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Bangalore, May 9 The country’s drug regulator plans to enforce mandatory registration and audit of CROs or clinical research organisations post-June this year. Details of the clinical trials they conduct across the country are to be brought into public domain on a Web site.

The CROs will have to register their trials with the Drugs Controllerate-General of India; they were advised to register with the Indian Council of Medical Research until now, which was often not done. The advisory comes to an end in June this year.

Dr Surinder Singh, DCGI, said here recently that CROs were mushrooming all over, with nearly 700 trials for drugs, vaccines and medical devices taking place in the country. “The issues of credibility, quality and reliability of these trials are weighing on our mind” and the measures would raise the benchmark for trials done in India, Dr Singh said. It would also improve the image of India, which, he said, was emerging in the pharmacy of the world.

The DCGI had got the USFDA to train its staff in all the four zones in auditing CROs. It next planned to introduce audit of BE or bio-equivalence tests.

More Stories on : Pharmaceuticals | Research & Development | Regulatory Bodies & Rulings

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