Costly lapse

The Central government’s failure to procure anti-TB drugs disrupts the country’s TB control programme.

It is a well-known fact that TB is curable only if the drugs are faithfully administered according to a strict regimen.

• India’s tuberculosis burden is estimated at 30 lakh cases.

• About 20 lakh more develop each year.

• Every three minutes two people die of TB in India—annually, around 330,000 Indians die of TB.

• In 2012, there were 81,482 paediatric TB cases.

• India accounts for one-fifth of the global TB incident cases of which 0.87 million are estimated to be infectious cases. Many remain undiagnosed.

• Only 5 per cent of diagnosed cases have access to proper and consistent treatment.

• Additionally, there are about one lakh patients who have multi-drug-resistant (MDR) TB.

AS if these facts were not appalling enough, there is more shocking news: there is likely to be a stock-out of essential drugs by the end of July. This means that existing stocks of the first-line TB drugs isoniazid and rifampicin being held by the Central government inventory are close to getting over and that government clinics and hospitals, which depend on receiving anti-TB drugs from the Centre, will soon cease to receive fresh supplies. The supply of the paediatric dose to these centres has already run out, which means that children have a Hobson’s choice of either interrupting their course of treatment or continuing it using adult pills that are cut and given in estimates of smaller doses. And the adult dosages will also be unavailable in many parts of the country.

It is a well-known fact that TB is curable only if the drugs are faithfully administered according to a strict regimen. The schedule is crucial to the cure. Quite simply, failure to keep to it means failure to be cured. So, in the present situation, the tag line of the Central TB Division, Ministry of Health and Family Welfare, which says “TB is fully curable with complete course of DOTS” (Directly Observed Treatment, Short Course) seems particularly insensitive. Apart from the issue of undermining the chances of the recovery of patients, the drug deficit has serious implications for overall public health.

The majority of TB patients are socio-economically deprived people. Since TB treatment is a long-term affair, the costs can be prohibitive, which is why years ago the Union government adopted the World Health Organisation-recommended DOTS strategy under which the diagnosis and treatment, including medicine, would be provided free to all TB patients.

There are more than four lakh DOTS centres in India, and almost all the patients that use them are economically deprived. These centres have been hit by the drug shortage. It must be understood that there is no shortage of the drugs per se —pharmaceutical companies continue to manufacture them.

There is just a shortage in government hospitals and clinics because the Central government failed to call for tenders from pharmaceutical companies to restock its inventory.

States depend on centre This process of restocking should have been started in 2011 so that by 2013 the Centre’s stock would have been replenished. But this was not done. The shortfall in stocks is being blamed on the procurement procedure and on Rites Ltd, the procurement agent. Rites is under contract from the Ministry of Health and Family Welfare to procure both first- and second-line anti-TB drugs. Although the Directorate General of Health Services (DGHS), which comes under the Ministry of Health and Family Welfare, itself says that uninterrupted supply of anti-TB drugs is essential to the success of DOTS, it also admits that in 2012 “the programme experienced some delays in supplies [but the situation was] managed by procurement of some individual drugs at the State/district level”. Most States depend on the Centre for the disbursement of TB drugs, so there is no provision to purchase them using State funds.

A memorandum sent to the Ministry in June, authored by Blessina Kumar, an activist for the rights of TB-HIV patients and vice-chairperson of the Coordinating Board of the Stop-TB Partnership, said: “Some States like Tamil Nadu have an efficient procurement mechanism such as the Tamil Nadu Medical Services Corporation, which has experience in procuring efficiently for public health programmes and will probably cope better than other States…. In Mumbai, the DOTS plus centres are already stocked-out of Category 5, i.e., XDR [extensively drug-resistant] TB drugs. XDR TB drugs are very expensive, have limited quality suppliers and are difficult to procure in small quantities.”

Calling for more transparency, Blessina Kumar said she believed that the Revised National TB Control Programme (RNTCP) knew that disruption of supplies was imminent but “is now denying the actual extent of the stock-outs of TB medicines in public health facilities and is even failing to share information with civil society on what actions it will take to address this situation”.

While the procurement process has been under fire for long, with activists saying there is no transparency, it may not be the key issue in the current situation. The Ministry seems to have been careless. Rites’ contract was up for renewal in March 2010, but the Ministry dilly-dallied and only renewed it early this year. This can only be termed dereliction of duty —why take two years to renew a contract, especially when the procurement process is a long one?

There was some speculation that inadequate funding was the cause of the logjam in procurement, but it can easily be put to rest. The majority of funding for the RNTCP comes from Central sources, including the World Bank. Money is also provided by donor agencies such as the Department for International Development (DFID) of the United Kingdom, the Global Fund and the United States Agency for International Development (USAID). About half the drug requirements of the RNTCP are procured using funds from the DFID.

The Centre itself increased the budget for the RNTCP in the Twelfth Five Year Plan, allocating it Rs.4,500 crore. Patting itself on the back, the DGHS says this amount is given “based on the physical and financial performance during the Eleventh Plan” and therefore indicates the success of the RNTCP. Energised by a certain degree of success, the RNTCP set grand targets during the Twelfth Plan. It aims to treat around 87 lakh TB patients and two lakh MDR TB patients. It has also planned to reduce the “delay in diagnosis and treatment of all types of TB cases”. The cost of this will be Rs.1,797 crore for anti-TB drugs, 62 per cent of which will be second-line MDR TB drugs, which most patients will find too costly to buy for themselves.

The Ministry’s projections of success are hopeful. The official annual status report brought out by the Central TB Division, entitled “TB India 2013”, says: “If the RNTCP is successful at achieving its objectives by the end of 5 years, modelling has indicated over the next 15 years that TB incidence may decline by around 30%, and MDR TB will be reduced by 50% as compared to 2010. This translates to 750,000 lives saved, 1.7 million TB cases and 100,000 MDR TB cases averted over 15 years.”

An admirable objective, but possible only if drugs are available. The present circumstances are such that India’s TB programme, which was fighting an uphill battle, now seems set for a tumble, and it all seems to be because of an inexplicable lapse within the Ministry of Heath and Family Welfare.