An Indian parliamentary committee has found
serious lapses in approvals for some drugs, sparking the order for a panel of
experts to look into the charges and suggest remedial measures.
T.V.
Padma/SciDev.net: After a parliamentary committee criticized the bypassing of
clinical trials and other irregularities in the approval of new drugs, India’s
health ministry has ordered a panel of experts to look into the charges and
suggest remedial measures.
The
three-member panel led by the director-general of the Indian Council of Medical
Research, Vishwa Mohan Katoch, will submit its report within two months,
according to a statement released this week (11 May) by the health ministry.
The
Katoch panel will “suggest steps to institutionalize improvements in other
procedural aspects of functioning” of the ministry’s Central Drugs Standards
Control Organization (CDSCO), which was criticized by the parliamentary
committee in its report this week (8 May).
Saying
that consumers’ interests were being ignored, the parliamentary committee
suggested that CDSCO change its stated mission of meeting the “demands and
requirements of the pharmaceutical industry” to one that will clearly protect
public health.
The
committee’s report was based on studies conducted in the manner in which 42
randomly selected medicines were approved by the body – 38 of them between 2004
and 2010.
Documents
for three controversial drugs – which have not been approved in advanced
countries – were missing, the committee said.
Eleven
drugs were approved without conducting Phase III trials (multi-centric trials
to test for populations’ differences in drug safety and tolerance), while
trials for two drugs were conducted on 21 and 46 patients instead of the
mandatory 100 before approval.
Phase
III trials and expert opinion were dispensed with in the case of four drugs.
“The
decision to approve these drugs was taken solely by the non-medical staff of
CDSCO,” the committee said. “A review of the opinions submitted by the experts
on various drugs shows that an overwhelming majority are recommendations based
on personal perception without giving any hard scientific evidence or data.”
“Still
worse, there is adequate documentary evidence to come to the conclusion that
many opinions were actually written by the invisible hands of drug
manufacturers and experts merely obliged by putting their signatures,” the
report said.
The
committee found “sufficient evidence on record to conclude that there is
collusive nexus between drug manufacturers, some functionaries of CDSCO, and
some medical experts.”
International
drug makers named by the committee have responded to the committee’s charges
saying that they had adhered to the law of the land, according to a report in The
Hindu Business Line newspaper on 11 May.
One
manufacturer told the Reuters news agency on 10 May that it
would investigate alleged drug approval irregularities.
Source: SciDev.net.
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