States must be informed about clinical trials: Experts
Ahmedabad: After the shocking allegations of
illegal clinical trials
at VS Hospital, experts are now calling for stronger checks and better sharing of information with state authorities. This recommendation was first made over a decade ago by the
Ranjit Roy Chaudhury Expert Committee
instituted to formulate policy and guidelines for approval of new drugs, clinical trials, and banning of drugs. This was also stressed in affidavits filed by
health authorities
before the Supreme Court between 2012 and 2014.
"Right now,
state drug regulators
have little or no say in the conduct and monitoring of
clinical trials
approved by the Central Drugs Standard Control Organization (CDSCO)," admitted HG Koshia, commissioner of the Food and Drugs Control Administration (FDCA) in Gujarat. "We are not even informed about trials happening in govt or private hospitals. The law does not require the central agency to update us," he added.
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The report by the Ranjit Roy Chaudhry Expert Committee, set up by the Union ministry of health in 2013, stated: "State authorities need access to information about clinical trials being carried out in their state, including the drugs, diagnostics, medical devices or biologicals, trial sites, and investigators. There needs to be a continuous and effective flow of information between the state drug regulatory authorities, state health authorities, and the CDSCO." The report argues, "Public health is a subject falling in the State List (Entry 6 of List II) in the Constitution. This gives the state drug regulatory authorities the responsibility of playing a role in monitoring clinical trials in their state."
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It added, "Drugs is a subject matter falling within Entry 19 of the Concurrent List (List III), meaning both the Union and the states have responsibilities," when it comes to clinical trials of drugs.
State health minister Rishikesh Patel told TOI, "I have instituted a team that is inquiring into all procedural aspects of clinical trials that took place in our institutions."
Amulya Nidhi, a public health expert belonging to Swasthya Adhikar Manch, argues, "The state's role is to ensure the safety of clinical trial patients, ensuring ethical, transparent, and accountable practices. Even if they do not have regulatory powers, it does not stop the state from seeking information for the purpose of monitoring risks and compliance with norms," Nidhi says.
He adds, "State drug regulators can always write to the DCGI to ensure adherence to regulations. Also, the state must compile information on adverse effects, deaths and compensation in trials — including those conducted by private hospitals."
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