The Hindu Business Line : WHO strikes at Ranbaxy now

MARCH 2004: A US-initiated conference in Botswana puts 3-in-1 anti-AIDS pills, like the ones made by Cipla and Ranbaxy, under the scanner on grounds of safety and efficacy.

June 2004: Two of Cipla's anti-AIDS drugs are dropped from the World Health Organisation (WHO) pre-qualification list, which facilitates selling to United Nations agencies.

August 2004: Three of Ranbaxy's anti-AIDS drugs dropped from the WHO pre-qualification list.

The uncanny fashion in which the tale unfolds has left industry representatives and analysts perplexed on whether the recurring hit to Indian companies is pure coincidence.

The incident per se is unlikely to dent the company's kitty, the industry representatives said. However, they worry that the global image of Indian drug companies will certainly take a knock.

Both Ranbaxy and Cipla make 3-in-1 pills or fixed doze combinations and at the Botswana meeting, representatives of the Indian government were out there endorsing that these drugs were technically sound.

In the recent Ranbaxy case, as was the case with Cipla too, the blame has been squarely laid at the doorstep of the contract research organisation (CRO) that conducted the bio-equivalence studies for both companies, respectively.

sources said the two CROs were different: Cipla's was in Mumbai and Ranbaxy's in Hyderabad. However, they admit that blaming the CROs does not absolve the companies of responsibility to churn out quality data and efficacious products.

The representatives now hope that the resubmission of data by the companies to the WHO has a positive outcome, to undo any negative impact it has had on the image of the domestic drug industry, timing notwithstanding.

Company initiates follow-up

RANBAXY Laboratories Ltd on Thursday said that it has already initiated new bio-equivalence studies of its anti-retroviral drugs (ARVs) or anti AIDS drugs. This comes after an audit carried out recently by the World Health Organisation (WHO), on an independent contract research organisation (CRO) in India, indicated certain anomalies in data handling and non-compliance with good clinical and laboratory practices relating to the bio-equivalence studies.

The CRO had conducted bio-equivalence studies on three of Ranbaxy's ARVs. "While these anomalies are being investigated, all further outsourcing work to this CRO has been suspended by Ranbaxy," said a company statement.

The company further reiterated that its products are manufactured at world class facilities that are routinely inspected and approved by the WHO-Geneva for compliance to good manufacturing practices (GMP) and meet all required quality standards and specifications.

It further said that the ARVS including fixed dose combinations have been extensively used since 2001, and have been available in more than 40 countries.

More Stories on : Pharmaceuticals | Standards & Benchmarks | Health

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page