The Hindu Business Line : Registration to be made mandatory for clinical research organisations

New Delhi, July 11 To bring more transparency to clinical trials happening in India, the drug regulator has drafted guidelines for mandatory registration of clinical research organisations (CROs) in the country.

A clinical research organisation is an entity that undertakes trials of drugs on humans on behalf of a pharmaceutical company.

The drug regulator had earlier made it mandatory for companies to register all clinical trials taking place in the country. The move is aimed at keeping a tab on organisations undertaking clinical trials, even as multinational pharmaceutical companies are looking to make India the hub for clinical research given the easy accessibility to humans volunteering to take part in the drug trials at cheaper rates.

According to the proposed draft rules for registration of CROs, the drug regulator will give licences for five years to each company. Comments on the draft guidelines have been sought within 45 days after which they will be formalised. While the drug regulator has retained the powers to cancel licences issued to CROs, it has allowed the company to appeal within 90 days.

“These guidelines cover all organisations, individuals, institutions and companies that take the responsibility of the initiation or management or coordination of a clinical trial. It does not include clinical trial sites. An individual who both initiates and actually conducts, alone or with other associates, a clinical investigation and under whose immediate directions the test article is administered or dispensed or used involving a subject would be exempt,” the draft guidelines stated.

Keeping records

The guidelines make it mandatory for CROs to keep written records of trial-related duties and functions being carried out. They will also have to keep records of quality assurance and quality control according to the standard operative procedures designed for the purpose.

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