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 a formal withdrawal of the Xience Alpine stent from Indian market saying that it is left with no choice as Department of Pharmaceuticals has not accepted the request of NPPA to exercise Government powers and extend the restriction on the stent manufacturers from withdrawing. At the same time, NPPA said that the company can only completely withdraw the brand from the Indian market in a year’s time.
NPPA said the immediate withdrawal will create a sudden shortage of stents which will not be in the interest of public health safety and in order to ensure adequate supplies supply of the product the company is allowed for the complete withdrawal of Xience Alpine brand in a period of one year from the date of issue of public notice.
Abbott in a letter dated 8th September 2017 had requested NPPA to consider their request for discontinuation of Xience Alpine stent under para 21(2) of Drugs Prices Control Order (DPCO), 2013 on the ground of commercial unviability post-fixation of ceiling price.
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 in Form-IV of schedule-H of this order in this regard 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.
NPPA said that as per the provision Abbott would first have to issue a public notice to withdraw Alpine, which it has not yet done.
The notice states that the request of Abbott for discontinuation of Xience Alpine stent was considered in the 49th Authority Meeting held on 19/09/2017. The Authority, after examining the legal status of the application and taking into account the fact that Department of Pharmaceuticals has not accepted the request of NPPA to exercise Government powers under Para (3) of the DPCO, 2013 and extend the restriction on the stent manufacturers from withdrawing, NPPA is left with no option but to allow formal withdrawal as per the provisions of Para 21(2) of DPCO, 2013.
The notice further states that the Authority, accordingly, examined the whole issue and found that the import cost of the Alpine brand is less than the ceiling price and adequate margins are there, so the reason of unavailability of sales in India is not understandable. It was also found that these brands have a sizable market share and its withdrawal will create a sudden shortage of stents which will not be in the interest of public health safety. Considering all the issues and availability of other brands in the country and in order to ensure adequate supplies of life-saving medical device like stent, Authority decided to invoke the public interest clause under Para 21(2) to allow the complete withdrawal of Xience Alpine brand by the applicant company in a period of one year from the date of issue of public notice.
NPPA has directed Abbott to issue a public notice intimating about the discontinuation of Xience Alpine stent. The public notice to be issued and published in at least two national newspapers (one English and one Hindi) along with its publication on manufacturer’s website (for at least six months). The counting of first six months period shall start from the date of publication and submission of the copy of the same to NPPA.
The authority has also directed the company to continue to maintain the uninterrupted supply of Xience Alpine stent for a period of first six months at the level of an average of total imports in the last three months (June to August 2017) from the date of issue of the public notice. From the seventh month, however, the manufacturer may start reducing supplies of stents of this brand @ 15% every month for another five months and at the end of the twelfth month, it can withdraw the same by hundred percent.
NPPA further said that if the company want to reconsider their decision of withdrawal, the company shall be required to submit a written request to NPPA within 60 days from the date of issue of this order failing which withdrawal shall be treated as irrevocable and the company shall be required to surrender its license for export and marketing of the brand with the licensing authority.
During the period of this one year, the manufacturers will ensure that uninterrupted supplies are made available on demand by the patients/hospitals/ distributors and no artificial barriers are created to hinder availability, supplies and sales in any manner which shall be taken as a very serious violation of law liable to legal action not ruling out even prosecution under Essential Commodities Act.
Abbott is also directed to submit monthly import, inventory and sales details, by 5th date of every month starting from October 2017 to NPPA.
Medical Dialogues had earlier reported that NPPA had 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.
Find the attachment for the notice.