New Delhi: The Department of Pharmaceuticals (DoP) has called for faster processing of applications by foreign stent makers to withdraw their products from India, or alternatively, reconsider their petition demanding differential pricing of stents.

The move comes ahead of a key meeting on 9 April by the US trade representative (USTR) which is facing calls from US stent makers to withdraw India’s benefits under generalized system of preferences (GSP) if they are forced to sell stents in India at prices set by the government.

At a meeting called by DoP with officials from National Pharmaceutical Pricing Authority (NPPA), Department of Industrial Policy & Promotion (DIPP) and the ministries of health and commerce, the DoP secretary asked the NPPA to “examine" and “dispose of" the applications filed by multinational stent makers without any further delay," two people aware of the matter said.

Last year’s price control on stents led to a price cut of up to 85% and prompted many multinational firms to demand a new category of high-end stents, which could be kept out of price control. However, an eight-member health ministry sub-committee that met on 25 January found “no grounds" for the same as the firms did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES" and dismissed their plea.

The DoP on Wednesday yet again asked the NPPA to examine the issue and dispose of the matter soon. “The health ministry has already given their decision. The NPPA can either take up the issue once again with their panel of experts seeking differential pricing or will have to let multinational stent makers withdraw their product from the market. The applications of withdrawal have been pending with the NPPA. In the meeting, the pharmaceutical secretary asked NPPA to take the decision in this regard soon," said one of the people.

The US is pressing India not to extend price caps on medical devices and wants India to allow firms to withdraw products from the market if they do not wish to sell at government determined rates. In September, USTR Robert E. Lighthizer wrote to commerce minister Suresh Prabhu and the Prime Minister’s principal secretary Nripendra Misra that the pricing policy had created serious problems for US stent makers in India. He also urged India not to extend caps to other devices. The matter was also discussed during Prime Minister Narendra Modi’s visit to Washington in June.

The American medical device makers had also asked the USTR to suspend or withdraw India’s benefits under GSP. Under the GSP, Indian exports to the US enjoy lower import tariffs compared to those imposed on non-GSP exporters.

The 9 April meeting is, therefore, significant. “India has the option to retaliate in case they suspend the GSP," said Malini Aisola of All India Drugs Action Network (AIDAN), adding US stent makers are trying to “arm twist" the government over interventions to protect public health. ‘There is no evidence to suggest that the companies fared badly from the price caps in stents as US-based MNCs still dominate the market. The NPPA has granted approval for withdrawal to some stent models as they would have negligible impact with low market share," Aisola said.

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