Regulate medical devices in phased manner: Cos

All medical devices will be regulated by the government as drugs for quality and price control.

Bp Apparatus, Medical Devices
Picture: Pixabay

NEW DELHI: India’s medical-devices companies have sought stagegated monitoring of output quality and product pricing amid mounting concerns that a big-bang approach to price controls would hurt profits and compromise the industry’s viability.

The National Pharmaceuticals Pricing Authority (NPPA) has called a meeting with stakeholders on July 1 to ensure that medical devices aren’t overpriced. The Centre had said earlier this year that all medical devices sold locally would be treated as drugs under the Drugs and Cosmetics Act with effect from April 1.

This means that all medical devices will be regulated by the government as drugs for quality and price control.

“In response to this, the NPPA received representations from the medical devices industry associations regarding regulation of medical equipment under the Drug Price Control Order (DPCO) in a phased manner, especially for products where no MRP is required to be printed as provisions of Legal Metrological Rules 2011. A stakeholder consultation will be organised through video conferencing on July 1,” said the NPPA’s order.

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All medical device associations, including MTal, AiMeD, CII, FICCI, Assocham, and PHD Chamber of Commerce, have been invited to the meeting. At present, only 24 medical devices are regulated under the Drugs and Cosmetics Act.

“At the last meeting, we had recommended that for products with MRP less than Rs 5, the condition of a maximum 10% increase in MRP in the last one year be relaxed,” said Rajiv Nath, forum co-ordinator, Ai-MeD. “We have also suggested that NPPA may enforce the new regulations in a phased manner.”

All medical devices — syringes, needles, cardiac stents, knee implants, digital thermometers, and machines for CT scan, MRIs and dialysis — will be regulated under the DCA.

As per the notification, four medical devices — cardiac stents, drug eluting stents, condoms and intrauterine devices — are scheduled medical devices for which ceiling prices have been fixed. These four medical devices are already under price control.

Meanwhile, the NPPA is monitoring the MRP of the remaining non-scheduled medical devices, which have been regulated as drugs, to ensure the prices are not increased by more than 10% of MRP during the preceding year.

To bring transparency and relief to consumers, the Centre had made it mandatory for all medical devices to carry the MRP label on their packaging.

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