Shruti Medi-Sciences, one of the distributors of Axxion Drug Eluting Stent (DES) in Maharashtra, has 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 court has directed the Maharashtra FDA Commissioner and DCGI to respond immediately. The court is likely to take up the case during the first week of September.

In the petition filed recently, R S Srivastava, Managing Director, Shruti Medi-science contended that despite submitting the import license as well as the CE certification according to the FDA demand, the company is 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.

About 20 leading cardiologists in Mumbai from hospitals like Jaslok, Lilavati, Wockhardt, Breach Candy and JJ have used Axxion stents for heart operations. It is also used by nearly 700 cardiologists worldwide. It costs only Rs 50,000- 60,000 in comparison to the stent offered by Johnson and Johnson which is sold at Rs 1,25,000, R S Srivastava told Pharmabiz.

As Pharmabiz had reported earlier, while the Drug Controller General of India (DCGI) cited lack of rules in the Drugs &Cosmetics Act to regulate medical devices, the Drug Consultative Committee (DCC) had suggested to evolve a medical devices act to take up the matter of regulating drug coated stents.

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. Maharashtra FDA contended that since the drug eluting stent contains drug and is implanted into the body of the patient, it is mandatory on their part to get prior approval from Indian drug control authorities. It is violation of section 3-B (1) of the Drugs & Cosmetics Act 1940 and the regulatory authorities have powers to take action against such violations. Following the issue, the government is now working to bring all sterile medical devices under the regulatory ambit of D&C Act.