Ranbaxy ends tie up in clinical research

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Ranbaxy ends tie up in clinical research

Khozem Merchant / Mumbai November 12, 2004

Ranbaxy Laboratories, India's biggest pharmaceuticals company, has

ended its partnership with a clinical research organisation whose data

for Ranbaxy's generic anti-Aids drugs raised doubts about the

authenticity of the medicines.

This week it emerged that Ranbaxy had withdrawn all of its

antiretroviral drugs from a list of HIV treatments approved by the

World Health Organisation, which said Ranbaxy had found

" discrepancies " in the data, suggesting that its generic drugs might

not be exact copies of patented originals.

Ranbaxy yesterday said that it would submit fresh dossiers to the WHO

prepared by a contract research organisation from outside India. The

first clinical tests had been outsourced to a contract research

organisation in India. Lembit Rago, head of medicines policy and

safety at WHO, said there was no evidence that Ranbaxy's HIV

treatments were unsafe or ineffective.

" Lack of evidence that they are bioequivalent to the branded products

does not mean we have evidence that they are not bioequivalent, " he

said. However, the rapid expansion of India's clinical research

organisation (CRO) industry in recent years had outpaced the ability

of companies to guarantee the quality of the research. " We are quite

pleased to see the Indian government has tightened the control of

CROs, " he said.

This is the second such recent blow for Ranbaxy. Germany's Schwarz

Pharma last week abandoned phase two trials of Ranbaxy's molecule to

treat prostate illnesses " due to unclear pre-clinical findings " .

Ranbaxy licensed the molecule to Schwarz Pharma in 2002 and has

received $10.3m in milestone payments. Ranbaxy is now conducting phase

two trials of the molecule in India.

The WHO withdrew three Ranbaxy antiretroviral drugs from its list of

prequalified products in August and two similar treatments by Cipla,

another Indian drugs company, because of concern about the

authenticity of data on their safety.

The organisation's action against the two companies highlights concern

about the quality of low-cost drugs manufactured in countries such as

India, where widespread bio-medical skills has given rise to a

thriving $5bn export-focused pharmaceuticals industry.

Growing downward pressure on the price of generic drugs has hit

Ranbaxy, whose sales for the first nine months of 2004 grew 4 per

cent. In 2003, Ranbaxy's sales totalled Rs 4,460 crore ($1bn) and,

according to analysts, the company is set to improve the performance

by 14 per cent for 2004.

Additional reporting by Firn

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