Submit weekly production report: Govt to stent makers

Order prompted by paucity of supply; weekly reports to be given to price and drug safety regulators

Cracking the whip on stent manufacturers, the Department of Pharmaceuticals (DoP) on Tuesday asked them to provide weekly reports on the production and distribution of the medical device.

The reports have to be submitted, for six months, to the National Pharmaceutical Pricing Authority (NPPA) and the Central Drugs Standard Control Organization, the drug safety regulator. The notification was issued after DoP got a number of complaints on shortage of stents.

NPPA, the top body that fixes prices of drugs, had on February 13 fixed the price of stents — a spring-like metal tube used to open blocked arteries — at Rs 29,600, if they eluted drugs, or at Rs 7,260 if they did not. Some medical professionals had predicted that there could be a paucity of stents in the market or an oversupply for low-quality devices.

According to Tuesday’s notification, the government “after due deliberation on the current situation and alternatives… to resume normal supply of the coronary stents …has decided to invoke Section 3(i) of the Drug Price Control Order 2013”. This allows the government to ask manufacturers to increase production of a particular drug. Last year, stents were classified as “essential drugs”, allowing NPPA to decide on their pricing.

Earlier, the DoP had asked the central and state drug controllers to ensure that stent manufacturers do not create a shortage of quality stents by withdrawing their products. Before prices of stents were capped, they were sold for anything between Rs 25,000 and Rs 1.8 lakh. NPPA’s order naturally made stent manufacturers unhappy.

While some of them started withdrawing stents soon after, purportedly for relabeling, NPPA clarified they need not do it, and also asked them to provide a revised price list. The government has said it would blacklist companies that try to create an artificial shortage.

Domestic manufacturers were happy with the order on Tuesday.

Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said “By invoking this section, the government will get to know what the reality is — whether there is an actual shortage of stents or multinational companies are creating an artificial shortage.”

Multinational companies who sell stents in the country did not want to comment on it.