The government today made it mandatory for stent makers to maintain production and supply of coronary stents by invoking an emergency clause under drug price control law citing reports of shortage in market.
"After due deliberations on the current situation and alternatives available with the government to resume normal supply of the coronary stents, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013," Department of Pharmaceuticals said in a letter to stent makers.
The department said there have been reports of shortage of coronary stents in the market/hospitals.
Last week, the government had slashed prices of stents by up to 85 per cent by capping them at Rs 7,260 for bare metal ones and Rs 29,600 for the drug eluting variety.
Under the Section 3 (i) of DPCO, 2013, the government can regulate distribution and direct any manufacturer to increase production and sell products to institutions, hospitals or any agency as the case may be in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest.
In its letter to the manufacturers, the department said: "The companies manufacturing stents in India are directed to maintain production/import/supply of the stents and to submit a weekly report on stents produced and distributed. They will also submit a weekly production plan for the next week to NPPA and DCGI".
The National Pharmaceutical Pricing Authority (NPPA) and the Drug Controller General of India (DCGI) are also empowered to extend these directions to "any other producers of coronary stents in India during this three months period," it added.
The 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, it added.
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