Pay up your bills promptly for clinical trial victims and be accountable for all trial-related injuries and fatalities . . . or else face the consequences! — This, apparently, is one of India’s many strongly worded messages to the erring clinical research firms in the country.

A recent spate of regulatory overhauls by the health ministry was triggered by a directive from the Supreme Court (SC) of India. The country’s top judiciary was acting on a public interest litigation alleging lack of transparency in clinical trial processes that eventually led to illegal studies and a significant number of trial-related deaths. Asking to investigate the “racket” of unauthorized trials, the court told the ministry to bring all studies using experimental drugs involving human beings under its direct supervision. 

The SC stricture comes in the wake of reports that the number of deaths due to adverse events during clinical trials is becoming unacceptably high in India. The regulatory agency itself had quoted a figure of 2,644 deaths and as many as 11,972 serious adverse events linked to clinical trials since the year 2005, when India opened the market for clinical studies of new drugs.

India, as a safeguard, prohibited Phase I studies of drugs developed elsewhere when it launched the revised GCP guidelines amending certain provisions in its Drugs & Cosmetics Act, the rulebook for governing pharma. But the rules allowed unrestricted permission for running Phase II and III trials in parallel with ongoing studies in other geographies.

Widening Net
Growing at a pace greater than 10% per annum, India’s $500 million CRO industry has been considered highly sought after for conducting clinical studies. Faster patient recruitment and significant cost savings are key advantages that attract several drug firms and transnational CROs to Indian shores.

Even as the regulatory agencies from the world’s leading markets started recognizing the data generated from Indian trails submitted for drug approvals, the drug regulator continued to bolster the mechanism to monitor the studies from time to time.
The Central Drug Standard Control Organization (CDSCO), the office of India’s top drug regulator, has initiated several regulations like mandatory registration of clinical trials with the centralized Clinical Trials Registry of India website, institutional ethical committees etc., in recent years. The agency also proposed deterrent measures such as empowering officers to conduct inspections in trial sites even without prior notice.

Nevertheless, errant CROs continue to operate, taking advantage of the regulatory oversight. These fly-by-night firms know full well that the agency cannot to put up surveillance across every nook and cranny of the country due to inadequate manpower, experts say. Figures also corroborate this view; only a little more than 38% of the total positions are currently filled in the drug regulator’s office, not to mention another 1,000-odd more posts recommended for addition.

With the judiciary intervening, the government has been compelled to put its foot down with stricter laws and harsher penalties. The new regulations will hold investigators and sponsors of drug trials responsible for medical management of subjects involved in trials in case of serious adverse events such as death, in addition to fixing norms for compensating them.

Fresh Rules Mean More Delays?
Financial compensation for trial victims has been a highly contentious issue in the Indian clinical research industry. Very few people who got injured or died from adverse reactions while in clinical studies have been compensated appropriately by the sponsoring companies as per the norms spelt out in GCP guidance, despite a high incidence of serious adverse events during trials conducted in India, reports said. While sponsoring companies contest the causes and numbers, human rights groups and NGOs allege the issue of compensation has never been considered with due seriousness by firms.

The government has also listed out a fresh set of conditions for giving permission to trials and reinforced the provision for inspecting of the premises of sponsors — by including their employees, subsidiaries, agents, contractors, sub-contractors and trial sites under its purview — even without prior notice. The rules come down heavily on ethical committees too. It is now mandated that all the ECs must be registered with government authorities before starting drug trials.

As these stringent conditions with deterrents of punishments seek to chart the way forward for clinical research in India, the industry responds with a cautious optimism. Most of the firms agree that a makeover is desperately needed. The fledgling business could suffer irreparably unless it is cleansed of dubious players.

“Any measure meant to further streamline the system is always welcome. At the same time, the new set of regulations should not prove draconian to CROs by creating more uncertainties and bureaucratic delays,” said Dr. Arun Bhatt, president, ClinInvent, an end-to-end clinical development services CRO from Mumbai.