HIV/AIDS Treatment in Asia and the Rise of Generics

More than 1.3 million people in Asia currently need antiretroviral treatment.  As indicated in Table 2, most countries in the region are administering antiretroviral medications to fewer than 25 percent of their HIV-infected populations.

In the absence of trained healthcare workers, a significant number of people are likely to begin “self medicating,” independently purchasing antiretroviral drugs in local pharmacies and haphazardly taking drugs with little or no direction. Stories abound of patients who have taken incorrect combinations of drugs, shared limited drug supplies with infected family members, or taken medications for just a few days or weeks each month. Prescriptions from unqualified healthcare workers have left many people with little or no instruction on the safe and proper use of ARVs. In place of an organized delivery and education system, the potential for treatment anarchy threatens the region.

The consequencesof widespread “self medication” can be catastrophic. As patients under-medicate or treat HIV with incorrect dosages, the potential for the emergence of drug resistance is significant.  Even patients on appropriate medications often develop drug-resistant HIV due to inconsistent supplies of medication.

The need for antiretroviral drugs varies widely throughout the region, mainly in direct relation to the age of the epidemic. Newer epidemics have higher percentages of recently infected people, and therefore populations with lower viral loads.  Older, more established epidemics have a much larger percentage of patients in need of ARVs.  

Generics

Generic antiretroviral drug manufacturers have proliferated in Asia in recent years, radically altering the regional treatment landscape. Together with the increasing availability of affordable branded drugs, this proliferation has created the potential for widespread access to treatment across the region. Unlike Africa, where only one generic antiretroviral manufacturer exists on the entire continent, 27 companies are currently manufacturing antiretroviral drugs or the components of these drugs in eight countries in Asia.

The biggest challenge in ARV production is not producing final formulations, but producing the active pharmaceutical ingredients (APIs) necessary to produce final formulations. ARV production is feasible for most manufacturers, while APIs are enormously expensive and difficult to produce, requiring substantial inventories of raw ingredients and costly equipment. “If I need to treat 100 million patients, at 200 million pills per day, that’s no problem,” says Yusuf Hamied, the founder and CEO of the Indian generic pharmaceutical manufacturer Cipla. “The problem is who will supply the active ingredients. If there’s no predictability of demand, who’s going to produce APIs and keep stocks?”

Currently, China and India produce the vast majority of bulk APIs, but do so inconsistently due to shifts in demand for these medications. Hamied called on the international community, including NGOs, the World Bank, the Global Fund, and World Health Organization (WHO), to create a predictable demand for ARV medications, which would allow ARVs and APIs to be produced on a sustainable basis—an important consideration for drug regimens that require rigid adherence over a period of years.  

Source for African manufacturers:
Roelf W.  “AIDS Drugs are Available – But Are There Enough?” Mail and Guardian.  May 17, 2004.  Available online at: www.journ-aids.org/reports/20040517b.htm.

Source for Latin America manufacturers:
WHO.  Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS. June 2003.  

The risk of unqualified manufacturers

While generic antiretroviral manufacturers have provided immense hope that widespread treatment may soon be available, many questions linger about the relative safety and consistency of these drugs.  Currently, only three generic manufacturers in Asia — the Indian companies Cipla, Ranbaxy and Hetero/ Genix — meet the WHO’s benchmark quality standards. 

The 24 other companies in Asia either have not been reviewed by WHO or do not meet WHO standards and are therefore not monitored for the quality or quantity of medicines produced.  

The Cambodian Pharmaceutical Enterprise, for example, produces and sells four AIDS drugs without formal documentation, leaving international officials in Cambodia with no access to data on production or consumption.   

In the absence of such basic manufacturer information, substandard AIDS medications can easily be sold to the general population.  WHO reports that counterfeiting of treatments for tuberculosis, malaria and AIDS is widespread in Cambodia, China, Laos, Myanmar, Thailand, and Vietnam.66 A WHO study in Southeast Asia in 2001 revealed that 38 percent of 104 antimalarial drugs on sale in pharmacies did not contain any active ingredients.⁶⁷  No regional studies have been done to assess the efficacy of available ARVs, but random testing of drug samples in Vietnam and Myanmar showed that 8 percent and 16 percent respectively were substandard, according to WHO.⁶⁸

Given the lack of available data, a regional database of generic manufacturers is urgently needed.  Without such a database, it is impossible to determine which medications are available in a given country, evaluate the quality of those medications, or accurately gauge unmet medication needs among the HIV population.

 Challenges

The paucity of healthcare infrastructure in many countries, and the acute shortage of trained doctors in particular, have impaired the ability of governments to set up long-term, lifelong treatment programs for millions of people with HIV.

In addition, many generic manufacturers have focus-ed on the international market over the needs of locally affected populations.  For example, in Thailand an estimated 84,000 people need antiretroviral treatment and are not receiving it; yet the Thai Government Pharmaceutical Organization (GPO) reportedly exported US$3 million worth of HIV/AIDS medications to other countries in Asia and in Africa in 2003.  “We have a production capacity for AIDS medicine of about 200 million tablets per year,” said Paricharit Claewplodtook, a GPO spokesperson. “Africa is a new market which we are beginning to explore.”⁶⁹   In the first seven months of 2003, the company exported AIDS medications valued at US$300,000 to neighboring Cambodia.

In addition to producing antiretroviral drugs, an increasing number of manufacturers have turned to producing APIs.  These companies export APIs to other generic producers, allowing them to avoid World Trade Organization rules forbidding the production of patented drugs.

“India and China will take on an increasingly important role in exporting APIs in the future.  They are exporting now, but the range of API products that are produced is very limited,” said Peter Graaf of the WHO AIDS Medicines and Diagnostic Service Department.  

Signs of progress

Many governments, such as those in Thailand, India and China, have recently launched new treatment access programs, promising to expand critical healthcare infrastructure throughout the region.  But these government programs also face challenges.  Within weeks of the launch of China’s free treatment program for 5,000 people with HIV, more than 20 percent of patients had already stopped taking medications, creating fertile ground for drug resistance.  Observers reported seeing healthcare workers “simply handing patients bottles of pills” without counseling.⁷⁰

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