| Ref: PXL/H.O./CIR-047/2007-08 Date: 09-10-2007 Hyderabad To All the Members of Council, Dear Member, Sub: Counterfeit Drugs I would like to inform you that Shri Rajeev Kher, Joint Secretary, Department of Commerce, called for a meet on the above subject, where Dr. M. Venkateshwarlu, DCGI, Dr. Malai Mitra and Representatives from PHARMEXCIL, Ranbaxy, Nicholas were present. Following points where discussed in the meeting which was chaired by Mr. Rajeev Kher, Joint Secretary, Department of Commerce and attended by Dr. Venkateswarlu, DCGI, Dr. Malai Mitra, and Representative from Pharmexcil, Ranbaxy, Nicholas Piramal, 1) Counterfeit drugs are those drugs bearing identical / deceptively similar Trade Marks and having identical colour scheme / getup of packing materials as used by genuine exporters. 2) Counterfeit drugs are also likely to be therapeutically ineffective and cause harm to human beings. Such drugs spoil the name and reputation of India in general and genuine manufacturer-exporters of pharmaceutical products in particular. 3) We are pleased to note that Ministry of Finance has formulated rules and regulations to prevent import of counterfeit goods bearing identical / similar well-known Trade Marks into India. This action is designed to safeguard the interest of genuine exporters of drugs imported into India. (copy of publication attached for ready reference). 4) There is an urgent need to take similar action to safeguard the interest of genuine exporters of pharmaceutical products from India. We therefore, suggest following guidelines to be included in the relevant policy documents: a) Documents presented to the Asst. Drug controller at the port of shipment should accompany the following: 1. Invoices from the manufacturer that the products have been from them. 2. Certificate of Analysis 3. Registration Certificate if the registration certificate is applicable in the importing country. 4. Central excise gate pass 5. NOC from the manufacturers This should become the part of FTP. b) The label should include a country code along with licence number. This will avoid being blamed for products entering through porous borders of any country. c) Shipping documents presented for clearance of pharmaceutical products for exports must clearly mention the name and address of the manufacturer of the pharmaceutical products. This suggestion is made as most of the counterfeit drugs are sought to be exported under “neutral labels” without the name and address of the manufacturer. d) A declaration from the exporter that Trade Mark of the exported drugs does not infringe any third party’s Trade Mark rights and that the exporter is liable for prosecution and penalties if the Trade Mark used by the said exporter in the export of drugs infringes any third party’s Intellectual Property rights. e) Each drugs sought to be exported should be supported by an “authenticated” copy of: i) Certificate of Analysis (COA) issued by the manufacturer. ii) Trade Mark Registration Certificate / Application accepted in the country of import. (In case the same Trade Mark is registered by party other than the exporter in India and the exporter produces documentary evidence of having registered the Trade Mark in the importing country, it should not be treated as infringement of the rights of the party holding the Trade Mark registration in India provided the goods are being exported to the country in which the exporter has valid Trade Mark registrations). 7) it is proposed that Exports of drugs and pharmaceutical will be allowed from only those ports which are earmarked and used for import purpose. As they will have all the testing ports, The Ports are : 1. Calcutta - -
Calcutta Airport -
Calcutta Customs 2. Chennai 3. Hyderabad 4. Ahmedababd 5. Mumbai -
Navasheva -
Mumbai Airport -
Customs 6. Delhi As per DCGIS data more than 80% of exports are being taking place from these ports. Counterfiet & Fake drugs are exported from India with identical labels of the products, however the contents in products are not as per the formula for the well known brand. There is therefore a need to strengthen the procedure. There is need to prevent the counterfeit & Fake drug exports. We would like to inform you that we have to give a response on the above points and I earnestly request you to kindly give us the feed-back as early as possible by10th Oct. 2007. Looking forward to get your cooperation in the above matter. Warm regards, D.B.MODY CHAIRMAN | 
