The Parliamentary Standing Committee on Health, which dug up serious irregularities in the Central Drugs Standard Control Organisation (CDSCO) and nexus between the officials and the companies, has come down heavily on the Government for failing to take action against the erring officials of CDSCO.
“The Committee is aghast to note the paralytic inertia gripping the Ministry which is preventing it from taking action against guilty official(s) of CDSCO and others involved in proven cases of delinquency and illegality six months should have been more than enough to not only inquire into the misdeeds of those who had so wantonly indulged in the cited gross irregularity but also sufficed to take exemplary action against them so as to deter others,” the hard-hitting report by the panel on the action taken by the government said.
“The Ministry by still dithering over issuing instructions to NDACs and DCGI has abundantly proved that it has neither the intention to clean the augean stables of CDSCO nor any concern for probity and rule of law. Hoping against hope, the Committee expects the Ministry to at least even at this late stage take immediate action on these proven cases of delinquency and irregularities so that a stern message is sent to all concerned that the drug regulatory mechanism is not up for grabs for perpetuation of unethical and illegal practices,” according to the recent report by the panel headed by Brajesh Pathak.
Putting the government again in the dock, the committee had expressed disappointment on most of the measures taken by the Government on its crucial findings including that on the approval of drugs without due trials and continued marketing of drugs banned outside the country.
“The committee is hugely disappointed to observe that in spite of the Government being afforded another opportunity to furnish conclusive responses on the various recommendations of the Committee, has once again chosen to come up with half measures, vague and dilatory responses to say the least. As the subsequent analysis of the Committee will bear out that general agreement of the Government with the recommendations of the Committee is mere platitude,” the panel observed.
“The Government has done nothing concrete or conclusive even for the recommendations and findings of the Committee, which directly concern the safety, and health of crores of our countrymen. The preliminary submissions, as is evident from its plain reading only, confirms the intent of the Government in staggering decisions and action on vital matters either by way of referring matters to committees after committees or evolving time-consuming policies. The Committee deprecates this tendency of the Government in strongest terms,” it said.
The panel had submitted its report in May last year. Though the Government had to submit its action taken report within three months (by August 7, 2012), the Health Ministry submitted the report only on September 12.
“The Committee is shocked to note this dilly-dallying by the Ministry on a matter, which could be affecting lives of lakhs of people in the country who are consuming these drugs. The Ministry agrees with 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 these proven cases of delinquency and omission and commission, it still continues to be in a state of profound procrastination and wants to refer the issues relating to continued marketing of these drugs and updating of their product monographs in the light of recent knowledge and regulatory changes overseas to the NDACs for examination and review,” the panel 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. Committees after committee are being constituted to postpone the day of reckoning of the guilty people. On another plane 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. While condemning this continued inaction of the Ministry, the Committee recommends immediate and conclusive action on this recommendation of the Committee without indulging into the charade of having a plethora of committees after committee to stall a decision in the matter,” it said.