New Delhi: The government has directed coronary stent makers to maintain the production and supply of stents in the country amid reports of shortage in market and hospitals, according to an official order.
The government has invoked powers of section 3 (i) of the Drug Prices Control Order, 2013 to ensure adequate availability of stents, according to a notification by the Department of Pharmaceuticals (DoP).
The notification has come after the National Pharmaceuticals Pricing Authority (NPPA), earlier this week, allowed Abbott Healthcare to withdraw its latest drug-eluting stent Xience Alpine from the Indian market.
The NPPA had said that as the Department of Pharmaceuticals had not accepted its request to invoke powers under para 3 of DPCO 2013, it was left with no option but allow formal withdrawal of the stent.
“Some reports regarding the shortage of coronary stents in the market/hospitals have now come to the notice of the department,” the DoP notification said.
After due deliberations of the current situation and alternatives available with the government to resume normal supplies of the coronary stents, it has been decided to invoke the powers of section 3 (i) of DPCO 2013, it added.
The department has directed the manufacturers of stents in India to maintain production, import and supply of the stents and to submit a weekly report on the coronary stents produced and distributed, the notification said.
“They will also submit a weekly production plan for the next week to the NPPA and the Drug Controller General of India (DCGI)”, it added.
The notification also said that the NPPA and the DCGI are also empowered to extend these directions to any other producer of coronary stents in India during the three-month period.
“This order will be valid for three months except for Absorb Classic BVS and Absorb GT 1BVS stents of Abbott Healthcare and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period”, it added.
Para 3 of DPCO 2013, empowers the government to direct manufacturers to increase the production to maintain the adequate availability of drugs/medical devices in case of emergency, circumstances of urgency or non-commercial use in the public interest.
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