U.S. FDA softens approach in meetings with Indian regulators

The U.S. FDA is adopting a "carrot and stick" approach to the problems with India's pharmaceutical production.

FDA deputy commissioner for global regulations Howard Sklamberg

Howard Sklamberg, deputy commissioner for global regulatory operations and policy, said as much on the opening day of a three-day visit with India regulators by him and two other FDA leaders in New Delhi.

Sklamberg said the new plan calls for rating India drugmakers and providing incentives for meeting good manufacturing practices along with use of its usual enforcement tools.

The official said the agency was still working on a rating system that would take into account the quality-producing procedures a company follows as well as its compliance with other drug-production and quality-control steps. He added that the rating system was not limited to India and that it would be imposed globally, even on the United States.

Sklamberg said the intent of the ratings was to enable the high achievers to stand out, possibly causing them to be inspected less often.

He said his agency planned to increase inspections and its personnel stationed in India, not because it expects to uncover more violations, he explained, but because of the expected growth in the nation's industry, particularly in its generics market.

Sklamberg also said the FDA intended to offer more training for India inspectors who would be part of joint inspections of India production and other facilities. That move would be aided by the FDA's new Office of Pharmaceutical Quality with "specialized, well-trained drug inspectors," he said.

In a newspaper interview, the deputy commissioner emphasized that his agency was not singling out India for enforcement and that drug quality and other standards should be the same in all countries. He also said the agency was working on establishing a permanent FDA head for India and that candidates were still being interviewed for the job.

- here are articles from LivemintBusiness Standard and The Hindu