'India is considered to be a 'next wave' country for HIV/AIDS'

With increasing prevalence and rising incidence of HIV in India, how well equipped are Indian drug manufacturers to handle the same. T Vijayakumar, Senior Manager-Export Formulations, Aurobindo Pharma discusses the antiretrovirals (ARV) market, in conversation with Arshiya Khan. Excerpts

What has been the growth rate of HIV/AIDS and the incidence of the disease in India?

The world's second most populous country, India, is experiencing a highly varied HIV epidemic, which appears to be stable or diminishing in some parts while growing at modest rates in others. Approximately 6 million people are suffering with AIDS in India. Today, the world's largest democracy has entered a critical period in its fight against the HIV/AIDS pandemic.

The first case of HIV disease was documented in India in 1986. India accounts for 75 percent of HIV/AIDS prevalent in South, South East Asia and 15 percent of global prevalence. Majority of people living with HIV/AIDS in India are from rural areas (57 percent in 2005). By comparison, India represents 20 percent of the world's population. With an estimated 5.7 million people living with HIV/AIDS, India has the highest HIV/AIDS prevalence in the world, according to UNAIDS. Among 15-49 year olds, an estimated 5.2 million are living with the disease, according to India's National AIDS Control Organisation (NACO).

Still, India's prevalence rate (the percent of the adult population estimated to be infected with HIV) is relatively low. However, India is considered to be a 'next wave' country; that is, it stands at a critical point in its epidemic, with HIV poised to expand, but where large scale prevention and other interventions today could help to contain a more serious epidemic in the future. As the second most populous nation in the world, even a small increase in India's HIV/ AIDS prevalence rate would represent a significant component of the world's HIV/AIDS burden.

AIDS being a non curable disease, tell us about the developments, availability, accessibility and affordability of ARV medicines, with respect to the contemporary market situation.

Promising developments have been seen in recent years in global efforts to address AIDS epidemic, including increased access to effective treatment and preventive programmes. However, the number of people living with HIV is growing as the number of deaths due to AIDS. A total of 40 million are living with HIV today. In many regions of the world, new HIV infections are heavily concentrated among young people.

Access to treatment and care has greatly increased in recent years. The expanded provision of antiretroviral treatment is reached by 2 million lives per year in recent years with the help of organisations worldwide.

Making drugs affordable to those who need them is a formidable challenge. Availability of HIV/AIDS drugs, like others, depends on sustainable financing for drug procurement at the national level, national and local health infrastructure for delivering drugs and monitoring patient compliance and affordable drug prices.

What are the characteristics of the ARV market?

Currently the ARV markets in the regions where HIV is grown up to epidemic levels is funded by two major funding agencies, namely, President's Emergency Plan for AIDS Relief (PEPFAR) and Global Funds. These are availed by various underdeveloped and developing countries to combat the growing menace of AIDS.

India is fortunate to have a vibrant domestic pharma industry that can play a crucial role in the fight against the pandemic by providing ARV drugs at low cost to the government. Several Indian pharma companies are manufacturing generic drugs at competitive prices.

Since the number of people living with HIV is increasing, what opportunities does the ARV segment offer to the manufacturers of the same?

There are two sides to this. Firstly, increasing resistance to existing drugs drives innovations in drug therapy. Estimates show that up to 78 percent of patients are now failing to respond to antiretroviral drugs. Research indicates that patients are developing resistance to more than one class of drugs that are in general use. There is an increased level of drug resistance even in drug-naive patients. In 1999, eight percent hike in resistance was recorded in treatment-naive individuals and the figure has now alarmingly risen to 20 percent. This can lead to a condition where patients are less likely to reach suppressed levels of HIV due to undetectable levels when they start treatment.

Using a resistant test prior to starting the treatment regimen ensures that patients with primary resistance will receive a good response from the antiretroviral treatment similar to those who lack it. According to various analysts, the need for newer and more effective therapies grows as treated patients increasingly develop resistance to currently available antiretrovirals. These older generation drugs are being replaced by products with lower pill burdens, enhanced potency, and reduced side effects. Compounds that are effective against multi-drug resistant strains currently dominate the clinical development scene and are likely to drive the future growth of this industry.

There were speculations about the quality of drugs in India by WHO what has been the impact and the outcome of the same on the market?

Indian medical experts see the hand of powerful Western drug manufacturers in the World Health Organisation's withdrawals of its recommendations, for some of India's cheap and popular combination drugs against HIV/AIDS using generic 'copycats.' Generic 'copycats' are alternatives to brand name drugs and according to WHO requirements they must show pharmaceutical equivalents -- which means that the amount of active ingredient, the dosage form, and the strength are identical to those of a comparable brand. The generic must also be bio-equivalent, meaning the drug must be absorbed into the blood stream at roughly the same rate and extent as the pharmaceutically equivalent brand.

With one in four new HIV cases being reported from Asia, the sprawling continent is on the verge of being felled by an AIDS epidemic that would dwarf the devastation wrought by the killer disease in Africa, the Joint United Nations Programme on HIV/ AIDS (UNAIDS) warned.

The WHO decision seemed to be in line with repeated claims made by Western drug manufacturers and US government officials that generic drugs do not have the same quality standards as the patented ones.

The outcome for this situation is that WHO's pre-qualification list was created to guide procurement by aid agencies that are fighting the HIV/AIDS epidemic and includes more than 60 anti-retroviral drugs made by both patented and generic drug manufacturers. To be fair to WHO, the organisation made clear that its target was not the generic combinations themselves but the contract research organisations (CRO) hired by the Indian manufacturers and their questionable standards.

What are the market drivers and market restraints of the ARV segment?

Regulatory and patent uncertainties constrain development of generic and biogeneric drugs in developed countries. With end users of prescription drugs seeking to pay less for medication, generic and biogeneric products are poised for strong growth, especially in the developing nations. In India, for example, drug manufacturers may patent a process but not a compound, thus, generic drug makers are able to synthesize the compound through another process and may legally introduce another version of the drug. In this manner, they can benefit from the original manufacturer's ongoing advertising and promotion of the drug while eliminating the need to depend on the American and European generics producers. In an endeavor to avoid the stringent patent processes, generic manufacturers may lose some quality in the process of reengineering drugs. Several Asian and ROW generics producers have faced similar difficulties and one recent example is the removal of two generic HIV drugs produced by a prominent Indian pharma company from the WHO list of approved medications meant specifically for patients in Africa.

Though generics and biogeneric drugs are emerging as strong contenders to branded medications, a number of consumers in developed nations have a perception that branded products are more effective than unbranded ones. Certain patient populations tend to view healthcare benefits as entitlements rather than privileges and resist shifting from more expensive to less expensive options. Even when they are compelled to switch drugs, they shift from one brand to another - popularly known as a 'brand name shift' - despite the availability of low-cost generics. This is one challenge that generic drug manufacturers are likely to find hard to overcome in their quest to extend market reach.

How can these problems be tackled?

Even more fundamental to combating the emerging HIV/AIDS pandemic in India, than drug treatment, plans and funding is to create a sense of national urgency about the pandemic. India must urgently ramp up its communication campaign to make its citizens aware of the disease as well as the dangers they face from the virus. Overcoming consumer belief in branded products, which restricts use of generics.

arshiya.khan@expressindia.com