Two million deaths are projected to occur in India alone due to antimicrobial resistance (AMR) by 2050; globally this number can touch 10 million. AMR occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines.
Antimicrobials, including antibiotics, antivirals, antifungals, and antiparasitics, are medicines used to prevent and treat infectious diseases in humans, animals and plants.
AMR contributed to 4.95 million deaths in the world in 2019 and was directly responsible for around 1.27 million of those deaths. In 2019, there were 297,000 deaths attributable to AMR in India, and 10,42,500 deaths associated with AMR. One in five of those deaths occurred among children under five years of age. No wonder state governments and even pharmaceutical companies are fighting against AMR and trying to increase awareness as well as reduce misuse of antimicrobials.
In fact, industry sources in Kerala claimed that there has been a 30 per cent decline in sales of antimicrobials in the state following steps taken by the government. Kerala health department created a state-level coordination committee dedicated to this mission.
“A district-level coordinator was appointed in each district after that, with some districts having an AMR squad too, roping in stakeholders. Then a campaign was launched targeting retail shops, as they are risk points in the perspective of AMR," said Shaji Varghese, state AMR coordinator for Kerala Drug Control Department.
There are around 27,000 retail outlets in Kerala and those traders and pharmacists were taken into confidence by the government first. After that, a statutory warning was showcased in each shop, stating that selling such medicines without prescription is unlawful.
In January 2024, the state drug control department launched Operation Amrith (AMRITH — Antimicrobial Resistance Intervention For Total Health) to prevent the overuse of antibiotics in Kerala. This operation was aimed at conducting surprise raids in retail medical shops for detecting over-the-counter sale of antibiotics, and a toll-free number was also provided for the public to lodge complaints against medical shops. Following this, strict departmental actions were taken against violators.
“Following such measures, significant reductions happened in antimicrobials trade,” Varghese said.
According to a state traders’ association, Kerala sees overall trade of Rs 12,000 crore per annum, and around 30 per cent of it is of antimicrobials. "We have seen a 30 per cent decline in the antimicrobial sales, which comes to the tune of Rs 1,000 crore per annum," said an industry source.
The state government is in the process of doing an official study in this regard. “With free availability of such medicines reduced, people are also getting educated by shops, giving the reasons for not giving such medicines. We are taking traders into confidence, giving a chance to improve. We are planning to use digital tools to monitor that,” Varghese added.
Meanwhile, some experts feel that first-line antibiotics should continue to remain available at chemists, and major restrictions on dispensation should be on second- and third-line antibiotics.
Dr Abdul Ghafur, consultant, Infectious Diseases, at Apollo Cancer Institute, Chennai, and also the managing trustee of AMR Declaration Trust told Business Standard that Kerala has a higher share of antibiotic sales when compared to the national average. In Kerala, almost 30 per cent of the overall drug sales come from antibiotics, whereas the national average is
around 15 per cent, or so.
“There has been a Rs 1,000 crore decline in sales of antibiotics after the state became stringent with over-the-counter sales of the medication. But the problem here is that Kerala gets most of its vegetable supplies from Tamil Nadu, and also there is significant migration from that state, exposing Keralites to antibiotic-resistant pathogens anyway,” Ghafur said, adding that he has written to the state government, urging them to follow a more judicious model. “We need to stop over-the-counter sale of second- and third-line antibiotics, but allow the sale of first-line ones as there are many parts of India where people don’t have easy access to doctors,” he added.
However, overall sales of anti-infective drugs have not gone down as such, data from market research firm Pharmarack shows.
Sheetal Sapale, vice-president (commercial) at Pharmarack, said that demand for anti-infectives remains strong, especially because the monsoons this year have been good, and the wet season coincides with infections of the respiratory tract and gastrointestinal tract. Sales of anti-infectives stood at Rs 25,928 crore for the 12 months ending July 2024, which is 10 per cent more than Rs 23,559 crore in the 12-month period ending July 2023.
Why is AMR a major threat to public health?
The reason behind the vigilance is that as a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability and death. Annually, more than 50,000 newborns are estimated to die from sepsis due to pathogens resistant to first-line antibiotics, claimed a study titled “Antimicrobial Resistance: Progress in the Decade since Emergence of New Delhi Metallo-β-Lactamase in India”. While exact population burden estimates are not available, neonates and elderly are thought to be the worst affected.
AMR is a natural process that happens over time through genetic changes in pathogens. The World Health Organisation (WHO) says that AMR’s emergence and spread is accelerated by human activity, mainly the misuse and overuse of antimicrobials to treat, prevent or control infections in humans, animals and plants.
Vegetables, poultry, and dairy contain antibiotic residues, which enter human bloodstream when one consumes them, further aggravating the exposure.
Pharma firms too working on stewardship programmes
Leading pharma companies like Cipla are working on stewardship programmes to raise awareness levels among medical practitioners as well as the general public.
Jaideep Gogtay, head, medical services, Cipla, told Business Standard that they launched a programme called Oasis essentially for the medical professionals wherein they cover things related to how antibiotics should be used “appropriately”.
“While, on one hand, we know that antibiotics should be used only in the case of bacterial infections, it's also important that the right antibiotic is used at the right time, in the right patient for the right duration and in the right dose,” he said, adding that in the Oasis programme, they covered a large number of healthcare professionals, people in hospitals, and doctors in the community as well. Cipla is also working with the Indian Academy of Paediatrics to talk about rational use of antibiotics.
“Very often we have patients or kids’ parents asking for antibiotics or they go and buy it off the shelf without a prescription. So, we have tried to create awareness by saying that you shouldn't buy an antibiotic without a certified doctor's prescription. Don't self-medicate. Don't be a Google doctor. If you're given antibiotics, make sure you take it to complete the course of treatment. Don't keep switching antibiotics,” Gogtay said.
Why are pharma companies, who stand to gain from sale of antibiotics, getting into AMR stewardship?
The reason is simple. As Gogtay points out, “Everybody wants their antibiotics to also last long. If they get overused, then they lose their efficacy, and they will stop working. So, if we market them responsibly, these drugs can actually last the company for a longer period of time.” Last year, Cipla had a webinar for all its employees in the sales and marketing teams to educate them on antibiotics.
Another company Venus Remedies has been actively involved in antibiotic stewardship for over a decade now. Saransh Chaudhary, president of Global Critical Care at Venus Remedies, said: “Our flagship programme ‘Preserving Life of Existing Antibiotics (PLEA)’ leads multiple activities throughout the year, with significant efforts during the World AMR Awareness Week (WAAW) in November last. Our focus for WAAW this year will be more on public awareness than antibiotic stewardship activities in hospitals,” he said.
Venus Remedies is also conducting public awareness events through rallies and public events; collaborating with healthcare professionals, including doctors and nurses, to promote hygiene practices and infection-control practices in hospitals; and public awareness campaigns like the “Antibiotic Police” initiative, where participants are encouraged to take an online pledge to self-regulate antibiotic use in their role as antibiotic stewards.
Similarly, Orchid Pharma is trying to expand its reach to 200 hospitals, where it is working on antibiotic stewardship. Dr Prabhu Vinayagam, medical advisor, Orchid AMS, a division of Orchid Pharma, said: “We intend to cover 12 hospitals in Phase-I and then extend to about 200 hospitals across the country.”
“There are a lot of discussions at industry level. The government has issued a national action plan to curb the menace. Various specialist associations are forming antibiotic guidelines. Specific state-level interventions are being undertaken, with Kerala leading the way followed by Tamil Nadu and Gujarat. However, more effort is needed by the pharma industry, including the manufacturers and the chemists,” Vinayagam said.
Industry bodies lay stress on responsible marketing of antibiotics. Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), said that rampant misuse of antibiotics can be controlled with restrictions at the chemist level. “Pharmaceutical companies are aware of the danger and support responsible marketing practices for anti-infectives,” he added.