Regulatory actions against Ranbaxy Laboratories Ltd.
Dear Therapeutic Goods Administration,
I am requesting information regarding Ranbaxy Laboratories Ltd. and its international subsidiaries, under the Freedom of Information Act.
I am requesting any of the following from between 01 January 2014 and today, 28 October 2014, regarding Ranbaxy Laboratories Ltd and its international subsidiaries:
- Any Internal Communications, including emails and letters, regarding the regulatory actions of and results of inspections undertaken by the Food and Drugs Administration or Health Canada of facilities owned and/ or managed by Ranbaxy and its subsidiaries,
- Internal Communications, including emails and letters, regarding the safety of pharmaceuticals produced by Ranbaxy and its subsidiaries which have previously received regulatory approval
I look forward to hearing from you soon either way.
Yours faithfully,
Kristof Wing
Attention: Kristof Wing
Please see attached correspondence in relation to your FOI request to the
Department of Health.
Kind regards
FOI Officer
Information Law Section| Legal Services Branch
Department of Health
Phone: (02) 6289 1718
GPO Box 9848, Canberra ACT 2601 | MDP 350
Dear Mr Wing
Please find attached correspondence relating to your Freedom of
Information request 091-1415.
Please do not hesitate to contact me if you have any queries.
Kind regards
Liz
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image003.gif@01CFA69C.488B9550
References
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1. mailto:[email address]
Our reference: RQ14/02784
Agency reference: FOI 091-1415
Mr Kristof Wing
Dear Mr Wing
Extension of time request under s15AB
On 27 November 2014, the Therapeutic Goods Administration (TGA) requested
further time to make a decision on your FOI request of 28 October 2014.
This request was on the basis that the processing period is insufficient
to deal adequately with your request, because it is complex and/or
voluminous.
The Information Commissioner has decided to grant the TGA an extension of
time of 14 days for this request, to 11 December 2014. This decision has
been made under s15AB(2) of the Freedom of Information Act 1982 (Cth) (the
Act).
Review rights
If you are unhappy with the way we have handled this matter, you may
complain to the Commonwealth Ombudsman. This service is free, and you can
contact the office on 1300 362 072 or visit [1]www.ombudsman.gov.au.
If you would like to discuss this matter you may contact me on 02 9284
9731 or via email [2][email address].
Yours sincerely
Timothy Fleming| Investigations Officer
Office of the Australian Information Commissioner
Level 3, 175 Pitt Street, Sydney NSW 2000
GPO Box 5218 Sydney NSW 2001 |www.oaic.gov.au
Phone: +61 2 9284 9731
Fax: +61 2 9284 9666
Email: [email address]
Please note: The Australian Government has introduced a Bill into
Parliament to abolish the OAIC on 31 December 2014. From 1 January 2015
privacy matters will be handled by the Australian Privacy Commissioner.
For more information about how the OAIC will handle FOI and privacy
matters until 31 December 2014 please see our [3]website.
Protecting information rights – advancing information policy
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References
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1. http://www.ombudsman.gov.au/
2. mailto:[email address]
3. http://www.oaic.gov.au/news-and-events/s...
Dear Mr Wing,
Please find attached correspondence relating to your Freedom of
Information request 091-1415 received 28 October 2014.
Kind regards
Emily
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Anna Theodore 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
References
Visible links
1. mailto:[email address]
Kristof Wing left an annotation ()
So, for some background, here's an article from Pharmacy News (part of the Cirrus Media Group which publishes Australian Doctor): http://www.pharmacynews.com.au/news/late...
The TL;DR is that Ranbaxy's overseas plants (including some in Ghana and India) were falsifying the results of quality tests, and were not following Good Manufacturing Practices (GMP).
An inspection by the FDA revealed this, and importation of the raw pharmaceutical ingredients to the US was halted - there have been no statements by the TGA on the matter, as far as I can tell (there are no media releases, etc.).
A full list of Ranbaxy's products marketed in Australia, is available here: http://www.ranbaxy.com/australia/product...