NPPA tells Boston Scientific to resubmit applications on pre
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About 5 months back, Boston Scientific was blocked from discontinuing its high-end coronary stents brands 'Promus Premier' and 'Synergy' in India. However, it has once again approached NPPA seeking permission to do so, according to minutes of the regulator's latest authority meeting. At the same time, the company has also sought price revisions for these brands. But since both the applications cannot be considered at the same time, the company has been directed to forward one request by withdrawing the other request and till then both the request may be kept in abeyance.

According to sources, Promus Premier was priced over Rs 1.60 lakh and Synergy over 1.90 lakh before NPPA capped prices of all drug-eluting and biodegradable stents at Rs 29,600, excluding taxes.

After the prices of the stent were capped in February, Boston Scientific had moved to discontinue these two brands in April, but its application was rejected as the Department of Pharmaceuticals had mandated companies to maintain uninterrupted supplies of all stent brands until August.

The company had also earlier requested the NPPA to consider setting a higher ceiling price for the brands under provisions that would allow the government to differentiate the price if the product was proven to be clinically superior but this request was rejected by an expert committee set up to review the matter.

NPPA recently gave Abbott Healthcare permission to immediately withdraw its stent brand 'Absorb' over safety concerns and told the company it could phase out the supply of its 'XIENCE Alpine' brand over the course of a year. Abbott had sought to withdraw these two brands claiming it was not commercially viable to sell them in India following the price caps...