Business Today

"DCGI's Autonomy Is for the Government to Decide"

Drug Controller General of India GN Singh speaks with Business Today about the government's plan to revamp the drug regulatory system.
twitter-logo E Kumar Sharma        Print Edition: March 29, 2015
Drug Controller General of India GN Singh
Drug Controller General of India GN Singh (Photo: Shekhar Ghosh)

When GN Singh was told about a Balaji temple on his way to Hyderabad city from the airport recently, he insisted on visiting it. "Temples keep you grounded, keep arrogance in check. As long as I'm in this position I pray I can serve the people better," he says. Singh, who would need a lot of divine support to oversee the government's plan to revamp the drug regulatory system, took time out to speak with Business Today. Excerpts:

Q. Do you agree the office of the drug controller needs to be revamped?

A. The quality, safety and effectiveness of medicines are of prime concern. We are keen to strengthen this area. In times to come you will see the regulator becoming the face of the pharma sector in terms of its strength, quality of services and in ensuring safety, effectiveness and quality of medicines.

Q. What changes will we see in the next year or two?

A. First, everything will be transparent. We want to have online services with fixed timelines. There will be training and capacity building for the regulators, drug inspectors and analysts working in drug testing laboratories.

Q. What is the timeframe to implement all your ambitious plans?

A. I cannot give you a date. But I'm sure the rollout will begin this year.

Q. Why do you think the drug regulator is criticised so much?

A. Our people have high expectations but procedures do not match the needs of the country. That is why the government is strengthening the process.

Q. Should the DCGI be allowed to function autonomously and made more powerful like the US Food and Drug Administration?

A. That is for the government to decide. The government has an open mind. It will do whatever is best for the country. As a regulator, why I should ask?

Q. How will the DCGI ensure that incidents like the sterilization deaths in Bilaspur last November do not recur?

A. It can be done by imposing severe penalty clauses. This will happen once the Drugs and Cosmetics Act rules are amended.

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