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USFDA sees more capacity building role in India

Giving a sense of the growing engagement between the Indian regulators and the FDA, Margaret A. Hamburg, said: "All of this is evolving and we are brainstorming... and as it comes along we will have more programmes in the coming year."

E. Kumar Sharma | February 4, 2015 | Updated 14:40 IST
US Food and Drug Administration Commissioner Margaret A. Hamburg
US Food and Drug Administration Commissioner Margaret A. Hamburg. Photo: Reuters

One year after the India visit of the US Food and Drug Administration Commissioner Margaret A. Hamburg, the FDA's India office is keen to work more closely with the Indian drug regulator and play an important role in capacity building in select areas.

"The government of India has passed regulations that require clinical trial sites to be accredited, ethics committees to be accredited. We feel there might be a need in that area to build the capacity of the regulators to conduct inspections of the ethics committees and to ensure that the ethics committees have the capacity to review the protocols that are submitted to them," said Soloman Yiman, Assistant Director (Clinical Research) in the FDA's India office, at a meeting in Hyderabad on February 3. He was responding to a query on the FDA's plans to work closely with the Indian regulators.

Yiman was in Hyderabad to attend BioAsia 2015, an annual convention organised by the Federation of Asian Biotech Association and supported by the central government and the government of Telangana. Giving a sense of the growing engagement between the Indian regulators and the FDA, he said: "All of this is evolving and we are brainstorming... and as it comes along we will have more programmes in the coming year."

Yiman said that when USFDA Commissioner Hamburg was in India in February last year, she had signed a memorandum of understanding with the government of India to collaborate in certain areas. Since then a number of activities have been conducted in India.

Yiman said that the FDA India office conducted a workshop on quality systems in three cities for manufacturers, regulators and other stakeholders to build capacity for the Indian industry that had been facing issues regarding good manufacturing practices. Another workshop was held last summer on data integrity in four cities, he said.

"The collaboration is continuing and we are working very closely with Indian government authorities. We are also working very closely with all our counterparts in the European Union. The most important thing is collaboration, working together, capacity building, interaction and identifying issues before they escalate to higher levels are the areas we are working on."

The FDA has two offices in India-one each in New Delhi and Mumbai-in addition to in-country inspectors who conduct inspections for pharmaceuticals and also undertake food inspections in case of manufacturers that produce food products destined for the United States.

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