Health Minister Ghulam Nabi Azad has constituted a three-member committee to look into the findings of the 59th Report of the Parliamentary Standing Committee on the functioning of the Central Drugs Standard Control Organisation (CDSCO).
It comprises Dr V M Katoch,Secretary and DG,ICMR; Dr P N Tandon,president,National Brain Research Centre,Department of Biotechnology,Manesar; and Dr S S Aggarwal,former director,Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow.
The committee will examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials,outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO.
It has been asked to submit its report within a period of two months.
The Parliamentary panel report is a scathing criticism of the countrys present drug regulation setup,from the resource crunch at the CDSCO to the implied references to collusion between CDSCO officials and drug companies. It also questions about how doctors write the requisite expert opinions for drugs with many of their letters being word-for-word identical.
Meanwhile,data supplied by the Health Ministry in the Lok Sabha on Friday on clinical trials where there were reports of irregularities,shows a curious trend where Madhya Pradesh seems to be emerging as the unethical clinical trial capital of the country.
Six of the nine trials on which action has been taken in the last three years happened in the state.