India drugs inquiry could prompt new U.S. scrutiny

By Aruna Viswanatha

WASHINGTON | Thu May 10, 2012 5:56pm EDT

WASHINGTON (Reuters) – Global drugmakers could face new U.S. scrutiny after a report from lawmakers in India alleged abuses in that country’s drug approval process, lawyers familiar with such investigations said.

An Indian parliamentary panel on Wednesday said officials of India’s drug regulator had been colluding with pharmaceutical companies to speed up approval procedures, allowing some drugs that are not permitted in other countries to go on sale.

The U.S. Justice Department and the Securities and Exchange Commission are conducting extensive inquiries into nearly every major drug and medical device manufacturer for potential violations of a U.S. law that bars bribes to officials of foreign governments, the Foreign Corrupt Practices Act.

Many of those probes focus on accusations of bribery in emerging markets, such as China and Latin America, but dealings in India have yet to come under major scrutiny.

“If the Indian parliament issued a report condemning practices, then I’m sure my clients will be getting calls from the DOJ pretty soon,” said one lawyer who works with pharmaceutical companies on such investigations. The lawyer spoke on condition of anonymity, as did others who represent drugmakers in FCPA cases.

Other experts familiar with the Justice Department’s workings agreed.

“There is certainly going to be Department of Justice interest, said Howard Sklar, who ran anti-corruption programs for several major companies and now works at Recommind Inc, which makes software used in corporate investigations.

The 78-page report by Indian lawmakers named several major international drug companies including Eli Lilly and Co. and Novartis. It cataloged a series of procedural failures that it said raised questions about how certain drugs were allowed to be sold in India, but it did not directly accuse the companies of wrongdoing.

“If these Indian drug regulators were in cahoots, then it’s not particularly a stretch of the imagination to say that part of the reward for their laxity was money, and that is very clearly a violation of the FCPA,” Sklar said.

Officials at the SEC and the Justice Department had no immediate comment.

CLINICAL TRIALS MAY DRAW SCRUTINY

When the Justice Department and the SEC sent letters in April 2010 to several drug manufacturers including Lilly, Bristol-Myers Squibb Co. and AstraZeneca PLC in its foreign bribery probe of the industry, it requested information on countries like Brazil, China, Greece and Russia but did not include India in that list, people familiar with the matter said at the time.

Most of those investigations have focused on sales and marketing practices, people familiar with the investigations said, rather than the higher-level drug approval issues that were cited in India.

Some of those cases are wrapping up. Lilly disclosed last month it was in “advanced discussions” with the SEC to resolve foreign bribery issues in Poland and other countries.

Johnson & Johnson paid $70 million last year to resolve FCPA charges that its subsidiaries made improper payments to healthcare providers employed at state-run hospitals in countries like Greece and Iraq to induce them to purchase its medical devices and drugs.

The same factors have not been at work in India, where much of the booming medical market is privately run, and expensive, brand-name products are rarely purchased by public hospitals, the people said.

But the Justice Department has signaled its interest in examining possible corruption in the clinical trials process, said John Kelly, a former federal healthcare fraud prosecutor now in private practice at the law firm Bass, Berry & Sims.

“With clinical trials, you’re going to have constant interaction with either foreign officials or entities that are operated by government entities,” Kelly said. “If they weren’t (looking at it), they will be now.”

Novartis said on Thursday it would investigate the drug approval irregularities alleged in the report. Lilly said on Wednesday it “followed all appropriate regulatory processes required by the regulatory agency in India.”

(Reporting By Aruna Viswanatha; Editing by Steve Orlofsky)

  • Link this
  • Share this
  • Digg this
  • Email
  • Reprints


Read the original post
India drugs inquiry could prompt new U.S. scrutiny

:, , , , , , , , , , , ,

Related Article(s)

Preparation

Before operation, please inform us if there are any allergies or serious medical conditions. Also please inform us all medication that you are taking.

Please contact us if you need any pick up on your arrival at the airport. We can help you reserve the hotel room and other arrangement if necessary.

However please inform us your flight itinerary one week before your arrival.

Post Operative Care

- No doctor's fee if any corrections are required.
- All post-operative aftercare is provided without cost.

If you have any question please contact us.


Preis.

Bitte klicken Sie hier für den Kostenvoranschlag zu bitten.

Zahlung

Wir akzeptieren Überweisung, Kreditkarten und Bargeld. Für weitere Informationen über Zahlungsmethoden bitte kontaktieren Sie uns .

Flughafen Immigration and Customs.

Bitte legen Sie die Unterlagen zur Bestätigung der geplanten Operation auf Anfrage. Bitte tragen keine unnötigen Medikamente oder gefährliche Gegenstände in Ihrem Gepäck.     

Termin mit Surgeon.

Bitte klicken Sie hier. einen Termin vereinbaren oder kontaktieren Sie uns für weitere Informationen.

Die Preise für unseren Service bereits enthalten (falls nötig).

1. Praxisgebühr.

2. Beitrag Betrieb Gebühr.

3. Medikamente gegen Gebühr.

4. Krankenhausaufenthalt Gebühr (falls nötig).

5. Anästhesie-Gebühr.

6. Labortest Gebühr.

7. Kostenloser Abholservice von der Luft-Port / Hotel.

8. Kosten der OP.

9. Doktor Gebühr.

>> Hotels in der Nähe SP-Klinik.




Cosmatic Surgery Procedures
Bauchdeckenstraffung
Botox Injektion
Brow Lift
Bruststraffung
Brustvergrößerung
Chin Augmentation
Dauerhafte Haarentfernung
Doppel-Lidkorrektur
Face Lift
Fat Übertragung
Fettabsaugung mit Body Jet (Water Assisted)
Gesäß-Implantate mit hoher Kohäsivgel
Gesichtschirurgie
Haartransplantation
Labia Chirurgie
Lidkorrektur
Lip Reduction
LipoSelection durch Vaser
Lippenvergrößerung
Nose Augmentation – Fat Injection
Restylane Injektion
Rhinoplastik – Umformen
Sex Change, Geschlechtsumwandlung
Vagina Anziehen
Vaser High Definition Sculpting
Verkleinerung der männlichen Brust
Verkleinerung der männlichen Brust
 

 


Awarded by
WhatClinic.com
 

SP Clinic 1519/69-70 Ladproud 41/1 Samsennog Huaykuang Bangkok 10310, Thailand
Mobile Phone For English please call + 6681 9011 030
Tel. +662 9304450-5 Fax. +662 9399061
 
email: spsansiri@yahoo.com       drsompob@sp-cosmeticsurgery.net
 
Website Designed, and Developed by RedOnion Co.,Ltd.