Indian pharma draws more scrutiny as US exports rise

India's drugmakers, battered by a rash of US regulatory rebukes including a record fine for Ranbaxy Laboratories, face closer FDA scrutiny as the agency ramps up its presence in the country.

Last Updated: Sep 15, 2013, 08:59 AM IST

Mumbai: US inspectors visiting a factory in India owned by drugmaker Wockhardt in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area.

And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration (FDA) to Wockhardt, which makes sterile injectable drugs and various forms of insulin.

Habil Khorakiwala, chairman of Wockhardt, last week told shareholders that the problem at its Waluj plant "is an inexcusable lapse, but we have taken swift and definitive action, both corrective and pre-emptive", including appointment of a new quality chief and hiring of outside consultants.

India's drugmakers, battered by a rash of US regulatory rebukes including a record fine for Ranbaxy Laboratories, face closer FDA scrutiny as the agency ramps up its presence in the country.

Increased on-the-ground oversight reflects India's growing importance as a supplier to the US and should ultimately bolster quality and confidence in India-made drugs.

In March, India allowed the FDA, guardian of the world's most important pharmaceuticals market, to add seven inspectors, which will bring its staff in India to 19. India produces nearly 40 per cent of generic drugs and over-the-counter products and 10 per cent of finished dosages in the US.

"As more trade happens, as more drugs are approved and applications are submitted we will have to inspect more," Altaf Lal, the new FDA office director for India, told Reuters.

"Many Indian firms fairly well understand and they know good manufacturing practices. The problems we have seen with some companies are why we choose to make quality as one of our highest priorities," he said.

The FDA's stepped-up presence should also accelerate what some in the domestic industry hope is a more rigorous attitude towards compliance in a country whose cheap generics have made it the low-cost pharmacy to the world.

In the near term, it means Indian drugmakers could be more frequently hit by enforcement measures or inquiries, unnerving investors.

Shares of Ranbaxy, controlled by Japan's Daiichi Sankyo, fell as much as 42 per cent in the months after it pleaded guilty in May to US felony charges related to drug safety and agreed to $500 million in fines.

Ranbaxy, India's biggest drugmaker by sales, remains barred from making US shipments from its plants at Dewas and Paonta Sahib. Ranbaxy has said the implementation of a consent decree it signed in January 2012 with the FDA to restart shipments has "progressed as per plan".

While Ranbaxy shares have recovered, the case put a cloud over the industry.

"We all know how Indian companies function and issues such as Ranbaxy and other import alerts have brought us a very bad reputation globally," said Ajay Kumar Sharma, director of research at the Organisation of Pharmaceutical Producers of India.

The urgency to be first with a generic version of a drug coming off patent is the main reason for quality problems, Sharma said. The company that first launches such a drug enjoys a 180-day exclusivity period, which can be lucrative for the generic version of a commercial blockbuster.

"We need to be sincere towards quality issues rather than following procedures just for the sake of it," said Sharma. "We are doing things fast but then losing out on certain aspects and facing import alerts."