“It is the patients who suffer the consequences of poor regulation of TB drug formulations in India. An increasing number of our patients are being diagnosed with drug resistant TB (DR-TB).
We encounter a spectrum of resistance patterns which range from mono-drug-resistant TB all the way through to extensively drug-resistant TB (XDR TB),” said Dr Simon Janes, medical coordinator with Medecins Sans Frontieres (MSF) in India.
“This makes it even more difficult for treatment providers like MSF and the government’s TB Control Programme to accurately diagnose and treat the different forms of drug-resistant tuberculosis,” Janes said in a statement released on the eve of World TB Day.
According to a MSF study, DR-TB infections are on the rise in the country and this has made the disease more difficult and considerably more expensive to treat.
The conditions for emergence of drug resistance are increasingly being linked to poor drug regulation in the country.
“In our experience of working in India since 1999, we have seen prescriptions from private health providers that were completely inappropriate.
For example we have seen many prescriptions that prescribe three out of the four first-line TB drugs in combination with a quinalone (antibiotic),” said Dr. Homa Mansoor, TB Medical Referent for MSF India. “The alarm on drug resistance has been sounded, and the Health Ministry must act now to address this public health crisis,” Mansoor added.
Lack of oversight from the drug regulatory authority – the Drug Controller General of India (DCGI) – has made even basic treatment of drug-sensitive TB difficult to monitor.
In the face of so many different formulations available in pharmacies across the country, ensuring the correct prescription of first-line TB drugs in the private sector is almost an impossible task for the Central TB Division (CTD), the MSF statement claimed.
As a result, poor compliance to World Health Organization (WHO) treatment guidelines is common among private doctors. TB patients being treated by private doctors in India might be facing a grave risk of developing drug-resistant TB due to irrational prescribing practices or indiscriminate use of non-WHO-recommended drug regimens, it said.
MSF has demanded strict regulation of first-line TB drug formulations and prescription practices in the private sector.
In a bid to prevent further emergence of drug-resistant tuberculosis in the country, the group has sought implementation by the Central TB Division of a standardised first-line daily drug regimen across the public and private sectors to help in simplifying prescription, adherence and drug supply management of first-line TB treatment.
“Other countries have already undertaken steps to control DR-TB, by ensuring drug regulatory authorities strictly regulate the quality and formulations of first-line TB drugs in the private market.
“Governments like Brazil have even taken the additional step of making the public sector the primary distributor of all TB drugs,” said Leena Menghaney, India Coordinator of MSF’s Access Campaign.
According to the Central TB Division, India has the highest burden of TB with two million cases every year. WHO’s Global Tuberculosis Report (2013) says India has the second highest MDR-TB burden in the world with an estimated 64,000 cases in 2012.
Yet only 14,000 people in India with MDR-TB have access to the treatment they need to stay alive, MSF said.