American Foundation for AIDS Research, June 2002
Anne-christine d'Adesky

India's Generics Play a High-Stakes Game

Seen from the air, the sprawling port city of Mumbai (formerly Bombay) resembles a rough gray and brown patchwork. There are shiny, well-scrubbed areas like Malabar Hill with sleek hi-rise hotels and designer boutiques favored by the stars of India's movie industry, Bollywood. [quote]Lying cheek-by-jowl with such extravagant wealth is a network of vast, dusty slums that spill into the surrounding countryside. Like New York City, Mumbai is a diverse, culturally dynamic mecca that attracts many with a promise of money and fame.

Since the early 90's, the city has also earned the unfortunate moniker, "AIDS capital of India." HIV infection itself has been dubbed "the Bombay plague" or "Mumbai disease." Over 250,000 Mumbai residents have HIV, including many of the city's 100,000 sex workers in its famed red light district, a dusty 12-block area with 10,000 brothels.

It is impossible to have an accurate picture of the total HIV prevalence in India because HIV is so stigmatized there. HIV doctors take it upon themselves to warn patients against disclosing their status, fearing discrimination. The national government estimates that four million Indians have HIV, but the frontline doctors mock that figure, placing it closer to 10 to 12 million.

Cipla Enters the Fray

It seems particularly fitting to find the corporate headquarters of Cipla Ltd., the now-famous Indian generic HIV drug manufacturer, located a stone's throw from Mumbai's brothels. Cipla burst onto the world stage two years ago when its maverick president, a chemist named Yusuf Hamied, offered a copycat three-drug anti-HIV regimen to poor African countries and aid groups like Médecins Sans Frontières (MSF) at $350 a year, one-thirtieth of the standard price.

The move tipped the scales in a high-pitched battle for global drug access being waged by AIDS activists and groups like MSF against the multinational pharmaceutical companies controlling drug patents. These companies denounced Cipla's act as a threat to the international patent system that makes pharmaceutical research possible. They also warned that Indian knockoffs were likely to be of poor quality and would contribute to drug resistance across Africa and Asia.

Undeterred, Hamied defended his company's reputation and his action as perfectly legal under a 1970 Indian patent act that protects the patents on drug-making processes but not on the final product. Indian companies can create alternative manufacturing steps to copy patented drugs and then legally sell those drugs in India. They can also export their products to countries or markets where no patents exist for them. Where compulsory licensing laws apply, the Indian manufacturers can apply to sell their generic versions of patented drugs and pay a licensing fee to the patent holder. That market, it turns out, covers much of Africa, Asia, Latin America and Eastern Europe, but not the US and Western Europe. The drugs involved include medicines for life-threatening opportunistic infections as well as for HIV.

"What Cipla did was show everyone that the emperor had no clothes," stated Mumbai lawyer Anand Grover of the Lawyers' Collective, an advocacy group working on AIDS drug access issues. "For years, the multinationals claimed it cost so much to make their AIDS drugs, and they were so hard to make. Now we know it's simply not true. The generics make these drugs for pennies, and they make other drugs too. So the secret is finally out. The truth is, the profits in this industry have been just staggering."

As it stands now, the HIV market for developing countries is roughly $2.2 billion in sales at the low end. This number is based on a generic industry estimate of the number of people living with HIV outside the US and Western Europe—some 38 million—and the percentage who probably need antiretroviral treatment—around 15%, or 5.7 million. That number is then multiplied by the current generic HIV drug price of around $400 per person per year. If universal access gets extended to people who want to begin therapy in order to stay healthy and avoid getting sick, the pie becomes much bigger.

Lots of Rivals

While Cipla spotlighted the needs in Africa, several other Indian rivals quietly entered the race, focusing their attention on South America and Southeast Asia. Cipla now has an edge as the leading exporter of finished product (FP) for HIV to 40 countries, including much of Africa, the Caribbean and Southeast Asia. But other companies are making more money by selling the active pharmaceutical ingredients, or APIs, for antiretrovirals.

Delhi-based Ranbaxy, India's largest pharmaceutical manufacturer, now claims one sixth of domestic generic HIV prescription sales; the rest mostly go to Cipla. But Ranbaxy is also competing well globally. It was the first to export APIs to Brazil, and claims $12 million in sales of bulk indinavir to that country. The company recently split a tender with Cipla to supply anti-HIV drugs to 10,000 Nigerian patients. It has partners in China and has begun marketing a generic hepatitis B drug there.

Hetero Drugs is an aggressive Hyderabad-based company that makes heart and antidepressant medicines and now has eight HIV products. With $12 million in sales of raw AIDS drugs to Brazil and $26 million to Argentina, it is the leader in the overall market. By comparison, Cipla's total antiretroviral sales are no more than 20 percent of Hetero's, according to figures compiled by Hetero.

Another newcomer, Aurobindo Pharma, has a few finished drugs being marketed in India. Aurobinda is chasing Hetero for a share of the "bulk actives" market, as APIs are also called, by offering low prices. Sun Pharma was recently rated the fastest-growing pharmaceutical company in India; it also manufactures bulk APIs. Others include well-reputed Zydus-Cadila, along with Torrent Pharma, RPF Life, Micro Labs, Sol Pharma, FDC, Pure Health Products, East India and Kopran. Dr. Reddy's Laboratories, a large, established company, is rumored to be considering entry into the HIV market.

In addition to manufacturing HIV drugs, the companies are making forays into HIV diagnostics and herbal drugs and are moving into R&D for new HIV drugs. Ranbaxy initially sold low-cost T-cell and viral load tests through a partnership with Specialty Labs that turned sour; it is now producing its own kits.

Beyond the Indian companies, generic rivals are emerging in a dozen countries including Brazil, Egypt, China and Thailand. They are poised to keep competition healthy, although only a few companies now produce high-quality APIs. The Brazilian and Thai governments pioneered the use of Indian generics in national treatment programs involving thousands of patients and imported Indian technical know-how. Brazil now makes its own HIV pills using Indian source material, as does Argentina. Elsewhere in the region, manufacturers in Mexico, Cuba, Costa Rica and Peru are planning to make pills from Indian raw goods. The regulatory agencies in several countries have independently reviewed Indian factories and products, providing outside proof of their laboratory quality and efficacy. The Asian countries of Cambodia, China, Indonesia and South Korea are importing and vamping up to produce their own drugs using Indian help.

In Africa, the governments of Uganda, Zimbabwe, Ivory Coast, Cameroon, Nigeria, Botswana, Kenya and Congo are moving fast to import pills and technical help from Indian producers, as are Ghana, Tanzania, Ethiopia and Sudan. Other African countries are also sniffing around for good deals. Several intend to manufacture the drugs using bulk source APIs from India—or a cheaper competitor.

The situation is finally changing in AIDS-stricken South Africa, where President Thabo Mbeki until this spring opposed importation or use of HIV generics.

GlaxoSmithKline, which was one of the plaintiffs in a withdrawn lawsuit to keep South African generic companies out of HIV, recently assigned a compulsory license to a local generic manufacturer, Aspen Pharmacare, to sell versions of AZT and 3TC. This will effectively block Indian competition—except that Hetero will supply the ingredients. In a counter-move, Brazil's state-owned FarManguinhos, which makes HIV drugs from Hetero's raw materials, recently shipped anti-HIV medicines for 50 patients in MSF's South African clinics.

Keeping Generic Drugs out of the International Market

The conflict over HIV generics reached a peak at last November's World Trade Organization (WTO) meeting in Doha, Qatar, when the 142-member body ruled that developing countries can override drug patents in national health crises. But the Doha Declaration requires each developing country to establish its own manufacturing base if it wishes to use generic drugs. The Declaration has no provision allowing export of these drugs. An infrastructure for producing drugs takes years of preparation and a lot of money. Doha's failure to cover exports, declared Amar Lulla, Cipla's outspoken Joint Managing Director, "is a complete eyewash and there is no gain. Not allowing exports is a major deterrent."

"For Africa and Latin America, there is hardly anybody with capability to produce finished product," explained Ranbaxy senior vice-president Bimal K. Raizada, who oversees global marketing for the company. "Even if you came down to making finished dosage form, there might be only three or four countries with industry capability: Brazil, Argentina, South Africa with limited ability, and maybe Egypt. And that's where it stops. When it comes to Asia, Thailand can do API and FP (finished product), India yes, and lastly there is China. China doesn't have the technology for API, but it has the technology and capability to produce formulations."

Even when allowed to export, generic companies must register their products in each country and market, something that can take many months and a lot of bureaucratic red tape. "The country-by-country application process is very time consuming," explained Hetero Drugs' Director of Global and Domestic Marketing, M. Srinivas Reddy. As he noted, many governments are not on top of their own patent applications and may not have enough trained experts in intellectual property or trade law who can approve generic drug applications. Last fall, a Harvard analysis of patents on 15 antiretroviral drugs in 53 countries concluded that in most of Africa, only two HIV drugs are patented, except for South Africa, where over a dozen drugs are patented. In East African countries, only four or five drugs are patented.

Indian companies will lose their legal advantages when a new WTO Trade-Related Intellectual Property Rights policy goes into effect in 2005. It calls for India and other member-states to respect 20-year patents on new products from then on. The Indian pharmaceutical industry is rushing to introduce as many generic drugs as possible before the 2005 cutoff point.

As Grover points out, the patent battle has revealed the real stakes at hand. It is not really the African HIV market, which in fact represents only one percent of global HIV sales, but "their [the multinational brand-name companies'] hegemony in the multibillion-dollar global pharmaceutical industry." The international corporations worry that AIDS provides a wedge for foreign generic producers to gain legitimacy and a foothold in other markets.

It is a valid concern: Cipla, the third-largest drug maker in India, is an 87-year-old company with 1,023 generic products in 130 markets; its US marketing partner is Andrx. Cipla's eight HIV drugs are making money, but it sees bigger profits in the blockbuster drugs of the 1990s, like antidepressants, which are going off patent soon. While HIV drugs have caught the world's attention, the Indian generic companies have made steady gains in major drug markets including the US, Germany, Britain, Brazil, China and Japan.

Hetero, for example, recently obtained FDA approval to market five generic products: omeprezole, tizanidine, fosinopril, cotrimoxazole (Bactrim), and itraconazole. The latter two are used to treat, respectively, HIV-related pneumocystis pneumonia and HIV-related fungal infections. Ranbaxy has more than 25 products approved by the US FDA.

Quality is the Sticking Point

The brand-name drug companies have argued that manufacturing standards are lower in India and other developing countries and that corruption is a huge problem. Product quality is not an idle concern, since generic manufacturers make money by cutting corners to keep costs low. Although Cipla, Hetero and Ranbaxy all have excellent industry reputations, the fact remains that a thriving unregulated gray market exists in India for many products, including medicine.

"Quality is an issue all of us are and must be concerned about," admitted Hetero Drugs' Reddy. "There are different standards in this industry, as with all industries. We realize there are many people who are unfamiliar with our products and need to be reassured."

The key dataset used to evaluate the quality and efficacy of a generic drug is something called a biological equivalence (BE) study, which is typically done in 24 to 36 healthy volunteers according to World Health Organization (WHO) guidelines. The BE test must show that the generic compound is equivalent to the FDA-approved brand-name or innovator drug, meaning that it affects the body in the same way. To be considered bioequivalent, a generic product must yield maximum and average blood levels that lie between 80% and 125% of the brand-name drug.

BE studies typically cost several thousand dollars in India and take several weeks to months to complete. But this is nothing compared to the testing a new drug goes through before US marketing approval.

As of April, Cipla had finished BE studies on eight HIV drugs and two fixed-dose combination tablets. It is now doing post-marketing studies of the drugs. Hetero initially had trouble recruiting volunteers for BE studies because of the stigma of AIDS. "They were ignorant and afraid of getting HIV," Reddy related. "We had to work a lot to educate them and this caused delays." Hetero has completed BE studies on five antiretrovirals and a two-nuke AZT-3TC combo. So has Ranbaxy, which is marketing two double-nuke combinations at different doses. Ranbaxy has completed BE for seven products and hopes to have BE data on four more by June, including a three-drug combination, 3TC/d4T/nevirapine. (Summary documents on these completed BE studies were shown to amfAR in April to prove the tests had been done, and the products approved by domestic regulatory agencies.) The other companies are also completing BE studies.

In mid-March, the Indian companies celebrated another victory when the WHO issued its long-awaited list of approved drugs for HIV and included Cipla's HIV products for the first time. Since none of the other Indian companies had yet been inspected by the agency, Cipla extended its edge for a little while. But probably not long; the WHO had scheduled visits to Hetero, Ranbaxy and other companies starting in late April.

For Cipla, the WHO endorsement was bittersweet. Just days before the WHO announcement, Cipla officials in Mumbai were openly complaining that the agency was deliberately delaying public approval of their HIV drugs. "Do you think the WHO is exempt from the influence of the multinationals? Not at all. It's all political," declared Lulla, the Cipla managing director. "They keep saying they want proof. But we've given it. They analyzed our products. Our plants have been inspected." Frustrated, he added, "They've [the brand-name multinationals] tried every trick in the book to say, ‘Hey, Cipla isn't quite, you know, up to snuff.' "

In Lulla's view, WHO officials went the extra mile to review Cipla products and found no problems, but refused to say so publicly. "In their talks with us, they keep saying there is so much politics and please do not push us to make a statement," Lulla huffed. Now that the agency has given its thumbs-up, Lulla is mollified, but his views about the deeply political nature of the battle have not changed.

Moving ahead, the Indian companies are now hoping to lure the market with clinical proof of the efficacy of their drugs in patients, something Brazil has publicly documented. Cipla has early results of a clinical observational study of its combination tablets containing nevirapine with two nucleoside analogs (either AZT/3TC or d4T/3TC). The study was carried out by two Indian doctors in 347 treatment-naïve patients (296 males, 51 females) attending HIV care centers in two cities, Pune and Ahmedabad.

The progress of the trial cohort was evaluated using clinical monitoring and CD4 and CD8 cell counts, but not viral load tests. On average, patients began treatment with a mean baseline CD4 count of 144. After a year, 64.6% of patients had CD4 count increases of 20%, and little difference was noted between the different nucleoside analog arms. Overall, 23 people in the study developed opportunistic infections and six died. As for toxicities, 10.5% of the cohort developed rash, including four who had Stevens-Johnson syndrome, which the study authors associated with female gender. Based on these results, the researchers concluded that nevirapine, being the cheapest third drug in India, "can be positioned as a first-line HAART option for antiretroviral-naïve patients."

Developing New Manufacturing Processes

In India, HIV medicines are made in a process called reverse engineering to avoid the patents that cover how a brand-name drug is manufactured. Chemists trace back the complex steps, or chemical reactions, used to make a given molecule, and substitute these to produce the same final product. Each alternative reaction can introduce impurities or be hazardous. It takes trial and error and very experienced technicians to get the process right. "In terms of reverse engineering, the only advantage is that the drug has been clinically tried and evaluated in trials by the multinationals. But everything else we have to start from scratch," said Reddy of Hetero Drugs.

Compared to antibiotics, which require five to six reactions and a production cycle of around 15 days, HIV antiretrovirals may involve up to 20 stages and a production cycle of 35 to 75 days. "Our own experience is that each molecule is hard because it has a different chemistry," said Reddy. "The larger the time cycle, the more the problems involved in that manufacturing process." Over time, Indian companies have become more adept at using fewer steps to make the drugs. That has led to reduced costs for consumers.

According to Reddy, the Hetero team found that nucleoside analogs like 3TC, d4T and AZT are "relatively quick and easier to make than protease inhibitors, which have long time cycles." Some aspects of manufacturing are more dangerous for certain drugs, namely nevirapine and 3TC. "We have to do it proficiently with so much caution," he said about 3TC. "In other products like ritonavir, the time is long, but there aren't the same hazards as with lamivudine (3TC) and nevirapine."

A surprise was efavirenz (Sustiva). "It is a most difficult process," Reddy explained, getting technical. "We use butyl lithium [a catalyst]. If things are fine, only the good reaction will come. If there is some small variation due to some mistake, or if only one percent of water comes into this reaction mask, the explosion will be venomous." So far, so good, remarked Reddy—there haven't been any explosions in Hyderabad.

Once the BE studies are ready, the Indian companies contract outside laboratories to review them and submit the results to regulatory agencies, including WHO and the United States' Food and Drug Administration. If an inspection turns up a shortcoming, the companies are given a period of time to correct the problem.

Since the global HIV market calls for companies to market the cheapest drugs possible, they are all making and testing nucleoside analogs first, then putting them into double-and triple-combination tablets. Up to now, the third drug has been nevirapine, which has turned out to be especially inexpensive. Indinavir is the cheapest protease inhibitor to copy, so it has been the most popular generic PI.

"Strategic Alliances" with the Brand-Name Multinationals

Quality control is a continuous process after the equivalence studies are complete and manufacturing begins. Indian generic drugs come under the purview of several regulatory agencies, notably the Drug Controller General of India (DCGI), which approves new drugs for the domestic market, and the CDIR, an Indian authority over bulk drugs. Foreign regulatory bodies such as the FDA also inspect plants that export to their countries. The main seal of approval for the companies is an inspection certificate of Good Manufacturing Practice (GMP) that shows their plants and other operations are up to industry standards. The drug companies then do regular testing of the individual products as they are manufactured and randomly test samples taken from warehouses and pharmacy shelves.

One of the richest ironies of the HIV drug war—and there are many—is that large multinationals generally accept the quality of products made by their Indian competitors. Outside of HIV, foreign generic companies, including those in India, have been supplying the bulk APIs to the brand-name producers for years. So what gets labeled a brand-name, FDA-approved and patented pill in the US may begin life as a cheap generic.

Ranbaxy, for example, has sold APIs to Bristol-Myers Squibb for doxycycline, cefalexone and amoxycillin. The FDA has approved four Ranbaxy active ingredients plants in India. The company also has a manufacturing facility in New Jersey. It has concluded marketing pacts with GlaxoSmithKline for cefuroxime axetil, with Eli Lilly for a half-dozen generic pain products, and with smaller US companies like Penwest Pharmaceuticals and Wockhardt.

The closer one looks, the more the lines blur. The public fight over HIV patents and profits is certainly real, but "a lot of that is also for a consumer audience," Lulla claimed. "What we do among ourselves in the industry is another matter. If they [the multinationals] have a problem, they can come to us and we will try to address it." Behind closed doors, Lulla said, the rivals work out disagreements. "They aren't interested in this [HIV] market. It is not commercially viable for them. They're not idiots to sell drugs at low prices like us," he quipped.

Or as Hetero's Reddy put it frankly, shrugging, "It's just business. That's what we all have in common."

Given the potential profits in the world HIV market, there are plenty of reasons to anticipate "new strategic alliances," as Lulla calls current and future deals between the brand-name multinationals and generic competitors. Sir Richard Sykes, chairman of GlaxoSmithKline, recently admitted that the company was considering an alliance with a quality Indian producer in order to do low-cost clinical trials of its HIV products. He mentioned Ranbaxy and Dr. Reddy's Laboratories as possible partners. Never mind that Sykes lambasted the Indian biotechs in the media. Meanwhile, a daily rivalry exists between the Indian companies. "It's cutthroat competition," said Hetero's Reddy, smiling. "I can talk to you, but not with Cipla."

The need for secrecy makes it hard for outsiders to accurately analyze the Indian industry or compare the various products to one another. All the companies—the brand-name multinationals included—regularly test their products against their rivals', yet the press and consumers never hear about it, or only selectively. "I can tell you that if some big company has a problem with one of our HIV products, they make sure the right people know," said Ranbaxy senior vice-president Bimal Raizada, adding, "No one has. We are confident of their quality."

Nonetheless, independent auditing of the manufacturing process remains an important concern for consumers. As International Dispensary Association (IDA) spokesperson Guido Bakker put it, "It's not that hard for a plant to get a GMP. They have their own people and labs. So you have to have outside laboratories that you can trust to review quality."

Toward that end, the IDA, a Netherlands-based procurer of essential medicines for community clinics, is initiating an independent inspection of the Indian companies. The group hopes to distribute the Indians' products to nonprofit and donor groups if the results are acceptable.

Extending Treatment Access around the Globe

Despite all this movement, not a lot of drugs are actually getting into bodies. According to a recent estimate by MSF, only 25,000 to 30,000 out of 2.5 to 3 million Africans with HIV/AIDS are getting access to low-cost anti-HIV drugs from the brand-name companies through a much-touted Accelerating Access Initiative. The number receiving generic drugs is growing, but remains difficult to estimate. It is still only in the tens of thousands, say the companies. Nearly every African and Asian government has sent a representative to visit Cipla or the other companies to shop for a good deal. But few have come through with the cash. Many hope that the United Nations' new Global Fund for AIDS, Tuberculosis and Malaria will help them buy the drugs. In late April, the Fund announced it was granting $378 million to 31 poor countries, with nearly half the money going to drugs for HIV and AIDS.

Of course, getting the money for drugs is only a small part of the battle. There is a huge gap in terms of infrastructure to distribute the medicines and use them properly in settings of poverty. Money is also urgently needed to educate doctors and community health workers about HIV disease, employ trained technicians in clinics and laboratories, buy HIV diagnostic tests and monitoring equipment, educate the general public about HIV and counsel those who are affected.

There also are the years and millions of dollars that developing countries require to build a manufacturing capacity to make generic HIV drugs—and hence sustainably afford them by controlling their costs. Brazil's experiences show how quickly the treatment train can move when a track has been laid. As a large country with a functioning economy, it had a decent public health care infrastructure as well as a large number of agencies ready to support a national AIDS treatment program. The government committed major resources to educate a core of physicians and health technicians on the finer points of HIV management and monitoring. It initiated pilot treatment programs to see what worked and to pinpoint problem areas. Similarly, private companies took the lead in manufacturing generic medicines. Only then did the state-owned company, FarManguinhos, get involved. "We used to supply to small manufacturers in Brazil and Argentina," stated Srinivas Reddy at Hetero Drugs. "They started with 50 to 100 kilogram batches in the initial lots. Now it's up to 200 to 500 kilogram lots."

"They didn't have the manufacturing process for finished dosages or the information about how to turn APIs into tablets," Reddy noted about FarManguinhos. "We have scientists there to simultaneously train and help to do finished product, and we transferred finished dosage formulations and technology to these manufacturing units. We gave them the analytical method, for example, how to compare to innovator products, how to keep on par with innovator products, et cetera."

Back in 1997, when Hetero first began making generic 3TC, GlaxoSmithKline was selling the drug at $80,000 per kilogram, said Reddy. "We gave the Brazilian government the drug at $5,100 per kilogram. Now we sell it to them at $700, and we have been able to reduce costs further." The result has been huge savings for Brazil, something that has inspired other governments hoping to do the same.

Today, the transfer of technology and hands-on training is part of the package that all the Indian producers are selling to interested governments. These new business relationships will also help the companies market other drugs in these countries.

While Waiting for the Global Fund

The Global Fund grants are likely to radically alter current consumption. Aside from India, Brazil and Argentina until now have been the largest users of generic drug ingredients and pills. In Africa, Uganda, Kenya, Nigeria and Cameroon have imported finished generic medicines for small national pilot programs. MSF and Oxfam have been the main users among nongovernmental organizations, but here, too, the scale is small.

African private sector use of the drugs is scattered, but also growing, though corporate use is almost nonexistent. Anglo-American and Debswana, two mining giants in South Africa and Botswana, respectively, announced plans to buy and give generic drugs to some employees, as did Coca-Cola, the largest employer in Africa. But in April, Anglo-American reneged, citing the high cost of the plan. Meanwhile, AIDS activists are protesting Coca-Cola's plan, saying it is unethical to selectively treat sick employees.

Private hospitals and AIDS centers are the main users of generics in Asia. Private doctors with their own pharmacies fly to India to fill their suitcases with pills.

HIV drugs are easily available in major Indian cities, less so in rural areas. Around 100 Indian physicians are now pioneering use of the generic versions, and more are being trained to do so through educational seminars sponsored by the generic producers. Several drug companies have HIV clinics and centers where their products are distributed gratis. Around 25 nongovernmental agencies distribute generic drugs, some for free. These agencies also are embarking on patient education for people with AIDS. "A year ago, only one percent of people [with HIV] were getting access to anti-HIV drugs; in private settings, it is now six to seven percent," said Reddy.

For now, the Indian government is not buying or distributing generic drugs despite pressure by groups like the Lawyers' Collective. The government has announced a plan to use anti-HIV drugs to treat pregnant women in 22 infectious disease centers with designated AIDS wards—a first step. Another is the government's recent decision to drop the excise tax on domestic HIV generics. This has reduced retail HIV drug prices by 10%.

AIDS activists in India are not impressed, and they spread the blame around. "These companies like Cipla began making HIV drugs without providing educational materials for the public," complained attorney-cum-activist Vivek Diwan of the Lawyers' Collective. "Now there is a gap in terms of who's going to do the education, and we are left holding the bag. The government isn't going to do it. Don't the companies have some responsibility?" To its credit, Cipla launched a major HIV public education campaign that was hailed by activists, but Diwan says, "It's a drop in the bucket."

Globally, there are other complaints. Smaller donor agencies and community networks hoping to acquire Indian drugs report limited success. "We've tried for months to order them from Cipla and couldn't get anyone to answer our e-mails," said Richard Stern of Agua Buena, a Costa Rican AIDS advocacy group, in March. His network wants to donate generic drugs to needy patients, not sell them, which is technically legal. "The generic companies say they'll provide the drugs, but no one has been able to get them. People are dying as we wait for an answer," Stern bitterly complained.

The companies acknowledge that few organizations outside MSF have received drugs. One reason, contended Cipla's Lulla, is that "we are ignorant of who these agencies and patient groups are. We know MSF. We can't afford to just give the drugs away carelessly. And we can't break patents." For the record, officials at several companies said they're willing to sell drugs to licensed physicians and legitimate donor groups.

How quickly such words will be followed by action is anyone's guess. In April, a physician-run Honduran AIDS network happily reported that it had received its first batch of Cipla drugs. Bought directly from the company, the drugs took a few weeks to arrive. They will be given free of charge to very ill patients, and physicians in the network will strictly monitor their use. With the United Nations agencies and groups like IDA ready to move, access could quickly expand. "There is a learning curve because we are new to this whole area," Lulla admitted. "It's all moved so quickly none of us can even keep up."

Many do not know that there is any progress to keep up with. Outside Cipla's well-guarded entrance, the district sexworkers pay no heed as they pass by on their way to the brothels. For them, universal access to cheap AIDS drugs remains somebody's dream, not—yet—their reality.

This article has been reprinted from the amfAR Global Link at www.amfar.org/GlobalLink

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