As many as nine cases of alleged irregularities in the conduct of clinical trials during the last three years were reported and the Central Drug Standard Control Organisation (CDSCO) had investigated and examined the same, the Government has said.
“The Government has been continuously making efforts at strengthening the regulatory provisions and the monitoring mechanism of clinical trials in the country and to avoid irregularities therein. The provisions in the Drugs & Cosmetics (D&C) Rules, 1945 relating to clinical trials have recently been amended,” according to Union health minister Ghulam Nabi Azad in the Parliament recently.
“Amendment vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 was made specifying procedures to analyse the reports of serious adverse events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines. Amendment vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 was made specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance,” the Minister disclosed.
The registration of the Ethics Committees has been made mandatory in the D&C Rules vide Gazette Notification G.S.R No. 72(E) dated 08.02.13 specifying requirements and guidelines for registration of Ethics Committees, he added.
According to the earlier data submitted before the Parliament by the Minister, the number of serious adverse events of deaths in clinical trials reported during 2011 were 438. But, serious adverse events of death due to clinical trials were 16. Out of 438 deaths approximately 55 per cent are in clinical trials conducted by foreign pharmaceutical companies and rest are in clinical trials conducted by Clinical Research Organisations (CROs) and domestic pharma companies, etc.