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Global healthcare company Abbott’s controversial bioresorbable stents — Absorb and Absorb GT1 — will be taken off shelves immediately, the National Pharmaceutical Pricing Authority (NPPA) said in an official memorandum on Thursday.
NPPA had received a request from the company to discontinue the products in India earlier this month. The request has been accepted on the grounds of “safety”, the Authority said.
“The Authority 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 (US Food and Drug Administration), 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,” the memorandum said.
Usually, if a company wishes to discontinue any drug or medical device in India, it has to inform the government at least six months in advance. The government may, keeping public welfare in mind, ask the company to continue manufacturing or importing the product for up to a year.
These particular products, however, have come under scrutiny globally following research trials that indicated that the use of these stents, which are fully absorbed by the body, could increase chances of heart attack and clotting.
Before the capping of the prices in February, these stents were priced at ₹1.9 lakh. The company had filed for discontinuation of its premium stents soon after the price control, claiming the capped prices were unsustainable.
The company has asserted that it was withdrawing the stents due “low commercial uptake”. However, it has also discontinued the brands globally.
NPPA in its memorandum said: “The safety ‘concerns’ is the prime reason behind low commercial global sales of these brands.”
The authority has also taken a strong position on patients who have already been implanted with these stents in India, asking the company to follow up with these patients and “attend to all follow up issues arising in the cases under trial and 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 (Drugs Controller General of India).”
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