Central Drugs Standard Control Organisation last week came out with a stand that it will not review or recall the 33 controversial drugs found to have been approved for marketing in the country during 2008-10 without clinical trials by the Parliamentary Standing Committee on health & family welfare. The conclusion of the Parliamentary Standing Committee was that a collusive nexus existed between medical experts, pharmaceutical companies and the CDSCO officials while approving drugs for marketing in the country. The report of the panel also pointed out the unethical deals between the pharmaceutical companies and the regulatory officials in getting approved the unsafe drugs in India. The CDSCO is of the view now that approvals granted by the competent authority were 'in order' and there was no need to re-examine the approvals or recall any drug from the market on grounds of errors in approval process. Therefore, there will be no action with regard to these 33 drugs unless some specific instruction come from the Union Health Ministry. An expert committee has been constituted to suggest measures to improve the functioning of the office of CDSCO and DCGI soon after Standing Committee’s report came out last month. The three-member committee is headed by V M Katoch, director general of the Indian Council of Medical Research. This committee is also expected to look into specific cases against medical experts and suggest actions to be taken by the Medical Council of India.
It seems that the reason for CDSCO to take a very casual stand with regard to these 33 drugs is its hesitation to make a precedent of re examining the approvals already given by the past DCGIs. The other stated reason is that the matter is under review by an expert panel headed by Katoch and its report is expected shortly. This is not at all an acceptable stand by the country’s apex regulatory authority in a serious issue like this. If the CDSCO cannot deny the fact that these drugs are approved for marketing without clinical trials then it has a moral and legal responsibility to suspend their marketing without any delay. It should otherwise provide a suitable explanation for its inaction. This is an issue of endangering the public health after knowing that these drugs are not safe. The health ministry has to remember that there was tremendous pressure from the public interest groups and independent medical experts for taking immediate action to suspend marketing of these drugs circulating in the country. The fact is that these drugs, without assessing their safety and efficacy, are already there in the market and are being prescribed by the physicians. It is quite difficult to estimate how many people might have already injured and suffering due to intake of such untested drugs. No drug control administration should ever dare to allow the pharma companies to market any medicine without proven efficacy and safety.