To further tighten clinical trials, Centre unveils new standards

The Centre plans to make accreditation mandatory for all clinical trials. The new standards, a draft of which has been put out by the Drugs Controller General of India, make any violation punishable with debarment, putting investigators, ethics committee members and even hospitals on notice.

The job of accreditation has been assigned to the Quality Council of India.

“We have burnt our fingers due to the lack of quality control in clinical trials. Our regulatory framework has been very weak, but we are moving towards stronger rules and have established a pool of experts to evaluate quality,” DCGI chief GN Singh told BusinessLine .

Singh said these standards would help prevent exploitation of trial subjects even while giving the industry more clarity on several issues.

While there are guidelines for ethics committees, investigators and trial sites, there was little effective compliance. Now, an attempt is being made to set up “minimum standards for ethics committees, investigators and hospitals/laboratories conducting trials,” Singh said.

Clear documentation The standards cover documentation for patient safety and protection, informed consent, review of consent, declaration of payments, conflict of interest, monitoring, minimum number of meetings, and so on.

The industry, however, appears to have a mixed reaction. Dhananjay Bakhle, Executive Vice-President (Medical Research), Lupin, said the proposed standards were not justified since most aspects were already covered under the Good Clinical Practices followed by the industry.

Further, he felt that accrediting hospitals, laboratories, ethics committees and doctors across the country could raise implementation issues and require a transition period of a couple of years.

“Also, it has not been made clear on how the regulators will ensure conformation of all these standards. The inspectors should also get GCP training, otherwise this would become subjective,” Bakhle said. He added that aspects such as declaration of a conflict of interest were too generic and could create confusion.

Clarity expected Shoibal Mukherjee, clinical pharmacologist and clinical trials expert, said that having clear standards has been the industry’s demand as it would bring clarity to the procedures involved.

However, in a couple of areas it could have been different, he said, adding: “We could have a graded set of standards, giving scope of improvement.”

Agreeing that these standards are not ‘revolutionary’, he added that the creation of such norms makes it “legally enforceable” — a positive for both patients as well as the industry.

Correction

This copy has been modified to correct Shoibal Mukherjee's designation from head, Asia Medical Sciences Group, Quintiles, as he has quit the company.

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