health crisis

Shortage of anti-HIV drugs is result of bid to reduce wastage, say national AIDS body officials

States are running out of life-sustaining drugs because they aren't monitoring stocks of drugs in their areas efficiently, NACO officials say.

The critical stock-outs of antiretroviral drugs – used against the Human Immunodeficiency Virus, in state-run clinics across the country – are being blamed on the governing body, the National Aids Control Organisation.

There have been shortages of antiretroviral, or ART, drugs in government centres for the past two years now. But from March, the stock-outs seem to have worsened, particularly in Maharashtra.

NACO has scaled down considerably over the last few years. Once a reasonably autonomous organisation, with a dedicated director-general and secretary, it is now managed by an additional secretary. NACO ceased to function smoothly after external donors reduced their funding in 2012.

In 2015, there was a huge furore when funding for the National Aids Control Programme was slashed by 22%, – from Rs 1,785 crore to Rs 1,397 crore. This year, it was partially restored to 1,700 crore.

Scroll.in spoke to Dr RS Gupta, joint commissioner, NACO, about the possible reasons for the increasing incidence of stock-outs of these life-sustaining medicines, and how the organisation planned to fix this. Dr Manish Bamrotiya, programme officer, ART, NACO, was also present during this interview, and has responded in places.

Why are there so many stock-outs? What processes are followed in the distribution of stock, and what is not working out?
RS Gupta: One thing we have to understand is that we have limited resources. We have to understand our requirements. Currently we keep only 5%-10% excess stock. We have a supply only for 15 months in a year, which is three months in advance. This serves the purpose of maintaining supply. Throughout the states, there is some deficient supply of drugs. The in-state management is handled by the State Aids Control Societies.

There are two things here. We are checking the expiry of ARV [antiretroviral drugs] and closely monitoring the stock at the state level. Earlier, many drugs would expire in states. Maharashtra itself disposed of a lot of expired medicines in the past. They were not keeping watch over expiry of medicines. That’s is the reason we got a lot of audit problems, both in those states and centrally. To avoid wastage of government money we are keeping a strict watch on medicines. The state body has to manage the stock in their state and ensure relocation of medicines between ART centres in the state. Whenever medicines are in critical stock, we divert medicines from other states too. States have to be more productive, and have to closely monitor the weekly status.

Is there a problem with funding? In the Bombay High Court, where a public interest litigation is being heard about stock-outs, your counsel spoke of the lack of funding.
RS Gupta: Money is not a problem. We are part of the Ministry of Health so funds are not an issue. If we get a good response in the bids, and are able to procure medicines on time, we are able to maintain adequate stocks in the field. But when the bid response is poor, and nobody comes forward to supply medicines, or we are not getting a good price, then it becomes difficult and we cannot procure medicines.

Recently we had a problem when the government changed the excise duty on medicines. One of the bids, which was the lowest earlier, became the second lowest. This then becomes an administrative and financial issue and then takes time [to resolve]. It may look like a small thing, but it is a difference of Rs 1.5 crore.

There seems to be a serious shortage of paediatric ART stock. Is that true?
RS Gupta: We have a critical stock of paediatric medicine. We are arranging it, though. It is not available in the market. Only some companies apply for the bids. The companies supply it only to international markets. It is not available here as they are not very profit-making. It is not a rapidly-circulating medicine. These medicines are not prescribed in the private sector as much either.

We are told that NACO has a rule that patients can buy medicines from the market if there is a stock-out, and can be reimbursed for it.
Manish Bamrotiya:
If there is a shortage, State Aids Control Societies can purchase from any funds available. If the states can’t, then the ART centre can. If both can’t, these situations [stock-outs] arise, then the patient can buy and it is reimbursable.

Has it been done earlier? Why aren’t the states doing it then?
It has been done earlier. It can be done via local tendering. You need to spend time, you have to put energy and make a tender.

So are you saying that when there was excess stock, the programme was running smoothly. And now that you are monitoring it closely, the states are not coordinating well?
RS Gupta: They have to keep watch over their stock and submit timely reports. See Himachal (Pradesh) has not submitted its report yet, how will I ensure the availability of medicines?

People have been complaining of stock-outs for two years now. Have we seen an increase in resistance? Are we getting more “lost to follow-up” cases?
RS Gupta: We have not seen an increase in resistance. We have 15,000 patients on second-line treatment in India. Loss to follow-up is on the lower side. It is 6%-9% across states.

There was a change in the distribution system that was referred to in the high court case. What is that?
Manish Bamrotiya: In 2011, the consignee was the ART centre. The stock would directly go from NACO to the ART centre. The ART centres were fewer then. With decentralisation and expansion of services, the states have been identified as the source. The lower down monitoring has been given to the state.

What do we do about stock-outs? State bodies says NACO is not giving, NACO says states are not monitoring?
RS Gupta: We are not saying this. Now, together with State Aids Control Societies and ART centres, we have to ensure regular monitoring and they have to keep watch over stock availability and compile the report at the state level and send it to us. Whenever the stock is at a critical level, the State Aids Control Societies have to refill the requirement. They have to ensure that they inform us on time so that we can ensure supply or relocate stock from other states. They can also procure [drugs] from the market. We have no objection. We have shared the specifications of the medicines, including last quoted price.

Manish Bamrotiya: I just want to add that we have launched an online management system too in November 2014. It was scaled up last year to all the ART centres so that we have more visibility on the field. For public convenience, we put out weekly stock on the website too.

This is the concluding article of a three-part series on the critical shortage of anti-HIV drugs in state-run centres.

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