The reported move of the Central Government to bring contract research organizations under mandatory registration has been strongly denied by the office of the Drugs Controller General of India. The move has also been set aside by the CROs as mere "wishful thinking".
Responding to pharmabiz queries, Ashwini Kumar, DCGI said that the department has called for consultations with all stakeholders to bring in more accountability in the functioning of Indian CROs. "We have not thought of introducing any registration procedures for CROs. We have called for detailed discussions on the functioning of CROs as it is an emerging segment. Currently our regulatory responsibilities are mainly focused on the manufacture and sale of drugs. The emergence of CROs has necessitated wider consultations for bringing in the best out of Indian CROs," he opined.
The DCGI felt that there was no country in the world where CROs are under regulatory control through licensing or registration. The issues associated with CROs cannot be handled by just introducing a registration process. The modalities have to be worked out based on the experience of other countries, Indian CRO segment and also the regulatory agencies, he explained. "Tell me about one country where there is such a registration is in place," he asks.
Echoing the feeling, Brijesh Regal, managing director of Apothecaries Ltd, a Delhi-based CRO, rubbished the reported move as a mere "fantasy". According to him, the CROs cannot be considered as a manufacturing facility, which needs registration. "A CRO is not an entity in itself. Every clinical research undertaken by us is a joint initiative of volunteers, CRO management, pharmaceutical industry etc. The responsibility is also shared among the various stakeholders. One cannot solve all issues by just getting the institution registered with the regulatory authorities," he said.
According to industry sources, the DCGI control / regulatory approval already exists in this segment. Every clinical trial needs lot of regulatory clearances. Even bio-equivalance studies of new drugs need prior approval from the office of the DCGI. The revised Schedule Y of the Drugs and Cosmetics Act is going to give clear guidelines for clinical research. In every sense, there are sufficient regulations in place, they say.
According to sources, a state drug control authority mooted the suggestion for registration of CROs. The state authorities had done this after some of the CROs in the particular state had been in news for all wrong reasons. Sources pointed out that transparency and integrity are essential qualities needed for CROs and it cannot be brought in through any kind of registration.