Despite the fact that India is a major producer of cheap generic HIV and AIDS drugs, India’s ART programme is poorly conceived, implemented and monitored, with a shortage of drugs, equipment and personnel. Such an unprepared public health system is in no position to handle such an intensive programme, say Sandhya Srinivasan and T K Rajalakshmi

More than two decades after the detection of the first AIDS case in India, the disease is now regarded as a ‘development’ problem and not just a public health issue. Government policy has also moved forward, from denial to practical acceptance of AIDS. The virus has moved from a few epicentres in the southern and northeastern states to 163 districts in 20 Indian states, though the overall prevalence remains low in the general population. It is also acknowledged that women and young people are becoming increasingly vulnerable to the infection.

However, the programme’s targeted intervention strategy does not meet needs like immunising the children of sex workers and providing alternative employment opportunities. Further, in analysing policy and implementation, one cannot afford to ignore the fact that AIDS does not constitute the leading cause of mortality and morbidity in the country.

Perhaps this is why public health experts argue that increased funding for a vertical AIDS prevention programme is no solution; spending that money on a holistic concept of public health and public good will help alter the landscape of morbidity and mortality, including that caused by HIV, in the country. Though the present government has increased allocations to the health sector by 21.9% in the Union budget for 2007-2008, it still remains below the World Health Organisation standard for public health expenditure, which is 5% of GDP. Moreover, a majority of the amount is to be spent on vertical programmes like polio prevention and HIV and AIDS control. In the era of economic liberalisation, stagnant public health budgets and decreasing government expenditure on public health facilities were worsened by the introduction of user charges in the public health sector.

In this scenario of low spending by the government on public health in general and increased spending on vertical programmes like AIDS, a new initiative by the government, to increase access to antiretrovirals (ARV) through the public health system has become the subject of a major debate in India.

The battle for access to medicines

The story of affordable antiretroviral drugs goes back some years, as new drugs changed the prognosis for people with AIDS. These patented drugs were out of the reach of most people even in the developed world. So, health activists and networks of HIV-positive people launched an international campaign to force governments and international organisations to recognise their right to treatment and care. Indian drug companies were, at that time, manufacturing and exporting cheaper generic versions of the branded drugs to Africa and Asia.

In February 2001, the Indian pharmaceutical company Cipla Ltd offered the three-drug ‘cocktail’ of first-line ARV drugs to international voluntary organisations at $ 350 per person per year – a fraction of the US price of $ 10,000-$ 15,000 per year. Other Indian companies followed Cipla’s lead, bringing down prices even further.

In response to global advocacy efforts, the UN convened a special session on HIV and AIDS (UNGASS) in 2001, calling for additional funding for antiretroviral treatment (ART). Two years later, WHO and UNAIDS declared the lack of access to therapy a “global health emergency” and launched the ‘3 by 5’ initiative to ensure that 3 million people living in resource-limited settings were treated for HIV infection by the end of 2005.

ART roll-out in India: A dramatic announcement

On November 30, 2003, the Government of India announced a plan to provide ART through public hospitals in the country from April 1, 2004. The programme was initially to cover HIV-positive pregnant women who had access to government antenatal clinics, children under the age of 15, and adults with AIDS who went to government hospitals for treatment. The programme would offer a fixed-dose combination of first-line drugs. The drugs would be provided by the three large generic drug manufacturers in India. The aim was to treat 100,000 people free of charge through the public sector by the end of 2005.

By December 2006, approximately 95,000 people were receiving antiretroviral treatment, including people enrolled through private facilities. Despite the fact that India is a major producer of cheap generic HIV and AIDS drugs, treatment reaches just 20% of those who need it.

In October 2007, the government finally met the target of providing 100,000 people with ART at its 127 centres across the country. From December 1, 2007, the government plans to introduce second-line anti-retroviral treatment in a phased manner.

While the government spends Rs 7,500 per patient per year for first-line ART drugs, it will have have to spend Rs 100,000 per patient per year for second-line drugs. The second-line treatment needs more
investment and infrastructure.

A look at the ART programme in 14 states

In this report, journalists reported on the Indian government’s scheme to provide ART in six high-prevalence states (Tamil Nadu, Andhra Pradesh, Karnataka, Maharashtra, Manipur and Nagaland), two medium-prevalence states (Goa and Gujarat), low-prevalence but highly vulnerable states like Punjab, West Bengal, and Uttar Pradesh and low-prevalence but vulnerable states (Himachal Pradesh, Union Territory of Chandigarh and Haryana). They looked at what it means to get ART from the government programme and outside the government’s scheme.

These articles are a mix of insiders’ views and journalistic insights. They contain the voices of HIV-positive people, vulnerable groups, health professionals, public health experts, government officials, industry representatives and others involved with the programme.

These interviews were conducted between December 2004 and January 2005 when the programme was initiated. The reports were updated through interviews and desk reviews. To a large extent, they reflect the situation more than two years after the programme was initiated in April 2004.

Two years after ART was launched in India, there seems to be a significant shift in the attitude of the government to providing antiretroviral treatment. While treatment was not a component in Phase II of the National AIDS Control Programme (NACP), 12.5% of the total funds will be spent on ART (11.5% on adult ART and 1.0% on paediatric ART) in the third phase. This makes funding for treatment the fourth largest allocation in NACP-III, after targeted interventions (19.7%), condom usage (17.3%) and providing a package of services such as STD treatment and counselling to ‘most-at-risk groups’ (12.0%). The plan of NACP-III also emphasises that first-line drugs will be made available to HIV-positive people referred from targeted interventions, seropositive women, particularly those who have participated in the PPTCT (prevention of parent to child transmission) programme, infected children and those below the poverty line. NACO recognises that to reach a target of 300,000 by the end of 2011, 250 ART centres need to be set up. NACP-III envisages building public-private partnerships free of cost to prioritised sub-populations.

When the programme was announced in 2003, NACO had stated that children would be a priority for ART. Yet, for two years, ARV was only available in adult doses for children under nine, leading to problems in physically administering drugs to children and fears of drug resistance. To fill this gap, NACO launched the National Paediatric HIV and AIDS Initiative which – for the first time in the country – allowed children under the age of 18 months to be diagnosed and provided free child-specific dosages of ARV.

A major criterion for enrolment under the ART programme is the CD4 count (NACO guidelines state that those with a CD4 count below 200 should be enrolled for treatment). Though ART itself is free, people had to spend an amount ranging from between Rs 500 and Rs 1,500 to get a CD4 test done. To reduce the cost, NACO sent an order to all states in January 2007 to waive fees for CD4 tests at government centres.

Some positive changes can be discerned.The most obvious one is that the number of people on treatment has increased. There are more public-private partnerships, which have helped scale up treatment and improve quality of service.

Management systems are being streamlined as well. When the programme started in 2004, there was just one ART consultant in NACO. The year 2006 saw ART consultants being appointed to manage the roll-out in all states. Currently, each high-prevalence state has an ART consultant, while a group of three or four low or medium-prevalence states share one ART consultant, depending on the number of centres.

The participation of HIV-positive people in programme implementation has increased considerably though their voices are still not really heard in planning fora. Today, HIV-positive groups across the country are involved in patient referrals and follow-up.

Basic infrastructure in some centres has improved. For example, in Sangli, the programme was started in 2004 without any NACO-deputed staff or equipment. The already overworked hospital staff had to do the data entry, and provide counselling and treatment. In the absence of a CD4 machine, they used total lymphocyte counts. There was not even an ink pad to take thumb impressions before obtaining informed consent from illiterate patients. So, the doctor coloured the person’s thumb with a ballpoint pen and pressed it to the form to obtain a thumb print. Two years later, the situation has improved. Now there is a CD4 machine and trained staff deputed by NACO.

However, a look at the programme in 14 states over a period of two years makes it clear that the ART programme is poorly conceived, implemented and monitored, raising questions as to the validity of the government’s claim of a “96.1%” treatment adherence. Shortage of drugs, equipment and personnel continue to be a reality. An unprepared public health system with no transparency is in no position to handle such an intensive programme. Communication and counselling are the weakest links in the programme. Access for vulnerable groups such as sex workers, men who have sex with men, and transgenders as well as those living in rural areas is extremely limited.

There is also limited involvement of those affected by HIV and AIDS, especially in planning. Further, inadequate prevention services, stigma and discrimination are also hindering successful implementation.

The government’s target is limited to a small fraction of those who need treatment. Reports point to only 20% of those who require treatment getting it.

There are several complaints about the availability of health personnel and equipment.

Counselling remains the weakest component in the ART programme. Several interviews with those on treatment point to treatment being started without proper counselling on side-effects, the possibility of drug resistance eventually requiring second-line treatment, and the need to take the drugs regularly for life.

Drug shortages are a great cause for concern as they affect adherence and further chances of drug resistance. The original draft programme does not spell out procurement plans and journalists’ reports point to many gaps in the procurement process. NACO officials admit that initially drug shortages were common, but claim the system has now been streamlined.

Paediatric formulations were not available for two years after the scheme started, though NACO’s guidelines specifically state that children will have priority for ART. Similarly, the drug combination with efavirenz, suitable for people with hepatitis B or concurrent TB treatment, was made available only several months after the programme started. Even so, there have been frequent shortages, apparently because of procurement issues.

Though NACO has started responding to the complaints on drug shortages, even today information about drug stocks and possible shortages is not in the public domain.

Second-line treatment is already becoming a concern in some parts of the country where ART has been available for a longer period and patients have developed drug resistance. A YRG Care study found that 20% of their drug-naïve patients were infected with resistant forms of the virus, requiring second-line treatment. Indian AIDS patients have been lobbying for the national programme to include second-line drugs, for which cheap, generic versions are not yet available.

However, experts caution against scaling up the ART programme until monitoring systems are strengthened.

Training for healthcare staff involved in the roll-out is inadequate to implement and monitor a relatively complex drug regimen. Though all the drugs have toxic side-effects, the programme gives drug toxicity a go-by. Training is currently limited to doctors in government hospitals providing ART.

There are fears too that a poorly monitored treatment programme will contribute to an increase in cases of drug resistance.

There are complaints that by limiting ART to those with a CD4 count of 200 or less, the government is effectively making people wait until they are ill enough to qualify for treatment.

The majority of people – even the poor – depend on private healthcare for treatment. Even with the expansion of ART roll-out, people depend entirely on an unregulated private sector because of fears of breach of confidentiality or in the hope of quality services. The private sector is known to be profit-driven, promoting expensive and sometimes irrational treatments.

NGOs and HIV-positive people seem to be poorly represented in discussions, with their involvement often confined to a token presence on committees. Some HIV-positive people suggest that the leadership of some of their organisations is not always concerned with the needs of the poor and uneducated among them, who largely look to the networks for support.

There is no material in local languages for HIV-positive people on where ART is available, enrolment procedures, drugs, possible side-effects and the importance of treatment adherence. A study concluded in 2007 pointed out that 41% of respondents did not take ART because of lack of knowledge about the treatment. More than half of all public and private patients had not heard of CD4 (57%) or viral load testing (80%).

ART is still beyond the reach of the marginalised. Though in some states like Goa, sex workers and migrant workers report being treated as “any other patient”, in other states like Tamil Nadu and Maharashtra, marginalised groups such as men who have sex with men or commercial sex workers report avoiding public hospitals, having experienced discrimination. Further, some selection criteria for enrolment in the treatment roll-out effectively deny ART to those who need it the most.

NGO workers in West Bengal report that ART is still inaccessible to those in rural areas or those not within the reach of NGO programmes. All state reports point out that HIV and AIDS prevention and treatment services are urban-centric. Quality as well as quantity of services starts reducing as one moves from the cities to the villages.

The training programme for doctors ignores the special skills needed to communicate with children. Though women make up about 40% of HIV-positive people, they make up less than 33% of the total number of people on treatment. It has been argued that women are at an earlier stage in the epidemic, so their CD4 counts are less likely to be low enough to qualify. These numbers need to be tracked closely in future to understand the true picture.

Despite ramping up voluntary counselling and testing services, marginalised groups still cannot access them. Awareness programmes still do not reach rural women and marginalised groups. Drugs for opportunistic infections and treatment of sexually transmitted diseases are unavailable in many public hospitals.

Beyond ART

Several people expressed the need for nutritional support as part of the ART programme, as well as care in general. Good nutrition does not mean high-cost nutrition. Some NGOs have developed inexpensive indigenous diets, and also organise sponsorship for those in need. Nutritional counselling and information on nutrition needs to be an integral part of the campaign. Despite the strong need, however, there are no plans for overall nutritional support within the government’s ART roll-out programme. Recently, the government has announced the provision of nutritional supplements to take care of 60% of the calorie, protein and micronutrient needs per day of over 3,000 children currently under the ART regime.

Though ART and CD4 tests are free, patients have to incur travel costs to reach the centres. Some states like Tamil Nadu have waived travel costs in public transport for HIV-positive people. However, various other diagnostic tests are not free till the patient is enrolled for treatment.

The programme needs to look beyond ART -- at ways of improving literacy among women, lowering rural indebtedness, food security, and improving access to quality low-cost healthcare.

ART vs public health

Numerous reports point to problems with the public health infrastructure in general, leaving aside ART. Public hospitals today are often under-staffed and under-stocked. Indeed, the quality of the ART programme in a state seems to depend, at least partly, on the quality of its healthcare system. In this regard, Tamil Nadu’s HIV management is far ahead of most other states in the country, though much remains to be achieved. At the same time, the abysmal public health infrastructure of states like Uttar Pradesh raises questions about both surveillance and the system’s ability to provide care.

The public health infrastructure must be strengthened not only in public hospitals, but at all levels down to the village community. In order for people to be referred to a hospital for ART, health centres at the primary level must be able to refer people for more advanced treatment. Public health is a state subject, while national programmes – such as AIDS treatment – are funded by the central government. Government funding has remained stagnant in the last three decades. The weakening of public health systems is linked to the increased reliance on market mechanisms to address welfare needs. But there are also variations in states’ commitment to social expenditure on health, education and welfare. Kerala, which has a history of state-supported services, continues to spend more on health compared to other states, despite cut-backs since the 1980s. The state announced its own ART scheme, the ‘Trissur model’, which integrates itself into the health system, providing comprehensive out-patient and in-patient care for about 800 people. Using funds from the state government and the Kerala State AIDS Control Society, it also provides ART for 200 people. However the question of sustainability is an issue, as the state government is starved of funds.

The NACP-III plan lays down a financial requirement of approximately Rs 134 crore for ART roll-out over a period of five years. The budget for paediatric ART is Rs 11.1 crore and Rs 1.56 crore for setting up paediatric centres of excellence. It is not clear where this money is coming from. Comprehensive information on the programme’s financing and disbursal of finances is not easily accessible. Some guidelines and statements mention provision of treatment for five years. This casts doubts as to whether the programme will ever be comprehensive and sustainable.

The Patents (Amendment) Bill 2005, passed on March 23, 2005, is expected to have serious implications for access to affordable essential drugs. This amendment to the Patents Act of 1970 was made to fulfil the government’s obligations on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as a member of the World Trade Organisation (WTO). India now recognises patents retrospectively from 1995; formulations developed since then may be manufactured only with the consent of the patent holder and on payment of royalty. Health networks lobbied hard for modifications to the original bill and managed to include clauses enabling the manufacture of essential drugs, including compulsory licensing of essential drugs. Still, it is felt that the Act is more restrictive than required by TRIPS, and the clauses difficult to implement.

First-line drugs currently in the ART programme date back to before 1995 and will not be affected by changes in the Patents Act, if any, and second-line antiretrovirals that are out of patent, such as tenofovir, will not be covered either. Some new applications on tenofovir are pending; if accepted, this would prevent off-patent production of the drug. Activists have challenged these applications.

Indian companies have not used compulsory licensing so far. However, the Indian health minister recently said that India may be forced to overrule patents and issue licences for firms to produce vital drugs. Much depends on mobilisation of public opinion.

We must strengthen our healthcare system so that it can meet the needs of people with HIV and AIDS, just as it must meet the needs of all people needing treatment for any illness. The ART roll-out must be seen as an opportunity to demand a better and more responsive healthcare system for all.

Excerpted from ‘Antiretroviral drugs for all? Obstacles in accessing treatment: Lessons from India’, Panos, March 2007

(T K Rajalakshmi is a correspondent for the Indian newsmagazine Frontline)

InfoChange News & Features, January 2008