As part of its ongoing efforts to bring in transparency in the conduct of clinical trials in the country, India’s drug regulator recently initiated a slew of measures. The draft proposals are now open for comments from the public. After reaching a consensus with the stakeholders, the government will amend the existing legislation to make room for the new set of rules.

The new document signals an uncompromising stand on unethical trials and spells out clear terms for compensating trial-related injuries. In the meantime, it additionally reinforces some key requirements pertaining to the registration and auditing of the studies.

Now the Central Drugs and Standards Control Organization (CDSCO), the top regulatory body, wants operating CROs to submit updates every year on all ongoing trials listed on the Clinical Trial Registry of India. CTRI was established in 2009 and most of the CROs have been zealously enrolling studies, as the prerequisite was made compulsory in subsequent years. The new rules also require them to detail the reasons when a particular study has been stopped midway.

This time, the regulator seems to be taking a hard look at the ethical committees, the most enigmatic and highly contentious aspect of the whole clinical research process in India. Proposing a thorough revamp of the constitution of ECs, it mandates that all such committees should have a minimum of eight members, including a layman.

Ethical Safeguards
In a bold move to safeguard trial participants, the guidelines stipulate two important requirements: 1) report all serious adverse reactions during the trials to the licensing authority within two weeks of time, and 2) ensure complete medical care for the injured and provide compensation for injuries or death. Study centers are required to attach a statement related to the compensation and medical care to the informed consent document. Details of the compensation provided should also be informed to the authority.

These two clauses would go a long way toward silencing some of the harsh critics who have bemoaned that compensating trial victims has yet to become the norm for CROs operating in India. The numbers of reported deaths during studies grow higher by the day, health ministry figures show.

To catch the miscreants red-handed the agency has heightened surveillance. The new trial site oversight rules enable CDSCO officials to inspect and confiscate records, data, document, investigational drugs and more, even without advance notice. Surprise raids could act as an effective deterrent for those who shy away from adhering to GCP.

Apparently, the draft rules are looking at raising clinical research out of the mire. Human trials in India have become a matter of concern for drugmakers. CROs have been drawing a lot of flak from human rights watchdogs and the media for poor compliance of GCP norms, despite the fact that India launched the standard practice guidelines several years ago.

“Rampant unethical practices in the conduct of clinical trials gave a twist to the much-lauded tale of India’s clinical research industry. The whole system is bogged down by the mounting criticism. Ethically driven organizations too bear the brunt due to some of their ill-behaved cousins,” said a senior investigator with a transnational CRO.

Policy Tailwind
Given the fact that the CRO sector finds itself at the vortex slammed with too many aberrations compared to other outsourcing services businesses, India should channel its energies to redeem the image of the sector first. As such, any policy effort to bring in accountability to this industry should not wait, added the senior investigator.

In addition, the draft rules are likely to provide an impetus to the fledgling CRO industry in India, which, currently grappling with steep odds, is looking for a policy tailwind.

Experts, however, tend to believe that the new set of rules could as well prove to be a damp squib if not enforced strictly. There has never been a dearth of regulations since the enactment of GCP norms in India. Requirements like mandatory registration of all trials, ethical committee approval for studies, auditing of trial data are very much there, but they are still wanting in strict enforcement.

So, as always, the intentions of the policy makers are clear. At the same time, the agency is faced with the daunting task of fostering the growth of this sunrise industry and safeguarding the well-being of the trial participants. It is not expected to compromise on precious human life for clinical experimentations.

Perennially plagued with issues like inadequacy of staff, the agency is in the lookout for the funds and manpower to handle even the routine affairs. Another major worry is finding trained personnel equipped to deal with the highly demanding tasks like auditing of trials. Until CDSCO address these issues, the rules would continue to hang in the air, leaving those CROs with dubious credentials to have all the sway.