Par panel flays Health Ministry's "inaction" on clinical trial

A Parliamentary panel has 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 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 ommission 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, 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 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.