The Hindu : Business : USFDA to work with drug firms

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Wednesday, Jan 09, 2008
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USFDA to work with drug firms

Special Correspondent

U.S. Health Secretary, FDA Commissioner visit Dr. Reddy’s Lab

Leavitt to meet Union Ministers
Dr. Reddy’s manufacturing standards lauded

— PHOTO: P. V. SIVAKUMAR

QUALITY CONSCIOUS: K. Anji Reddy (right), Chairman, Dr. Reddy’s Laboratories, in conversation with Michael O. Leavitt (centre), Secretary of Health and Human Services, U.S., at the company’s lab in Hyderabad. Andrew C.von Eschenbach, Commissioner, U.S. Food and Drug Administration, looks on.

HYDERABAD: The U.S. Food and Drug Administration (USFDA) will work with drug manufacturers across the globe for granting product-specific regulatory approvals to biosimilars, as there is no general framework of rules for them. The FDA has not changed its approach to according clearances, but wants to make the system more efficient to ensure speedy approvals.

U.S. Health Secretary, Michael O. Leavitt, and Commissioner of the FDA, Andrew C. von Eschenbach, visited the R&D facility of Dr. Reddy’s Laboratories (DRL) here on Tuesday.

Addressing a press conference, Mr. Leavitt said the U.S. imported food and drugs costing $2 trillion from eight lakh manufacturing sources. “President Bush asked me chair a working group to examine our importing practices. I have been visiting several manufacturing facilities in the last seven months to personally inspect them. We do redesigning the practices for the future so as to provide American consumers access to high quality food and drugs,” he said.

“We want to build quality into products by ensuring a check at every level. Because our expectations of quality and safety of products is very high,” he observed. Dwelling about his recent visit to China, he said the two countries would work together on safety and quality of drugs and devices, foods and feed so that the consumables were produced in accordance with best manufacturing practices. Mr. Leavitt said he would wrap up his discussions on the safety standards in India when he would meet the Union Ministers of Commerce and Agriculture so that Indian companies could gain access to American markets.

Mr. Eschenbach said any product entering the U.S. would have to be approved by the FDA. The FDA was working in engagement of the entire lifecycle of products through intervention and response to take a comprehensive view on the standards.

To a query, Mr. Leavitt said transparency in manufacturing practices was fundamental for choosing high quality products. “We are looking at the quality of clinical trials. It is not generalised,” he said in response to another question.

Founder-chairman of DRL, K. Anji Reddy, said that the company would announce a major collaboration by month-end. Mr. Leavitt and Mr. Eschenbach lauded the manufacturing standards maintained by DRL.

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