Illegal drug trials: Notice to Health Ministry

NHRC asked Health Ministry to respond within 6 weeks on issue of unauthorised clinical drug trials in Andhra Pradesh or face action under law.

New Delhi: Annoyed at non-submission of
reports with regard to unauthorised clinical drug trials in
Andhra Pradesh, the National Human Rights Commission (NHRC)
on Monday asked the Health Ministry and state officials to respond
within six weeks or face action under law.

The Commission had sent notices to the Union Health
Secretary, Secretary of the Indian Council of Medical
Research, Drug Controller General of India and Andhra Pradesh
Chief Secretary last year, asking them to file reports with
regard to unauthorised drug trials on six women in the state.

"The Commission has now asked them to submit these within
six weeks positively failing which the Commission may invoke
the provisions contained in Section 13 of the Protection of
Human Rights Act, 1993," an official statement said.

While issuing notices in June last year, the NHRC had
also directed its investigation team to ascertain the facts
that 25 poor women in Guntur were lured to take part in a
cancer drug trial by a Hyderabad-based pharmaceutical company.

After taking the drug, six women had to be hospitalised
for complications, media reports had said.

Subsequently, the state and Central authorities concerned
were again asked to send reports on September 26 and December
5, 2011, the release said.

The investigation team of the Commission found that there
were eight more laboratories in Hyderabad in addition to Axis
Clinicals Ltd. which were conducting clinical drug trials.

The team had asked Health Secretary, Andhra Pradesh, to
properly assess health condition of the villagers and ensure
suitable compensation for the victims.

It also asked the Central Drugs Standard Control
Organisation (CDSCO) to conduct proper study in various parts
of India to ensure lapse adhere to the guidelines on clinical
drug trials.

"The amount paid to the volunteers for drug trials needed
to be adequately increased and it should be monitored by
CDSCO," the NHRC said.