NEW DELHI: A Parliamentary panel has criticized 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 drugs with violation of law and “with 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.
“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,” Parliamentary Standing Committee on Health and Family Welfare said in its 66th report.
On grant of approvals to 33 new drugs between January 2008 and October 2010 without conducting clinical trials on Indian patients, the panel 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 Committee, headed by Brajesh Pathak, 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.”
While the Health Ministry agreed with the Committee’s earlier recommendations regarding review of approvals to ensure safety of patients, fair play transparency and accountability, it said “the continued inaction on the part of the Ministry on this serious matter almost borders on collusion with an intention to save the guilty”.
The Par panel said “Committees after committees are being constituted to postpone the day of reckoning of the guilty people. On another place this inaction which has led to unhindered marketing of these drugs with unknown and unspecified risks to the unsuspecting people who are consuming them amounts to a serious violation of human rights of the hapless patients.”
On the issue files going untraceable in case of approvals granted to three drugs, the Committee said “the continued inaction of the government on this vital matter of public health needs to be deprecated in strongest terms.”
It further said the Health Ministry should come out of its “contemplation mode” and take action as recommended by the Committee in the context of these three drugs without any loss of time.
The panel also took strong note of the Health Ministry uploading information about banned and discontinued drugs on its website and called for their immediate removal from the CDSCO website which may prove life threatening.
The Parliamentary Committee also called for effectively implementing all strong mechanisms in approval of new drugs and appreciated the steps taken in this regard. It also called for adoption of bestglobal practice in drug regulation, especially with regard to two burning cases of Analgin and Buclizine.
In the case of irregularities in fixed dose combinations (FDCs), the report has sought curtailing the timeframe from 18 months to nine months to the state drug authorities in proving the efficacy and safety of drugs before the CDSCO. -PTI
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