India has rolled out a series of measures to streamline the country’s clinical research industry in recent years. Regulatory activity reached its peak recently with some bold steps, like compulsory registration of institutional ethical committees.

The idea behind strict regulatory controls, according to the authorities, is to make sure that people who conduct clinical research across the country go by the rulebook. A large number of players in the growing CRO sector are still not very keen to follow the guidelines, even though India enacted Good Clinical Practices (GCP) by amending certain provisions of its Drugs & Cosmetics Act several years ago.

The Central Drugs Standards Control Organization (CDSCO), under the health ministry, started cleaning up the fledgling sector by weeding out the errant CROs amid a flurry of reports alleging lack of transparency in the way trials are run in the country. A Supreme Court directive to ensure safety of the participants in the trials further compelled the authorities to closely monitor the studies.

Following this, all clinical study centers were “asked” to register their ethical committees (it was a mandatory request). The role of these committees has always been dubious and marred with controversies. Many people even doubted such a committee of experts for approving and reviewing trials ever existed in several CRO set-ups. However, as soon as the regulation came into force, ECs of a good proportion of CROs got themselves enlisted in the registry.

Regulator Gets More Teeth
The ministry has also given the regulatory agency more teeth to deal with the emergent situation. The Drug Controller General of India (DCGI), the country’s top regulatory authority, sent out a notification arming the agency with the powers to carry out inspections in the trial sites even without prior notice. Nevertheless, surprise raids remained largely as a paper tiger due to the perennial shortage of staff in DCGI’s office.

Enforcement should never be a hurdle for a genuinely motivated regulator. This is likely the motive for DCGI to rope in the services of the divisional offices as well. In May, Dr. DN Singh, DCGI, asked zonal offices to set up expert panels to conduct routine inspections at clinical trial sites.

“It has been decided that the zonal offices of CDSCO [DCGI’s office] should keep the records of the details of names, qualifications of investigators and clinical trial sites falling under their jurisdiction and also constitute expert committees to conduct clinical trial inspections,” Dr. Singh stated in a notification.

According to him, the committee of experts (along with drug inspectors) shall visit clinical trial sites at least once a year in order to check the compliance level of GCP guidelines and other applicable regulatory requirements. The decision is considered the first step towards divesting powers from the highly centralized regulatory agency to make the reform measures much more effective.

Fresh Filings Fall
The reform spree, inevitably, had its own repercussions, ruffling the feathers of some players who were anticipating a “less stringent” regulatory environment in India.

CROs with a poor history of GCP compliance started operating in India, as they were never expecting a level of stringency in regulatory enforcement on par with certain highly developed markets. To these CROs, any reform went too far, owing to lack of implementation and inadequate manpower in the agency, experts said.

Secondly, the new regulatory requirements led to more delays in the prevailing “red tape-ism.” With insufficient infrastructure, the overload resulting from the newer requirements can only worsen the already delayed approval timelines, CROs feared.

In fact, the number of trial approvals has slowed recently as the “tougher norms” discouraged several players with short-term goals. Until April, only around 12 approvals have been granted by the DCGI for trials of drugs in India. More than 70 applications are currently pending for approvals. This is in sharp contrast to the past when the number of global clinical trials approved for conduct in India was in the hundreds, according to a PTI report.

Dr. Singh said the safety of trial participants is paramount. Firms conducting trials should be held accountable for that safety; that is why tougher provisions were put in place for the first time.

In a disclosure, meanwhile, the health ministry said there were nine reported cases of alleged irregularities in the conduct of clinical trials during the last three years and CDSCO had investigated and examined them.

Union health minister Ghulam Nabi Azad told the Parliament recently, “The government has been continuously making efforts at strengthening the regulatory provisions and the monitoring mechanism of clinical trials in the country and to avoid irregularities. The provisions in the Drugs & Cosmetics (D&C) Rules, 1945 relating to clinical trials have recently been amended.”