Orders manufacturers to maintain production, import, and distribution of the medical device
To ensure availability of coronary stents post slashing of prices, the Centre on Tuesday invoked the special provision under the Drug Price Control Orders (DPCO), 2013, directing manufacturers to increase production of the medical device.
According to the Section 3 (i) of DPCO, “The government may, with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be.”
Authorities said that they decided to invoke Section 3 (i) after due deliberations on the current situation (reports of shortage of stents since price ceiling) and alternatives available with the government to resume normal supply of coronary stents.
“Manufacturers have been directed to maintain production, import, and supply of the medical device. They will also have to submit a weekly report on coronary stents produced and distributed besides a weekly production plan to National Pharmaceutical Pricing Authority (NPPA) and Drug Controller General of India (DGCI),” Barnali Khastgir, Under Secretary (DPCO Pricing), Department of Pharmaceuticals stated in an order. “NPPA and DCGI are also empowered to extend these directions to any other producers of coronary stents in India during the three-month period. This order will be valid for next six months, and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period,” Khastgir stated.
Back story
The government last week brought down the cost of coronary stents by around 380 per cent.
The Centre looked at this step as a major action on the unethical margins charged at each stage in the supply chain of coronary stents. The government has said that the new prices are not likely to make much adverse impact on industry, however the industry has shown unrest over the decision. Now the ceiling prices of Bare Metal Stents (BMS), that has 10 per cent market share, have been capped at Rs 7,260 and Drug Eluting stents (DES), that has 90 per cent market share, at Rs 29,600. These prices are exclusive of VAT and other local taxes. Since most States have five per cent VAT on stents, the maximum retail price of BMS and DES would be Rs 7623 and Rs 31,080.
Based on price reduction, patients will get average benefit of Rs 80-90 thousand per stent, resulting into a gross relief of Rs 4450 crore in one year.
Meanwhile...
Regulator National Pharmaceutical Pricing Authority (NPPA) on Tuesday asked hospitals to prominently display revised price list of stents while ordering manufacturers and importers to report to it in case of withdrawal or non-availability of products.
“All hospitals which are billing to the patients must display the revised price list of the cardiac stents on a conspicuous past of the premises of the hospitals in such a manner so as to be easily accessible to public...,” NPPA said in a notification.
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