[Ip-health] Hindu Business Line: Cipla re-submits data to WHO

[Jordan]

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[ Picked text/plain from multipart/alternative ]

This is a great step towards ensuring that the AIDS drugs are safe and effe=
ctive for thousands of patients around the world.



Jordan





Hindu Business Line

Anti-AIDS drug: Cipla re-submits data to WHO

P.T. Jyothi Datta

Mumbai , Aug. 13



Drug company Cipla has submitted the bio-equivalence data for its anti-AIDS=
 drug Lamivudine to the World Health Organisation (WHO), Geneva. Lamivudine=
 is one of the two drugs from Cipla that was dropped from the WHO pre-quali=
fication list in June this year.



In submitting the data, Cipla may help dull some of the intense internation=
al glare that Indian anti-AIDS drugs have been facing in recent times, acco=
rding to industry-watchers. Only last week, three of Ranbaxy's anti-AIDS dr=
ugs were dropped from the WHO pre-qualification list.



"We have submitted the bio-equivalence data for one of our drugs (Lamivudin=
e) to the WHO, Geneva. Similar data for the other drug dropped from the WHO=
 list, (Lamivudine 150 mg plus Zidovudine 300 mg tablet) is likely to be su=
bmitted by mid-September," Mr Amar Lulla, Joint Managing Director of Cipla,=
 told Business Line.



Whether the drug gets re-listed or not by the WHO would depend on the outco=
me of the processing of the bio-equivalence data supplied by Cipla. However=
, Mr Lulla added that the whole episode was unlikely to dent its sales.



A WHO pre-qualification list acts as a safety endorsement of sorts, guiding=
 the procurement policy for UN agencies and governments that look to buy me=
dicines for its people. Bio-equivalence tests help establish that the gener=
ic drug is chemically equivalent to the original branded products, which in=
 this case belong to GlaxoSmithKline.



Cipla's anti-retroviral (ARV) or anti-AIDS drugs =97 Lamivudine 150mg table=
t and Lamivudine 150mg plus Zidovudine 300mg tablet =97 had been dropped fr=
om the WHO pre-qualification list on grounds of "inadequate bio-equivalence=
 data."



The WHO communiqu=E9 had, however, pointed out that the contract research o=
rganisation (CRO), engaged by Cipla to do the bio-equivalence studies, had =
not complied with good laboratory practices (GLP). Cipla's medicines were "=
still compliant with quality standards," the note had said.



Meanwhile, the whole episode has generated a heated debate internationally =
on the quality of Indian anti-AIDS drugs. Organisations that claim to be wo=
rking in the health sector have been demanding a reassurance from Cipla and=
 Ranbaxy on the fate of patients who have consumed the drugs that have now =
been dropped from WHO's list.



This week saw a joint representation from The Treatment Action Campaign (TA=
C) and Medecins Sans Frontieres (MSF) urging Cipla to address their concern=
s on its drugs.



Another interesting communication, received here on Friday, was from the Sw=
eden-based "think-tank" Eudoxa that called for the "WHO director and senior=
 leadership to step down after recent AIDS drug scandals."



"Last week's decision by the World Health Organisation to remove three Indi=
an-made generic AIDS drugs from the list of approved medicines underscores =
the need for new and responsible leadership at the helm of what should be t=
he world's preeminent health agency," the Eudoxa communication said.



Responding to some of these concerns, Cipla's Mr Lulla said that the safety=
 and efficacy of Cipla's drugs had never been in question, it was only a do=
cumentation-related issue.



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