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Thursday, Nov 11, 2004

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Drug withdrawal may impact generic cos

P.T. Jyothi Datta

Mumbai , Nov. 10

DRUG major Ranbaxy Laboratories Ltd has informed the World Health Organisation (WHO) that it was voluntarily withdrawing all its anti-AIDS drugs from the UN agency's pre-qualification list.

The announcement breaking in the country late on Tuesday night is one in a string of similar developments regarding anti-AIDS drugs from the Ranbaxy stable.

The recent development is an image setback for a company like Ranbaxy which has in the past taken the battle of generic, or chemically similar drugs, right into the backyard of its global competitors, according to industry watchers. Further, they cautioned, global repercussions are likely to be felt by the entire Indian generic industry, with questions now being raised more frequently on the quality and credibility of their drugs.

According to the WHO communiqué from Geneva, Ranbaxy was voluntarily withdrawing all its anti-retrovirals (anti-AIDS drugs) from the WHO pre-qualification list since "the company found discrepancies in the documentation relating to proof of the products' bioequivalence with originator medicines."

Further, the note said Ranbaxy intended to submit new study reports on these products. The first study was expected to be completed by December 2004.

Ranbaxy spokesperson told Business Line that there were no issues with the regard to the safety and efficacy of these drugs. "There were anomalies in data handling and issues regarding the good clinical practices and good manufacturing practices (GMP). We have changed the contract research organisation (CRO) doing the bio-equivalence studies. By March 2005, we expect to complete the studies for all the anti-retroviral (ARV) drugs. The patients' interest is foremost and no doubts should be there on the drugs, which is why we are doing the whole exercise again," he said.

"There will be little impact to the topline or bottomline of our company, as there are small margins in this business. It is more a social responsibility for us," he added.

In August, WHO had dropped three other ARV medicines from Ranbaxy and prior to that, two of Cipla's ARVs from the pre-qualified list.

The blame, in both the cases, was laid at the doorstep of the CROs that did the bio-equivalence test for the companies. Subsequently, in October, Ranbaxy also withdrew some ARVs from the South African market. A WHO pre-qualification acts as an endorsement of sorts for a drug.

Countries looking to procure a certain drug can take guidance from this list, as safety and efficacy are assumed to be established.

Currently, there remain 89 products on the WHO list, 54 of which are ARVs for the treatment of HIV/AIDS.

Ranbaxy has also been on prestigious programmes such as the Clinton Foundation's campaign for affordable AIDS drugs.

"We are in touch with all agencies. As for other global markets, we are open to anything. We will deal with every country as per their laws," said the Ranbaxy spokesperson.

Industry watchers, however, feared that Ranbaxy may have to opt out of such programmes.

Withdrawn drugs: The seven pre-qualified medicines Ranbaxy is withdrawing are Indinavir 400-mg capsule, blister (60, 100); Lamivudine 150-mg tablet, blister (60, 100); Lamivudine/Stavudine 150-mg/40-mg tablet, Al strip (10), 60 in box; Lamivudine/Stavudine 150 mg/30 mg tablet, Al strip (10), 60 in box; Nevirapine 200 mg tablet, blister (60, 100); Stavudine 30 mg capsule, Al strip (10), 60 in box; Zidovudine 300 mg tablet, blister (60, 100)

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