India Lapses Test Relationship But Let’s Listen And Learn: U.S. FDA

In their latest trip to India, senior U.S. FDA officials mulled several new ideas including a rating system for drug companies, noting that the main aims of the visit were to “listen and learn” and draw up programs that benefit patients in both countries.

MUMBAI – The U.S. FDA and leading Indian industry associations are likely to initiate active collaborative steps with an aim to address specific concerns pertaining to quality and data compliance at some Indian sites.

A representative from a lobby group said the move is important as the U.S. agency has identified specific product categories like injectables, parenterals and oral solids, among others, to engage in extremely granular discussions, with the ultimate aim of meeting international regulatory requirements.

Discussions held between industry and the FDA representatives in New Delhi last week focused on allocating roles and responsibilities to local associations which, it is said, will take forward a series of programs to ensure quality compliance. “The idea is to create what could ultimately be a national database and include an annual chart for capability building,” the source informed.

The FDA team led by Howard Sklamberg, deputy commissioner for global regulatory operations and policy, is touring several Indian cities to meet industry and regulatory officials as the agency keeps up its pressure on the quality of generics exported to the U.S. from India (Also see "U.S. FDA Officials To Stress Quality, Skilling On India Visit" - Scrip, 17 Mar, 2015.).

Betting On Rating

Besides, the FDA is also reportedly mulling a rating system for generics firms - a step it expects will bring greater efforts to comply with the agency’s expectations.

Speaking to media in New Delhi, Howard Sklamberg was quoted as saying, “If a firm has a high commitment to quality, it will show in the metrics, and firms can be inspected less often. Inspections cost money both for FDA and the companies….By building a system that uses ‘carrots and sticks’ to encourage firms to seek higher quality, the U.S. FDA wants to recognize firms that have achieved quality.

“We want patients and purchasers of drugs to recognize such firms and say that they wanted to deal with them because they are committed to quality.”

However, the plan to kick-start a rating system will need comprehensive parameters that will have to be adhered to rigorously. An official who was present at the meetings in New Delhi said the efforts for a rating system can be put in place only after the U.S. agency is convinced of uniform quality standards and that will take a few years, given the recent observations against some of leading Indian generic companies.

While the initiative is still ongoing as evidenced from meetings that the agency held with industry groups in November last year, Sklamberg along with Michael Taylor, deputy commissioner, food and veterinary medicine, further summed up the FDA’s efforts to collaborate with the Indian industry in a March 18 blog.

High Quality: Good For Both Nations

The senior FDA officials said, “India is quickly becoming a significant player in the global marketplace, representing an important source of FDA‐regulated products. With a diverse population, highly skilled work force, and favorable economic conditions, India has become an increasingly attractive location for companies to operate.”

Noting the importance of India in supplies to the U.S., they wrote, “It is no secret that relationship has been challenged in the recent past by lapses of quality at a handful of pharmaceutical firms. And while our first regulatory responsibility is to protect the American patient and consumer, we are also very willing to collaborate with Indian regulators and other stakeholders to ensure the achievement of highest standards of safety and quality, something we feel only benefits both nations.”

The FDA maintains its activities are directed towards listening and learning. Building on the visit of then Commissioner Margaret Hamburg last year, Sklamberg and Taylor said, “Before the trip we discussed with our teams what we expect from our journey. Our top goal is to listen and learn. We want to understand what challenges the Indian government is facing with regard to drug and food safety. We want to hear from both American companies operating in India, as well as Indian manufacturers.

“And we want to discuss with our Indian counterparts a number of significant changes in the American regulatory system that affect our relationship.”

Expressing confidence in constructive conclusions from the latest visit, the two agency officials added, “Our trip will yield more examples of such fruitful collaboration, moving the regulatory relationship between two of the world’s largest democracies to the next stage, from the intention to work together, to the ability to work together to solve the complex globalization issues facing both nations.”