Why taking Azithromycin indiscriminately could lead to medication resistance

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Although the per-capita usage rate is still lower than that of Europe and America, India is the world’s largest producer and consumer of antibiotics. However, India consumes a lot of broad-spectrum antibiotics, which are best administered sparingly because they work against a variety of bacterial kinds. These and other findings from our recent study, which was published in Lancet Regional Health Southeast Asia and used one of the largest datasets on medicine sales in India, PharmaTrac, demonstrate the magnitude of antibiotic misuse in India.

No matter the size of the container, the potency of the formulation, or the amount, we were able to consistently quantify medication consumption by using a standard metric called defined daily doses (DDD). Using the WHO ‘Access-Watch-Reserve’ (AWaRe) classification, which is a generally accepted norm, we looked at the levels of inappropriateness. Antibiotics marked “Watch” are often broad-spectrum medications that should only be used in extremely specific circumstances, as their name suggests. On the other hand, “Access” antibiotics should always take priority whenever an antibiotic is necessary, and the global goal is to have at least 60% of all consumption come from “Access” molecules.

Our study showed a complete flipping of the “Access-Watch” ratio, with “Watch” antibiotics making up 72.7% of all DDDs used in India in 2019. The most popular antibiotic in 2019 was the broad-spectrum “watch” group antibiotic azithromycin. (640,000,000 DDDs, or 12.6% of all antibiotic dosages) The potential of currently accessible antibiotics is threatened by the use of these medications for even minor upper respiratory infections, which are typically viral diseases and do not require any antibiotics. An key factor in the formation of drug resistance is the indiscriminate use of broad-spectrum antibiotics.

So which medications are utilised the most frequently? a large number

Azithromycin: Throat pain, fever, and cough in both adults and children

Amoxycillin: For use in treating cough, fever, ear, and throat pain.

Fever, throat soreness, and cough in adults treated with amoxycillin and clavulanic acid together

Ofloxacin, ciprofloxacin — Diarrhea, urinary infection

Cefixime: Cough, fever, and sore throat

We compared the improper usage to India’s current antibiotic market structure, licencing structure, and regulatory environment. India is one of a select few nations that employ numerous fixed dosage combinations (FDCs). Antibiotic FDCs are troublesome because of decreased efficiency and incorrect dose-scheduling, which can lead to either under- or over-dosing and the formation of antibiotic resistance, with the exception of a very small number of FDCs that have scientifically demonstrated benefit. Previous assessments, such as those from a parliamentary standing committee and an expert committee of the Indian Council of Medical Research, identified the rise in “irrational” FDCs as a problem for public health.

India has a complex regulatory structure, with 28 state-level regulators sharing authority with one central regulator (the Central Drugs Standard Control Organization, or CDSCO). While the CDSCO must approve all new molecules (drugs), state regulators can issue marketing licences that are specific to products (brands/formulations). However, these state level organisations have limited human resource and technical capacity to judge the quality of the formulations in the product. As a result, there is an enormous influx of antibiotic FDCs with various strengths and combinations onto the market that, unlike the individual parts of these FDCs, have not undergone comprehensive clinical trials or investigations.

These FDCs frequently include drugs from many antibiotic families in unsuitable combinations, which encourages the development of antimicrobial resistance. Only 45% of antibiotic brands and 23% of FDC dosages had CDSCO-approved formulations, according to our data.

These findings demand thorough policy evaluation at the highest levels of government given the grave threat that antibiotic resistance poses to the entire world, but especially to India. We have a fantastic opportunity to improve India’s drug regulatory environment because the Indian government is in the process of enacting a new law to replace the Drugs and Cosmetics Act, 1940. The CDSCO should have the legal and regulatory authority to reject state regulators’ decisions if state regulators approve improper formulations or products. First, we need a single central regulator for drug clearance and licencing like the US FDA. There must to be a procedure for contesting state regulators’ approval rulings. Second, we must equip state regulators with sufficient financial and personnel resources to make scientific judgments regarding the approval of pharmaceutical items. Third, the new rule should put at least all of the “Watch” and “Reserve” antibiotics on the list of Schedule H1 drugs since a pharmacist cannot dispense these drugs without mandatory written proof of a valid prescription from a licenced physician. Last but not least, the government’s digital health efforts ought to be used to streamline the safe exchange of prescription information between physicians and pharmacists. To make sure that antibiotic prescriptions and sales adhere to particular requirements based on regional microbiological and drug sensitivity patterns, they should conduct routine audits of prescription and sales data. Even while we continue to invest in enhancing access to appropriate antibiotics through the Jan Aushadhi outlets and a productive procurement system, these policy actions remain crucial.