MPs panel raps health ministry for clearing 33 drugs without trials

Sunday, April 28, 2013

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.

In a report tabled in parliament last week, the panel headed by parliament member Brajesh Pathak said: “This is yet another instance where the ministry, in spite 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.” [IANS]

Read the full report [Department-related parliamentary standing committee on health and family welfare sixty sixth report on action taken by the government on the recommendations / observations contained in the fifty ninth report on the functioning of central drugs standards control organisation (CDSCO) (ministry of health and family welfare]

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