Home / Politics / Policy /  USFDA to adopt incentive-based policy in India

New Delhi: The US drug regulator Food and Drug Administration (FDA) on Wednesday announced it will adopt an incentive- and regulations-based policy in India and expand its presence in the country after a three-member delegation held talks with Indian government officials in New Delhi.

“The talks with the officials were very encouraging. We are going to adopt a ‘carrots and sticks’ method for policy implementation from now," said Howard Sklamberg, deputy commissioner for global regulatory operations and policy at FDA.

The trip comes roughly a year after FDA commissioner Margaret Hamburg visited India following import alerts issued against all the Indian plants of drug maker Ranbaxy Laboratories Ltd.

The US FDA and its Indian counterpart had agreed to take account of the regulators’ concerns, and exchange expertise to ensure higher levels of compliance, training and adoption of systems and procedures. Sklamberg’s visit is intended to reiterate the issues raised during Hamburg’s trip and find an implementation plan for the same. The US agency will now evolve a matrix for ranking Indian companies and will use enforcement tools when necessary but will also offer incentives for areas where good manufacturing practices are being followed, Sklamberg added.

The plan to increase its presence in India, both in terms of staff and number of inspections, is on account of the burgeoning size of the Indian pharmaceutical industry and not because of lack of faith, Sklamberg said.

“You cannot sell a pill in the US market without inspections, and with the growth in number of generic manufacturers in India, added interactions will naturally follow." The FDA has the same standards for all the drugs it imports—whether from China, India or Germany, he added. During the meeting with Indian government officials, both sides discussed data sharing, quality systems implementation and training of drug inspectors for a better understanding of the FDA’s standards. They are expected to sign a memorandum of understanding.

Sklamberg said, “After last year’s visit, a series of workshops were conducted, which saw participation by almost 500 stakeholders from the industry. Joint inspections were held and training more people will help further."

“The Indian regulatory authorities have the ‘Track and Trace’ system to monitor subsidized drugs. Such tracking systems ensure quality," said Sklamberg. “The FDA too has gone through reshuffling and the Office of Pharmaceutical Quality was opened. We now have specialized, well-trained drug inspectors," he added.

The team will now visit Goa, Chennai and Mumbai.

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