New Delhi : Neurologist challenges Stroke Drug Approval in high court

New Delhi: In what would be probably a first, a Delhi based- neurologist has dragged the Union Government and DCGI (Drug Controller General of India) to court challenging the latter’s approval given to Emcure (Gennova) pharma's Tenecteplase injection to be used in brain stroke. Sources say that Gennova has also been made party to the case.

This comes after the marketing approval was recently received by Pune-based Gennova, the biotech arm of Emcure Pharma, for a biologic drug "Tenecteplase” to be used for brain stroke. The company has pointed that this has come after clinical trials of over 100 patients, with the help of research that spanned over a decade. Priced at Rs 29,000 per dose, the approval makes the drug, one of the cheapest in the market for stroke treatment.

Traditionally, the drug has been used worldwide only for thrombolysis in heart attacks.

Objecting to the approval, Dr Deep Das has filed a PIL (Public Interest litigation) with Delhi High Court in the matter.According to the industry experts, this is one of its kind cases where a doctor has challenged the approval of government.

And the Clot Thickens...........

The case has given new heights to the already ablaze brawl between Boehringer Ingelheim (a German based MNC) and Gennova Biopharma.

Alteplase, which is worldwide used for brain stroke is sold by Boehringer at cost of Rs 73,000, while the recently domestically approved medicine “Tenecteplase” only costs Rs 29,000 per dose.

As reported by TOI, Boehringer Ingelheim which sells alteplase, (brand Actilyse) for treating brain stroke, says it does not recommend or advocate the use of Tenecteplase for stroke treatment. The company has informed doctors and regulatory authorities about the concerns regarding use of tenectaplase for brain stroke, saying that it is approved and used globally only in heart attacks.

Responding to a TOI query on its future course of action, Boehringer Ingelheim India MD Sharad Tyagi said the issue is being discussed at the global level, and a decision will be taken soon.

Confirming the court case, when contacted, DCGI, GN Singh said "the decision (on Gennova) was science-based and keeping in mind the data and regulatory framework of the country. The approval process was multi-layered and was studied by several experts".