Stricter vigilance, including surprise inspections to trial sites, will immediately become part of the law governing clinical research industry, India’s drug regulator announced recently.

The new guidance is to ensure the much-needed safety of study participants as well as to stay vigilant on the level of compliance with GCP-ICH norms on clinical trial conduct, the Central Drug Standards Control Organization (CDSCO) said.

The agency’s decision comes in the wake of rising concerns among the world’s leading pharma markets on the quality of clinical trial data generated from locations where regulations are either minimal or lax.

India started implementing GCP standards as prescribed by WHO a few years ago as soon as the CRO industry came into operation. A large number of studies are being conducted in India, at present, across various therapeutic segments, by more than 200 CROs.

Not all CROs, however, are strict on sticking to every detail of ICH-GCP norms, especially the ones operating within the boundaries of the country. This is either because the GCP guidance is overlooked or because of lack of stringent enforcement. Hence, a stricter regime could bring in more accountability on the safety of trail subjects besides helping to weed out errant practices.

More Accountability, Better Acceptability

Industry watchers see that the new inspection guidance will also send out “strong messages” to the world that the data generated from clinical trials conducted in India are more acceptable globally and thereby a boost to Indian CRO sector (which at the moment is slowing).

“The new guidelines will provide clearer directions to regulatory inspectors in conducting clinical trial inspections which will lead to greater consistency in the quality of how clinical trials are inspected,” said Dr. Ferzaan Engineer, chief executive officer, Quintiles India.

According to him, as far as globally operating CROs like Quintiles – which operates by all international guidelines – are concerned, there was no need to spend too much time and energy in preparing for inspections. At the same time, even if there was an increase in the time companies have to allocate to inspections, it was worthwhile because of the value it would add to the overall quality of clinical research in India.

Inspection of the trial sites is definitely the only way to ensure the quality of the data. Periodic auditing can give the required consistency and acceptability to the clinical data. Considering the quality, Indian CROs claim, standards are on par with any competent market. They are very much part of the global drug development business. Investigators who oversee the operations too were found immensely capable of doing the job. The clinical data contributed by Indian firms have been consistent with global standards in all respects and have been accepted by all the leading regulatory agencies.

“There are no issues to date about the data generated by investigators in India,” said Dr. Kiran Marthak, director, Veeda Clinical Research, the largest Phase I CRO in India with facilities in the UK and Belgium. He added that only inspections can resolve any doubts about the quality of the data.

Dearth of Trained Inspectors?

Inspections will help validate the standards and keep a watch on trials that may not be done as per required standards of ethics and quality.

Even as they welcomed the drug regulator’s move to periodically inspect the trial sites, some CROs wondered exactly how surprise inspections, or the checks carried out “without prior intimation,” could help streamline the process. CROs are generally given a few days or even weeks of advance notice to keep people and documents available for the inspection.

This is generally preferred since the purpose of the inspection is to review documents and interact with key personnel involved in the trial to assure that the trial was conducted as per ethical and scientific norms. “If inspections are carried out withoutprior announcement there are chances that the objective of conducting the inspections are not fully met due to unavailability of key team members for discussions,” commented Dr. Ajit Nair, president, India Operations, Siro Clinpharm. Siro is a leading full-service CRO from India.

The agency requires trained inspectors for the job. This is another concern for the CROs. “Within the present infrastructure, it is absolutely impossible for the drug regulator’s office to conduct audits and inspections of all the CROs and the sites,” said Dr. Marthak.

Dr. Surinder Singh, the Drug Controller General of India, has tried to allay such fears. Dr. Singh, while announcing the inspection plan, maintained that his office has quite a number of inspectors trained by their USFDA counterparts to be deployed immediately for the job. The agency is also in the process of hiring another 200 inspectors.

S. Harachand is a pharmaceutical journalist based in Mumbai.He can be reached at [email protected].