Drug trials should follow procedures: Azad

Union Health and Family Welfare Minister Ghulam Nabi Azad on Monday said clinical drug trials should be conducted as per “laid down” procedures with the consent of the apex body — Drug Controller General of India.

Reacting to a Supreme Court’s notice issued on Monday, the minister said: “Clinical trails only alleviates medical science, but while conducting drug trials on human beings, a laid down procedure must be strictly followed. India’s pharma sector is growing in a rapid phase where our country is supplying drugs and vaccines to over 150 countries. So such clinical trials must have the mutual consent from participants to make it people-friendly,” he said.

The Supreme Court on Monday issued notice to the Central government on a plea seeking investigation into illegal and unethical clinical trials of drugs which are yet to be approved by the drug controller. 

A Bench headed by Justice R M Lodha issued notice on a plea filed by Madhya Pradesh-based Swasthya Adhikar Manch, which claimed in large number of cases, multinational corporations are using contract research organisations for carrying out clinical trials of drugs which are not even approved.

Senior counsel Sanjay Parikh, appearing for the petitioner NGO, told the court that as a consequence of these illegal clinical trials, a total of 1,727 patients have died between 2007 to 2010. The Centre has been asked to respond to the notice within six weeks.

Azad reacting to the notice on the sidelines at an event here, said sometimes a few companies do not follow the procedures which causes great harm to both parties.