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
21 Jul
TOPO
Kurshop -  Der findes tusinder af Biotekfirmaer i verden som du kan gå ud og investerer i ! Hvad er ..
17
23 Jul
VWS
Jeg sidder og graver mig ind i dette lille interessante skriv:   http://www.power-technology.com/new..
15
20 Jul
VELO
Sidder ig gennemlaser tidligere traade og samler her lidt op og vil komme med betragtninger for den ..
13
18 Jul
VWS
Pokerchamp - Du er da gået helt fra koncepterne. Din angreb på meddebatørene er da røget helt ud i h..
12
23 Jul
PNDORA
Det er helt naturligt, at aktiekursen på et selskab, som er steget meget, svinger kraftigt forud for..
10
18 Jul
VWS
sku vi prøve med en afstemning,ang hvem der er mest ude i hampen Alle dem der hellre vil tro på good..
9
22 Jul
VWS
Mon dette forum og skribenterne mon nogensinde bliver så voksent, at vi er undgår dette evindelige b..
8
21 Jul
E:VWS
Du kan da umuligt fjerne kernemedarbejdere med 10-30 års erfaring når de ikke engang har haft fabrik..
8
18 Jul
GEN
Skønt - det må være det brede fase Ib studie der afføder disse fase III studier:   http://www.clinic..
8
11:23
OMXN40
Det bliver/er hverdagskost i alle europæiske lande inden længe.. Men tankevækkende, at terrortruslen..
7

Tech Companies Send Criticism Along With NSA-Related Data -- Update

04/02/2014 00:06:00
By Danny Yadron Technology companies including Google Inc. and Microsoft Corp. released new figures on the amount of data requests they received from U.S. ..

U.S. Hot Stocks: Hot Stocks to Watch

03/02/2014 14:07:00
Among the companies with shares expected to actively trade in Monday's session is Herbalife Ltd. (HLF). Herbalife Ltd. (HLF) raised its fourth-quarter outl..

Pfizer Study Meets Primary Endpoints

03/02/2014 13:05:00
Pfizer Inc. (PFE) said Monday that a Phase 2 trial of its advanced breast cancer treatment met its primary endpoint. Pfizer said a study comparing the effec..

Most read news

  • 24 hours
  • 48 hours
  • 1 week
1
Cliffs Natural Resources Inc. Reports Continued Capital Spending Reduction and Cost Improvements in Its Second-Quarter 2014 Results
2
Zacks Small-Cap Research Updates Coverage on Northstar Healthcare (TSX:NHC) with an Outperform Rating - Video Research Alert on InvestmentPitch.com
3
ASM INTERNATIONAL N.V. REPORTS SECOND QUARTER 2014 RESULTS
4
ADVA Optical Networking Reports Q2 2014 Financial Results In Line with Guidance
5
Bombardier Announces New Organizational Structure
Euroinvestor around the globe: Euroinvestor.dk | Euroinvestor.se | Euroinvestor.no | Euroinvestor.fr | Forexinvestor.com| Wisselkoersen.nl | Valuta.se | Valutaveksel.no | Divisas.es | Valute.it
Copyright Euroinvestor A/S 2014   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.
 
24 July 2014 13:59:42
(UTC) Dublin, Edinburgh, Lisbon, London
Version: LiveBranchBuild_20140723.1 - EUROWEB1 - 2014-07-24 14:59:42 - 2014-07-24 13:59:42 - 1000 - Website: OKAY