NPPA Allows Abbott To Withdraw ‘Absorb’ Stent In Public Interest
India's drug pricing regulator has allowed Abbott Healthcare to withdraw its Absorb and Absorb GT1 coronary stents on an immediate basis in view of "safety concerns" raised by the U.S. Food and Drug Administration and the European Medical Agency.
The National Pharmaceuticals Pricing Authority (NPPA) has decided to allow the withdrawal under exceptional circumstances and by relaxing the mandatory six months prior intimation in public interest, it said in a memorandum. The decision was considered by the authority in a meeting on September 19, it added.
Abbott requested the watchdog to let it withdraw the stents, as it was putting a stop on manufacturing, and withdrawing the brands globally due to ‘low commercial uptake', said the NPPA. This was being reflected in the sales figure of these brands in India, it added.
The regulator, however, took note of the fact that the safety concern is the prime reason behind the low sales of these brands. "Taking specific note of the issue of global safety concerns of the 'enhanced adverse cardiac activity including increased level of thrombosis' already raised by the U.S. FDA, EU, Government of Australia and also in India in this regard", the NPPA decided to approve and allow immediate withdrawal of these stents, the regulator said.
Also Read: No Mid-Term Revision Of Stent Prices Before February 2018, Says Drug Pricing Regulator
This has been done under exceptional circumstances and by relaxing the mandatory period of six months prior intimation under provisions of the Drugs Prices Control Order (DPCO) 2013 in public interest, it added.
The regulator also directed the company to follow up the implanted patients in the existing Absorb clinical trials and to follow up issues arising in the cases under trial.
Abbott Healthcare will have to issue a public notice in the prescribed format in at least two national news papers, their own website and send a copy to the regulator to complete the withdrawal process.
Also Read: After Coronary Stents, Regulator Caps Prices Of Knee Implants
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