Just after the National Pharmaceutical Pricing Authority (NPPA) fixed the price of the cardiac stents, manufacturers have withdrawn all high-end stents from hospitals illegally under the garb of relabeling for new prices, creating artificial shortage of stents.
The recall comes despite NPPA, the apex drug price regulator, notifying that relabeling is not necessary and old stocks can be sold in the same packaging as long manufacturers circulate a price list with new prices.
Most manufacturers had expressed their displeasure on the capping of stent prices -- Rs 7,260 for bare metal stents and Rs 29,600 for Drug eluting stents and bioabsorbable stents.
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The prices, which were fixed by the NPPA after considering all costs incurred by the companies and adding a margin for profits, had upset manufacturers who said the new prices dissuade research and development.
Companies such as Abbot and Medtronic have gone for a selective recall by pulling out only stents which they say are highly superior such as bioabsorbable stents and certain drug eluting stents.
The recall violates the Drug Price Control Order that prohibits withdrawal without adequate warning and notice which might create shortage in the market.
A clause in Para 21 (2) of the Order states, “Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the Government in Form-IV of schedule-II of this order in this regard at least six month prior to the intended date of discontinuation.”
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Bhupinder Singh, the Chairman of NPPA, said “The office memorandum issued by the NPPA has clearly stated that creating artificial shortage is unlawful and in case any company is found to indulge in such activities, the NPPA will take action”.
Singh said the prices were calculated keeping research and development in mind. “Our calculations have shown that out of the 52 brands of stents imported in the country, there are only five brands that are imported at prices above Rs 26,999. The average landed costs for all such stents is Rs 16,918,” he said, indicating that companies still have a high profit margin under the new prices.
In response to Outlooks questions on the non-availability of certain medals of stents in the market, Medical Technology Association of India, said, “In the interest of patient safety, the process of relabeling needs to maintain sterility and proper handling of products.”
Companies claim that drug eluting stents have different qualities and cannot be clubbed under the same umbrella. But companies were unable prove the superiority of such DES’s over others. An independent committee of 20 cardiologists under the ministry of health has concluded that all drug eluting stents available in India are similar.
The DPCO already provides for differentiated prices for superior quality products. Malini Aisola of the all India drug action network said, “Para 11 (3) of the DPCO clearly states that if a company can prove incremental innovation and added value of a product through clinical evidence, the NPPA can price the product in a preferential manner. Yet, no company has come up with such evidence.”
