San Francisco Chronicle - July 7, 2004
Sabin Russell, srussell@sfchronicle.com.

A combination of three antiviral drugs that would sell in the United States for about $12,000 a year, Triomune is vastly cheaper because its maker, Cipla Ltd., ignores the international patents owned by the giant U.S. and European pharmaceuticals firms that brought the three medicines to market.

Pirated copies of AIDS drugs are illegal to sell in the United States, but under rules hammered out during years of contentious debate, they may be sold to poor nations. The World Health Organization in June endorsed Triomune for its "3-by-5" program, which aims to put 3 million AIDS patients in poor countries on antiretroviral drugs by 2005.

India has been slow to provide the drugs to its population. A government plan to provide them free to 100,000 AIDS patients was launched in April, but only a few hundred have been enrolled thus far.

At its plant in Patalganga, in an industrial zone east of Bombay, 750 miles southwest of New Delhi, Cipla stamps out 4 million Triomune pills per month, selling them for about 30 cents each.

Just outside the factory gates, another India co-exists in the shadow of the drug plant and of the neighboring petrochemical factories. Cows, held sacred in India, and the occasional pig wander across the asphalt. Women walk balancing jugs of water on their heads for their homes, which for many is a sheet-metal-roofed shack.

It would take a fifty-fold increase in production to meet the WHO's 3-by- 5 goal. Nevertheless, Cipla managers said that they and other generic drugmakers could do it.

"Overnight!" insisted Muku K. Hamied, director of domestic operations in Bombay, and brother of Yusuf Hamied, Cipla's London-based chairman.

"The more important issue," said Muku Hamied, "is whether governments have the commitment of resources. Will the rich nations help out?"

Cipla's Patalganga plant is one of 22 factories it has in India. Ingredients for Triomune arrive at the loading dock in large, plastic blue barrels, shipped from bulk chemical suppliers in Japan, China and elsewhere in India. The plant itself operates like a high-tech bakery. Under sterile conditions in air-locked rooms under strict temperature and pressure controls, Triomune's components are sifted, measured and blended in giant, stainless steel containers into a doughy mass. The drug preparation is dried, worked into granules and mixed with lubricants and binding agents.

Then the mixture is precisely measured into the revolving cylinders of the pill press, which can stamp out 2,000 pills per minute. Each pill is passed through a metal detector, to spot microscopic contaminants. The newly minted pills are sprayed with a polymer coating to seal in odors and protect them from humidity.

Highly automated packing equipment loads 30 Triomune pills into a plastic bottle, each of which is sealed and boxed for shipment by workers wearing surgical gowns.

"There is no scarcity of technical staff, no scarcity of raw materials," said P.P. Deshpande, production manager at Patalganga. "The capacity of this plant is for 100 million tablets, of all kinds, per year."

Cipla executives say the only thing holding back production is the political will on the part of wealthy nations to pay for it. The Bush administration, however, has cited quality concerns, refusing to accept the WHO process that cleared Triomune.

A study in the July 3 issue of the British journal The Lancet found that Triomune was "at least as good" at knocking down the AIDS virus and boosting infection-fighting CD4 blood cells as the Western-made cocktails.

"There is no question about the safety and efficacy of generic antiretrovirals," said Dr. N. Kumarasamy, who has cared for more than 6,000 AIDS patients since 1994 at the Y.R.G. CARE clinic in Madras, on India's southeast coast.

U.S. Health and Human Services Secretary Tommy Thompson, under pressure to buy the lower-cost Indian drugs for the president's $15 billion overseas AIDS initiative, announced in May a "fast track" Food and Drug Administration approval for copied drugs. If the FDA determines that they are as safe and effective as the original patented products, they can be approved in a matter of weeks. None of the four Indian companies making these copied medicines has won approval, and the FDA will not confirm that any have even applied.

Meanwhile, Cipla has run into trouble over bioequivalence for two other AIDS drugs previously approved by the WHO. In late June, the U.N. agency abruptly delisted the drugs, finding inadequate written proof that the pills were equivalent to the patented, brand-name pharmaceuticals they are meant to copy.

Cipla executives insist that the pills meet the WHO standard and that the problem lies with paperwork at an independent firm that conducted bioequivalence studies. Cipla pledged to repeat the studies by the end of this month.

"We believe the issue will be resolved shortly," said Amar Lulla, Cipla's managing director.

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