Drug Controller General of India Dr M Venkateswarlu has indicated that the central government will soon bring in a law to monitor and regulate clinical trials in the country. "The government has already initiated steps in this direction", he said.
Any deviation from the ethics will cost five years of imprisonment and fined amounting to Rs 20 lakh, he added Dr Venkateswarlu was participating in a panel discussion on 'Clinical Research Harmonisation: Scope and Challenges', hosted by Bilcare Research as part of inauguration of the company's first research academy and launch of India chapter of Association of Clinical Research Professionals (ACRP).
Replying to a query regarding the delay in bringing the lay, he said, "Regulations are brought in only when a practice matures and becomes a sizable one and not in the evolving stage. Now clinical trial in India has become a sizable one and regulations have become inevitable to put an end to the unprincipled competitions and the subsequent deviations from the ethics." "The clinical trial arena has turned to a place of floating consultants and attrition of documentation," he added.
Asked about the current status of the proposed law, Dr Venkateswarlu said, that a Bill has been submitted to the central government in this regard. He also said that the law is nothing but translating the Mashelkar report into action. As any law, the proposed law will promote transparency, visibility and discipline in the clinical trial field, he added.