Govt likely to keep drug-eluting stents under price control2 min read . Updated: 07 Oct 2016, 04:54 AM IST
Many medical device lobby groups have been pushing for differential pricing for drug-eluting stents
The government is likely to reject the demands of stent makers to keep drug-eluting stents out of the ambit of price control, two ministry officials said, requesting anonymity.
Drug-eluting stents account for close to 95% of stents used in patients. Many medical device lobby groups have been pushing for differential pricing for drug-eluting stents.
There will likely be no differential pricing for drug-eluting stents based on the technical recommendations of multiple industry bodies. These recommendations, or metrics, range from the stent diameter, polymer material and coating, stent length and strut thickness to clinical evidence of the stent’s effect on patients.
Two officials said that the prices of drug-eluting stents will be capped soon.
Both requested anonymity because they are not authorized to speak to the media.
“An order to include stents is expected to soon be made through the Drug Pricing Control Order (DPCO). After that it is the prerogative of the National Pharmaceutical Pricing Authority (NPPA) on when and how it will cap the prices," said one of the officials.
The stent-making industry’s fight has been led by its desire to corner a part of the stent market which is valued at over Rs1,500 crore domestically.
The health ministry’s decision earlier this year on the inclusion of stents—drug-eluting stents and bare metal stents—in the National List of Essential Medicines (NLEM) had meant an inevitable price cap.
After a product is bought under NLEM by the health ministry, the pharmaceutical department’s Drug Price Control Order enables the NPPA to cap prices through preset mechanisms.
Industry organizations and executives have questioned the rationale behind the move and pointed out that stents are medical devices while the government has classified them as drugs in order to include them in NLEM.
In June, a month before introducing the stents in the NLEM, the government withdrew the Drugs and Cosmetics Act from Parliament citing the need to introduce a separate bill for medical devices.
“The cabinet has, keeping in view the role of the sector in managing public health, decided that it’ll not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial/investigation, etc., cannot be effectively regulated under the existing law," the government said while withdrawing the bill.
Industry bodies had also questioned the need to start a move to cap stent prices at a time when a new medical devices bill was imminent. The draft medical devices bill has recently been moved to the public domain for discussions and comments.
“We’ve held consultations with the government expressing our long-term concerns about capping the price of medical devices in the country. We understand the need to ensure accessibility and affordability but this move may jeopardize the government’s initiatives to give manufacturing an impetus in India," said Abby Pratt, vice president, global strategy and analysis, Advanced Medical Technology Association (AdvaMed), the lobby group of device makers.
“The mechanism to determine the price cap for stents is yet to be arrived at so we will have to see how to go about it," said the second of the two officials cited above.