Mumbai: The Indian drug price regulator has asked the department of pharmaceuticals to ensure the availability of coronary stents in the wake of reports that manufacturers may be creating an artificial shortage after stent prices were slashed by up to 85% earlier this week.

The National Pharmaceutical Pricing Authority (NPPA) has asked the government to invoke Para 3 of the Drug Price Control Order (DPCO) to direct manufacturers and importers to maintain production, import and supplies of stents at the pre-price cap level, according to NPPA’s official Twitter handle. A stent is a tiny tube-shaped device placed in narrowed or blocked coronary arteries to maintain blood supply.

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Para 3 of DPCO states that the government may direct any manufacturer to increase production and supply of a product in order to achieve adequate availability and regulate distribution in case of an emergency or in circumstances of urgency or in case of non-commercial use in public interest.

After the government’s decision to slash prices and enforce a single ceiling price for all the different variants of drug-eluting stents, manufactures and distributors started pulling off the high-end stents across the country, several media reports indicated.

According to industry officials, four or five types of drug-eluting stents are available in the market which are priced based on the innovation and technology. Advanced stents are more expensive than the base products.

“Stent manufacturers are pulling off their premier stents from the hospital shelves. This will set a bad precedence. The decision to use a particular stent involves the life and death of the patient on the angiography table. By no means can we underplay the fact that certain blockages call for good deliverability of the stents and therein the use of appropriate stents. Labelling them all into one category will kill the scope for further newer innovations," said Dr Amit Sharma, a cardiologist at Mumbai’s Holy Spirit Hospital.

On 13 February, NPPA fixed ceiling prices of bare metal stents at Rs7,260 per unit and those of drug-eluting stents and biodegradable stents at Rs29,600 per unit in a bid to provide affordable treatment to patients. The ceiling prices came into effect immediately and were also applicable to all stocks in the trade channel.

Amid allegations of an artificial shortage, manufacturers have promised a continuous supply of stents.

“Given that stent manufacturers have always prioritized well-being and safety of the patients in India, we refute the claims that medical device companies are trying to create an artificial shortage of stents. As all the AdvaMed member companies remain compliant to the laws of the land, no member companies have withdrawn any stents from the market," Advanced Medical Technology Association (AdvaMed) said in a statement. AdvaMed is a lobby group representing international medical device companies.

“Abbott continues to market our full range of coronary stents available in India. In certain cases, we had initiated the process of relabelling to comply with the revised pricing notified by the government order of 13 February. We have also advised trade partners and hospital partners to abide by the ceiling prices determined by the NPPA order," said Anand Kadkol, director (public affairs) at Abbott India Ltd.

With NPPA issuing a notification on Thursday that relabelling of existing inventories in the trade channel is not mandatory, manufacturers believe there is no need to recall stocks from the market.

“The current hype created about stent shortage is completely wrong and designed to create panic among the public, thereby pressurizing the government. All the Indian manufacturers have their current generation drug eluting stents available in ample quantity in various hospitals across India," said Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, a group representing domestic manufacturers.

Ganesh Sabat, chief executive officer of Sahajanand Medical Technologies, said the company is supplying all its brands, including the most advanced stents, at government-fixed prices across India.

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