Health Ministry clears proposal on regulation of clinical trials

A proposal to regulate clinical trials and to treat medical devices as separate from drugs and cosmetics, has been vetted by the Health Ministry as it seeks to strengthen the Drugs and Cosmetics Act, 1940.

New Delhi: A proposal to regulate clinical trials and to treat medical devices as separate from drugs and cosmetics, has been vetted by the Health Ministry as it seeks to strengthen the Drugs and Cosmetics Act, 1940.

The proposal has now been sent for inter-ministerial consultation after which it will be tabled in Rajya Sabha, a senior Health Ministry official said.

"There have been incidents of mishaps during clinical trials in the past and also there are increased health risks involved. The regulatory norms will ensure ethical conducting of clinical trials in the country and prescribes penal provisions for its violations that include imprisonment of maximum 10 years and penalty of up to Rs 30 lakh," the official said.

"It will provide high degree of transparency as to the manner in which clinical trials are to be conducted and consequences of violating the processes, procedures and protocol," said the official.

As per the proposed amendments, there has to be mandatory accreditation of sites where clinical trials are to be conducted and the investigators along with the ethics committee which supervises the trial, are required to have accreditation.

As far as the amendments related to medical devices are concerned, they will be treated separately from drugs. Currently, medical devices are regulated on par with drugs.

Under the proposed amendments, there will be a separate set of norms to monitor medical devices which includes diagnostic equipments, hospital equipments and implants.

"Medical devices have been divided into three categories - high risk medical devices which will be directly regulated by Central Drugs Standard Control Organization (CDSCO), medium risk medical devices to be regulated by notified bodies and lower risk devices which will be self regulated.

"All these devices will be subject to surprise inspections, checking and conformance with quality," the official said.