Drug regulator seeks strict adherence to drug rules to end indiscriminate use of antibiotics, painkillers

India’s apex drug regulatory agency Central Drugs Standard Control Organisation (CDSCO) has directed the hospitals and healthcare institutions of the country to strengthen their systems for rational prescribing and monitoring of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics to reduce the instances of chronic kidney diseases associated with the indiscriminate use of such medicines.

In a circular issued on September 21, the Drugs Controller General of India wanted the hospitals to promote antimicrobial stewardship, prescription review and appropriate patient counselling to prevent avoidable adverse drug reactions, renal complications and antimicrobial resistance through responsible use of NSAIDS and antibiotics.

The circular instructed the medical doctors to prescribe NSAIDS and antibiotics only when clinically indicated, after considering the patient’s clinical condition, age, co-morbidities, concomitant medicines and relevant risk factors. Lowest effective dose of the shortest appropriate duration should be considered when prescribing NSAIDs, particularly in patients at increased risk of renal impairment, it said and adding that unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily prolonged duration of antibiotic treatment should be avoided.

It reminded the pharmacists, retailers and distributors to strictly comply with the rules relating to the sale and distribution of these drugs that come under various classifications such as Schedule H, H1, etc., under the drug laws. The circular reminded them not to encourage or facilitate self medication with antibiotics or prescription only NSAIDs.

The circular also contained instructions to the general public which cautioned them against use of these type of medicines without medical advice. It wanted the public to seek medical advice where pain, fever, or other symptoms persist or recur rather than repeatedly using pain killers or antibiotics on their own.

The circular was only reiterating what is already included in the Drugs and Cosmetics Act 1940 and its subordinate rules. The rule says that it is dangerous to take Schedule H1 drugs without medical advice. It also clearly states that such medicines should not be sold without a valid prescription from a qualified doctor.

The message to all stakeholders, including general public, healthcare professionals, pharmacists, retailers, wholesalers, hospitals and other healthcare institutions was necessitated after indiscriminate use of such medicines was found to be rampant across the country.