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NPPA allows Abbott Healthcare to withdraw Absorb stents in public interest

LiveMint logoLiveMint 21-09-2017 PTI

New Delhi: Drug price regulator National Pharmaceuticals Pricing Authority (NPPA) on Thursday said it has allowed Abbott Healthcare Pvt. Ltd to withdraw its Absorb and Absorb GT1 coronary stents on an immediate basis in view of “safety concerns” raised by the USFDA and the EU.

The 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 request of Abbott Healthcare for discontinuation of Absorb and Absorb GT1 brands of bioresorbable vascular scaffold was considered by the authority in a meeting held on 19 September, it added.

“The authority took note of the company’s assertion that it is stopping the manufacturing and doing global withdrawal of these brands based on ‘low commercial uptake’. This was being reflected in the sales figure of these brands in India,” the NPPA said. 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 USFDA, EU, TGA-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.

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 on the implanted patients in the existing Absorb clinical trials and to follow up on issues arising in the cases under trial and others in India in the same manner it has been asked to do by the US and European drug regulators and by the DCGI.

The NPPA also asked Abbott Healthcare to issue a public notice in the prescribed format in at least two national newspapers and also publish the same on their website and send a copy to the regulator to complete the process of withdrawal.

Abbott Healthcare had earlier written to the NPPA to consider withdrawal of these brands of stents under the provisions of para 21 (2) of the DPCO 2013.

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