Antimicrobial resistance has now emerged as one of the most daunting challenges to global health in the 21st century. The state of antibiotic production, regulation, and use in India needs urgent consideration given the unique combination of challenges and opportunities that this country faces regarding addressing AMR as the world observes AMR Awareness Week.

Although Indian pharmaceutical companies are among the world’s largest producers of generic medicines, no patents on original antibiotic drugs have been secured by them. A large gap gets widened by two important factors: this patent gap and complete availability of antibiotics as over-the-counter drugs. These make the AMR crisis worse.

The Global Patent Landscape

The leading global pharmaceutical patents in 2024 tell the story of a mismatch in the research and innovation between MNCs and Indian companies. Novartis leads the race with milestone scientific improvement of 154 patents, followed by Roche Pharma with 131 patents, and J&J Innovative Medicine with 111 patents. These are the companies that invest heavily in R&D to invent new formulations, enhance efficacy, or address resistance.

Conversely, the commercial strategy of Indian pharmaceutical companies has been one of mapping, relying mainly on the manufacturing of generic medicines without the development of new antibiotics. While such a strategy enables them to assure more affordable health care for millions around the world, it certainly limits the contribution of India in finding a novel solution to address AMR. This is clearly an imbalance in health security that calls for policy reforms and increased investment in antibiotic R&D in India.

The AMR Crisis in India

India is presently facing a twin challenge: unbridled misuse of antibiotics and lack of regulatory enforcement. Certain factors that drive this AMR for this country, with a stronger force, are:

  • Sale of Antibiotics over the Counter: Despite legal restrictions, in most parts of India, antibiotics are available over the counter. This is engendered by generally poor regulatory oversight and aggressive marketing strategies by MNCs, which focus on market penetration rather than responsible use of drugs.
  • Aggressive Marketing Practices: The MNCs, as well as domestic pharmaceutical companies, are involved in heavy promotion of antibiotics amongst healthcare professionals and lay people. Very often, the profit motive overrides ethical considerations, leading to uninhibited prescriptions and self-medication.
  • Ignorance and Lack of Education: Most patients, and at times even doctors, are unaware of the long-term implications of misuse of this arsenal of antibiotics. The problem is further enhanced due to a lack of public health campaigns.
  • Poor Health Infrastructure: The absence of proper diagnostic facilities leads to empirical prescription of antibiotics without ever affirming the occurrence of any bacterial infection. The consequent excessive use of broad-spectrum antibiotics fast tracks resistance.
  • Environmental Pollution: In India, pharmaceutical manufacturing units are a major contributor to environmental contamination with antibiotics. Improper pharmaceutical waste disposal practices allow resistant bacteria to overgrow in water and soil.

Implications for the Indian Healthcare System

The impacts of AMR on India’s healthcare system are far-reaching and multi-dimensional:

  • Increased Morbidity and Mortality: Resistant infections lead to longer bouts of illnesses with more expense for treatments and, ultimately, higher mortality rates. The failure in the treatment of common infections may cancel several decades of medical progress.
  • Economic Burden: The management cost of the infection is much higher in AMR-related infections due to the use of expensive second-line or third-line treatments. For developing economies like India, this creates an immense financial burden on public and private healthcare facilities.
  • Threat to Medical Advancements: AMR diminishes the effectiveness of procedures like surgical interventions, chemotherapy treatment, and transplantation of organs, which depend on effective antibiotics to curb infections.
  • Global Impact: India is one of the major exporters of generic medicines. The AMR crisis in India thus has a linked potential to spill over globally. Resistant strains originating in India can spread internationally, jeopardizing global health security.

Steps to Mitigate AMR

For the fight against AMR, a multi-pronged approach is necessary for India to embark on policy reforms and be guided by public health and stakeholder collaboration.

  1. Strengthen Regulations: The selling of antibiotics over the counter needs to be contained through strict regulation by the government. In addition, close monitoring of retail pharmacies is required, with penalties for cases of non-compliance.
  2. Encourage R&D in Antibiotics: Incentives should be provided for investment by Indian pharmaceutical companies in antibiotic R&D. Tax breaks, grants, and public-private partnerships will help bridge the innovation gap.
  3. Educate Providers of Health Care and the Public: Awareness among the providers and the public is long overdue. Education through modules for all concerned must highlight the rational use of antibiotics, along with the gravity of the problem of resistance.
  4. Improve Diagnostics: This will help in better diagnostics, thus reducing the empirical use of antibiotics because inexpensive and quick diagnostic tools will be widely available. Improvement in diagnostic infrastructure is very much required in both rural and urban areas.
  5. Address Environmental Contamination: Pharmaceutical companies should adopt environmentally friendly waste management strategies that don’t contaminate the environment. Laws should ensure that environmental safety standards are met to a certain extent.
  6. Engage in International Collaboration: India should be an active participant in international initiatives on AMR by sharing data, resources, and strategies. Partnerships with international organizations and other countries will help to act more quickly and take further steps toward combating AMR.

Opportunities for Indian Pharmaceutical Companies

While the challenges are significant, the AMR crisis also creates myriad opportunities for Indian pharmaceutical firms to innovate and lead:

  • Generic-to-Innovation Transition: Indian firms can make a transition from a generic producer to innovator of antibiotics by investing in R&D.
  • Collaborative Research: Collaboration with global MNCs and research institutions will enable the company to access state-of-the-art technologies and expertise.
  • Artificial Intelligence Tapping: Artificial intelligence-driven drug discovery of new antibiotics will hasten identification and provide a competitive edge to Indian companies.

Path ahead

The situation is an awakening factor for the entire ecosystem of healthcare in India. While appreciable strides have been made in the country to make medicines affordable and accessible for all, misuse of antibiotics goes on without oversight and poses a grave threat to the health of the masses. AMR requires collective action on the part of policy framers, healthcare providers, pharmaceutical companies, and the public. By promoting innovation, developing better regulations, and ensuring proper usage, India can create an environment in which the tide against AMR turns and offers its population a healthier future.

Dr. Prahlada N.B
MBBS (JJMMC), MS (PGIMER, Chandigarh). 
MBA (BITS, Pilani), MHA, 
Executive Programme in Strategic Management (IIM, Lucknow)
Senior Management Programme in Healthcare Management (IIM, Kozhikode)
Postgraduate Certificate in Technology Leadership and Innovation (MIT, USA)
Advanced Certificate in AI for Digital Health and Imaging Program (IISc, Bengaluru). 

Senior Professor and former Head, 
Department of ENT-Head & Neck Surgery, Skull Base Surgery, Cochlear Implant Surgery. 
Basaveshwara Medical College & Hospital, Chitradurga, Karnataka, India. 

My Vision: I don’t want to be a genius.  I want to be a person with a bundle of experience. 

My Mission: Help others achieve their life’s objectives in my presence or absence!

My Values:  Creating value for others. 

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