Union Health Minister Ghulam Nabi Azad on Monday said that pharmaceutical companies and hospitals conducting trials should compulsorily follow the procedures laid down by the Drugs Controller General of India (DCGI).
Court notice
Responding to the Supreme Court's notice to the Union Government on a plea seeking investigation of “illegal and unethical” clinical trials of drugs which are yet to be approved by the Drugs Controller of India, he said: “With the Indian pharma industry supplying drugs to more than 212 countries and vaccines to more than 150 countries, clinical trials are necessary. But to sustain at this level, clinical trials should be people-friendly. The consent of the participants is a must. If not, the DCGI will track down illegal trials and stop them.”
Cancer trials
Recalling the controversy about cervical cancer clinical trials tried out on young girls in Andhra Pradesh without their consent, Mr. Azad said that the DCGI had put a stop to them soon after.
“It is unfortunate that sometimes companies don't go by the procedures, which causes great harm to individuals on whom the tests are carried out,” the Minister said and added that he was yet to see the court order.
The Supreme Court notice followed a plea by the NGO, Swasthya Adhikar Manch, that in many cases, multinational corporations were using contract research organisations to do clinical trials of their drugs which are not even approved.
As a consequence, 1,727 people died in four years from 2007 to 2010.
The Union Government has been asked to respond to the notice within six weeks.
Earlier, speaking after presenting the accreditation by Association for Accreditation for Human Research Protection Program (AAHRPP) for standard practices in Clinical Research to Manipal Hospital, Bangalore, and Kasturba Hospital, Manipal, Mr. Azad called upon the private sector to join hands with the Government to provide affordable healthcare to the poor.
The Union Government had started a new system to track the actual number of children vaccinated as there were suspicions that officials concerned were exaggerating the figures.
The accreditation certificate was presented to Rajen Padukone, chief executive officer of Manipal Health Enterprises, and its president, S.C. Nagendra Swamy.
