In what could be one of the biggest setbacks for India’s tuberculosis control programme, there is a massive stock-out of anti-TB drugs across the nation.
Every year, 18 lakh patients need treatment for TB along with 1 lakh multi drug-resistant TB cases. However, the Central government will exhaust its inventory of drugs by July end. This means patients run the risk of either developing drug-resistant TB or losing their lives.
Across the nation, in almost every State, there is limited supply of drugs like Rifampicin and Isoniazid, the first line drugs used to treat TB. A senior Union Health Ministry official, who declined to be quoted, said that the situation is critical. Paediatric drugs have already run out and children were not being able to avail of the treatment in the public sector. Many are being turned away from centres.
The government is caught in a quandary because it has failed to procure TB drugs since 2012. The tendering for procurement should have been done a year before in 2011 but it wasn’t.
For two years, a drug like Streptomycin, used to treat TB, has not been bought. By March, this year, it was apparent that the department would fall short of the required medications. According to the Ministry of Health and Family Welfare (MoH&FW) data, there were only 5,39,269 doses of Rifampicin and 43,034 prolongation pouches required for patients who have to continue with medication even after completing their treatment. For paediatric patients, it was worse. There were just 61,062 doses for all four weight categories.
In August last year, the Joint Monitoring Mission, steered by Mario Raviglione, head of the STOP TB Programme at WHO, which reviewed the TB programme, had informed the Central TB Division (CTD) that there was an impending stock-out situation for paediatric drugs as well as prolongation pouches needed for patients who require to extend their treatment. But despite the warning signs, no steps were taken by the Centre to avoid a stock-out. As a stop-gap measure, Dr. Ritu Gupta, ADG, CTD wrote a letter to State TB officers in February stating that the stock position was precariously low and that, while the Division was in the process of procuring these drugs, States should use the available drugs carefully and, if there was extra supply, the drugs should be transferred to other needy districts after informing the CTD.
However, by the end of April, 2013, Dr. K.S. Sachdeva, Additional Director General, (TB) CTD, issued another letter to State governments and the Union Territories stating that there was a delay in the awaited supplies and that the States can go ahead with emergency procurement of Rifampicin at the district level as required for a period of three months.
However, since these drugs are procured and disbursed by the Centre, the States had not earmarked any funds for anti-TB drugs. Besides, since the money was disbursed late by the Centre, out of the Rs. 710 crore allocated for the TB programme by the MoH&FW, only Rs. 560 crore was spent in 2012-2013.
India bears the largest burden of TB in the world. Two people continue to die every three minutes even though the government spends approximately Rs. 300 crore annually to detect and treat TB. Since 1993, when the Revised National TB Programme (RNTCP) was launched, 5.5 crore people have been screened for TB and 1.6 crore patients have been treated, saving 28 lakh lives. Mortality rates dropped sharply from 28 per cent before 1993 when the new programme began to 7 per cent by reaching out to the population through its Directly Observed Treatment Short Course (DOTS) programme. Currently, the mortality rate is 4 per cent. Out of 15 lakh TB cases, 55,000 deaths are reported yearly.
But shortage of drugs can impact this success story severely and could undo all the effort that has gone into combating tuberculosis comprehensively.
Ironically, India is among the largest producers of anti-TB drugs globally. But at home, patients are struggling to obtain medicines. In a letter addressed to Ghulam Nabi Azad, the Union Health Minister, T. K. Ray of Voice of Patient, an organization representing TB patients, said: “[A] large number of patients being treated under the public health system are being deprived of the full course of proper treatment. Around 3,00,000 re-treatment cases, about 90,000 child TB cases and about 5,000 multi-drug resistant TB patients are not being treated according to existing protocols due to shortage of drugs at hospitals, State and district stores in the last one year. There has been no or very erratic supply of many drugs, both first and second line to the States.”
As a result, Mr. Ray mentions there has been a rising incidence of re-treatment cases being initiated into a treatment regimen without the availability of drugs. Similarly, paediatric patients are also being missed or turned away due to lack of drugs under the programme.
The problem, he says, stems from the ministry itself. “Timely and adequate supply of drugs is the single most important component that has been hit the hardest due to poor political commitment and difficult procurement procedures followed by the government.”
Currently, procurement of drugs is outsourced through a hired agency, Rites, whose contract is renewed every year. However, in March, 2010, the Ministry did not renew the contract. Since the TB division places requests for drugs between the months of January to March, procurement was stalled as the contract was almost going to be over. The renewal took a long time and was finally processed in February, this year. As a consequence, TB drugs for the years 2010-11, 2011-12 and 2012-13, were not bought.
The impact is being felt throughout the country. There is almost no stock of paediatric drugs. Children infected with TB are being turned away from DOTS centres in districts where the case load is high. But patients cannot approach the private sector since the regimen and schedule are different from the government programme. Under the DOTS programme, patients are prescribed an alternate day course while in the private sector patients are advised daily medication. For this reason, doctors find it hard to treat patients in the private sector.
Besides, with the government programme offering free treatment, chemists do not stock TB drugs any more since it is not commercially viable. So families who can afford to get treated in the private sector are also finding it difficult to source TB medicines.
A TB official in Kerala said that the demand for medicines is very high in Kerala since new technologies are being used to diagnose patients. About 30,000 patients are diagnosed with TB, nearly one-fourth of which are children. Since the stocks will run out by the end of this month, the principal secretary has decided to procure it locally but this is only a short term measure. A senior health official in Kerala said, “The Centre has to help us otherwise there will be a serious crisis.”
In Tamil Nadu, too, the State government has issued orders to procure drugs locally for 72,000 patients and officials say there is no shortage under the DOTS programme. Following the CTD’s letter about an impending stock out, paediatric drugs are also being procured.
“We have stocks of more than 10 months consumption for 5 of the 10 second line drugs, and of more than 5 months consumption for 4 of these drugs,” said Anshu Prakash, Joint Secretary in the Union Health Ministry, when queried about the precarious TB drug situation in the country. “Only in the case of one drug, Kanmycin, the stock availability is of 2.58 months. However emergency purchase for 6 months supply has been approved already for this drug and supplies are expected in the next 45 days or so. For the first line drugs, 7-8 months consumption requirement is available with us for drugs for adults, new as well as retreatment cases.”
Acknowledging that there were problems of procurement, Mr. Prakash said, these “have been overcome in time.” “Yes, we have dipped into our buffer stock. But presumably that is the very purpose of maintaining a buffer stock. This dip in stock is being recouped in a time bound manner,” he said.
But even in a State like Kerala, which is procuring the drugs locally, only 18 out of 80 patients in Kollam district have received prolongation pouches. The rest have been forced to go back to the normal regimen, which poses risks for patients.
Mr. Prakash also acknowledged that the problem area has been the paediatric drugs. But he said the “emergency purchase for these has been approved and sufficient stock for these drugs would be available in the next 45 days or earlier.”
However, other Health Ministry officials say this is not feasible. Even though approvals have been given for emergency procurement, States like Bihar, Jharkhand, Uttar Pradesh and Madhya Pradesh are not in a position to buy anti-TB medicines locally. Besides, the bigger concern is the timeline for acquiring medicines. Even though tenders have been placed about a month ago, manufacturers will take around six months to supply TB drugs since it takes longer to package multiple drugs into one DOTS kit. CTD officials believe that despite all efforts, it could even take up to a year to procure the drugs since the number of doses required is very high.
Such delays can only lead to a bigger crisis — more multi drug-resistant TB due to lack of compliance and even high rate of mortality among TB patients, especially children with severe infection. The government is walking on cinder and if it doesn’t act fast, the consequences could be disastrous.
(Mohuya Chaudhuri, former Senior Editor (Health) at NDTV, is an independent journalist. She also contributes to the British Medical Journal . This article has been written exclusively for The Hindu )