The onus of granting approvals to medicines marketed in the country is on the regulator Drug Controller General of India (DCGI), say drug companies, adding that they have adhered to the law of the land.

The drug-makers were responding to a Parliamentary panel report on health that severely indicted the drug regulatory authority, besides alleging that “invisible hands” of drug-makers were involved in getting favourable reports on medicines before they are marketed in India.

Bayer has conducted the mandatory clinical trials for Rivaroxaban (indicated for VTE prophylaxis) in India after getting necessary permission from the DCGI, the company said.

The Parliamentary panel had observed: “Three opinions (from Professor of Orthopaedics, All India Institute of Medical Sciences, New Delhi; Consultant at Dayanand Medical College, Ludhiana and Professor of Orthopaedics, St. Johns Medical College, Bangalore) on rivaroxaban (Bayer) a drug for prevention of clotting are merely ditto copies of each other.”

Bayer responded that the required data and an application for the indication was submitted to the DCGI. “As per practice, the DCGI then seeks advice from experts. Our company does not play any role in selecting these experts or evaluating their opinions. This is entirely an internal process of the DCGI. The experts send their opinion letters to the DCGI directly. The DCGI office then evaluates the experts’ opinion internally,” it added.

GlaxoSmithKline Pharmaceuticals said it had licensed Volibris (ambrisentan), a treatment for pulmonary arterial hypertension (PAH), from Gilead for marketing outside the US. Volibris was approved in Europe (2008) and US (2007), and is available in 43 countries.

“It was evaluated in 400 patients in two pivotal phase III studies, including a range of different ethnicities, to assess its safety and efficacy. The complete global clinical data set was submitted by GSK to regulatory authorities in India in 2009 and Volibris gained marketing approval in India in 2010. Since PAH is a rare disease which is life threatening and debilitating, GSK was granted a local clinical trial waiver in India,” the company said.

Further, the company said, the Drugs & Cosmetics Act stated: “for drugs indicated in life threatening / serious disease or disease of special relevance to the Indian health scenario, the toxicological and clinical data requirement may be abbreviated / deferred or omitted as deemed appropriate by the licensing authority.”

The panel report had said, GSK had not conducted the mandatory Phase III trials (involving safety and efficacy trials on patients) on the drug.

Reacting to a similar observation on its Colistimethate and Pirfenidone by the panel, Cipla said, it followed procedures outlined by the law and there has been no violation. “As per the law, it is not mandatory to carry out Phase III trials in India for each and every new drug. Both the drugs in question are marketed in a number of countries internationally and have been proven to be life saving. We deny that there has been any collusion with the DCGI,” the company said.

(This article was published on May 11, 2012)
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