New Delhi: India’s top health research agency has recommended that antibiotics newly launched in the country should only be sold through certain hospital pharmacies, amid concerns around their misuse and abuse and an alarming increase in resistance to critical antibiotics, including last-resort treatments. The recommendations, scientists at the ICMR told ThePrint, have been submitted to the Union health ministry and the Drug Controller General of India (DCGI) after consultations with researchers working on the issue.
Also, in a scientific paper published in the Journal of Global Health last month, researchers associated with the Indian Council of Medical Research’s (ICMR) antimicrobial resistance (AMR) division, along with some others, said that while the introduction of new antimicrobials offers hope, historical patterns suggest that resistance may develop rapidly.
The paper, also funded by ICMR, argues that new antibiotics should only be sold at hospitals implementing antimicrobial stewardship, infection prevention and control standards, and mandating AMR surveillance reporting. “Our suggestions are for high-generation antibiotics reserved for very sick patients and can be used only in hospital settings,” Dr Kamini Walia, programme officer of ICMR’s AMR division, told ThePrint.
The changes, she said, can be affected through modifications in the Drugs and Cosmetics Act & Rules. The recommendations are mostly based on findings of a survey which showed that a high number of doctors in tertiary care hospitals, part of the Antimicrobial Resistance Research and Surveillance Network (IAMRSN), prescribe antibiotics responsibly.
Between 3 and 10.4 lakh people in India died in 2019 due to bacterial antimicrobial resistance or AMR—a condition in which pathogenic bacteria become resistant to antibiotics—according to the Global Research on Antimicrobial Resistance (GRAM) Project, the first global analysis of AMR burden released last year.
Misuse, abuse and over-the-counter sales of antibiotics in the country have been identified as a key factor driving AMR in the country.
Now, the latest paper notes that over the past decade, all newly introduced antimicrobials failed to demonstrate improved effectiveness against multidrug-resistant gram-negative pathogens—which are particularly difficult to treat and major contributors to the AMR. Therefore, given the rise in resistance of pathogens to available drugs, new treatment options are urgently needed, the paper states.
Several new antimicrobials, such as plazomicin, cefiderocol, and novel β-lactam combinations—which are awaiting registration in India—may offer a promising solution.
The GRAM project report from last year had said that in India, 6,86,908 deaths were associated with six major superbugs—germs that were resistant to multiple drugs.
These six superbugs included Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, Acinetobacter baumannii, Mycobacterium tuberculosis, and Streptococcus pneumoniae, and caused over 2.14 lakh attributable deaths as well.
AMR-associated deaths occur due to conditions triggered by drug-resistant infections, and as a result of drug-resistant infections left untreated.
Now, scientists have pointed out that data from ICMR’s AMR surveillance network highlights rising antibiotic resistance rates, with Klebsiella pneumoniae showing 62.3 percent resistance to carbapenem, specifically meropenem, considered among last resort treatment.
Also, the susceptibility of Escherichia coli to imipenem—another type of carbapenem—has declined from 81 percent in 2017 to 63 percent in 2023, while its sensitivity to piperacillin-tazobactam, a very strong antibiotic, dropped from 56.8 percent to 42.4 percent during the same period.
Klebsiella pneumoniae isolates also exhibited low susceptibility to piperacillin-tazobactam, at just 26.5 percent in 2023. High resistance to carbapenems and piperacillin-tazobactam has significantly limited treatment options for infections caused by pathogens resistant to multiple drugs.
“Medical practitioners in India are therefore compelled to prescribe polymyxins, such as colistin, as a last-resort treatment. Yet an uptick in colistin prescriptions is contributing to the rise in resistance to this antibiotic as well,” the scientists noted.
The scientists noted that since the introduction of the National Policy for Containment of Antimicrobial Resistance in India in 2011, the government has implemented various regulatory strategies to curb the inappropriate use of antimicrobials.
These measures include the introduction of Schedule H1 to restrict over-the-counter sales of antimicrobials, the launch of the red line campaign (on the drug package) to raise public awareness, and periodic revision of the National List of Essential Medicines. But these initiatives have had limited success, likely due to implementation challenges.
A more robust example of regulatory stewardship for new antimicrobials, with an intention to increase the longevity of drugs while ensuring access for patients in India can be seen in the case of the tuberculosis (TB) programme, they cited.
The rollout of new TB drugs for drug-resistant TB—bedaquiline, delamanid, and pretomanid—is only allowed through healthcare facilities registered as DOTS-Plus centres in an online portal, which in turn manages TB notification, treatment, and financial aid for nutrition for patients, the scientists underlined.
Diagnostic quality is maintained by involving public and private laboratories accredited for culture and drug susceptibility testing. “Although restricting access to new TB drugs and ensuring their judicious use caused short-term challenges, it has resulted in long-term benefits in managing multidrug-resistant TB patients,” they also stressed.
Independent experts, too, supported new recommendations by ICMR.
“I think reserve category antibiotics should only be available in hospital formularies,” said Dr Aravind R., head of the department of infectious diseases at Government Medical College in Thiruvananthapuram. “Also, pharmaceutical companies should be barred from offering free samples of antibiotics to physicians as they end up with patients,” he added.
According to AWaRe classification of antibiotics developed by the World Health Organization (WHO) in 2017, access antibiotics are those with a narrow spectrum of activity, generally with fewer side effects and a lower potential for the selection of antimicrobial resistance and are cheaper; watch antibiotics generally have a higher potential for the selection of antimicrobial resistance and are more commonly used in sicker patients in hospital facilities.
These medicines, as per the global health body, should be used carefully to avoid misuse.
The classification also includes a third group: reserve antibiotics, last resort medicines in the class that should only be used to treat severe infections caused by multi-drug resistant pathogens. But a first ever large-scale multi-centric government report on usage of antibiotics in India had shown in 2024 that 57 percent of these medicines prescribed in the country are those with the potential to cause high antimicrobial resistance.
