One of India's best performing health programmes is in trouble, and the cause seems to be red tape
Few would have heard of Perambalur, the landlocked district in eastern Tamil Nadu. But it is emerging as ground zero in the next stage of India’s fight against the deadly HIV, or human immunodeficiency virus.
Eight patients who have tested HIV positive, despite being enrolled in the local government-run antiretroviral treatment (ART) centre since November, don’t have medicines to treat the infection. Similar stories are trickling in even from bigger towns like Tiruchirappalli and Namakal.
Their situation is symptomatic of a larger crisis that has been developing across the nation.
The supply of antiretroviral drugs, which has been erratic since December 2013, has worsened. Without replenishments, stocks depleted rapidly in 2014, eventually resulting in empty shelves from January this year. Over the last nine months, every ART centre in the country has run out of at least one drug for several weeks.
At ART centres, patients are initially given so-called first line drugs, which keep the virus count down and thereby prevent infections. Those who turn resistant to these drugs, or require alternative medication, are moved up to second line drugs.
Health experts are sounding the alarm. Any disruption in the course of medication leads to the virus developing drug resistance. Not only does it increase the risk of transmission of the virus from an infected mother to her child, but also means that patients will be forced to consume stronger—and correspondingly more expensive—dosages in the future.
“The trouble is, with HIV, the effects are not visible in a week or month. By the time drug resistance seeps in, damaging gains made in the past two decades, it will be a different government at the Centre," said a senior health ministry official.
The irony is that the crisis in the making has been known to all stakeholders; and, for some time at that. A series of emails exchanged between the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), World Health Organization (WHO), National AIDS Control Organisation (Naco) and the Clinton Foundation between May and October 2014, reviewed by Mint, shows that there was continuous correspondence among them even as stocks dwindled at ART centres.
It all began when Cipla Ltd, a key supplier of antiretroviral drugs, stopped participating in government tenders from June 2013 to May 2014 after it did not receive payments for previous supplies.
Yet, it was only in September last year that the government moved on it. A senior Naco official wrote to Cipla, pleading to the company to continue supply of paediatric HIV drugs as the AIDS control programme risked running out of medicines to dispense to children by 30 September.
On 20 September, another senior official, Naco’s national programme officer B.B. Rewari, renewed the appeal: “It is a crisis situation. As a stopgap arrangement, you are requested to provide minimum three months quantities (nearly 2,500 bottles) under CSR (corporate social responsibility) so that the infants/and children who are on this drug do not suffer from discontinuation of treatment."
Cipla did eventually supply the requested drugs. Even though it has decided to bid for the next tender, its future participation is unclear. Without divulging details, the company’s spokesperson said: “We have already supplied part quantities of LPV/R syrup of last year’s tender and are in the process of supplying the balance quantities. We haven’t supplied Nevirapine syrup to the Unicef."
Both LPV/R syrup and Nevirapine are paediatric antiretroviral drugs that Cipla supplies to the United Nations Children’s Fund (Unicef) for further distribution.
With a stop-gap solution for paediatric drugs in place, attention has now moved to adults, with first line drug Tenofovir going out of stock.
In a bid to exert pressure on the authorities, activists wrote to WHO, GFATM, Unitaid and Clinton Foundation, to raise the issue of timely approvals with the then health minister, Harsh Vardhan.
It was then discovered that Aurobindo Pharma Ltd had already won the tender for supplying this drug in June 2014—a month earlier the Bhartiya Janata Party (BJP)-led National Democratic Alliance had assumed office. However, for three months, the ministry failed to issue a “Notification of Awards (NOA)" through its procurement agent, RITES Ltd.
“Since the NOA was not issued, the company could not start manufacturing the drug," said an activist on condition of anonymity.
Finally, the NOA was issued in the last week of September. However, the authorities were now facing a new problem. While the drug supply was resumed, stocks of second line drugs and diagnostic kits, or equipment to test for viral load, were running out.
As of January, all 10 centres in the country that are capable of viral load assessment had run out of diagnostic kits. In the absence of kits, there is no means of assessing whether a treatment is working for a patient.
September and October saw the most widespread incidents of shortages of first line HIV medicines at ART centres, claims Vikas Ahuja of Delhi Network of Positive people.
By December, the ministry was accepting handouts from any and every available donor to deal with the crisis of lack of supplies. In fact, the Clinton Foundation diverted 1,200 bottles of LPV/R syrup for children from Nigeria. “The drugs were sent to Nigeria from India—given that we are the pharmacy of the world," a senior Naco official said.
On 9 October, National Coalition of People Living with HIV in India donated 15,000 bottles of NVP syrup to the health ministry, Naco to be specific. By December, the AIDS department was awaiting a donation of 50,000 bottles of NVP syrup from Unicef.
“WHO is assisting the health ministry in its efforts to smoothly and effectively avoid potential stock-outs," said Andrew Ball, senior adviser (strategy, policy and equity) at the department of HIV/AIDS in WHO.
“Since the last six months, more than 7 lakh HIV-positive patients across India are frustrated and angry with the government as there have been severe shortages and stock-outs in the supply of HIV medicines and kits," said Eldred Tellis, spokesperson for the Mumbai AIDS Forum and director of Sankalp Rehabilitation Trust.
In the past 25 years, India has made impressive progress through its national AIDS programme. In fact, the anti-HIV programme—with its vocal community and activist base—is one of its best performing health initiatives. The country is on track to meet the Millennium Development Goal of halting and reversing the HIV/AIDS epidemic.
The government estimates that about 2.4 million Indians are living with HIV. According to the health ministry, recent data suggests there are signs of a decline in HIV prevalence among female sex workers in areas where focused interventions were implemented, particularly in the southern states.
So, how did one of India’s best performing health programmes (possibly second only to the polio campaign) disintegrate so fast? The cause seems to be government red tape. Like in the case of polio, the success of the programme was due to the fact that it was mostly donor-funded and, hence, not bound by the plethora of government rules and regulations. And more importantly, there was greater accountability accompanied with scrutiny by non-governmental agencies.
“Because GFATM and other donors were watching like a hawk, timelines were met. Most importantly, having external donors means that the government cannot shut out civil society. Every decision was taken after consultation with patient groups, advocacy groups. When problems arose, decisions were quick and course corrections were prompt," said another senior Naco official on condition of anonymity.
In 2013, GFATM, a multilateral funding agency that offered the grant, wrote a 20-page note charging Naco and the ministry with putting the lives of HIV patients across the country at risk by failing to act. Mint reported this on 25 November 2013.
This memo was prompted after the health ministry sat on a $187 million international grant offered to the National AIDS Control Programme (NACP) for some 18 months, triggering the first spate of drug shortages.
In 1991, with a credit of $84 million from the World Bank, the government launched its first NACP. For the second phase, the World Bank credited another $191 million. By 2006-07, the third phase was launched with $250 million from the World Bank.
The fourth phase (2012-17) of India’s national response to AIDS, the NACP-IV, is being funded mostly by mobilizing domestic financial support. Naco estimates this to be 80% of the total budget.
“Therein lies the problem. AIDS is not sexy any more. The government is short of cash. Most importantly, AIDS is not a priority for the (Narendra) Modi government," explained the Naco official.
Union health minister J.P. Nadda maintains that tenders have been a persistent problem and something that has now been sorted by the government. The minister denied that any cuts in the budget related to the AIDS programme were being effected, while he conceded that a reprioritization of spending was being undertaken across the government given fiscal pressures.
“Having said that, none of our flagship programmes are going to suffer due to lack of funds," said Nadda.
Subscribe to Mint Newsletters
* Enter a valid email
* Thank you for subscribing to our newsletter.
Never miss a story! Stay connected and informed with Mint.
our App Now!!