New Delhi: More than six months after the drug price regulator—National Pharmaceuticals Pricing Authority (NPPA)—slashed the prices of stents, manufacturers hurt by the authority’s decision have approached the Prime Minister’s Office (PMO) seeking revised rates for their products.
The PMO on Saturday met officials from the health ministry and department of pharmaceuticals (DoP), under the ministry of chemicals and fertilizers, to seek suggestions on the representation of the manufacturers who have sought exemption from price caps for their high-end stents.
The stent makers have been engaged with the government since the price cap was announced in February. Stents are small wire-mesh structures used to treat blocked arteries.
The manufacturers have told PMO that the dealer price or the landed cost, which is the company’s cost of manufacturing the stent in the country of origin, is higher than the selling cost.
“Citing commercial unsustainability, the manufacturers are of the view that slashed prices are not competitive for them to sell their products in India. While price control is the mandate of NPPA, the PMO had sought our suggestions, too, on the revised pricing of stents," said a senior official in the health ministry, requesting anonymity.
The ripple effects of reduced prices have already started to show with Abbott Laboratories, one of the biggest makers of coronary stents, halting global sales of their fully absorbable stent—Absorb bioresorbable vascular scaffold (BVS)—citing low “commercial sales".
The price of drug eluting or drug-coated stents were slashed by NPPA to about Rs30,000 from as much as Rs2 lakh. The move, which was preceded by several rounds of deliberations with firms, had upset manufacturers who said the new prices dissuade research and development.
Absorb, was priced at Rs1.9 lakh each before the cap.
Likewise, another stent- Xience Alpine, introduced in 2016, was priced at Rs1.5 lakh till 14 February, when NPPA slashed stent prices.
Additionally, Meril Life Sciences—the manufacturers of indigeneous BVS stents—have halted the launch of new stents in the market.
In February this year, Meril had received the approval from the Drug Controller General of India (DCGI) for its MeRes100—a naturally dissolving cardiac stent made out of biodegradable material and used for clearing blockages in arteries of the heart. However, the company has still not launched its product in India.
“We have built a generation next product. Meril has invested a lot of time and resources on the new technology. We are committed but we can’t decide on its introduction in India as of now," said Sanjeev Bhatt, vice-president, corporate strategy, Meril Inc.
Officials in DoP disclosed that manufacturers of indigenous BVS stents-Meril Life Sciences, have expressed their displeasure on the capping of stent prices and had also given a representation to the minister of chemicals and fertilizers and the officials in DoP.
The price capping has sparked a showdown between the firms and the government with some stent manufacturers keen to withdraw premium stents from the market.
Earlier, firms like Abbott and Medtronic had even filed for withdrawal of some of their stents from India. Another company Boston Scientific, too, had argued with the government citing that the cap was much lower than what it cost the company to import the device. The company asked for the price cap to be raised for their stent-Synergy.
However, the government rejected their request, citing contravention of drug laws. The government directed these firms to maintain their production of stents using its powers under Section 3(i) of the Drugs Price Control Order (DPCO). In cases of emergency, urgency or non-commercial use in public interest, paragraph 3 allows the government to direct manufacturers to increase or continue the production of a notified medical device and to sell these to institutions, hospitals or any agency.