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Gujarat FDCA to monitor retail drug supplies to patients towards achieving drug quality & patient safety

Shardul Nautiyal, Mumbai
Friday, January 12, 2018, 08:00 Hrs  [IST]

As part of its crackdown on spurious drugs through post-marketing surveillance programme, Gujarat Food and Drug Control Administration (FDCA) is planning to glean clinical data on drugs consumed by patients from drug retail chain to assess drug quality in the interest of patient safety.

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.

Gujarat FDCA through its ongoing random sampling surveys at retail and wholesale stores, hospitals and manufacturing sites consolidated on an yearly basis across the state registered a collection of 13,540 samples in 2016 which is the highest in the country.

This was followed by states like Karnataka, Tamil Nadu, Andhra Pradesh, Maharashtra and Himachal Pradesh.

“This will prove to be a two pronged approach at identifying the drug compliance followed by patients who are undergoing treatment for certain chronic ailments and drug quality at the same time. Post identification, patients who are mostly treated under private healthcare set-ups can be referred to the government healthcare institutions towards enhancing quality of patient care at an affordable price,” explains Gujarat FDCA Commissioner Dr HG Koshia.

Meanwhile, a programme to monitor sale of anti-TB drugs through the retail supply chain is also going on for effective oversight on the quality of drugs consumed by TB patients.

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

Trends on sub-standard drugs based on a nation-wide study coupled with routine random- sampling exercises done few years ago also reveals that presence of sub-standard drugs in India has considerably come down from 8 per cent to 4.5 per cent.

Substandard drugs are medicines that are of lower quality because of poor manufacturing, quality control, storage or packaging practices. Such drugs are different from spurious drugs, which are mostly imitations of genuine drugs and are often conspicuously labeled to deceive the patient about the ingredients, effects or manufacturer.

A pan India spurious drugs survey on 48,000 drug samples has also been done by the health ministry recently to assess for the first time complete testing of not-of- standard quality (NSQ) drugs as per Indian pharmacopoeia and other pharmacopoeias. Only 10 per cent of the samples were tested during the pan-India study done for the first time in the country in 2009.


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