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India to Allow First-in-Human Phase I Studies of Molecules Developed Abroad Soon?

Thursday, July 19, 2007

India may allow first-in-human phase I studies of molecules developed abroad in the near future. Currently, India only allows first-in-human studies developed in India—a boon to the burgeoning domestic clinical research industry, and a bane of the global clinical research industry.

A year ago, the then Drug Controller General of India, Mr. Ashwini Kumar, said at the DIA Annual Meeting in Philadelphia that India was not ready for these types of studies. Some wonder if India is ready now.

CenterWatch spoke with Navaneetha Rao for perspective. Rao has worked in India for many years and is currently head of clinical R&D at Vicus Therapeutics, a small U.S.-based biotech. Prior to that he worked for an India-based contract research organization (CRO), as head of clinical research services.

“Imagine if what happened in the UK with TeGenero were to happen in India. Not only would it have a huge negative and adverse impact on phase I studies, but it would have a very big dampening effect on clinical research in general. There are right things happening, there are right steps being taken, but is it sufficient to handle the load that is being placed on the industry?”

The Central Drug Standard Control Organization, India’s main regulatory agency headed by the DCGI, promulgated “Good Clinical Practices for Clinical Research in India five years ago, and it’s been two-and-a-half years since India upgraded its Schedule Y (equivalent to the U.S. Code of Federal Regulations) to harmonize it with U.S. and International Conference on harmonization (ICH) standards.

India’s participation in global clinical trials nearly quintupled between 2001 and 2005, but it is in competition with other emerging markets, all of which allow first-in-human phase I clinical trials for molecules developed outside their respective countries…

The Drug Technical Advisory Board (DTAB) met recently in Delhi and has recommended that the Health Ministry allow first-in-human trials in the country for molecules discovered in other countries. The recommendations of DTAB, which is composed of senior Health Ministry officials, including the DCGI, are generally accepted by the Ministry, according to Pharmabiz, an Indian pharma portal.

While opening up the country to these phase I studies would offer the opportunity for its clinical research market to grow even larger than it has, there are still some major drags on growth that cannot be changed by a regulatory amendment, namely a growing shortage of experienced clinical research personnel to meet demand.

Both big pharma and CROs engage in training activities but find it difficult to keep pace with their own requirements. In addition, personnel are poached frequently, and competition is fierce, which drives up salaries.

Rao said, “You have people fresh out of college with a year-and-a-half, two years experience getting titles like clinical trial leader, associate director, and whatnot. You give these titles in order to retain these young kids, but it doesn’t fully reflect the person’s true professional skills. I’m experiencing that now as a sponsor.”

Big pharma, CROs and India may get what they’ve wished for, but they may find that being able to conduct first-in-human studies for molecules developed abroad is a double-edged sword.

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