http://articles.timesofindia.indiatimes.

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standard-control-organization-cdsco

Clinical trials in India to get stringent

Shobha John, TNN Sep 17, 2013, 05.10PM IST

(For the drug trial itself,…)

NEW DELHI: In an attempt to bring about reforms in drug regulation and clinical trials, a six-
member expert panel constituted by the ministry of health and family welfare has said that in
future, these trials can only be carried out in accredited centres. Also, the principal investigator
and ethics committee of the institute where the trial is being done, should also be accredited.
Only then will trials be approved.

These recommendations, already up on the website of the Central Drugs Standard Control
Organization (CDSCO), are part of the Professor Ranjit Roy Chaudhury Expert Committee on
New Drugs and Clinical Trials Approvals and attempt to weed out fly-by-night operators who
collude with drug companies and doctors to approve drugs whose trials have never taken place.

"While some of the recommendations can be implemented within two months after
consultations, others will require an amendment of rules," says a senior health ministry official.
"The government will ensure that clinical trials are done legally and the safety of participants is
adhered to."
Dr Roy Chaudhury, adviser, department of health and family welfare, says the lack of regulation
in clinical trials has seen India lose out to China, Malaysia and Singapore. "But this is set to
change; we want India to once again be the centre for clinical trials."

Another recommendation was to set up a Central Accreditation Council to oversee these

accreditations. Selection of assessors and experts to review new drug applications will be
randomly made from a roster of experts which will be prepared after a nationwide search. A
roster of accredited institutes for clinical trials too will be made and pharmaceutical houses can
choose from these, it said.

To reduce bureaucratic tangles, the present 12 drug advisory committees will be replaced by one
Technical Review Committee for speedy clearance of applications. Also, the CDSCO should
give a written assurance to a pharmaceutical company seeking approval for a trial that a decision
will be given within three months if all papers are in order.

For the drug trial itself, informed consent from participants is mandatory. For special groups
which can't protect their interests, consent will have to be taken from the guardian in the
presence of an independent person who will also have to sign the consent document. Audiovisual
recording of this is mandatory.

In case of injury/death, compensation has to be paid, it said. This includes any drug-related
anomaly later. And in a humane move, it said that strong provision be made for ancillary care for
patients suffering from any other illness during the trial. But no compensation needs to be paid
for therapeutic inefficiency as the very purpose of a clinical trial is to determine the efficacy and
safety of a drug.

As for the clinical trials themselves, phases I-IV of all new drugs developed in India to be
marketed in India will need to be carried out in India, the panel said. Drugs undergoing trials
outside India can also undergo parallel phase II and phase III trials in India after carrying out a
safety assessment through phase I trials.

Hopefully, these measures will re-establish public trust in clinical trials.