New Delhi: Through a recent notice, Government of India , Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, and National Pharmaceuticals Pricing Authority (NPPA) has allowed Abbott to withdraw its bioresorbable cardiac stent from Indian market immediately giving the relaxation in the mandatory period of six months prior intimation in public interest, taking note of the issue of global safety concerns.
Abbott in a letter dated September 8, 2017, had requested NPPA to consider their request for discontinuation of Absorb and Absorb GT1 brands of Bioresorbable Vascular Scaffold (coronary stents) under para 21(2) of Drugs Prices Control Order (DPCO), 2013 on the ground of stoppage of manufacturing of these stent brands globally.
Para 21(2) of the DPCO, 2013 stipulates that any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the government at least six months prior to the intended date of discontinuation and the government may, in public interest, direct the manufacturer of the scheduled formulation to continue with required level of production or import for a period not exceeding one year, from the intended date of such discontinuation within a period of sixty days of receipt of such intimation.
The notice states that the request of Abbott Healthcare Pvt. Ltd for discontinuation of Absorb and Absorb GT1 brands of Bioresorbable Vascular Scaffold was considered in the Authority Meeting No.49 held on 19/09/2017. The Authority took note of the company’s assertion that it is stopping the manufacturing and doing a global withdrawal of these brands based on “low commercial uptake”. This was being reflected in the sale figures of these brands in India.
The notice further states that the authority, however, taking more specific note of the issue of global safety concerns of ‘enhanced adverse cardiac activity including increased level of thrombosis’ already raised by USFDA, EU, TGA-Government of Australia and also in India in this regard decided to approve and allow immediate withdrawal of Absorb and Absorb GT1 brands of coronary stents of the company under exceptional circumstances and by relaxing the mandatory period of six months prior intimation under Para 21(2) of DPCO, 2013 in public interest. The Authority took note of the fact that the safety ‘concerns’ is the prime reason behind low commercial global sales of these brands.
The Authority has also directed Abbott to continue to follow up implanted patients in existing Absorb clinical trials and attend to all follow-up issues arising in the cases under trial and has also told the company to do follow up with others who have got the device implanted in India in the same manner it has been asked to do by US and European Federal Drug Regulators apart from instructions by DCGI.
NPPA has directed Abbott to issue a public notice in at least two national newspapers (one in English and one in Hindi) in the prescribed format and also publish the same on their website and send a copy of the same to NPPA in order to formally complete the process of withdrawal.
Below is the attachment for the same.NPPA-notice