Not targeting Ranbaxy or Indian companies: US FDA

Increase in regulatory action reflects India's growing importance, says FDA chief

The US is not targeting Ranbaxy or any other Indian company but only ensuring quality control and compliance with norms to see drugs sold in the country are safe for patients, Margaret Hamburg, commissioner, US Food and Drug Administration (FDA), told the international media while briefing on her recent India visit this morning.

Emphasising that increased inspections in India is the fallout of the fact that India is a large supplier of medicines and food products to the world’s largest pharmaceutical market, the FDA chief said she was also set to visit other countries soon.

“We are not targeting Indian companies. We are undertaking our required regulatory activities. We inspect and take appropriate actions for companies within the US. If a company is manufacturing a product for sale in the US, they have to meet our regulatory standards and requirements and we inspect facilities in other countries as well,” Hamburg said replying to questions on the regulator’s increasing enforcements, particularly on Ranbaxy. “So, what is happening in India is consistent with what happens in the US and other parts of the world,” she said.

GROWING INDIAN PRESENCE

• uring 2012-13, Indian pharma exports grew 10.55% y-o-y to $14.6 billion from $13.2 billion a year ago
• India is home to 200 drug factories approved by the US Food and Drug Administration, including many run by multinational companies
• India is the biggest foreign supplier of medicines to the US
• Pharma exports from India to the US rose 32% last year to $4.23 billion
• India accounts for 40% of generic and over-the-counter drugs and 10% of finished dosages used in the US

Four of Ranbaxy’s key factories in India have been banned from supplying to the US. Some of these received an import alert immediately after an FDA Form 483 detailing deviations from norms observed by the US watchdog’s inspectors during inspection.

Usually, companies get a chance to respond to the Form 483 and a warning letter precedes an import alert. With Indian companies fast expanding sales to the US in the past few years, FDA’s inspections in India have also increased. Apart from Ranbaxy, Wockhardt, RPG Life Sciences and Agila Specialities that have factories in India making drugs for sale in the US have faced bans.

‘India stands out’
Hamburg insisted FDA’s increasing activities in India only reflected the country was now a significant and growing player in the US. Stressing her India trip was of immense importance given FDA was transforming itself from a local regulator to a global health organisation, Hamburg said, “India stands out and is particularly important, considering the country is the third largest trade partner for the US, second largest supplier of the over-the-counter and prescription drugs and eighth largest supplier of food.”

FDA is set to expand its staff in India to 19 from 12. The commissioner also indicated inspections would only increase and compliance procedures become more stringent, with focus on the whole supply chain right from active pharmaceutical ingredient (API) manufacturing to finished formulation one.

Ranbaxy’s Toansa (Punjab) factory was one of the major API producers in India to come under FDA’s scanner in recent times.

The US regulator is also planning to open more offices in China, Latin America and Europe. Hamburg said she had already visited China twice and planned to continue to engage with other nations.

Hamburg visited India during February 10-18. She is the first FDA chief to visit India. During her trip, the US drug regulator met Minister of Commerce and Industry Anand Sharma and Health Minister Ghulam Nabi Azad, among others. Hamburg also met the Drugs Controller General of India, G N Singh, and other state drug regulators. Besides, she spoke to company officials including heads of Ranbaxy and Wockhardt, as well as many food producers supplying to the US. During her visit, the two countries signed their first statement of intent to cooperate on medical products.