Organizations and individuals who violate approved procedures in drug tests and clinical trials that use human subjects may soon face a maximum imprisonment of five years and a fine of Rs20 lakh, according to M. Venkateswarlu, drug controller general of India.
The Union health ministry plans to regulate clinical research activities by bringing them under the scanner of the Central Drugs Authority (CDA). A draft Bill, which is likely to be tabled in the monsoon session of Parliament, will empower the drug regulator, CDA, to prosecute clinical research organizations, investigators and trial sponsors—pharmaceutical companies—for any violation in the approved clinical trial procedures.
The government’s efforts are targeted at bringing the currently unregulated clinical research activities under the purview of a set of laws. This will ensure safety of uninformed human subjects, who are allegedly exploited by clinical research organizations and investigators.
The Drugs and Cosmetics Act sets down the rules and regulations for the drugs and pharmaceuticals industry. The drug controller general said that the proposed law would give legislative sanction to the rules framed under Schedule Y of the Act, which deals with clinical trials.
Currently, there is no penal provisions in Indian law to book offenders because clinical trials have not been considered to be an important and sizeable activity. However, clinical research has emerged one of the fastest growing activities in the drugs and life sciences business, with India becoming a preferred location to which multinational pharmaceutical firms can outsource clinical trials. Drug research activities by domestic companies are also on the rise.
Currently, over 200 clinical trial projects involving new drug tests on human volunteers are going on in India. In the absence of a clear regulatory system for controlling and monitoring of such trials, several lapses in these have been reported.
In a two-part series published on 30 May and 31 May, Mint had highlighted the inconsistencies in the Indian regulatory mechanism when it came to safeguarding human subjects in drug trials.
Following this, the Union health ministry initiated necessary steps to strictly monitor the trials by proposing to conduct on-site inspections, which are expected to start shortly.
“Clinical trial activities have emerged to a considerable size now in the country and it is the time to evolve a strong regulatory mechanism by making suitable laws. We cannot continue like this and there is a need for more transparency and a systematic regulatory approach,” Venkateswarlu said.
“The people who undergo clinical trials of drugs should not be exploited. They should be well informed about the risks. Their safety should be ensured,” he added.