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Gujarat FDCA launches programme to monitor sale of anti-TB drugs in retail drug stores

Shardul Nautiyal, Mumbai
Saturday, December 30, 2017, 08:00 Hrs  [IST]

The Gujarat Food and Drug Control Administration (FDCA) has recently launched a programme to monitor sale of anti-TB drugs through the retail supply chain which will help keep effective oversight on the quality of drugs consumed by TB patients.

There are around 37,000 drug retail shops in the state of Gujarat. Gujarat has continued its crackdown on spurious drugs through its post-marketing surveillance programme. It collected 11,300 samples in 2014-15 and 9,713 samples in 2013-14.

Says Gujarat FDCA Commissioner, “Through this exercise, we will generate data which will help assess the prioblem of spurious drugs in the interest of patient safety. The circulation of substandard and spurious, falsely-labelled, falsified or counterfeit medicines has been acknowledged as a serious public health problem.”

This comes close on the heels of Central Government also upscaling sensitive diagnostic modalities across 10 cities of the country as a part of its implementation research projects by using Genexpert to pick up TB and Multi-Drug Resistant TB (MDR TB). Genexpert test is a molecular test which detects the DNA in TB bacteria. It uses a sputum sample and can give a result in less than 2 hours.

Moreover, the proportion of MDR-TB among previously treated TB cases has exceeded 50% in several countries. In 2006 extensively drug-resistant TB (XDR-TB) was reported in all regions of the world and was rapidly classified by World Health Organisation (WHO) as a serious emerging threat to global public health. By March 2011, 69 countries had reported at least one case of XDR-TB. MDR-TB and XDR-TB are much more complex and costly to treat than drug-susceptible TB.

Reports on medicines quality problems with their serious health repercussions appear to be on the increase, the exact magnitude of the problem is unknown. The diversity of sources of information makes compiling statistics a challenge. Sources include reports from enforcement agencies, pharmaceutical companies and nongovernmental organizations, as well as ad hoc studies of specific geographical areas or therapeutic groups.

Counterfeiters, by contrast, are extremely flexible in the methods they use to mimic products and prevent detection of their activities. Medicines quality problems are particularly prevalent where regulatory and legal oversight is absent or weak.

Survey of the quality of anti-tuberculosis medicines circulating in selected newly independent states of the former Soviet Union in November 2011 by WHO states that since 2000, no country outside of Eastern Europe and Central Asia has reported proportions of MDR-TB among new cases exceeding 6% (for countries reporting more than 10 MDR-TB cases).


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