11/07/2013 18:45:00

U.K. Recalls Drugs Made in India

LONDON--In another sign of possible manufacturing problems in India's pharmaceutical industry, the U.K.'s medicines regulator said it was recalling 16 drugs made by Wockhardt Ltd. (532300.BY) after finding "manufacturing deficiencies" at one of the company's factories in India.

The Medicines and Healthcare products Regulatory Agency, or MHRA, called it a "precautionary recall," as there is no evidence that the medicines are defective. The agency said it is recalling the drugs from pharmacies and wholesalers but isn't asking patients to return their Wockhardt medicines.

"There is no evidence of a patient safety risk. ...however, the MHRA has to act in the interest of public health as poor manufacturing standards cannot be allowed to continue," the agency said.

The recalled drugs, manufactured in the central Indian city of Waluj, include treatments for infections, hypertension, diabetes, epilepsy and other diseases. The MHRA said the plant suffered from "poor cleaning practices" and defective ventilation systems. The agency inspection also found evidence of "forged documents relating to staff training records."

In an emailed statement, Wockhardt confirmed the news and said the recall would result in a one-time charge of 1.5 million pounds ($2.25 million) this year. Exports from the Waluj plant constitute less than 5% of the company's total U.K. sales and less than 2% of overall sales, it added.

It was the second recent setback for the company and its Waluj factory. In May, the U.S. Food and Drug Administration imposed an import ban on products from the factory after it failed an FDA safety inspection. The FDA didn't elaborate on the problems it found.

In a conference call at the time, Wockhardt Chairman Habil Khorakiwala said the company was implementing "corrective measures to be in compliance with the FDA guidelines." He said the U.S. import ban could cost the company $100 million in revenue this fiscal year. Wockhardt generated total revenue of 25.6 billion rupees ($460.6 million) in the year ended March 31, 2012.

Also in May, India's Ranbaxy Laboratories Ltd. (500359.BY) agreed to pay $500 million in civil and criminal fines for exporting adulterated drugs to the U.S.

In a phone interview Thursday, D.G. Shah, secretary-general of the Indian Pharmaceutical Alliance, an industry body, said the group has written to the FDA asking it to conduct workshops with Indian companies to correct erroneous practices.

"Companies need to better understand FDA processes, and there needs to be a correction in their organizational culture, right from drug discovery to development and production," Mr. Shah said.

Write to Jeanne Whalen at jeanne.whalen@wsj.com and Anirban Chowdhury at anirban.chowdhury@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

(END) Dow Jones Newswires

July 11, 2013 13:45 ET (17:45 GMT)

Copyright (c) 2013 Dow Jones & Company, Inc.

Post comment

Related debate

  • 1 week
  • 1 month
  • 1 Year
04 May
 
- 6212 var henne i "VORES ALLES BANK" for at hæve lidt til den forlængede weekend og kunne ikke nære..
32
04 May
EI
Vi har nu fået rettet topbanneret til, så siden ikke springer op eller ned mere.    Hvis i mod forve..
26
30 Apr
OMXC20CAP
Sell in may, and go ...   Det er blevet tid til en mindre opdatering. Jeg har været bortrejst, og sa..
23
04 May
NOVO-B
Lad os tage Fremtidige produkter (pipeline) i alfabetisk orden:   Fiasp godkendes ultimo 2016 i USA ..
22
03 May
C:PWTIUSDBR\SP
Der er vigtige tests på vej. Lad os se på dem!   Men først lige et ord om olien.   OLIE     Den dril..
21
03 May
BAVA
Nu svarer jeg lige på hovedtråden, i stedet for under alle de forskellige indlæg.   hvis i ellers læ..
21
28 Apr
BAVA
Så fik jeg pløjet data ind i et excelark, og her er konklussionerne:   data kommer fra et forsøg, hv..
18
04 May
EXQ
Godmorgen Jeg har modtaget nedenstående referat fra Lars Kongsbak af de spørgmål og svar som var opp..
15
03 May
FING-B
Jo, lidt naivt da LG allerede havde et sammenarbejde med FPC, men du lagde op til at LG havde måske ..
13
01 May
BAVA
Bavarian bliver ikke opkøbt. Stop nu med jeres drømme og løgne og bilde folk dette ind. Hvornår har ..
13

Corona Extra Starts New Cinco de Mayo Tradition With the First Nationwide #LimeDrop

05/05/2016 14:15:25
Actor Diego Boneta partners with the number one imported beer in the United States to encourage fans to share photos of their best #LimeDrop CHICAG..

Alliance Trust PLC : Net Asset Value(s)

05/05/2016 13:31:29
ALLIANCE TRUST PLC At the close of business on Wednesday 4 May 2016, the unaudited net asset value per ordinary share of 2.5p, valued on a bid price ba..

Majedie Asset Management Ltd : Form 8.3 - VECTURA GROUP PLC

05/05/2016 10:40:51
FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTI..

Most read news

  • 24 hours
  • 48 hours
  • 1 week
1
MURPHY OIL CORPORATION ANNOUNCES PRELIMINARY FIRST QUARTER 2016 FINANCIAL AND OPERATING RESULTS
2
TESORO LOGISTICS LP REPORTS FIRST QUARTER 2016 RESULTS
3
Transocean Ltd. Reports First Quarter 2016 Results
4
BLACKPEARL ANNOUNCES FIRST QUARTER 2016 FINANCIAL AND OPERATING RESULTS
5
SWM ANNOUNCES FIRST QUARTER 2016 RESULTS

Buy and sell signals

  • Trend
  • Moneymachine

Copyright Euroinvestor A/S 2016   Disclaimer and Terms of Use
Quote information is delivered by Interactive Data.
Data is delayed 15-20 minutes according to the distribution agreements set by the different exchanges.
 
05 May 2016 17:13:30
(UTC) Dublin, Edinburgh, Lisbon, London
Version: LiveBranchBuild_20160502.2 - EUROWEB7 - 2016-05-05 18:13:30 - 2016-05-05 17:13:30 - 1000 - Website: OKAY