The Union health ministry has finally put the much-debated proposal to allow drug companies to conduct phase-1 clinical trials in the country for which molecules were developed outside India on a backburner now. The permission is not likely to be granted at least for the next three years, it is learnt.
Though few experts were in favour of granting permission, the health ministry has shelved the proposal now on various grounds including the insufficient skill and infrastructure existing in the country for the same. The proposal will be cleared only after putting in place needed infrastructure and introducing enabling provisions in the Drugs and Cosmetics Act, sources said.
Though, the DTAB sometime back cleared the proposal, an attempt was made to hammer out a general consensus in the wake of widespread concerns, especially from the public interest groups. A meeting was convened with the NGOs, CROs, pharmacologists, and other experts in this regard, leading to finally the dropping of the proposal for the time being. The majority felt that India was not ready at this point of time.
Besides the lack of manpower, technical infrastructure and facilities, the issue of monitoring was also raised as there are not enough safeguards in the present regulatory system to closely monitor such trials. Another argument was making it binding on the companies to simultaneously launch the product, for which the clinical trial is carried out here, in India and elsewhere.
"If the multinationals are conducting trials in India for their molecules developed outside, it should be made binding on them to launch the final product simultaneously here also. They should not be left free to launch it in other countries first and take it to India after a gap of many years. As Indians also become subjects, we also have the right to that drug at the earliest," DCGI Dr Surinder Singh told Pharmabiz, while referring to the issue.
At present, it was felt that India was not ready for the idea and the country lacked enough technical facilities for radio-levelling or designing of drugs. Besides, the provisions like making compulsory the recording of fingerprints of trial subjects also should be put into practice. It will check the same volunteer from going for another trial even when undergoing trial for drug or immediately after that. It will check the duplicacy, it was argued.
Dr Singh also felt that it would take at least three years for the country to set up the entire required infrastructure, skilled manpower, technical facilities and enabling regulatory provisions. "Once we are ready in all levels, we will think of allowing phase-1 and phase-0 trials," he added.