Delays in procurement of tuberculosis drugs and stock-outs across the country are affecting tuberculosis patients, say people familiar with the country-wide treatment programme.
Says Leena Menghaney of international humanitarian organisation Médecins Sans Frontières, "As a country with such a high burden of tuberculosis, MSF is deeply disturbed that India is experiencing stock-outs of critically needed drugs to treat children and those with drug-resistant TB."
“In this instance, it’s a stock-out that can cost people’s lives and the government must act urgently to fix the problems,” says Menghaney, India Manager of MSF’s Access Campaign.
A spokesperson with drug-maker Lupin, that makes TB drugs, said that companies were waiting for the Government to start the procurement process, so that they could participate in the tender system, and supply drugs to the programme.
He denied the view that companies were not making the drug, waiting for the new drug price control norms.
India is experiencing stock-outs across the country of both paediatric TB drugs and those used to treat drug-resistant TB (DR-TB). Under India's public TB treatment programme, the central government is responsible for buying drugs and distributing them to the States which then provide treatment, MSF explained.
Tendering issues
The stock-out is related to never-ending issues with drug procurement that India faces in many of its public health programmes - the routine but deadly delay in tendering for these drugs - and the resulting drug stock-outs are one of the reasons why India has one of the world's highest burdens of DR-TB, the note added.
“As a TB treatment provider, MSF is witnessing the impact this is having on our own patients," says Dr Homa Mansoor, the TB Medical Referent for MSF India.
“In our Mon, Nagaland project, I’ve seen a 12-year-old girl on treatment arrive with her father after a long journey to get her medicine. The medicines were out of stock, but luckily we had six days’ worth of drugs available from a patient who had died. Otherwise, we’re having to resort to breaking adult pills to give to children, which is really dangerous as it could over- or under-dose them.”
Other patients have been forced to purchase medicines from private pharmacies, but have received lower-dosage drugs, which – if it causes a patient to under-dose on that drug – could lead to resistance.
“A continuous, sustainable supply of quality-assured medicines is vital for TB patients to have even half a chance of being cured," Dr Mansoor said.
“As a doctor, I know the disease, I know how to manage it, but I feel powerless because we don’t have the medicines to treat.”
“It’s just not good enough that India talks of scaling up DR-TB treatment, but finds the medicine cabinet empty at a time when the most vulnerable patients – those diagnosed with DR-TB - are most desperate to get the medicines that can treat them," Dr Mansoor added.
The stock-outs in India are occurring as the World Health Organisation late last week issued interim guidelines on bedaquiline, the first new drug to treat TB in 50 years, approved by the US Food and Drug Administration at the end of 2012.