Uniform standards being imposed on all countries, says US FDA Commissioner

On the second day of her 10-day visit to India, US Food and Drug Administration (USFDA) Commissioner Margeret Hamburg held two separate closed-door meetings with the senior management of the Indian pharma and food industry. The meetings, which lasted over four hours , were organised by industry body FICCI. The meetings held significance since, for the past few years, the US FDA has been coming down heavily on Indian pharma companies exporting drugs to the US, such as Ranbaxy and Wockhardt, for their failure to meet US standards.

Some 52 representatives of the pharma and food sectors were invited though not all of them showed up. Among those who attended were Arun Sawhney of Ranbaxy, Dilip Shanghvi of Sun Pharmaceuticals, Habil Khorakiwala of Wockhardt, Arjun Handa of Claris Lifesciences, Neeraj Aggarwal of Jubilant Orgnosys and Pankaj Patel of Zydus Cadila from the pharma sector, as well as Abhay Jaiswal of Nilgai Foods, Rajesh Srivastava of Rabo Equity from the food sector. A.K. Gupta of Agricultural and Processed Food Products  Exports Development Authority (APEDA) was also present.

The meeting gave Indian pharma companies an opportunity to express their concerns. Dilip Shanghvi, Chairman and MD of Sun Pharmaceuticals said that it was the beginning of a new chapter. "It's a continuous process, there are no outcomes. It's a question of establishing relationship," he said.

Though many of the participants refused to disclose details of the meeting, Habil Khorakiwala, Chairman of Mumbai-based Wockhardt, was an exception. His company has been at the receiving end of some of the US FDA' s actions In November last year, the US FDA issued an import alert against drugs from Wockhardt's Chikalthana plant. Earlier in May, another Wockhardt plant in Waluj was also banned by the FDA from exporting to the US. As a result, company's net profit dropped 29 per cent to $48.75 milion in the third quarter of 2013/14. Khorakiwala said Hamburg had told the group that uniform standards were being imposed on drugs from all countries. The US FDA's focus was purely on quality no matter where the drug came from.

Hamburg added that the new regulations required the US FDA to ensure that the quality of innovative products and generics were the same. "She said that generic players could extend their cause by following the same standards," said Khorakiwala adding that nearly 80 per cent of the prescriptions in the US are generic.

Industry leaders  had made some suggestions to deal with the Indian situation, Khorakiwala said. One suggestion was for the US FDA to conduct workshops in India to make Indian companies aware of its evolving procedures and standards. Hamburg responded by saying that the US FDA was indeed looking at conducting three or four workshops a year in different parts of India. Another suggestion was that the dialogue between the Indian pharma industry and US FDA should continue. "She welcomed our suggestions that delegations of leaders and scientists should visit US and interact with a larger group at the US FDA," said Khorakiwala.

No doubt the FDA had taken some harsh steps in the recent years, but Khorakiwala insisted Indian companies did maintain quality standards. "Today, 25 per cent of generic products used in US go from India," he said.

Some pharma industry representatives also pointed out to Hamburg that health authorities in other countries, like the MHRA of the UK, usually informs the Drug Controller General of India (DCGI) in advance while carrying out inspections and give the Indian regulator an opportunity to accompany them. "We made a request to the FDA to follow such a practice. We have to wait and see how it responds," said Khorakiwala.

The problem, Khorakiwala said, was  that different regulators had different standards. "There is no single standard. The Indian regulators looks at whether the end product is okay. The US FDA emphasises more on systems. It believes that if you follow the system, product quality will be fine."