Gujarat FDCA new plan to monitor to ensure drug quality & patient safety

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A good initiative planned to be taken by the Gujarat FDCA through Post-marketing surveillance programme, which will be going to be a part of state’s efforts to crackdown on spurious drugs.Food and Drug Control Administration (FDCA), Gujarat working on a plan to extract clinical data on medicines used by patients from drug retail chain to assess drug quality in the interest of patient safety.

In Gujarat state, around 37,000 drug retailers are running chemist shops. This is not the first state’s attempt as Gujarat has continued its crackdown on spurious drugs through its post-marketing surveillance programme and collected 11,300 samples in 2014-15 and 9,713 samples in 2013-14.

Gujarat state FDCA is very active and trying best to keep the check on spurious drugs and its ongoing random sampling surveys at pharma stores, hospitals, and manufacturing plants consolidated on a yearly basis across the state registered a collection of 13,540 samples in 2016 which is the highest in the country. The other states like Karnataka, TamilNadu, Andhra Pradesh, Maharashtra and Himachal Pradesh following Gujarat respectively.

Dr. HG Koshia, Commissioner of Gujarat FDCA explained that this step will help us to identify the drug compliance followed by patients under treatment for chronic ailments and quality of the medicines at the same time. Post inspection, patients who are mostly treated under private healthcare setups can be referred to the government healthcare institutions towards enhancing the quality of patient care at an affordable price.

Gujarat state running a programme to extract the report of the sale of anti-TB drugs through the retailers, additionally continuing for successful oversight on the nature of medications devoured by TB patients. FDCA noticed an increase in the reports regarding quality issues of the drugs and their adverse reactions on patient’s health as the exact magnitude of the problem is unknown.

Supply of substandard medicines in the market is very common and to keep the check on that random- sampling routine helps a lot. A few years ago, reports reveal that presence of sub-standard drugs in India has considerably come down from 8 percent to 4.5 percent. Poor manufacturing practices, quality control, and poor packaging leads to manufacturing substandard drugs are medicines that are of lower quality because of poor manufacturing, quality control, storage or packaging practices. And Spurious drugs are different from these drugs as spurious drugs are mostly imitations of genuine drugs.

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