Sibal on Clinical Trials

From CIOL

He further added that the government is also putting in place a system to help various projects starting from research and development stage to proceed till manufacturing phase. “For this, continuous support in the form of public private partnerships to continue the chain of things has to be in place,” said Sibal.

Foreseeing the potential in the area of clinical trials, Sibal said that DBT has decided to set up a clinical trials center where large number of trials can be taken up. “Though huge investments are getting into this area, we don’t have industry best practices yet. The proposed center will also set protocols to establish standards to carry on clinical trials,” said Sibal.

India USFDA alliance? From the Hindu

THE Centre has sought the help of the US Food & Drug Administration to put in place a US FDA-like entity with world-class protocols for clinical trials.

The proposal mooted by the Union Ministry for Science & Technology is to get the US to agree to accepting clinical trial data and outcome from India for approving drugs meant for use in that country, the S&T Minister, Mr Kapil Sibal, said here on Friday.

This could be extended to include Japan and Europe too, he said during a seminar on Indo-US S&T cooperation.

This would be one of the areas of pursuit when the two countries are slated to sign an umbrella agreement on S&T in the US in October. Mr Sibal said the S&T agreement itself was the outcome of nearly a decade of negotiations. It would pave the way for cooperation in several other areas, such as biotechnology, nanotechnology and healthcare.

According to Mr Sibal, dialogue has already been started by the Health Ministry and the USFDA is ready to help out in preparing special protocols for this and reorganise the national Drugs Controllerate General and align its clinical research norms to USFDA-level standards.

And this is what FDA is saying (from Detroit News)

The FDA, however, always conducts its own assessment of clinical trials done in other countries when those studies are part of an application to have a drug approved in the United States.

“There is no automatic acceptance,” Murray Lumpkin, deputy commissioner for International and Special Programs at the FDA, said by telephone from Washington, D.C.

Still, Lumpkin said that over the summer the head of the FDA met with India’s health minister to discuss how the United States might be able to help with the new initiative.

“Now we are trying to work through what kind of technical assistance would be helpful and feasible,” said Lumpkin. “We also have to look at what our own resources are.”

Lumpkin said the agency is frequently asked for this type of help.

He added that the new agency might help raise India’s profile as many countries around the world are competing to host clinical trials.

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