Price-cap: Stent-makers told to maintain supply, file weekly reports

Shortage of stents in the market following the decision of the government to cap prices of the medical device has raised an alarm. The Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, wrote to manufacturers of the device on Tuesday, asking them to maintain supply and comply with the new prices.

“After due deliberations on the current situation and alternatives available with the government to resume normal supply of the coronary stents, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013,” the letter said.

The Section 3 (i) of the Drugs Price Control Order 2013, says: “…with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be.”

The companies have been asked by the Department to submit weekly reports on the number of stents produced and distributed, as well as the production plan of the next week to the National Pharmaceutical Pricing Authority (NPPA) and the Drugs Controller General of India (DCGI).

The order will be applicable for about six months, the letter added.

Manufacturers, meanwhile, have blamed the need for re-labelling of existing stock of stents, for the shortage in the market. They have also said the process could jeopardise sterility of the devices, making them unsafe.

The government, however, has made it clear that there is no need for re-labelling as long as manufacturers notified the new prices to retailers.

Last week, the NPPA had slashed the prices of stents by up to 85 per cent, bringing down prices of drug-eluting stents to ₹29,600 and those of bare-metal stents to ₹7,260. Massive fluctuations were earlier seen in prices of these life-saving devices, which are used to treat blockages in arteries. Prices of drug-eluting stents would earlier go up to as much as ₹2 lakh, while bare-metal stents could also touch ₹75,000.

Coronary stents were brought under the National List of Essential Medicines in July 2016.