New drugs likely to escape local clinical trials

New drugs that are already marketed in developed countries may be exempted from local clinical trials in India if subject experts vet their safety and effectiveness, a move that can lead to faster introduction of latest therapies in the country. 

The exemption will take effect after the Drug Controller General of India approves a study designed to monitor the new medicines' performance through what is called 'post marketing surveillance', according to a decision of Drug Technical Advisory Board (DTAB), India's apex drug safety body.

 

"New drugs are approved in well regulated markets such as the US and the European Union after deep scientific scrutiny and regulatory review of extensive clinical trials which span across various countries. In many of these cases, by making companies repeat large trials in India, we could be delaying the launch of new drugs by a few years at least," said a DTAB member.

At present, such mandatory trials involve 100 to 400 volunteers and last between one and four years, or even longer if the disease type is rare. By definition, any drug which is yet to be introduced in India, even if it has been marketed overseas for years, is considered a 'new drug'.

Drug makers have cheered the move, saying if the government does away with this "policy formality of repeating trials", newly-discovered drugs can be ushered in faster.

"Correcting this existing policy aberration will be an immensely progressive step. Every clinical trial must be justified by the social merit it offers and the uncertainty it is trying to address. In that sense, these trials are ethically questionable, because they repeat exercises which don't add much value," said Dhananjay Bakhle, executive vice-president of Lupin.

There are times when 4-5 generic drug makers conduct the mandatory trials for the same drug simultaneously to bring their drug faster to the market, Bakhle added. Of the total 140 newly discovered drugs that were launched between 2006 and 2010 globally, only 39 (28%) are available in the Indian market, an IMS Health global study found in 2012. But that could be partly because American and European innovator firms are admittedly sceptical of India's patent policies and fear losing their monopoly rights in the country.

 

Drug experts are, however, sceptical of the move. "The basic purpose of these Phase III trials is to determine if there are any ethnic differences that can alter the metabolism, efficacy and safety of the drug when administered to patients of different ethnicities living in India," said drug regulatory expert CM Gulhati.

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