Former US president Bill Clinton has roped in four Indian and two Chinese pharmaceutical firms to cut the price of anti-malarial drugs by a whopping 30 per cent, which is likely to benefit 500 million people worldwide.

The firms have also agreed to lower the price volatility of artemisinin, the key raw material for artemisinin-based combination therapy (ACT), by 70 per cent, said Clinton, whose charitable foundation helped broker the deal.

Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.

Congressmen John Dingell and Bart Stupak have said the ongoing FDA-Ranbaxy row over alleged supply of "fraudulently approved and manufactured" medicines by Ranbaxy in the US should be seen in the larger context.

Dingell is chairman of the energy and commerce committee, which oversees the FDA, while Stupak chairs its oversight and investigations subcommittee.

P B Jayakumar / Mumbai July 19, 2008, 0:40 IST

Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.

HIT hard by mounting scrutiny and falling stocks, Ranbaxy CEO and MD Malvinder Singh said a big global pharma company was trying to scuttle the deal with Daiichi Sankyo. "This is part of a larger game of a global innovater company to block low-cost generic drugs,'' he said.

Ranbaxy Laboratories, the leading Indian pharmaceutical firm, has been in the eye of a storm over allegations by US federal investigators about the manufacturing practices followed at its Paonta Sahib plant in Himachal Pradesh. The plant has what is considered the most prestigious certificate in the world for such an operation, an approval from the Food and Drug Administration of the US.

Pb Jayakumar / Mumbai July 18, 2008, 0:41 IST

Indoco Remedies, a leading Mumbai-based generic drug maker, is planning to launch about 40 drugs in the domestic market within a year. Also, they are forming a new marketing division targeting gynaecologists and paediatricians.

After rising 15 per cent Wednesday, the Ranbaxy stock resumed its downward journey on reports in the US media that a US Congressional Committee will examine Ranbaxy's drug approvals in the US and potential violations of manufacturing regulations.

The committee will also scrutinise the US drug regulator Food and Drug Administration's (FDA's) role in approving products of the Indian drug major.

AUS Congressional Committee is launching an investigation into whether US Food and Drug Administration (FDA) was lenient in allowing Ranbaxy to sell new drugs in the US market when it was still investigating discrepancies at the Indian pharma major's manufacturing facility in India. The committee will also examine whether the USFDA took timely action against Ranbaxy.

The Ranbaxy sale to Daiichi Sankyo could herald a new phase in the evolution of the Indain pharmaceutical industry. In order to cope in a world after the agreement on Trade-related Aspects of Intellectual Property Rights came into force, some of the larger Indian firms pursued the two strategies of a greater internationalisation of sales of generic drugs and a focus on research and development as junior partners of global giants. Ranbaxy had mixed success with the two strategies.

THE hurdles that pharmaceutical companies face in accessing global markets may now ease. The drug regulator's office is likely to extend the tenure of export licence and other approvals from one year to at least three years. The move is expected to help many pharma companies that export huge quantities by reducing compliance cost.

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