Updated on 17 April 2013
Dr Gyanendra Nath Singh – The Drug Controller General of India (DCGI)
India's drug regulator, the Central Drug Standard Control Organization (CDSCO), had in 2012 received World Health Organization (WHO) endorsement for establishing new drug standards for approval of new drugs; for screening of imported and exported drugs; for clinical trials monitoring, and for meeting the prescribed international standards by the Drug Controller General of India (DCGI).
The Indian DCGI, Dr G N Singh, who completed one year in office on February 20, 2013, has been handling responsibilities of secretary-cum-scientific director of the Indian Pharmacopoeia Commission (IPC). He has been making efforts to bring together all stakeholders for the benefit of public at large. In his an exclusive interaction with BioSpectrum, Dr Singh talked about the new image building exercise, meetings, and new initiatives being taken at CDSCO.
In wake of the recent Supreme Court judgment on compensation, what is your reaction on getting full powers to decide for the suffered patients in clinical trials?
The Supreme Court did not pass an order. It took a sue motto notice to make the system better. The reason why it is being discussed is that we have to take utmost care of patient safety, well being and rights. That was the concern of everyone including the regulators. The power that has come to us is from the drug regulatory law that has been framed. In that direction, the government has amended rules and the gazette notification on January 30, 2013 by the health ministry is a great step.
It is the monitoring and compensation system that has to be strengthened. Now we are having a proper system and an enabling role so that we can assure the participant of his safety. This is a historical step taken by the Government of India. Till then you were not having a proper system in place, or the law, you can't enforce law. Now we have the teeth to say that the compensation has to be given immediately.
You have started meeting the stakeholders from January onwards. What is the purpose and outcome so far?
I wanted to get updated on the reactions of patients and all the other stakeholders on the clinical trial system. In that direction, we initiated meetings with common people, manufacturers and civil society members from time to time. Since the civil society represents the aspirations of people, we would like to work closely with them. In fact, the mistrust that existed earlier has evaporated gradually. I think this is the time to build up expectations and regulator must know that. It is the high time to build up the confidence among the public that we are there.