As essential antibiotics fail, regulator mulls R&D push, curbs on misuse

A high-level sub-committee of the Drugs Consultative Committee (DCC) has submitted its report to the Central Drugs Standard Control Organisation (CDSCO), outlining over a dozen urgent recommendations for the National Action Plan on Antimicrobial Resistance (NAP-AMR). In India’s robust $50 billion pharmaceutical industry, as the demand for medicines grows, so does the risk that they would be misused, further fueling the cycle of resistance.

The national action plan on AMR was unveiled in 2017, with its Phase 2.0 (2025-29) launched by the government last year.

The panel's findings, discussed at a high-level meeting in New Delhi on 17 November last year, reflect India’s strategy shift of active intervention at every step of a medicine's journey: from the research lab to the local pharmacy.

According to the minutes of the 67th Drugs Consultative Committee (DCC) meeting of 17 November, the sub-committee report on the national action plan was reviewed. “DCC noted the recommendations of the sub-committee and recommended that the CDSCO may share the report with all the states for appropriate action," it said.

With essential antibiotics failing, AMR has now become a public health crisis for India, with 267,000 deaths directly attributed to it each year, according to the National Centre for Disease Control (NCDC).

Beyond loss of life, its economic impact is staggering. A World Bank report of 2017 warned that if AMR was not checked, it could cost the world trillions of dollars in healthcare expenses and lost productivity. In India alone, the failure to control superbugs could lead to an extra $21 billion in economic losses by the middle of the century, said a 2024 study by the Center for Global Development (CGD).

The report's recommendations include computerized billing and mandatory CCTV monitoring at wholesale and retail outlets and annual review of antimicrobial categorization for restricted marketing in India’s growing $2.9 billion antibiotics market.

Environmental protection is another major part of the plan, given that people throw away old antibiotics in the trash or pour them down the drain; with traces of these wastes in the environment contributing to the development of drug-resistant pathogens.

Seized of the issue, the DCC report has also recommended an ‘Extended Producer Responsibility’ (EPR) policy for the safe disposal of expired or unused antibiotics, alongside stricter inspections of manufacturing units to ensure compliance with bio-medical waste management rules.

A specialized sub-committee was set up in early 2023, chaired by Gujarat’s Commissioner of the Food and Drugs Control Administration. These experts were tasked with exploring ways to halt the rapid decline of antibiotics' effectiveness in India. After a study on how drugs are sold, used, and misused, the panel delivered a roadmap to the country's top drug controllers.

“The battle against these ‘superbugs’ is no longer a distant threat but a present-day health emergency," said a senior official privy to the development.

The panel pressed on the urgent need to strengthen India's ecosystem for the development of new antibiotics and proposed an innovation ecosystem that develops targeted antimicrobial profiles specifically for the Indian context. This includes making regulatory and procedural changes to facilitate the research and development (R&D) of relevant "watch and reserve" antimicrobials, those intended to treat critical-priority pathogens.

"There is an urgent need to give special emphasis to strengthen ecosystem for R&D for development of new antibiotics. Effective coordination and exchange of information among the institutions, universities and industries, are the need of the hour to accelerate the development of new antibiotics. Streamlining the regulatory landscape plays an important role in the ecosystem," the report said.

It also called for separate guidelines for the approval of clinical trials and approvals for manufacture and import of various categories of antimicrobial new drugs in the form of API and finished formulation.

"Creating an innovation ecosystem for antimicrobial R&D involves developing targeted antimicrobial profiles for the Indian context and making procedural changes to facilitate R&D of relevant watch and Reserve antimicrobials to treat critical-priority pathogens in India," the report said, also calling for expediting regulatory approvals to ensure uninterrupted supply of quality antimicrobials.

Seeking “structured applications with comprehensive and rational contents", it said these would help the CDSCO review and take necessary actions “in a better way" and would also ease the preparation of fully electronic submissions.

The DCC report also recommended mandatory display of legal warnings at all drug shops, stating that Schedule H and H1 drugs cannot be sold without a valid prescription. Schedule H and H1 drugs are prescription-only medications: Schedule H includes over 500 common drugs that require a prescription, while Schedule H1 includes 3rd and 4th generation antibiotics and anti-tuberculosis drugs that require the chemist to maintain a separate register with patient and doctor details for three years.

Also, maintaining dedicated registers for the sale of Schedule H and H1 drugs; and an annual review of antimicrobial categorization to include high-end and newly researched molecules in Schedule X or H1, ensuring they remain under strict restricted marketing. Schedule X are narcotic and psychotropic substances that require a duplicate prescription and meticulous documentation, including keeping the prescription copy for two years.

To minimize the impact of substandard or spurious antimicrobials, which contribute significantly to resistance, the panel proposed appointing nodal officers in each state for enforcement.

The report also focusses on misuse of antibiotics in animals, which accounts for a significant portion of global antimicrobial use, and has recommended restricting them in animal feed and phasing out their use as growth promoters and for disease prevention. It has proposed registration of all farms, factories, slaughter-houses, wet markets, aquaculture units, food processing units, feed manufacturers, healthcare facilities and vet facilities.

Queries on the matter emailed to the spokespersons of India’s health ministry and the CDSCO on Tuesday remained unanswered until press time.

The issue is not just about manufacturers and sellers of antibiotics. “The AMR problem has to be looked at holistically... From the patient perspective, there is a lot of pressure," said the second official. Patients often bypass doctors to skip high fees for consultation and diagnostics.

The official added that regulation alone is insufficient, and this will not work until “medical advice is made easily available, meaning it is not expensive and is within the reach of the patient".

Health sectors experts say battling AMR is an uphill task.

Dr Suranjeet Chatterjee, a senior consultant at Apollo Hospital in Delhi, said the situation is worsening due to lack of strict regulation. "We see people buying antibiotics without any prescription, often just because they heard from someone else that a specific drug worked for their illness. Patients often stop their medication after two days when they feel better, which directly creates resistance. By the time patients reach a hospital, the bugs have already become resistant to advanced drugs. We are reaching a point where there is almost nothing left in the arsenal," he said.

The pharmaceutical industry seems to be on board with the proposed regulations on antibiotics.

Sheetal Arora, chief executive officer of Mankind Pharma, said antibiotics are not routine medicines and should be used judiciously.

"Their misuse through self-medication or incomplete courses accelerates antimicrobial resistance and reduces treatment options for future generations. Companies must align their products with national guidelines and work with doctors to promote responsible use. Tackling antimicrobial resistance requires collective action across industry, doctors, policymakers, and patients," Arora said.

A November 2024 report from the Indian Council of Medical Research (ICMR) found that in hospital intensive care units, some of the most trusted medicines are failing; with common bacteria that cause pneumonia and urinary tract infections now frequently resistant to drugs such as imipenem and meropenem, which were once considered highly reliable.

Doctors are being pushed into a corner, forced to use older, more toxic "last-resort" options because the standard treatments simply do not work anymore. Even common illnesses, including typhoid, are becoming nearly impossible to treat with standard tablets because the resistance levels have climbed above 95%.

This crisis has caught the attention of the highest levels of government. Prime Minister Narendra Modi in his recent Mann Ki Baat broadcast had warned citizens about the dangers of self-medication and the misuse of these life-saving pills.

AMR threatens to undo decades of progress by making common infections, routine surgeries, and cancers harder to treat, said Payden, the World Health Organization acting representative to India said. “The challenge is balancing access to life-saving antibiotics with curbing their misuse across human health, agriculture and the environment."

“The drivers of AMR are well-known: widespread misuse and overuse of antibiotics in human health, livestock and agriculture; weak infection prevention and control; limited access to diagnostics and vaccines; and poor management of wastewater, including from pharmaceutical industries," said Payden.

Addressing AMR requires balancing access and excess, ensuring life-saving antibiotics are available to those who need them, while curbing inappropriate use driven by OTC sales, growth promotion, misinformation and economics. State-level implementation, public participation, and a strong ‘One Health’ approach that links human, animal and environmental health are essential, Payden added.