Local drugmakers can aspire for less regulatory inspections by the United States Food and Drug Administration, provided they achieve quality standards in their facilities, higher than that required by the regulator.
Explaining the shift to a “carrots and stick” approach, Howard Sklamberg, USFDA’s Deputy Commissioner (global regulatory operations and policy) said, firms that pose a lower risk to consumers are likely to have less frequent inspections. And companies would want less frequent inspections, he told Business Line, since inspections are expensive for companies and the FDA.
The USFDA is working to refine the regulatory supervision of drug companies in India and across the world, he said, adding that new tools were being developed to assess targeted facilities that pose the greatest risk to patients and consumers. More risk will see more enforcement, he said.
Drug firms are encouraged to have incentive and reward systems in place to prevent a situation before a faulty product goes into the market and has to be recalled, he said.
Meanwhile, local food exporters are likely to see more inspections as US companies sourcing food from overseas suppliers are being made more accountable to the US regulator on the food they import into the US, said Michael R. Taylor, USFDA’s Deputy Commissioner ( Foods and Veterinary Medicine).
The USFDA representatives were in Mumbai to wrap-up their delegation’s two-week long India visit, interacting with Central and state government officials and food and pharmaceutical industry representatives.
Echoing USFDA Commissioner Margaret Hamburg’s statement after her visit to India about a year ago, Sklamberg said, there is no country by country agenda for the FDA. There is no India agenda for food, drugs or enforcement. The only agenda is for quality and uniformity of products selling in the US and efforts are underway to build a system of incentives, of carrots and sticks, he said.
His response was to the perception that Indian companies were being “singled out”, given the spate of India-based companies, including Ranbaxy, Wockhardt, Sun Pharma and more recently Ipca and Lupin, that have come in for the stick from the regulator.
Commenting on a key transgression that comes up with Indian companies, Sklamberg said, data integrity is vital. The FDA cannot do its job without reliable data and it is important for firms to ensure reliability of data, he said.
On intensifying verification of food exports from India, Taylor explained, US food importers now have to verify the food safety of its overseas supplier. The FDA is also working with Indian authorities to parallely have a system of verification before the product leaves Indian shores, he said.
Second nature
In the case of food and drugs, it is important to have a deep culture of quality and that should start from the top and that commitment to quality should be inculcated down to the shop-floor. It should be so much part of the culture that it’s almost second nature, Sklamberg said.
Quality is not just a check-list, it is building a maintaining a culture, he said. The FDA was developing a quality matrix for companies, he said, without getting into details on whether there would be a rating or grading system. But companies that achieve a higher quality and reliability of products will be able to attract more consumers on that achievement, he explained. “We want to develop a tool to foster a market place of quality,” he said.
India head
On appointing a new India-head for the FDA, Sklamberg said, Mathew Thomas was the new acting director, having taken over about a month ago. There will be a permanent director position, he said, responding to a query on the exit of the earlier chief mid last year.
jyothi.datta@thehindu.co.in