Index · Artikel · Analysis: Indian pharma draws more FDA scrutiny as U.S. imports rise

Analysis: Indian pharma draws more FDA scrutiny as U.S. imports rise

2013-09-12 10
résuméMUMBAI U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing are

Analysis: Indian pharma draws more FDA scrutiny as U.S. imports rise

MUMBAI U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters 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 U.S. Food and Drug Administration 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 U.S. regulatory rebukes including a record fine for Ranbaxy Laboratories Ltd, 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 United States, and should ultimately bolster quality and confidence in Indian-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 percent of generic drugs and over-the-counter products and 10 percent of finished dosages in the United States.

"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 Co, fell as much as 42 percent in the months after it pleaded guilty in May to U.S. felony charges related to drug safety and agreed to $500 million in fines.

Ranbaxy, India's biggest drugmaker by sales, remains barred from making U.S. 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."


Wockhardt's once-soaring shares fell as much as 79 percent in the months after the announcement of an "import alert" banning shipments from the Waluj factory in May. By the middle of this week, the stock was down nearly 59 percent.

On July 31, Strides Arcolab shares fell as much as 17 percent on worries over FDA scrutiny of its manufacturing practices, although the Indian company said on that day that it had answered the FDA's queries, made in a so-called form-483 letter, and continued to make U.S. shipments. Its stock has more than recovered.

The FDA's power cuts both ways. Last week, IPCA Laboraties shares gained 7.6 percent on the day it said the FDA had cleared its oral solid formulations plant in Indore for U.S. shipments. In November, IPCA had voluntarily reported "non-conformances" at the plant to the FDA.

"More inspectors initially could mean some more enforcement actions, but eventually that would end up meaning even fewer enforcement actions going forward," said Macquarie analyst Abhishek Singhal.


India is the biggest overseas source of medicines to the United States and is home to over 150 FDA-approved plants, including facilities run by global players. Pharmaceutical exports from India to the United States rose nearly 32 percent last year to $4.23 billion.

As U.S. demand for generics grows, especially under President Barack Obama's healthcare program, the FDA is under pressure to clear product applications while ensuring quality.

New U.S. legislation requires the agency to inspect global plants on the same schedule as domestic facilities, and to clear its backlog of drug applications within five years. Indian firms account for more than one-third of U.S. drug approval filings.

Lupin Ltd was the top Indian drug seller in the U.S. market last year by prescriptions, followed by Dr. Reddy's Laboratories, Cadila Healthcare and Aurobindo Pharma, according to IMS Health. All have had past FDA run-ins.

In May 2009, Lupin received a warning letter from the agency over deficiencies at a plant in Bhopal, which it resolved in January 2010. Last year, the FDA lifted an import alert at a Mexican plant owned by Dr. Reddy's.

In 2011, Cadila's parent received an FDA warning letter over its plant in Ahmedabad, which was resolved last year. In March, the FDA lifted an import alert that it imposed in 2011 on non-sterile products made by Aurobindo at a plant in Hyderabad.

The companies did not immediately reply to requests for comment from Reuters.

Many in India note that drugmakers globally, including in the United States and Europe, have also run afoul of increasingly stringent FDA inspection.

"When you are such a major player for the U.S. market, you will also have larger number of inspections," Ranbaxy CEO Arun Sawhney said in June.

(Additional reporting by Toni Clarke in WASHINGTON and Abhishek Vishnoi in MUMBAI; Editing by Jeremy Laurence)


  • Day/
  • Week/
  • Original/
  • Recommand


  • Ist risperdal oft bei Kindern verwendet, wie es schon ab 6 Jahre alt?

    meine 6-jährige Enkel hat in der Schule und ein Kind phsych agressive, trotzige Verhalten. denkt er an ADHS leidet und will ihn auf risperdal.has beginnen diese für Kinder geprüft und zugelassen, dass die jungen? ----schneiden---- In Antwort auf stop
  • Cleveland Bürgermeister wird Bedingungen OK medizinische Mart Lage erfordern

    Cleveland Bürgermeister wird Bedingungen OK medizinische Mart Lage erfordern
    Bürgermeister Frank Jackson CLEVELAND, Ohio - Cleveland Bürgermeister Frank Jackson hat kalte Füße über den vorgesehenen Standort der medizinischen Mart und Kongresszentrum, nach The Plain Dealer und Cleveland - Business die Crain . Die Beschreibunge
  • Ist Ihr Kind in Gefahr Bei einem Masernausbruch?

    Ist Ihr Kind in Gefahr Bei einem Masernausbruch?
    Der Anstieg der Masernfälle und eine wachsende Zahl von Ausbrüchen hat wahrscheinlich einige Eltern fragen, ob ihre Kinder gefährdet sind. Die meisten Eltern verstehen, dass Masern eine Impfung vermeidbare Krankheit ist, aber einige können nicht abso
  • NIAAA Fonds Research in Alkohol und Alkoholismus

    NIAAA Fonds Research in Alkohol und Alkoholismus
    Mit der Unterstützung von NIAAA, Wissenschaftler an der medizinischen Zentren und Universitäten im ganzen Land studieren Alkoholismus. Das Ziel dieser Forschung ist es effektivere Wege zur Behandlung und Prävention von Alkoholproblemen zu entwickeln.
  • Zehn Arten von Übermäßiges Essen

    Zehn Arten von Übermäßiges Essen
    Übermäßiges Essen ist ein häufiges Problem, aber es gibt viele verschiedene Arten von Überernährung. Hier sind zehn der am häufigsten zitierten Möglichkeiten, dass ein Problem werden kann übermäßiges Essen. 1 Binge Eating Binge-eating beinhaltet in k
  • Wie lange dauert es, für cyclobenzaprine zu nehmen beeinflussen und die Krämpfe zu stoppen?

    Mein Mann hat zwei Dosen und die Muskelkrämpfe genommen und Schmerzen in den Hals ist nicht besser. Advil scheint bei der Linderung der Schmerzen mehr, dass das Muskelrelaxans zu helfen. ----schneiden---- In Antwort auf heatherl ... bei 2013.01.12 18
  • Was ist Hyperhomocysteinämie?

    whiat dieses Medikament ist und was es für verwendet in laymans Bedingungen, damit ich verstehen kann, ----schneiden---- In Antwort auf 2013.02.27 18.37 bis bloggermom Hyperhomocysteinämie ist kein Medikament. Es ist eine Störung der Blutgerinnung. E
  • Derzeit auf Lexapro 20 & 150 wellbutrin, sich besser fühlen ich noch leichte Depression und Angst haben?

    Irgendwelche Vorschläge?? Ich sehe eine pschychologist morgen und ich hoffe, dass wir gemeinsam mir normalisieren. ----schneiden---- In Antwort auf Macintos ... bei 2013.03.19 15.52 Hallo nenag, Sind Sie einen Psychologen oder Psychiater zu sehen, wi
  • Autismus-5-mal häufiger unter einem niedrigen Geburtsgewicht

    Autismus-5-mal häufiger unter einem niedrigen Geburtsgewicht
    Bildnachweis: Dreamstime Babys geboren mit niedrigem Geburtsgewicht sind fünf Mal häufiger als die allgemeine Bevölkerung mit irgendeiner Form von Autismus diagnostiziert werden, schlägt neue Forschung. Die Studie ist die erste in den Vereinigten Sta
  • Famotidine Wirkung auf die Nierenfunktionen?

    Hallo, ich hatte eine Nierentransplantation vor 20 Jahren. 3 Monaten begann ich Famotidine (FAMO 40mg) nach Hiatushernie gefunden zu verwenden. Der letzte Bluttest meiner Nierenfunktion war schlecht zu den üblichen Vergleich. Kreatinin (1,6 bis 2,7)