In an effort to infuse a fresh dose of vigor into the country’s clinical research sector, India has initiated the process of easing out some of the stringent clauses in the new draft clinical trial rules.
 
CROs per se and the clinical research industry in general, have been faced with the set back of stalling growth, of late.
 
According to ClinicalTrials.gov, 3634 trials were registered in India as of the first week of March, which comprises roughly around 1.2% of the total number of ongoing clinical studies world over. The figures indicate a declining trend as India shared nearly 1.5% of the clinical studies until a few years ago. These numbers fall way below the expectation for a country which has 17 percent of the global population and 20 percent of global disease burden. Further, the CRO industry pins its hopes on the huge potential in India’s growing reserve of treatment-naive population and highly skilled pool of investigators.
 
Several players have moved their base to other regions of the world. Many others came out in the open conveying that certain proposals in the guidelines unacceptable.
 
One of the key proposals the CROs took strong objection to was a clause pertaining to the compensation to the patients who die or suffer injury in the course of the study. The rules proposed a stricter penalty clause for such solatium demanding the trial sponsors to pay 60% of the total amount to the patient as soon as the ethical committee decides on it.
 
“If a trial subject suffered from a permanent disability or died during a clinical trial or bioavailability study or bioequivalence study, the sponsor would have to pay 60% of the compensation within 15 days of the opinion of the ethics committee,” according to the draft guidelines.
 
This amount paid was not refundable even if a subsequent investigation proved that death or disability was not the result of the study.
 
The health ministry is likely to modify this clause in the final guidance. The revised rules may require the firms to pay the total amount once it is proven that the death or injury happened because of the trial, instead of the mandated 60% upfront pay.
 
The policymakers have been confronted with questions on the feasibility of this contentious section from both national and international industry bodies and lobby groups. Officials from the WHO asked to reconsider the compensation clause as the global agency found it could hamper their work in India. The WHO also pointed out that it is not the usual practice internationally for ethics committees to make such decisions. While the Indian Council of Medical Research (ICMR), the public-funded body for the coordination and promotion of biomedical research, alerted that such a section could prove detrimental to the future of India’s clinical research.
 
Speedy approval timelines is another step which is being considered to facilitate clinical studies by Indian firms. Presently, there is no definite time frame to clear proposals seeking approvals to conduct clinical trials. The agency has been repeatedly urged to bring in the practice of timely approval to the system as delays in granting approvals cause a lot of uncertainty among the applicants. The authorities are moving to fix a 30-day period to grant permissions for studies run by Indian companies, it is learnt. The proposals shall be deemed approved if the applicants did not receive any communication on the status of the application, within 30 days after filing, from the Drug Controller General of India. The DCGI’s office grants approvals to clinical trials.
 
However, it is still unclear whether the 30-day ‘fast-track clearance’ would be extended to the MNCs, as well.
 
The new set of draft guidelines was brought out in February last year and put it on the public domain for feedback.
 
India went on to overhaul the regulatory roadmap for clinical trials following a stricture from the Supreme Court for enhancing oversight to ensure that the drug trials involving humans are conducted in accordance with the standard practices. The top judiciary had also wanted to know the measures taken by the government make sure that compensation for patients who had died or had suffered serious side effects linked to clinical trials were paid, while ruling on a public interest litigation filed by an NGO alleging large-scale deaths and violations of rules in drug trials due to inadequate regulatory oversight in the country.
 
Reports suggesting dubious operations, lack of transparency among select firms running trials, a bad press and subsequent public outcry cast a shadow on the prospects of the fledgling CRO sector for some time.