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P.T. Jyothi Datta
C.R. Sukumar

Mumbai/Hyderabad , Nov. 19

ANOTHER week came to a close, but not on a happy note for a clutch of Indian drug companies which felt the heat for different reasons.

The Hyderabad-based Hetero Drugs has withdrawn all six of its antiretroviral drugs (anti-AIDS medicines) from the World Health Organisation's (WHO) list of approved drugs following concerns over its laboratory tests, according to agency reports quoting the WHO.

``There are certainly major concerns about the lab testing, about the quality of it, about the situation that has been found by these (WHO) inspections,'' the report from Geneva said, quoting a WHO spokesperson.

Hetero's experience comes close on the heels of a similar development with Ranbaxy earlier this month. Earlier this year, Cipla and Ranbaxy had a clutch of its anti-AIDS drugs dropped from the WHO's pre-qualification list.

An official dealing with regulatory issues in the Union Health Ministry told Business Line that the issue needed to be examined. "The qualification criteria of the WHO may be different from that of the Government. The quality of the drugs do not seem to be in question, it may be a case of different benchmarks," the official said.

5 more drugs under US scrutiny: Meanwhile, in the aftermath of the global recall of the painkiller drug Vioxx by Merck, US regulatory authorities have singled out five more drugs for close scrutiny.

The drugs are: GlaxoSmithKline's (GSK) asthma drug Serevent, Pfizer's painkiller Bextra, Abbott Laboratories' Meridia for obesity, Roche AG's Accutane for acne and AstraZeneca Plc's cholesterol-lowering pill Crestor. The five drugs have all been linked to risks of rare but serious side effects, and safer options generally exist for patients, according to a report quoting a Food and Drug Administration scientist.

The environment becomes that much more piquant in the Indian context, with all the mentioned drugs have a bevy of clones.

Analysts tracking the sector told Business Line: "Generic or chemically-similar versions of GSK's Serevent are produced by Cipla and Kopran in the local market. Cholestrol drug Crestor's clones are made by Torrent, Nicholas Piramal India Ltd (NPIL) and Unichem and obesity drug Meridia finds similar versions from Glenmark. Ranbaxy launched an Accutane-clone in the US last year, but it does not sell the drug in the domestic market. "

The spotlight on Bextra or Pfizer's painkiller brand of Valdecoxib brings in some serious worry for a host of Indian companies, including Ranbaxy, NPIL, Unichem, IPCA, Cipla, Torrent, Ajanta, Glenmark etc. "All these companies make similar versions of Valdecoxib, which belongs to the family of Cox II inhibitors. This class of drugs have come under a cloud after the Vioxx or Rofecoxib recall."

The weekend also saw news on another drug major, Dr Reddy's Laboratories (DRL), reportedly facing criminal prosecution in Russia, for not sticking to an investment programme.

A senior DRL official said: "We cannot comment on the issue immediately without ascertaining the facts. We are yet to receive communication from the Russian authorities."

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