The Maharashtra Food and Drug Administration (FDA) has issued an order allowing Shruti Medi- Science, importer and distributor of Axxiom Drug Eluting Stent (DES), manufactured by Occam of Netherlands, to market the product in the state.

The order was issued on 10th October 2005. The state authority in its order stated that the parent company Occam has been permitted to market its product in Maharashtra, since they have submitted CE certification for the same. Speaking to Pharmabiz, Om Prakash Sadhwani, joint commissioner, FDA, said, “ We have issued an order to Shruti, stating that Occam can market its CE certified products in Maharashtra. All the products having CE certification including Axxiom DES can be marketed in the state.”

The issue surfaced during June this year following the Maharashtra FDA’s decision mandating marketing approval for DES, from DCGI or to submit US FDA or CE approvals to sell drug-eluting stents in the state following news reports on the suspected quality of DES used in JJ hospital, Mumbai. Maharashtra FDA contended that since drug-eluting stent contains drug and is implanted into the body of the patient, it is mandatory to get prior approval from Indian drug control authorities.

Shruti Medi-Sciences filed a case in the Bombay High Court against the Maharashtra Food & Drug Administration (FDA) and the Drug Control General of India (DCGI) for denying the company the rights to market Axxion DES in the state. The division bench of the Mumbai High Court had directed the Drug Control General of India (DCGI) to notify the sterile medical devices for external or internal use in human beings as drugs with immediate effect within three weeks and the Maharashtra FDA to take a decision on Shruthi’s claims within two weeks, as per its order on 19th September, 2005. The case is still pending in the court.

Shruti Medi-science contended that despite submitting the import license as well as CE certification according to the FDA demand, the company was not permitted to market its product in the state. Though CE certification for Axxion was obtained only on July 11, 2005, the parent company OCCAM had received CE certification for manufacture and marketing of all its medical devices in Europe and abroad, since September 29, 2003. When the matter was referred to DCGI, the regulatory authority clarified that the DES is a medical device and it does not come under the purview of the Drugs & Cosmetics Act. Further, even US FDA and European CE also considers DES as a medical device and not as a drug. The product has quality certifications like ISO 9001 and ISO 13485 European CE certification. It is polymer-free and incorporates Calix stent delivery system and the commercially available drug, Paclitaxel.

Meanwhile, as Pharmabiz reported yesterday, the Central Government, as per the court directive, has notified 10 medical devices as drugs that require central clearance prior to import, manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.