Is it time for India to put antibiotic drugs under Schedule X of the Drugs and Cosmetics Act, 1945? This schedule normally controls the sale and distribution of highly addictive drugs like ketamine, methamphetamine and amphetamine, among others, which are also used in illegal narcotics.Dr Nageshwar Reddy, leading gastroenterologist who has been conferred all the three Padma awards, calls the measure harsh but adds that may be the only way to stop Indians from popping antibiotics like candy and sparking a full-blown public health emergency due to antimicrobial resistance (AMR). According to a global study he co-authored, there is a distinct possibility of every third person being hit by superbugs that have developed resistance to antibiotics largely because of misuse and overuse. As a result, they end up suffering longer from ailments, get hospitalised for longer periods of time and pay much heftier medical bills, draining their hard-earned savings. Disturbingly, the study also found that these organisms are exchanging resistant genes among themselves in the gut. At present, antibiotics are under Schedule H1 of the Drugs and Cosmetics Act, which also imposes penalties if the drugs are sold over the counter, but these are not as harsh as those under Schedule X and fail to act as a deterrent.AMR at alarming proportionsEnforcement has been so lax that selling antibiotics over the counter is an accepted norm. “We need a law that permanently seals a shop if found selling antibiotics over the counter,” Dr Reddy says. He admits that one just has to step out of his swanky hospital campus in Hyderabad and the chemist next door will hand over antibiotics without prescription and without batting an eyelid.Dr Vinay Nandicoori, director of the CSIR-Centre for Cellular and Molecular Biology (CCMB), on the other hand, says, “It doesn’t matter whether antibiotics are put under Schedule X, Y or Z. What we need is strict implementation of existing laws. And we need a holistic approach. Not only should antibiotics be given only with a prescription, but we also need to reduce the usage of these drugs in other sectors like farm, fisheries, poultry and dairy.” He adds that India can expect a major public health hazard on its hands by 2050 if easy access to antibiotics is not restricted now. “Look at the history of antibiotics. There has always been some distance between discovery of the drug and resistance building up. Because of overuse, that distance has been reduced substantially now.” For instance, penicillin was discovered in 1928, it was widely used by the 1940s and resistance was noticed in 1942. On the other hand, streptomycin was discovered in 1943, and resistance was found in 1946. Studies show that by 2000, bacteria had developed resistance to almost all new antibiotics within one year. Many life-saving medicines then become ineffective, and infections become difficult to treat. World Health Organisation data shows that AMR was directly responsible for 12.7 lakh global deaths in 2019 and contributed to 49.5 lakh deaths. And if international studies are anything to go by, India is the epicentre of this public health catastrophe. Various studies have put India’s AMR rate at one in three people with even Africa faring better at one in six people. The problem is so severe that even Prime Minister Narendra Modi spoke of cutting back on antibiotics in his last Mann ki Baat of 2025. Dr Reddy adds that compared to many other countries, India does an excellent job of policing narcotic drugs, but an equally bad job at policing the sale of antibiotics. “We need such controls for antibiotics as well to avert a disaster.”Rising burden, lives at stakeIn most cases, these superbugs infect people when they come to hospitals for specific treatments. “But we are saying that there is AMR in the community now. There is high resistance and high infection rate. When these people get admitted to a hospital, antibiotic costs increase and, in many cases, also result in death. So, this is a deadly triad.” And at least two recent studies have shown that India is at the heart of this crisis globally. The study Dr Reddy co-authored in the Lancet – ‘Procedural screening for multi-drug-resistant organisms in endoscopic retrograde cholangiopancreatography’ – found that a massive 83% of the patients walking into his AIG Hospital already carried drug-resistant bacteria. The global study was conducted on 1,200 patients and included institutions from the Netherlands, Italy and the US.On the other hand, Indian Council of Medical Research (ICMR)’s annual report 2024 ‘Antimicrobial Resistance Research & Surveillance Network (AMRSN)’ used one lakh laboratory-confirmed infection samples to show how the most common infections like urinary tract, pneumonia, sepsis and diarrhoea were becoming increasingly difficult to treat.Mapping, pharmacovigilance and awareness the keyExperts are now calling for mapping the use of antibiotics in the community and for pharmacovigilance – the practice of closely monitoring the use and side-effects of drugs once they are licensed for use. Internationally, govt authorities track prescriptions continuously from different medical shops and hospitals to understand the pattern of use of antibiotics.“In the Netherlands, they know exactly the type of antibiotics prescribed in a particular region last year,” Dr Reddy says. “They have complete data down to how many tablets have been given out. We (in India) don’t have the data and need it urgently. If, suppose, too much ciprofloxacin is being used and there is a fear of resistance developing, you restrict its use.” But ICMR alone may not be capable of collecting all the data and other govt agencies may have to be brought in to map antibiotic use. But, in the end, individual doctors will have to aid in this effort. And medical shops will have to be closely monitored. “I have been talking on a number of forums about AMR and I’m surprised at the widespread ignorance,” says Dr Nandicoori. “It is important to not only educate people about the adverse effects of the excessive use of antibiotics, but we also need to inform doctors as well. In many foreign countries, doctors don’t immediately give you an antibiotic just because you have a fever. They will try to diagnose if it is a viral or bacterial infection. If it is a viral infection, you must wait it out. If it is bacterial, only then antibiotics are prescribed. We need to develop a similar approach here,” Nandicoori emphasises. Doctors add that colistin, known as the last resort antibiotic, is one of the few antibiotics available to doctors now to treat AMR. But it is being increasingly used with fears that resistance will soon develop, hurting healthcare even more.
