After stent, NPPA starts process to cap other medical devices

Next on the radar: lenses and ortho implants; Pharma lobbies wants representation in price fixing

After capping coronary stents, the National Pharmaceutical Pricing Authority (NPPA) gears up for price control of other medical devices. The NPPA met intra-ocular lens manufacturers today to discuss the matter. They will subsequently meet orthopaedic implant manufacturers this week. Both these categories of devices are under the pricing regulator's radar to bring them under price control.

Capping prices of coronary stents was the first move in slashing prices of medical devices. In February this year, the regulator slashed the prices of coronary stents by 85 per cent.

This event brought about a change in the thinking of medical device manufacturers. The CEO of a multi-national device maker said, "The price cap on coronary stents shook us. The NPPA brought down the price of stents by 85 per cent in one go. We would rather opt for self-regulation than have the NPPA reduce prices like this."

Domestic manufacturers of medical devices have written to the Department of Pharmaceuticals (DoP) saying they would like to voluntarily bring down prices of devices that are non-scheduled but part of the DPCO 2013. The drug price order gives the NPPA the power to control prices of drugs that are part of Schedule 1 and monitor the prices of drugs that aren't scheduled. Further, the drug price order also allows the NPPA to fix prices of non-scheduled drugs in the interest of the consumer.

"There are fundamental issues in considering the Drug Price Control Order 2013 (DPCO 2013) for fixing the prices of drugs," says Rajiv Nath, Forum Coordinator Association of Indian Medical Devices Industry (AIMED). He explains that there are multiple distribution patterns for medical devices. Further, there are many kinds of intra-ocular lenses or orthopaedic implants. Thus, one size doesn't fit all.

"We would rather bring down our prices and ensure that margins are reasonable. We have written to the department but haven't heard from them on our proposal," he says.

Intra-ocular lenses are of three kinds: rigid plastic, foldable and, refractive lenses. According to estimates, 15 per cent intra-ocular lenses are imported while the rest are domestically manufactured. Companies that manufacture these lenses are Bausch and Lomb, Auro Laboratories, Johnson and Johnson, Novartis.

Realising that price capping is inevitable; lobbies of pharmaceutical companies are of the view that the DoP should constitute a technical advisory board that includes industry representatives. The NPPA has only capped the price of 18 per cent of the industry.

They wish this group should be consulted by the NPPA while fixing and revising prices of drugs. Deepnath Roychoudhry, President Indian Drug Manufacturers Association says, "Sometimes there is misinterpretation of the DPCO 2013."

"Further, not all doses of the same drug are the same. A plain coated tablet is different from an extended release tablet, which deserves better pricing," he says. IDMA is an industry body that has representation from a number of large companies.

In response to the demand raised by the pharmaceutical industry, (DoP) has sought justification. The pharmaceutical industry is proposing an advisory board on the lines of the Drugs Technical Advisory Board (DTAB) which has industry representatives. The DTAB advises the central drug standards regulator on various policy issues including processes for approval of various drugs.

The domestic manufacturers of medical devices have written to the DoP saying they would like to voluntarily bring down prices of devices that are non-scheduled, but part of the DPCO 2013.