Nine cases of irregularities in clinical trials in 3 years: Azad
New Delhi: Nine cases of alleged irregularities in clinical trials have come to light in the last three years and action was taken on them, the Rajya Sabha was informed Tuesday.
Of these, six were from Indore and Bhopal in Madhya Pradesh, Minister for Health and Family Welfare Ghulam Nabi Azad said in a written reply.
In reply to another question, Azad said rules were being made or amended by the government for strengthening of provisions for conducting clinical trials in the country.
The Minister said during the current year, Quintiles (Research), Bangalore, and the principal investigator of a drug, were in March this year told to be careful while conducting clinical trials in the future after the Drug Controller General of India (DGCI) noticed some discrepancies during its investigation into the trials.
The company was conducting a drug trial in Bhopal Memorial Hospital and Research Centre. Deficiencies of non-payment of compensation to trial subjects and non-reporting of serious adverse events within the prescribed timelines were found during the investigation by the DGCI.
The Minister said warnings have been issued to Cadila Healthcare, Ahmedabad, Emcure Pharmaceuticals, Pune, Intas Pharmaceuticals, Ahmedabad and investigating doctors Abhay Paliwal, Ujwal Sardesai, Ramghulam Razdan and Pali Rastogi after certain irregularities in conduct of clinical trials were found by the inspecting team of Central Drug Standard Control Organisation.
The warnings were issued in the drug trial conducted in Indore on mentally ill patients in 2011. The companies and medicos were asked to ensure strict compliance of good clinical practices.
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