India’s drugs and pharmaceuticals regulator plans to put in place a system to monitor drug tests and clinical trials using human subjects on a war footing, the first time on-site inspection of drug trials will be conducted in the country.
The drug controller swung into action following a directive from the ministry of health and family welfare, which wants to kick off on-site inspections and real-time audit of drug trials with immediate effect. The aim is to ensure safe handling of test subjects in clinical research firms and hospitals across the country.
In a two-part series published on 30 and 31 May, Mint had highlighted the inconsistencies in the regulatory framework governing clinical trials in India and the plight of human test subjects while undergoing drug trials.
The Drug Controller General of India has called for an emergency meeting this week with state regulators, Central Drug Standards Control Organization as well as experts from the field of clinical pharmacology across academic and medical institutions to prepare the master plan.
Drug Controller General M. Venkateshwarlu told Mint that the first series of inspections will start in a month from 15 to 20 drug trial centres.
“The three-member inspection team will have one official each from the headquarters and the regional offices of the drug control organization and one clinical pharmacology expert from a leading medical academic institution,” said Venkateshwarlu.
The department said it has selected 30 investigating officials who are trained to conduct inspections but will keep their names under wraps. “We cannot disclose the names of the officials assigned for on-site inspection as we do not want to expose them to the public,” said an official of the drug standards organization who didn’t want to be named.
Responding to the development,Vinod Mattoo, medical director, Eli Lilly and Co. (India) Pvt. Ltd, a leading multinational firm conducting drug trails in India, said: “It’s a good development... because it sends out the right signals. It gives assurance to companies worldwide that the country is serious about ensuring that clinical trials done out of India conform to the highest quality standards.”
This week’s meeting will also prepare a comprehensive check list for the inspection.
The inspections will target clinical research organizations, bio-equivalence laboratories (laboratories that test copy drugs in healthy human subjects), offices of drug test sponsors (drug companies), drug trial data management centres and hospitals where trials are conducted and ethical committees who approve trials at various sites.
The checklist will be based on three key set of guidelines and rules for conducting drug trials. They are ICMR (Indian Council for Medical Research) guidelines; Schedule Y of the Drugs and Cosmetics Act that governs the norms for drug trials; and good clinical practices—the set of standards codified by the health ministry that all clinical research firms are meant to maintain.
Apart from complying with these guidelines, the check list will also include practical verification of procedures followed for recruitment of volunteers, seeking their consent, emergency medical care available at the facilities, general awareness of test subjects about the drug, its side effects and the risks involved in participating in the trial.
The surprise audits will also inspect accuracy of data generated during the trials, veracity of approvals given by ethical committees, credibility of members in such committees, payments and compensation provided to volunteers and the extent of involvement of trial sponsors.
Inadequate staff strength of the regulator as well as reluctance of drug investigators to cooperate with the regulator are the primary reasons for not initiating such audits in the past.
Mint has learnt from people familiar with the inspection strategy that, in the initial phase, inspectors will target hospitals and clinical research organisations with a history of not conforming to the regulatory norms. The Drug Technical Advisory Board, a high-powered committee of the regulator, met in the capital on 4 June to discuss the issue.
“It’s important to have some quality check,” said Y.K. Gupta, head of pharmacology at the All India Institute of Medical Sciences in the capital. “This will ensure that the human subject is no way exploited and that the quality of data is not compromised.”