Audit of clinical trials to begin from Sep 1
The government will begin an audit of clinical trials by pharma companies in India from September 1, a move aimed at protecting the poor and gullible patients from being exploited for such trials.
Mumbai: The government will begin an audit
of clinical trials by pharma companies in India from September 1, a move aimed at protecting the poor and gullible patients from being exploited for such trials.
"We have decided to conduct quality related audit of
clinical trial... We would be soon identifying the sites and by September 1 we would start the audit work," Drugs Controller General of India (DCGI) Surinder Singh told reporters here today.
He noted that guidelines for the registration of ethical
clinical trials would also be framed.
According to him, a data bank having all the details of
various clinical trials is expected to be operational by
"The data bank would have all the details of the clinical
banks functioning across the country. At the click of a
button, we would get to see the list of the existing clinical
trial sites as well as the new entrants," he added.
As part of efforts to strengthen the overall system for
clinical trials, plans are on the anvil to carry out overseas
inspection of drugs which are imported into India.
Singh said the DCGI has already received an in-principle
approval for the plan from the Union Health Ministry.
"We import a huge amount of drugs and vaccines from the
foreign countries. To ensure that best quality drugs come to
India through imports, we would be carrying out such
(overseas) inspection," he said.
The body would also seek help of the US Food and Drug
Administration (FDA) in training inspectors for carrying
out such inspections.
Meanwhile, Union Health ministry has joined hands with
the pharmaceutical industry and airport developers GVK and GMR
for setting up dedicated cargo zones to handle the import and
export of pharma products.
Singh said that as a pilot project, the first such
facility would be set up at Delhi and about Rs 25 crore would
be spent on establishing each of the zones.
"Once this project is successful, we would set up similar
cargos at Hyderabad, Mumbai, Bangalore and even at Nhava-Sheva
Port," he said.