007-Cus.IV dated 22nd January 2007, setting provisions in the same lines should be strictly implemented.

"The increasing presence of counterfeit drugs of Indian origin in foreign countries is tarnishing the prestige of Indian drug companies in overseas. The ministry should include the suggestions we have made on merchant exporters in the next Exim policy to curb further issues," D B Mody told Pharmabiz.

The label of the drug should also include a country code along with license number to avoid India being blamed for products entering through porous borders of any country. The council maintained that there is urgent need to strengthen the procedures, to curb counterfeit drugs with identical labels to the genuine products, in consultation with the Drugs Controller General (India), Industry and Pharmexcil. It also added that the Ministry Of Commerce And Industry should take a leading role to address the issue.

Pharmexcil has sent these suggestions in response to a letter from the ministry, seeking opinion from the council on the issue. The ministry has called for opinion from the council, to answer a letter put forward by Nicholas Piramal India Ltd to the secretary of Commence ministry with queries on Indian origin counterfeit drugs in foreign countries, it is learnt.