Mandatory registration for Indian clinical trials
Surinder Singh, drugs controller general of India (DCGI), told Livemint that: “Until now, clinical trials were being registered on the website of the Indian Council of Medical Research (ICMR) voluntarily. From January, it was made advisory. But by June, we will make it mandatory.”
Last August the Indian trials sector was rocked by the revelation that 49 infants have died during clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi since January 2006.
While subsequent investigation showed that the mortality rate was below the national average and did not link the deaths to the drugs under assessment, the scandal led some members of the Indian congress to call for a halt on all trials.
The issue was compounded in October when news emerged that an infant had died after during a trial of a pneumonia vaccine being developed by US drugmaker Wyeth Pharmaceuticals.
In fact, according to contract research organisation (CRO) GVK Biosciences who conducted the trial on Wyeth's behalf, the child had received a reference product rather than the candidate vaccine.
However, a DCGI audit found that the child should never have been enrolled in the trial due to an existing heart condition. This later revelation only intensified pressure for greater regulation.
Patient safety issues aside, the DCGI’s registration decision may also be designed to protect the reputation of the Indian trials sector as a whole, particularly among multinational drug firms thinking of outsourcing research to the country.
According to data gathered by the Indian Government’s Planning Commission, outsourced trials were worth some $300m (€229m) in 2008, up a 65 per cent on 2006. The commission estimates that the sector will be worth $1bn a year by 2010.
As a result, starting on June 1, study sponsors and partner CROs must supply information on the trial, the source of funding and details of an ethics committee that will monitor the study all before the first patient is enrolled.
Unethical trial firms face 10 years in prison
In related news, India’s Economic Times reports that under a proposed law change, those convicted of carrying out unethical trials as defined by new DCGI guidelines could face ten years in prison and revocation of their trial licenses.
Vishwa Mohan, from the ICMR, told the paper that the “guidelines would ensure that those who do not follow the norms approved by the DCGI for conducting clinical trials on humans are brought to book and punished.”
The guidelines, which have been cleared by India’s Health and Legal ministries, require that study subjects are made fully aware of any potential risk involved in participating.
They also require that those recruited for trials meet specific eligibility criteria for participation, with a great emphasis on the health of any potential subject.
