Need to clamp down on prescription-less sales of antibiotics

Most of us have the experience of getting antibiotics from a pharmacist without a doctor’s prescription. Commercial pressures propel the pharmacist to commit a blatant violation of law. Nobody complains, because whether the ailment goes after taking the antibiotic or not, the episode of buying the medicine without a prescription is quickly forgotten.

But several studies have emerged to show that the rampant practice of consuming antibiotics indiscriminately silently contributes to a much bigger health issue, namely, antimicrobial resistance (AMR, aka antimicrobial drug resistance or ADR). This refers to the infection causing microbes developing resistance to an antibiotic — the medicine fails to cure.

Studies show that India has a high prevalence of AMR. For example, in 2019, a group of Indian and American researchers led by Sumanth Gandra of the Centre for Disease Dynamics, Washington DC, conducted a patient-level antimicrobial susceptibility test (AST) over 5,103 patients from ten hospitals. “The overall mortality rate of patients was 13.1 per cent and there was a significant relationship between multi-drug resitance and mortality,” the authors say in their paper.

AMR comes from several sources. “The OTC sale of antibiotics is recognised as a pathway for the emergence of antimicrobial resistance; a serious public health challenge in need of urgent regulatory responses,” says another, 2021 paper which delves into the regulatory aspects of antibiotics dispensation. The authors conducted a study of 261 pharmacies in Bengaluru, in which the pharmacy was requested to give antibiotics, without a prescription, for two ailments — for an adult complaining of upper respiratory tract infection and a child suffering from acute gastroenteritis. As many as 174 pharmacies gave the medicine over-the-counter (OTC), even though neither condition didn’t require antibiotic treatment.

Similarly, in Tamil Nadu “observations and interviews with pharmacists at 24 pharmacies revealed that 78.7 per cent of antibiotics sold within the study period were given without a prescription.” Another study of the same authors reported that of the 40 New Delhi pharmacists, none said they refused to sell antibiotics without prescription. “Despite being illegal, OTC sales of antibiotics by pharmacies without a valid prescription from a registered medical practitioner (RMP) appear widespread in India, highlighting serious problems around the regulation of this pathway for emergence of AMR,” the paper says.

Often people take antibiotics even for viral infections, which are indifferent to antibiotics and self-limiting.

The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules (DCR), 1945, designates all antibiotics as prescription drugs under the Schedule H category. In 2014, an amendment was made to the Schedule H category to include second- and third-generation antibiotics into a new category called Schedule H1. For Schedule H1 drugs, pharmacists are required to maintain a separate register for the sale of these antibiotics and retain prescription copies. This amendment was implemented to curb the widespread practice of antibiotic purchase from retail pharmacies without a valid prescription (old or outdated). “However, several studies before and after 2014 indicate that consumers can still purchase antibiotics without a valid prescription as pharmacists still dispense antibiotics to their customers/clients/patients by attending to their symptoms,” notes yet another paper.

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