NPPA allows Abbott to discontinue bioresorbable stent over safety concerns

NPPA decided to allow withdrawal under exceptional circumstances and by relaxing mandatory six months prior intimation in public interest

Drug price regulator NPPA on Thursday said it 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 USFDA and the EU.

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.

Request of Abbott Healthcare Pvt Ltd for discontinuation of Absorb and Absorb GT1 brands of bioresorbable vascular scaffold was considered by the authority in a meeting held on September 19, 2017, 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 concerns is the prime reason behind the low sales of these brands, it added.

"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 the implanted patients in the existing Absorb clinical trials and to follow up 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 if 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 DPCO 2013 on the ground of stoppage of manufacturing of these brands globally.