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The Department of Pharmaceuticals (DoP), part of Ministry of Chemicals & Fertilisers on Thursday invoked the powers under Section 3 of DPCO, 2013 to restrict stent manufacturers from withdrawing their products from the market.
The Section 3 of DPCO allows the government in cases of emergency or non-commercial use in public interest to direct any manufacturer to ensure adequate availability of drugs or devices. The Section 3 also enables the government to regulate the distribution.
The DoP said its order will be valid for three months.
As per the notification the National Pharmaceutical Pricing Authority (NPPA) and Drug Controller General of India (DCGI) will recommend withdrawal or extension of stents two weeks before the expiry of the period.
The DoP directed the stent manufacturers to maintain production, import, supply of the coronary stents, in addition to submitting weekly report on coronary stents produced and distributed.
The manufacturers were also asked to submit a weekly production plan for the next week to the NPPA and DCGI.
DoP notification empowered NPPA and DCGI to extend these directions to any other producers of coronary stents in India during this three-month period.
The move comes after NPPA while allowing the withdrawal of Abbott Healthcare’s drug-eluting stent sold under the brand name Xience Alpine from the Indian market, blamed DoP for not accepting its request to exercise government powers under Para 3 of the DPCO, 2013 and extend restriction on the stent manufacturers from withdrawing.
NPPA said it was “left with no option but to allow formal withdrawal.”
NPPA also warned the government that the the withdrawal of stent brands with a sizable market share “will create sudden shortage of stents which will not be in the interest of public health.”
Abbott earlier this month approached NPPA seeking to discontinue sale of its Xience Alpine stent from India citing lack of sales viability following capping of prices of medical devices by the drug price regulator early this year.
Last week, NPPA allowed immediate withdrawal of Abbott’s two bioabsorbable stents on safety grounds, while Abbott differed citing withdrawal due to low commercial sales.
US-based Boston Scientific sought NPPA permission to withdraw its drug- eluting stent Promus and biodegradable stent Synergy.
About 60 percent of the market for stents is shared by multinational companies such as Abbott, Medtronics, Meril Lifesciences and Boston Scientific.
Analysts, who track healthcare, say that drug price regulator NPPA has become ever more assertive during BJP rule. The regulator received backing from SJM - the economic arm of the Rashtriya Swayamsevak Sangh, of which the ruling Bharatiya Janata Party (BJP) is the political arm. SJM warned against diluting existing powers of NPPA and alleged that DoP is acting in the interests of the industry.
The Modi government used price controls and margin caps as a popular policy tool to reign in healthcare costs. With no universal health coverage - much of the healthcare spending in India happens from patient's pockets.
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