Cipla stops sale of 2 AIDS drugs to WHO followed by removing those from the list

[Guest guest]

Dear FORUM,

" On May 27th 2004, the WHO removed two products from its prequalification list.

The products are two antiretroviral medicines manufactured by the Indian company

Cipla: lamivudine (3TC) 150 mg tablet (LAMIVIR®), and the fixed dose combination

lamivudine (3TC) 150mg/zidovudine (AZT) 300mg tablet (DUOVIR®) " "

For details please review the next posting on MSF briefing note. Details of WHO

pre-qualification process follows the news item [Moderator]

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Cipla stops sale of 2 AIDS drugs to UN: report 6/16/2004 3:20:38 PM IST

Cipla Ltd. has reportedly halted sales of two generic AIDS drugs to the

United Nations (UN) for distribution in poor nations after an

independent research on the two medicines was found to be inadequate.

It is the first time that WHO. has removed any HIV. drug from its list,

Lembit Rago, an official of the Geneva-based agency, said yesterday.

Cipla, India's No.3 company by sales, had got the approval to sell these

drugs in poor countries. The two drugs, Lamivudine and Zidovudine are

generic copies of GlaxoKline Plc's Epivir and Retrovir.

According to reports, the Mumbai-based pharmaceuticals major is

conducting its own clinical trials on the two drugs and would submit its

report by the end of July.

However, the problem is not expected to hurt WHO's initiative to treat

three million HIV-infected people, mostly in Africa, by next year.

http://www.indiainfoline.com/news/news.asp?dat=41561

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WHO Removes Two Generic Antiretroviral Drugs From List of Approved HIV/AIDS

Treatments [Jun 16, 2004]

A World Health Organization official on Tuesday said that the agency has

removed two generic antiretroviral drugs produced by Indian generic drug

manufacturer Cipla from its list of approved HIV treatments, the New York

Times reports. Dr. Lembit Rago, WHO's coordinator for quality assurance and

safety of medicines, said that Cipla's versions of lamivudine and zidovudine

were removed from the list because of problems detected during a routine

inspection of an independent laboratory that Cipla had hired to conduct

bioequivalence studies of the drugs. WHO routinely conducts inspections among

makers of drugs included on its list of medicines that are " acceptable for

procurement " by United Nations agencies, the Times reports (Altman/McNeil,

New York Times, 6/16). The WHO inspection found that the company's records

did not meet industry standards known as " Good Clinical Practices and Good

Laboratory Practices. " Following the inspection, the WHO Department of

Essential Drugs and Medicines Policy's Prequalification Project on May 27

removed from its approval list 150 mg tablets of lamivudine produced by Cipla

at a facility in Kurkumbh, India, and 150 mg lamivudine plus 300 mg

zidovudine tablets produced at Cipla's Vikhroli, India, facility (Access to

HIV/AIDS Drugs and Diagnostics of Acceptable Quality, 5/27). The

bioequivalency tests, which were conducted among volunteers whose blood had

been tested after receiving treatment with the two drugs, determine whether

the blood concentration of the generic drug is similar to the patented

version. Although the drugs were removed from the list of approved treatments

because of Cipla's poor documentation, they still may be bioequivalent to the

patented drugs, Rago said, the Times reports.

'On the Mend'

Cipla Chair Dr. Yusuf Hamied said that the removal of the drugs stemmed from

" inadequate record keeping in the testing laboratory, " according to the

Times. He added that the company's generic version of lamivudine had

undergone bioequivalency tests in a U.S. laboratory in anticipation of

applying to FDA to sell the drug when the U.S. patent expires in 2006,

according to the Times. Cipla said that the situation is " on the mend " and

that it expects to have the medicines relisted with WHO within a few weeks,

the Times reports. Rago said that delisting the two medicines would not

affect WHO's 3 by 5 Initiative to treat three million people with

antiretroviral drugs by 2005, the Times reports (New York Times, 6/16).

Hudson Institute Senior Fellow Carol Adelman, adjunct fellow Norris

and research assistant Weicher said in a statement that WHO should " be

applauded for taking these responsible steps on behalf of AIDS patients "

because " [d]eficient products can catalyze a serious public health concern

specifically by promoting HIV resistance. " They added that WHO should " use

this delisting experience to develop recall procedures for the products it

had prequalified whenever that becomes necessary, " saying that the agency

could " reevaluate its entire prequalification program " (Hudson Institute

release, 6/15).

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=24230

<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=24230>

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WHO Fact Sheet: " PREQUALIFICATION PROJECT: Ensuring the Quality, Safety

and Efficacy of HIV/AIDS Medicines and Diagnostics "

http://mednet3.who.int/prequal/documents/Prequal-one-pager.pdf

WHO Brochure: " Prequalifying Priority Medicines " :

http://mednet3.who.int/prequal/documents/prequal_brochure.pdf

WHO Requirements specified for generic medicines: " Guide on Requirements

for Documentation of Quality For Pharmaceutical Products Related to

HIV and AIDS " :

http://mednet3.who.int/prequal/hiv/generic_hiv.pdf

WHO Fixed dose combinations for HIV/AIDS, Tuberculosis, and Malaria:

Current status and future challenges from clinical, regulatory,

intellectual property, and production perspectives, " Geneva, 16-18

December 2003.

http://www.healthgap.org/press_releases/04/WHOFDCSUMMARYfinal.pdf

The website of the WHO Pre-qualification Project is:

http://mednet3.who.int/prequal/default.shtml