Editorial: Epicentre of antibiotic resistance

58% of fixed-dose combination of antibiotics sold across India are on the WHO’s ‘not recommended’ list

Antibiotic resistance is rapidly turning into a global menace. Unfortunately, India is the epicentre of this catastrophe. Easy access to the strongest of antibiotics without prescriptions or diagnoses and their indiscriminate use have created a perfect storm, leading to the super-resistant microbes that irreparably damage our health. India has no public database of mortality caused due to antimicrobial resistance. Providing proper sanitation, clean water and increasing public health expenditure and better regulating the private health sector are necessary to reduce antimicrobial resistance. A study has found that most of the antibiotic FDC (fixed-dose combination) formulations sold in India are unapproved or banned. The study, done by researchers from India, Qatar and the UK, found that as a proportion of total antibiotic sales, the sale of FDCs increased to 37.3% in 2020 from 32.9% in 2008. Though the drug regulators have taken several initiatives to deal with the issue, including imposing a ban, several banned FDCs continue to be available in the market. What is alarming in the Indian context is that the doctors routinely prescribe strong antibiotics even in cases where such doses are totally unnecessary. All drugs in India are required to secure marketing approval from the Central Drugs Standard Control Organisation (CDSCO) before obtaining a manufacturing licence from state drug administrations. But in the case of FDCs, companies secure manufacturing licences from states without getting marketing licences from the CDSCO, which would require them to submit a therapeutic justification for the drug.

It is observed that the majority of FDCs sold in India lack scientific rationale but are produced and marketed in order to create a brand and then marketed aggressively. Pharmaceutical companies spend large amounts of money on sales promotion to influence doctors to prescribe their products to increase drug sales. Earlier this year, the Supreme Court categorically ruled that the act of pharmaceutical companies doling out freebies to doctors was “clearly prohibited by the law”. However, there is no effective monitoring of doctors prescribing any particular brand of medicine and there is no provision for taking legal action against any doctor for prescribing any specific brand. A study published in the World Health Organisation bulletin found that 58% of FDCs of antibiotics sold across the country were on the WHO’s “not recommended” list. As many as 13 among India’s top-20 selling antibiotic cocktails have been classified as neither evidence-based nor recommended. Experts have been calling for making the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) statutory and strengthening monitoring mechanisms to increase transparency and accountability. At present, the functioning of the CDSCO is quite opaque. There is no method to evaluate its performance or impact on curbing substandard or spurious drugs. There is also no mechanism to ensure that the regulator is independent and free from pressures from the government or the industry.

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