The Mumbai High Court has directed state Food and Drugs Administration (FDA) to stay away from the dispute with the Bangalore-based Vascular Concepts over the sale of medical devices in Maharashtra, as the Central Government has already come out with the regulatory guidelines for the same. The Court has asked the company to comply with the guidelines and get the No Objection Certificate (NOC) from the DCGI for selling the product in the state.
"The centre has formed the guidelines for the import and manufacture of medical devices in India. Therefore, there was no need for FDA to interfere in the issue. Now, as the court has directed them to stay away from the matter, we would obtain the DCGI permission soon, to market our product in Maharashtra. The necessary documents have already been sent to the DCGI and the approval is awaited," said the company sources.
The notification will not only allow market to grow but also help patients to access the best services available for diagnosis, the sources said. If the DCGI is satisfied with the compliance status of the company the approval for the product can be expected soon, the sources added.
The Bangalore-based Vascular Concepts is the principal operating company of the Vascular Concepts Group, which is engaged in the design, development and manufacture of Endo-vascular medical devices that address the treatment of arterial diseases.
As Pharmabiz reported earlier, the Union ministry of health and family welfare has come out with the guidelines for licensing of import and manufacture of medical devices in India. The guidelines for the devices including Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, I.V. Cannulae, Bone cements, Heart Valves, Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic replacements are effective from March 1, 2006.