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Karnataka DC dept intensifies surveillance on antimicrobial drug sales to prevent AMR
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Nandita Vijayasimha, Bengaluru
November 25 , 2023
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The Karnataka drugs control department has further intensified its surveillance on pharmacy outlets and pharma companies in an effort to monitor sale and manufacturing practices of antimicrobial medications. This will begin with the close monitoring of all antibiotic, anti-viral, anti-fungal and anti-parasitic medications. In the case of the over-the-counter sales, pharmacists will need to vend these medications with caution.
The department has noted the need for a concerted effort across pharma companies, pharmacies, regulatory authority and pharmacy colleges.
From a regulatory perspective, implementing and enforcing regulations to control the manufacture, sale and distribution of drugs is an ongoing process. Yet, our directive to the pharmacy outlets is that drugs for infectious diseases, which come under the Schedule H and H1 categories, need to be dispensed with a latest prescription from a registered medical practitioner. There are 18 antibiotics under Schedule H1. The pharmacy retail needs to maintain records systematically on the quantum of stocks and sales incurred for antibiotics, among others, said Karnataka drugs controller BT Khanapure.
Calling upon the pharmacy outlets to team up to prevent the spread of the deadly antimicrobial resistance (AMR), Khanapure said, “Think thrice before dispensing an antibiotic. It should be the right prescription, right antibiotic and right quantity.”
Our enforcement team has filed 51 cases against pharmacy outlets over the last three years with regard to sale of Schedule H and H1 drugs, without prescription. Pharmacists play a major role in the dispensing and disposal of antibiotics. There is need to advice and counsel patients on how to take antibiotics and put in place proper disposal of unused and expired drugs, Khanapure said.
For the World Antimicrobial Awareness Week (WAAW) 2023, from November 18 to 24, Karnataka drugs control department under the aegis of the state health and family welfare department along with the Royal Society of Chemistry and PATH organised an event titled ‘Preventing AMR together’ which was attended by thousands of people.
It is reported that AMR fatality could be10 million annually by 2050, at a cost of US$ 100 trillion to the global economy through loss of productivity. In 2019 alone, 4.95 million succumbed to AMR where 2.7 million fatalities were directly caused by bacterial AMR.
Amaresh Tumbagi, Karnataka additional drugs controller said that lack of new medicines to treat AMR is a serious concern. It is here that the pharmaceutical industry plays a critical role as it is the reservoir for antibiotics. Of course, the burden of infectious diseases is also driven by poor sanitation, meagre implementation of infection control practices, close animal-human interface, lack of specific diagnostics.
Quoting ICMR study, Dr Tumbagi said that high incidence of AMR is because of non-adherence to standard treatment guidelines, irrational self-administration, medicine purchase without prescription, poor drug quality, all of which see the need for advancing antimicrobial stewardship in a time-bound manner.
From a pharma company perspective, there is need for responsible antibiotic marketing and research. Pharmacy colleges must engage with the community to create awareness on antibiotic abuse, besides contribute to research and innovation. Pharmacies have the onus to dispense antibiotics responsibly, educate patients and put in place safe disposal practices, noted Dr Tumbagi.
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