How big is the antimicrobial resistance crises in India and what is majorly causing it?  

According to a Lancet report, an estimated 1.27 million people died of drug-resistant bacterial infections in 2019 alone, and 30 per cent of these cases were from South Asia with India being the flashpoint. India’s AMR burden has reached alarming proportions. The unrestrained use of antibiotics since the onset of Covid-19 has only made matters worse. 

The Lancet report has identified five pathogens in the country which have got the better of the most powerful antibiotics, including the last-resort Carbapenem class of antibacterial drugs. Up to 70 per cent of the isolates of gram-negative bacteria like Escherichia coli, Klebsiella pneumoniae, Pseudomonas Aeruginosa, and Acinetobacter baumannii have developed resistance to all safe antibiotics, as pointed out in the 2017 Scoping Report on Antimicrobial Resistance in India. The incidence of multi-drug-resistant tuberculosis in our country happens to be the highest in the world. 

A major factor contributing to this crisis is the over-the-counter sale of antibiotics, which encourages people to self-prescribe these drugs for even non-bacterial infections like common cold and conditions presumed to be bacterial without going through the necessary tests. Limited access to public healthcare facilities, particularly in rural areas, is another cause for concern as it encourages people to consult pharmacists instead of qualified doctors. We also need to adopt better infection control practices and implement antibiotic stewardship programmes more effectively in hospitals, especially ICUs, which are a major breeding ground for antibiotic-resistant bacteria. 

With the majority of Indian population constituting of meat eaters. How big is the threat of extensive use of antibiotics on animals?

The use of antibiotics by poultry and dairy farmers on livestock to quicken growth and improve productivity makes drug-resistant bacteria enter the environment and human food chain, thus compounding the problem. Antimicrobial resistance is a complex problem accentuated by the interconnection between the animal, environmental and human ecosystems.  

On the lines of the European Union, India should also regulate the use of antibiotics on animals by restricting it to prevention, control and treatment of diseases. The government should formulate strict guidelines on the proper disposal of carcasses and take measures to prevent the contamination of water bodies with animal waste. Additionally, all animal food products should be examined for their antibiotic residue levels, complemented by regular checks on the hygienic conditions under which they are produced, processed and packed. Poultry farms should be inspected for best practices and certified for their antibiotic-free products.  

How well is the Indian pharmaceutical industry tackling the antimicrobial resistance crisis in India currently?

The Indian pharmaceutical industry is doing its bit to tackle this grave public health crisis by ensuring the appropriate disposal of antibiotic waste, fostering research to come up with novel antibiotic solutions, implementing responsible manufacturing practices and collaborating with other stakeholders in waging a determined battle against antimicrobial resistance. But a lot more remains to be done. 

Among India’s top 20 R&D spenders, Venus Remedies Ltd (VRL) is possibly the only pharmaceutical organisation in India that has made an enduring mark on all these fronts. Since the Indian research ecosystem, especially for antibiotics, is extremely small, only a handful of companies are into innovation-driven antibiotic research. 

 VRL has also joined the league of over 100 globally renowned organisations as a member of the AMR Industry Alliance (AMRIA) in continuation of its resolve to curb AMR through a coordinated and multi-pronged response.  

With the AMR diseases exploding globally, do you think Indian pharmaceutical sector can cater to both the needs of both India and the rest of the world at the moment?

As the world’s largest producer of antibiotics, we are in a strong position to cater to the needs of patients suffering from AMR-related health conditions by building on our manufacturing and research capabilities on one hand and bolstering our distribution network on the other. We have the wherewithal to make it happen, be it infrastructure, dedicated manpower, expertise or innovation.  

 The Indian pharmaceutical industry can make all the difference by ensuring access of important antibiotics to all the low- and middle-income countries (LMICs) which need them the most and setting new standards in high-quality manufacturing. 

The majority of the Indian population still lives in remote areas and depends on over-the-counter drugs. How big is the awareness challenge going forward? 

The National Rural Health Mission should conduct concerted campaigns on a nationwide scale among pharmacists, doctors and the general public to make them aware about the dangers of misuse of antibiotics, in collaboration with NGOs, health activists, hospitals, research institutions and pharmaceutical firms. Such campaigns should involve elements like street plays and local folk traditions which villagers can identify with to caution them against the serious trouble they are inviting by using antibiotics without a doctor’s prescription.  

As part of the campaign, renowned doctors should be roped in to clear infection-related doubts in public gatherings, and these functions can be broadcast live on radio and TV channels. We must also drive home the importance of hygiene and sanitation in containing this public health threat and carry out one-on-one meetings with pharmacists to motivate them not to sell antibiotics without the prescription of a registered medical practitioner.  

Since most villagers carry mobile phones nowadays, bulk SMSes and Whatsapp messages as well as social media can go a long way in spreading more awareness among them about the pitfalls of self-medication. In order to create a lasting effect, all these efforts should coincide with frequent crackdown on quacks and strengthening of rural healthcare infrastructure. Furthermore, the recently announced Unified Health ID can help in digitising data collection, thus reducing prescription-less disbursement of antibiotics. 

Apart from this, antibiotic-free labels should be prominently displayed on packaged products to improve consumer awareness on the issue. Food outlets should be required to mention details about the eatables on their menus. Outlets like Shake Shack and Pret-a-Manger have already been doing this since many years now and others should follow suit. 

Are there any barriers that the pharmaceutical sector is facing in relation with producing new antibiotic solutions?

Developing a new class of antibiotics involves a lot of time, effort, scientific research and funds. Coming up with new antibiotic solutions to treat highly drug-resistant bacterial infections is much more challenging. A majority of pharmaceutical companies, be it in India or abroad, have abandoned research on antibiotics because they do not find it lucrative owing to the short duration of use and high R&D costs. In such a situation, there is an urgent need to develop new antibiotics through public-private partnerships on the lines of Innovative Medicines Initiative, a joint undertaking between the European Commission and the pharmaceutical industry which seeks to accelerate antimicrobial development through effective incentives.  

It is imperative to encourage collaborations between the government, industry and academic stakeholders to make our research efforts work. Resources need to be generated to rigorously test novel compounds for safety and efficacy. This will require a strong policy thrust and an indomitable resolve involving all stakeholders. We need to remove all financial and regulatory hurdles coming in the way of antibiotic research before it is too late. We must develop new economic models where the economic risks and profits for developing new antibiotics can be shared between different stakeholders. 

Considering the enormous costs involved in developing antibiotics to counter increasingly drug-resistant bacteria, the government should come up with push and pull incentives for firms engaged in R&D of antibiotics on the lines of advanced countries like the US and UK. The government can play an important role in enabling a sustainable antibiotic research ecosystem in collaboration with R&D-driven pharma companies and young biotech start-ups.  

What are the important steps that are needed to be taken by the government and the pharmaceutical industry to reverse the AMR crisis in India? 

The government, in association with other stakeholders like pharmaceutical companies, hospitals and research institutions, should get the WHO’s Global Action Plan on AMR going by improving the awareness and understanding of AMR, carrying out antibiotic stewardship activities, implementing infection control protocols and promoting investments for antibiotic research.  

While the National Action Plan on Antimicrobial Resistance formulated in 2017 is a step in the right direction, the guidelines are still waiting to be implemented. The Central Drugs Standard Control Organisation had enforced Schedule H1 rules eight years ago to prevent over-the-counter sale of certain antibiotics, but the results are yet to be seen for want of effective regulatory mechanisms. Government policies and guidelines to deal with AMR, like the proposed draft standards for antibiotic residues in treated effluents, may appear good on the face of it, but these measures will not bring any perceptible difference unless implemented in earnest. 

All said and done, government intervention alone will not suffice. We need coordinated efforts from all stakeholders, be it hospitals, civil society groups, pharmaceutical companies or common people. They must join hands and put into place a functional surveillance system to collect region-wise data on AMR. Only an integrated surveillance of resistance can equip clinicians and policymakers with the requisite information to address the most pressing concerns posed by AMR and support opportunities for research collaborations.