Eight months after the expiry of deadline for medical device manufacturers and importers to submit their price data, the National Pharmaceutical Pricing Authority (NPPA) has budged on the issue and extended the time limit to March 15, 2018. This would be “the last opportunity” for companies to submit their data failing which their licences could be revoked, the regulator stated in a circular.

To monitor the prices of 19 out of 23 medical devices notified as drugs under the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945, the regulator had ordered manufacturers, importers and marketers to submit particulars by May 31, 2017. The last date for submission was later extended to June 9.

“The deadline for data submission is missed twice. But many companies still have not submitted it. These records are imperative for us to keep a close watch on retail prices,” a top official said.

According to the circular, which is sent to all manufacturers and importers, the regulator will request the Central Drugs Standard Control Organisation (CDSCO) to revoke the licence of companies that fail to comply with the directive.

Paragraph 20 of the Drug Price Control Order (DPCO) empowers the regulator to monitor maximum retail prices (MRPs) of all drugs, including the non-scheduled formulations, to ensure that no manufacturer or importer increases the price by more than 10 per cent of MRP during the preceding 12 months. As per the regulation, if the increase is beyond 10 per cent, the firm should reduce the price to the level of 10 per cent of MRP for the next 12 months. Nineteen devices notified as drugs under Drugs and Cosmetics Act include disposable hypodermic syringes and needles, catheters, intra ocular lenses and orthopedic implants.  

The NPPA’s move to crack down on companies that refuse to submit data would have significant implications for the healthcare sector. Sources in the government have revealed that the pressure is building on authorities to expand the ambit of price control to more medical devices after a cap on prices of coronary stents has brought their prices down substantially. The health ministry is discussing with industry stakeholders and analysing data to bring more critical medical devices under the National List of Essential Medicines (NLEM), they say. All devices under the NLEM automatically fall under the purview of price control.

Recently, the All India Syringes and Needles Manufacturers Association (AISNMA) decided to cap trade margins at 75% after the regulator levelled criticism against manufacturers over excessively high prices of disposables. Industry observers see the move as a pre-emptive measure to avoid the regulator’s wrath. However, the plan to embrace self-regulation is facing hurdles as a few multinational firms are refusing to comply with it.