USFDA scrutiny: Will pharma majors like Ranbaxy, Wockhardt be affected in long-term?

Japanese companies do not mind erring on the side of caution. They are known to think longer and harder than their counterparts in other countries about big decisions, especially when it comes to entering a new market or acquiring a foreign company. But Japan's third biggest drugmaker Daiichi Sankyo would now wish it had spent more time doing due diligence on RanbaxyBSE -0.72 % Labs, in which it bought a controlling stake in 2008 for $4.6 billion.

Just after the deal was announced, the US Food and Drug Administration (USFDA) banned import of 30 generic drugs from two of Ranbaxy's facilities in Madhya Pradesh and Himachal Pradesh which did not meet the FDA standards.

One-two Punch

Things got worse a few months after the deal was concluded when the USFDA accused Ranbaxy of falsifying data and test results at the plants. The drama came to a head when on May 13 Ranbaxy pleaded guilty to charges related to drug safety and falsifying data and agreed to pay $500 million, the biggest ever settlement by a generic drugmaker. Just under 10% of that will go to Dinesh Thakur, a former Ranbaxy executive who blew the whistle on the wrongdoings.

Daiichi has now accused "certain former shareholders" of Ranbaxy of concealing critical information related to the USFDA and Department of Justice investigations. Ranbaxy's former chairman Malvinder Singh hit back at Daiichi saying there was no misleading and that the Japanese drug maker has not been able to manage the company.

Ranbaxy has also been battling another hit to its image when in November it recalled its generic version of Pfizer's cholesterol-lowering drug Lipitor from the US after it found glass particles in some batches. Though it has since resumed protection, the recall and Ranbaxy's settlement could make the going tough for India's generics exporters.

No sooner had the pharma industry swallowed this really bitter pill than the USFDA struck again — this time banning import of generic drugs from Wockhardt's Aurangabad facility. While the stock took a hammering, dropping 20%, its chairman Habil Khorakiwala certainly did not help matters when he said there would be a $100-million hit on the company's sales. "I don't think the USFDA is targeting a certain company, they are internally tightening norms; that is all," he told ET.

Acting Tough

Khorakiwala is right in saying the USFDA is targeting no particular company. The body is considered the most stringent regulator in its field around the world. It oversees the world's biggest pharma market, valued at $360 billion in 2012, nearly a third of the global market. It regularly inspects manufacturing facilities around the world from where it imports food and pharma products. If it finds that it does not conform to the agency's current good manufacturing practices (cGMP), it issues a warning letter. And if the company still fails to take corrective measures, it may issue an 'import alert' which means an import ban.

But the USFDA may not always warn companies. "[The] USFDA is under no legal obligation to warn individuals or firms...before taking enforcement action, except in a few specifically defined areas," says their website. After the company complies with USFDA standards, it issues a 'close-out' letter, revoking the warning. The USFDA also issues 'drug marketing and advertising warning letters' which are sent out to companies that mislead consumers about products in their communications.

Almost every Indian generics maker which exports to the US has received a warning letter or an import alert. In fact, earlier in the week around the time WockhardtBSE -6.50 % got its import alert, another similar warning to a Gujarat unit of Sterling Biotech went unnoticed. Sterling Biotech had received an earlier alert in end-November 2012 when the USFDA collected and analysed samples of pharmaceutical use gelatin and "found them to be contaminated with spore forming bacteria."

Nitin Sandesara, chairman and managing director of Sterling, says the new import alert on the USFDA website must be "a mistake" and that the one issued in November has been revoked. He adds: "We supplied 50 samples from different batches to the USFDA last year, and we resolved the issue and started shipping gelatin again in early March." Gelatin is used in making capsules. It takes months or even years to get it revoked and Indian companies like Lupin and Aurobindo have got clearance from the USFDA after getting a warning or an import alert (see Under the FDA Scanner).
Even global pharma majors are not exempt from this. For instance, Novartis Intl AG and Sanofi Aventis Deutschland GmbH got warning letters in 2011 for violating USFDA's manufacturing standards. But they get more warning letters related to marketing and advertising than cGMP. Generics are copies of drugs whose patents have expired. They can be branded or non-branded. Almost 90% of India's exports to the US are non-branded generics. India is among the biggest producers of generics in the world and exports over $10 billion of those drugs every year, the majority of it going to the US.

The spend on global generics is expected to grow from $242 billion in 2011 to $400-430 billion by 2016, according to a report by US-based IMS Institute for Healthcare Informatics Bhavika Thakkar, an analyst at IIFL, says investor response to an import alert depends on how much the drugs in question contribute to the company's top line and also on how soon the company can transfer production to another facility which complies with USFDA regulations. Earlier this week a subsidiary of Glenmark Pharma recalled batches of three drugs in the US owing to an "odd smell".

Closer Scrutiny

"The FDA norms are a lot more stringent than what Indian companies are used to in India or other emerging markets so warnings are not surprising," says Sarabit Kour Nangra, vice-president, research, Angel Broking.

But she says import alerts are more serious since there is an impact on revenues, as in Wockhardt's case. She adds that it will take a while for Indian companies to raise their standards. "In any industry we always look elsewhere to develop our standards." The manufacturing standards for products sold in India are far less stringent than the ones prescribed by the USFDA.

"Now there is increased scrutiny by the USFDA across countries. While Ranbaxy is an isolated case, I don't see long-term implications for companies who have got a warning or an import alert. Lupin was able to get a clearance after its warning in a really short period," says Siddhant Khandekar, analyst at ICICI Securities.

According to Sujay Shetty, India leader for pharmaceuticals and lifesciences at PricewaterhouseCoopers, the USFDA could be under pressure from US lawmakers to crack down on errant pharma companies. "They will be even more stringent in their inspections now," he adds.