Hetero Drugs Limited withdraws AIDS drugs from WHO certification

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Indian firm withdraws AIDS drugs from WHO certification

Press Trust of India

New York, November 20

Hyderabad-based Hetero Drugs Limited has become the

second Indian pharmaceutical company after Ranbaxy to

withdraw its anti-AIDS drugs from special World Health

Organisation certification, saying it is not certain

about their bioequivalence with patented medicines.

The company, which is withdrawing generic versions of

six antiretroviral drugs from the WHO's approved list

of drugs for treatment of HIV/AIDS, told the UN health

agency that the " centres " it had used for studies of

bioequivalence were " incompatible with the current

standards " and that there were " deficiencies " in the

date submitted for the studies done, the WHO said.

Last week Ranbaxy had withdrawn its generic drugs for

HIV/AIDS for similar reasons.

Hetero evaluated the Contract Research Organisations

(CROs) it had used after receiving a warning letter

sent by WHO to all manufacturers earlier this year,

and found them non-compliant with international

standards of Good Clinical Practice and Good

Laboratory Practice, the WHO said.

Hetero Drugs has committed to contact different CROs

and submit new test results for the bioequivalence of

the six medicines as soon as possible.

" Our findings, and the companies' admission of

responsibility by withdrawing their products, show

that CRO inspections are necessary, " said Lembit Rago,

Coordinator of Quality, Safety and Efficacy of

Medicines at the WHO.

" Current WHO procedures are ultimately improving

medicines monitoring mechanisms which will, in the

long term, ensure better quality treatment for

patients. "

http://www.hindustantimes.com/news/181_1113719,00050001.htm