The Hindu Business Line : Govt to allow simultaneous clinical trials in India, abroad

"The decision to relax the norms was taken after it was found that a large portion of the clinical trials business has been moving to China, Indonesia and Thailand."

New Delhi , Oct. 18

IN a move that is expected to give a boost to clinical trials in the country, the Government is set to permit pharmaceutical companies to conduct simultaneous trials in India and overseas.

While it will permit companies to conduct phase II and III trials in India along with other countries, it is not likely to open the doors for phase I trials.

The Health Ministry is planning to amend Schedule Y of the Drugs and Cosmetics Rules wherein it is planning to do away with the condition that there should be a phase lag between India and the rest of the world. A notification on this is expected shortly.

"The earlier condition virtually ruled out conducting trials in India along with the rest of the world. It was felt that India should not be the world's proving ground for unproven therapies," said highly placed sources.

The launch of a new drug normally has to go through various stages, including trials on animals.

Once the drug company files for investigational new drug (IND) application, trials are conducted on human beings.

Normally, phase I trials involve the services of 24-100 healthy young volunteers and drug safety would be tested on them for about a year.

Phase II trials are conducted on several hundred patients for whom the treatment is intended for a period of one-two years, while phase III tests the products on several thousands of patients across many countries for two-four years.

"The decision to relax the norms was taken after it was found that a large portion of the clinical trials business has been moving to China, Indonesia and Thailand.

However, there will be safeguards and trials will be monitored with checks and controls to address ethical concerns," said sources.

For instance, clearances are likely to be given on a case-by-case basis only and foreign companies may not be permitted to conduct trials exclusively in India.

Currently, the market for clinical trials has been pegged at $70 million and several major companies such as Pfizer, Novartis, GlaxoSmithKline,Eli Lilly and Astra Zeneca plan to make India their hub for clinical research activities.

In fact, Pfizer's cumulative investment on clinical research in India is believed to be $13 million.

Companies can save anywhere between 30-50 per cent on cost of conducting trials in India than in the the West.

Another advantage is the biodiversity of population and the wide and varied gene pool available in the country.

A wide spectrum of diseases is prevalent in the country including multi-drug resistant pneumonia, hepatitis B, diabetes; and some kinds of cancer are more prevalent in India compared to other parts of the world.

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