Stung by the Parliamentary panel on the delay in taking action against those 'experts' who allegedly colluded with the officials of the CDSCO to give identical recommendations for approval of drugs in the past, the Health Ministry will refer the cases to the Medical Council of India (MCI) for further action.
As recommended by the Parliamentary Standing Committee on health, the ministry will refer the issue to the MCI for necessary steps. For Government employed doctors, the matter will be brought to the notice of the concerned medical colleges and hospital authorities for appropriate action, Ministry sources said.
The committee, in its report on the functioning of the CDSCO, had recommended follow-up action as these doctors were found to have violated the code of ethics of the MCI. The experts allegedly colluded with the CDSCO officials to write identical recommendations for approval of drugs, reportedly to favour the drug manufacturing companies, the panel had pointed out.
The Ministry had constituted a three member expert committee. The expert committee has recommended instituting an enquiry into the matter. The committee has also recommended laying down a code of conduct for the members participating in these bodies as also Ethics Committees. An expert committee would be constituted to define policies and SOPs for identification of experts and their participation in these bodies, according to the ministry.
However, the panel has recently again come down on the issue claiming that the Ministry was 'dragging its feet when it comes to punishing the people who have compromised the system over the years through their sheer illegal activities, which are totally against public interest'.
“It is incomprehensible as to what is stopping the Ministry from forwarding these proven cases of gross illegality and proven collusion of the MCI and the medical colleges/hospital authorities concerned for appropriate action though more than six months have elapsed since the Committee brought these cases to the knowledge of the Parliament and the Government. The Committee, therefore, while expressing its strong displeasure with the Ministry, recommends that these cases be referred to MCI and medical colleges/hospital authorities concerned within seven days of presentation of this Report to the Parliament,” the report presented by the panel last month said.
“With a view to expedite action against these errant experts who have indulged in unethical and illegal practices without any concern for the health and well being of common people the Committee further desire the Ministry to impress upon MCI and all other authorities concerned to act against these experts in a highly time bound manner and report back to the Ministry at the earliest so that the Ministry is able to furnish the feedback on all these cases to the Parliament within one month of presentation of this Report to the Parliament,” it said.
According to the original recommendation by the panel, a review of the opinions submitted by the experts on various drugs showed that overwhelming majority of recommendations were based on personal perception without giving any hard scientific evidence or data.
“Such opinions are of extremely limited value and merely a formality. Still worse, there is adequate documentary evidence to come to the conclusion that many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures,” it said.
“If the above cases are not enough to prove the apparent nexus that exists between drug manufacturers and many experts whose opinion matters so much in the decision making process at the CDSCO, nothing can be more outrageous than clinical trial approval given to the Fixed Dose Combination of aceclofenac with drotaverine which is not permitted in any developed country of North America, Europe or Australasia. In this case, vide his letter number 12-298/06-DC dated 12-2-2007, an official of CDSCO advised the manufacturer, Themis Medicare Ltd., not only to select experts but get their opinions and deliver them to the office of DCGI! No wonder that many experts gave letters of recommendation in identical language apparently drafted by the interested drug manufacturer,” the report had claimed.