The Association of Contract Research Organisations is planning to release a code of conduct for clinical research/trials soon, according to its Chairman Mr Apurva Shah.

“We have readied a draft which is likely to be discussed in a meeting on January 13,” Mr Shah told Business Line here on Thursday.

The code assumes significance in the wake of alleged malpractices in clinical trials by some contract research organisations in Andhra Pradesh and some other parts of the country.

Clinical research was a well-regulated industry and most of the allegations of malpractices were not substantiated by evidence, Mr Shah claimed.

“There is a need to go beyond allegations and find the truth, which in most cases, is on the side the industry,” he said.

The association, which has over 40 companies as its members, is also working on creating an apex advisory board.

It was being examined whether this board could be allowed to conduct independent enquiry if some things goes wrong among its member organisations, he said.

COMPETITION

The nascent industry of contract research is facing stern competition from China, S. Korea and some Latin American countries, among others.

According to the association's data, the domestic contract research market fell by 9.6 per cent, but China's and S. Korea's grew by 15 and 21 per cent, respectively.

The size of contract research business in India is estimated to be around Rs 1,200 – Rs 1,300 crore.

“There is opportunity to grow but clients are also looking for value addition. Though there are 20-30 per cent savings for multinational companies in clinical research in India, it is no longer the sole-criterion,'' Mr Shah said.

The association has also been requesting the Union Government to make clinical trials mandatory for generic drugs as well , he added.

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