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October 01, 2023 04:35 am | Updated 04:35 am IST
The story so far: TB drug shortage began last year when Rifampicin — a medicine used for treating drug-sensitive TB — was not available in many parts of India. Since June this year, three important medicines used for treating drug-resistant TB — Linezolid, Clofazimine, and Cycloserine — too faced a stockout. On September 26, a PIB press release said that some media reports alleging shortage of anti-TB drugs in India are “vague and ill-informed, without any specific information on the availability of anti-TB medicines in stock”. But in the same release, it also said that “in rare situations, States were requested to procure few drugs locally for a limited period by utilising the budget under National Health Mission (NHM) so that individual patient care is not affected.”
On August 23, The Hindu reported the Tamil Nadu State TB Officer Asha Frederick as saying that the Union government had “not supplied adequate doses of Rifampicin and some drugs used for treating people with multidrug-resistant TB (MDR-TB), and the State have been asked to procure the drugs themselves but no additional funding has been provided”. Several media reports quoting TB patients in different States facing drug shortage have also been published.
On September 14, Dr. Tereza Kasaeva, Director, Global TB Programme at the World Health Organization, had written, saying: “We at WHO — across 3 level [sic] — are also deeply concerned and closely following the situation with the TB drug stockouts.” She also said: “Our colleagues from WHO country office are in contact with the Government of India and have visited at least four States this month to evaluate the situation on ground and support. We’ve been informed that actions are underway.” She ends the mail addressed to Lucica Ditiu, Executive Director of the Stop TB Partnership, and others, saying: “We agree with you that there are some systemic issues that allow stockouts [to] happen periodically. These issues should be urgently addressed and avoided in future.” The same day, Lucica Ditiu of Stop TB Partnership in an email said: “The situation [in India] is worrying and… the MoH [Ministry of Health]… are aware as well.”
On September 21, in response to a query from Banjot Kaur of The Wire during the WHO virtual presser, Dr. Kasaeva said: “We are aware and noted with concern the recent reports of shortage of TB drugs affecting some provinces and facilities in India. The WHO country and regional offices are closely following this situation by visiting States and facilities… The assessment is still going on… We are working closely with the government and partners and this unfortunate situation will be sorted out soon… by the end of this month or beginning of next month.”
In a September 26 press release, the government claimed that all drug-sensitive TB drugs are “available with sufficient stocks ranging six months and above”. In the case of drug-resistant TB drugs, it shared the stocks available at the national level and in Maharashtra without explicitly saying how long the stocks would last.
Based on the stocks of MDR-TB drugs said to be available in Maharashtra in the press release, Vaishnavi Jayakumar, a member of ISthmUS (a pan-Indian network of volunteers focusing on life-sustaining medical supply access during a crisis), pointed out in a tweet that Maharashtra has less than a month’s stock of two MDR-TB drugs. While 79,926 capsules of Clofazimine were said to be available in stock, she pointed out that the monthly requirement was 97,408; the stock available would not last even a month. In the case of Linezolid, the stock available in Maharashtra was put as 86,443 while 1,34,958 medicines are needed in a month. At the national level, she calculated the stocks of different MDR-TB drugs from the data of tenders available on the Central Medical Services Society (CMSS)’s website. While the stock of Clofazimine (100mg) as on September 26 was found to last for over three months, the stock of Cycloserine (250mg) would last only for one month and just over two months for Linezolid (600 mg).
Ms. Jayakumar told The Hindu that as per the 2021 guidelines for programmatic management of drug-resistant TB in India, the Centre procures TB drugs which remain at the Central Medical Services Society (CMSS) warehouse, and supplied to States when demands are raised. In the case of MDR-TB drugs, at the district level, the drugs are sorted keeping in mind the particular requirement of each MDR-TB patient, which is called a patient-wise box. “Such patient-wise boxes are to be prepared for each MDR-TB patient and handed over to them,” she said. “Apart from the logistics of distributing the drugs to the States, the MDR-TB drug boxes for each patient have to be prepared. According to the 2021 guidelines, at the State-level, there should be two months’ stock of medicines and one month stock of patient-wise boxes at a minimum. So a minimum stock of three months is needed, as per the guidelines.”
She also pointed out that two tenders published in early May for MDR-TB drugs for two months’ supply were cancelled in late-June for administrative reasons. “Two short online tenders were published only in early July. That is where the trail ends,” Ms. Jayakumar said. The PIB release says the drugs were procured in August.
Ms. Frederick told The Hindu in August that the short-course drug combination regimen of Isoniazid-Rifapentine given once weekly for 12 weeks (3HP) to prevent TB in people with latent TB infection was never supplied to States. The new drug regimen was launched by Prime Minister Narendra Modi in March this year.
No. In September 2021, India faced a shortage of MDR-TB drug Delamanid. In 2013, India faced a TB stockout of first-line TB drugs Rifampicin and Isoniazid, and paediatric TB drugs.
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