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MPs panel raps ministry for clearing 33 drugs
without trials
Sunday April 28, 2013 06:52:33 PM,
IANS
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New Delhi: Thirty-three new drugs were granted approval by the health
ministry without clinical trials on Indian patients between
January 2008 and October 2010, a parliamentary panel has found.
It a report tabled in parliament last week, the panel headed by
parliament member Brajesh Pathak said: "This is yet another
instance where the ministry, inspite of appreciating the serious
problem the continued marketing of these 33 drugs may pose to
Indian patients, has chosen to take no action to resolve it".
The panel criticised the union health ministry for its "inaction"
on certain alleged irregularities in clinical trials of drugs
before their introduction in the country.
It also charged the officials involved in granting approval to
these drugs with violation of law and "an intention to save the
guilty".
"The committee is shocked to note this dilly-dallying by the
ministry on the matter, which could be affecting lives of lakhs of
people in the country, who are consuming these drugs," it said.
"The ministry agrees with the committee's viewpoint about review
of approvals to ensure safety of patients, fair play, transparency
and accountability but instead of taking strict and immediate
action in all proven cases of delinquency and omission and
commission, it still continues to be in a state of profound
procrastination," the parliamentary standing committee on health
and family welfare said in its 66th report.
It said that even after a lapse of more than seven months the
three-member expert panel looking into this contentious matter has
come out with "virtually nothing concrete" and observed that the
government "intends to delay a decision by referring it to yet
another committee".
"These tactics have been, as stated at several places in this
report, resorted to by the government to delay indefinitely the
decisions and consequent actions that would be required to be
taken against several officials and non-officials who have
indulged in rampant acts of omission and commission while
approving these drugs in gross violation of the law of the land."
The committee has taken strong objections to these "dilatory
tactics" and recommended immediate decision on these "proven gross
violations, lest the health of the people is compromised
irrevocably."
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