India generic drugmakers' woes put new focus on quality over price

March 25 Tue Mar 25, 2014 5:56pm EDT

March 25 (Reuters) - A spate of regulatory warnings for India's generic drug manufacturers will add a new emphasis on the quality of such medicines in an industry long dominated by the ability to deliver treatments as cheaply as possible, analysts say.

In the short term, that is expected to benefit larger global competitors, such as Teva Pharmaceutical Industries Ltd , Actavis Plc and Mylan Inc, which will be called upon to supply drugs no longer available from some of their rivals in India, they said.

Over the longer term, the trend will put a new premium on manufacturers who can demonstrate a strong quality record over time and limit supply disruptions, particularly as U.S. drugstore chains and pharmaceutical wholesalers make deals that consolidate their buying on a larger scale than ever.

"When you talk to companies they will tell you that this was an industry that used to be about nothing but price. Now the ability to supply the market and have a reliable supply, to be in good favor with the FDA, that's starting to mean something to customers," said Gabelli & Co analyst Kevin Kendra.

The biggest setback for India's $14 billion a year generic drug industry came in January, when the FDA banned imports from all the Indian plants of Ranbaxy Laboratories Ltd, India's No. 1 drugmaker by sales, over repeated production quality lapses.

While generic drugmakers based in the United States and elsewhere have also been cited by the U.S. Food and Drug Administration for quality control problems over the years, India's industry has come under fresh scrutiny recently as the agency steps up its inspections there.

On a smaller scale, the U.S. health regulator banned medicines made at a Sun Pharmaceutical Industries Ltd plant at Karkhadi.

Sun has said that plant accounts for less than 1 percent of its sales.

Wockhardt Ltd and Dr Reddy's Laboratories Ltd have also run afoul of the FDA or been involved in recent major product recalls.

Some U.S. doctors say the headlines have raised new concerns about the quality of the generic drug supply.

Pharmacy chains including CVS Caremark Corp and Walgreen Co would not comment on whether they have altered their purchasing operations in any way.

Pharmacy benefits manager Express Scripts Holding Co , one of the largest purchasers of generic drugs, would not single out India, but said it has taken notice of quality concerns on a company-by-company basis.

"We have increased our surveillance throughout the supply chain," said Express Scripts spokesman Brian Henry.


When products are temporarily removed from the U.S. market, "that has given some larger manufacturers the ability to take up pricing and pick up some share," said RBC Capital Markets analyst Randall Stanicky.

Jason Kolbert, an analyst with Maxim Group, sees Teva, with its vast geographic reach and huge product portfolio, as a "direct beneficiary" of Indian drug company setbacks. It sells, for example, a version of the antibiotics made at the Sun plant under FDA sanctions.

"These companies have to spend six months or a year fixing a manufacturing quality control problem, so Teva is likely to pick up a little bit of growth because this is not their problem," Kolbert said.

Morningstar analyst Michael Waterhouse said purchasers would likely make a distinction between Ranbaxy, which has repeatedly been cited by the FDA for lapses, against its Indian peers that have had more sporadic problems, not unlike companies elsewhere around the globe.

"The FDA overall is trying to raise the bar because it's a brutal industry for a lot of these companies where the pricing pressure is so hefty," he said.

Wockhardt, Ranbaxy and Dr. Reddy's did not respond to requests for comment.

Piyush Nahar, an analyst with Jefferies India Private Ltd, said Indian drugmakers have increased their investment in compliance and some are considering investing in U.S. or European plants to overcome regulatory challenges.

Waterhouse expects those efforts to pay off.

"Ultimately you would think standards would be raised in India and they would still remain a formidable opponent," he said. (Reporting by Bill Berkrot in New York, additional reporting by Zeba Siddiqui in Bangalore; editing by Michele Gershberg and G Crosse)

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Comments (1)
KleinTim wrote:
I do not think the assumption is correct that only certain Generic manufacturs in India have major GMP deviations. I know from many audit reports (I am heading a GMP auditing firm in Europe) that India does have a fundamental problem. This is not limited to certain companies. If you are acting in a GMP environment you need to have staff which is fully aware of potential problems and there must be a culture which allows to report own mistakes without problems. This is not the case in India. In addition senior management is totally different to colleagues in USA and Europe. They are focussed on business only. No employee would report problems. It’s a cultural problem. If they would report problems nobody will listen.
FDA performed inspections for many years. But in past years not much was found. Why? FDA Investigators had to fly in Economy to India and sometimes they just stayed in the hotel and asked for documents. When they visited the facility they did not access the production and QC area. Documents can be manipulated but they just checked the documentation. Look at the last 10 FDA Warning Letter – now the investigators go to production areas and talk to the people. The recent FDA Warning Letter to India all contained data integrity issues and even falsification of data. The European Inspectors did inspect less and each EU Members State performed their own inspections without informing the other member states! A European problem. This changed with a new database (EudraGMDP) but this database is still in an early phase.
In summary: There is manjor problem which was highlighted by some individuals at a congress hearing in the US. And this is only the tip of the iceberg. But the situation reminds me of the Heparin case. Action will be taken only when people will die. Experts new the problems for years. This is no good new for patient safety. The Generic business is focussed on money, but in India they go even a step further and do nearly everything to make profit. On the web there are pictures from the Wockhardt facility in India (na press). Everybody who has seen that will not need to know more. We are just in front of a major incident and nobody will react until it is too late. If you want my advice: do not use Generic medicine from India. You would also not book a flight in an 40 years old plane which is used by a former soviet state airline, won´t you?

Mar 27, 2014 12:18pm EDT  --  Report as abuse
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