The Drugs Controller General of India (DCGI) has said that the present rules do not empower his office to regulate the quality of medical devices like drug eluting stents and granting of marketing permission to them.
Responding to pharmabiz query on the validity of Maharashtra FDA's decision asking importers of drug coated stents to obtain marketing approval from DCGI and drug licenses from state FDA, the DCGI Ashwini Kumar said that the authority controls only very few diagnostic devices and does not have the powers to regulate most of the medical devices. He felt the need for a comprehensive regulation to control and monitor the sale of medical implants in the country.
The medical community did not endorse the official view as they opined that the office of DCGI should come out with interim measures to regulate medical devices that are being marketed in the country without any regulatory check.
The DCGI also said that he has not received any official communication from Maharashtra FDA on the matter.
"The drug control authorities cannot shy away from their responsibilities by saying that Medical Devices does not come under the purview of Drugs and Cosmetics Act. The Central drug control authority is the sole institution to handle this situation." Dr Sanjiv Malik, President Elect, Indian Medical Association said.
The Maharashtra FDA investigated into the use of drug eluting stents in several hospitals in Mumbai and ordered the importers and manufacturers to at least obtain drug license for selling the products to the hospitals.