Our approach towards countering disease-causing microorganisms has changed drastically since the advent of the first antibiotic in the late 1920s. Bacterial infections are a major cause of human mortality worldwide, especially in third-world countries where medical infrastructure may not be very evolved. A study by The Lancet reveals that antibiotics have been successful in increasing life expectancy from 48 to 71 years between 1950 to 2017[1]. Today, such medicines form a critical pillar of the modern medical and pharmaceutical industry with the consumption of antibiotics being 46% higher than the preceding two decades[2]. Although this is considered as a significant step forward in the domain of medicine, antibiotics must be looked at as a double-edged sword. With the widespread use of antibiotics, the risk of antimicrobial resistance has grown multifold across the world. Alexander Fleming, at his 1945 Nobel Prize lecture, had said, “The time may come when penicillin can be bought by anyone in the shops. There is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” The World Health Organisation describes antibiotic resistance as a phenomenon where disease causing bacteria evolve in order to develop immunity towards medicines that inhibit their growth[3]. This phenomenon is a major public health threat across the world and has caused significant impact in terms of mortality and economic losses due to the advent of difficult to treat ‘superbugs.’ In a study published by Klein EY et al, 9 out of the top 10 countries that contribute to antibiotic resistance are low to middle income countries, with India topping the list[4]. This paper aims to uncover the economic and policy-oriented reasons why this is a major problem in India. This paper will also attempt to answer if changes in Government policies and legal framework surrounding the prescription and consumption of antibiotics will help in addressing this issue.
Legal and administrative framework on the sale of antibiotics
Any laws, rules and guidelines related to the medical and related professions fall under the concurrent list under Schedule Seven of the Constitution of India. The Indian Ministry of Health and Family Welfare sets policies around the production, prescription, and consumption of antibiotics, largely through The Drugs and Cosmetics Rules, 1940 notified under The Drugs and Cosmetics Act, 1940. Several guidelines for the usage of anti-microbial medicines for treating bacterial infections are also published periodically by the National Centre for Disease Control (NCDC) and the Indian Medical Centre for Research. The control over distribution and regulation of such drugs is exercised by the Central Drugs Standard Control Organisation (CDSCO) and several State Licensing Authorities (SLAs). This means that the implementation of guidelines regarding regulation, sale, manufacturing, and licensing for manufacture of drugs falls under the purview of each state government. For this paper, we shall focus on antibiotics which fall under the category of schedule H (prescription drugs) and schedule H1 (prescription drugs that are dangerous and must be consumed only under medical supervision) of the Drugs and Cosmetics Rules, 1940. The above-mentioned system of administration and its surrounding socio-economic issues shall be analysed in order to understand the root causes of the misuse of antibiotics and the consequent drug resistance the country is facing today. Despite antibiotics being classified as a prescription drug, commonly sold antibiotics are available as over the counter (OTC) and are dispensed illegally. The term “over the counter” is not defined in any of the concerned legal documents mentioned above, but it refers to medicines that are dispensed without any restrictions and can be used by consumers for self-medication. This practice is dangerous as it leads to the creation of an illicit, unregulated market of antibiotics which is, according to the NCDC, a major contributor to the rapidly rising levels of antibiotic resistance in India[5]. The major socio-economic and legal reasons why this market came into being are discussed as follows.
Challenges faced by the Indian medical market
The biggest hurdle that many Indians face is that they are not able to afford quality medical guidance at an affordable price. Overburdened government and non-profit hospitals and medical centres cannot cater to all and provide timely treatment. It is estimated that Indians have to pay around 63% of their medical bills out of pocket, making it one of the highest in the world[6]. With 7% of Indians being pushed below the poverty line annually due to medical expenses, it is clear why many Indians prefer obtaining antibiotics without a doctor’s advice and prescription[7]. In cases where people are able to afford quality medical guidance, the medical infrastructure available might be inadequate. Data suggests that India has 1.4 beds per 1,000 people, 1 doctor per 1,445 people, and 1.7 nurses per 1,000 people, with 75% of these resources being concentrated in urban areas[8]. According to a report published by WHO, over 469 million people in India do not have everyday access to essential medicines. In such a scenario, the common man is inclined to self-medicate over the counter under the guidance of a pharmacist, especially for common ailments and not resort to a doctor’s prescription and diagnosis for suitable treatment. This idea is further reinforced by a study conducted by Gupta P et al in Malwani, an urban slum in Mumbai. The survey, which aimed to analyse the number of adults indulging in self-medication practices found that 75.6% of such people were labourers. This shows that certain vulnerable communities that work on a daily wage basis prefer self-medicating rather than spending time to visit a doctor, which might consequently cost them half a day’s wage. Furthermore, it was found that many people in this survey did not have enough knowledge of how to consume antibiotics and medicines of a similar nature responsibly[9].
Often, medical professionals themselves prescribe antibiotics without good cause. A study by the Pew Research Centre suggests that medical practitioners have a financial incentive to prescribe antibiotics to provide “quick relief” to the symptoms of the patient. Since it is in their interest to not lose a customer, often antibiotics are prescribed as a “quick fix solution” for treating patients with viral infections, where the virus itself is seldom treatable with any medications and only the symptoms surrounding it can be addressed. Pharmacies are bound by a similar economic incentive where they dispense commonly used antibiotics over the counter in an attempt to retain customers. Azithromycin happens to be the most abused medicine, which is commonly used to treat chest and throat infections. A large number of customers also use old and invalid prescriptions in order to purchase medicines in case of chronic diseases, but a pharmacist is forced to provide medicines under schedule H and H1 over the counter in order to sustain its business[10].
This irresponsible sale and consumption of antimicrobial medicines leads to the consumer holding the shorter end of the stick. While commonly used broad spectrum antibiotics are affordable and can be orally consumed, a patient is forced to consume second line antibiotics once the infectious microbe becomes resistant to the previously used medicine. Second line antibiotics are much stronger in potency and are used to target disease-causing microbes that have become resistant to the first line broad spectrum antibiotics. Since such medications cannot be consumed orally, a patient has to be admitted to a hospital for the drug to be administered via IV drips. This not only increases the cost of treatment substantially, but also eliminates the possibility to self-medicate. A growing list of infections – such as pneumonia, tuberculosis, blood poisoning, gonorrhoea, and foodborne diseases – are becoming harder, and sometimes impossible, to treat as antibiotics become less effective. In India, multi drug-resistant tuberculosis has become a major problem with over 20% of patients dying during the course of the treatment[11].
Is this situation a failure of policy? Will stringent regulatory measures solve the problem?
Chapter 4, Section 27 (d) of the Drugs and Cosmetics Act, 1940 mentions that:
“(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years 8 [and with fine which shall not be less than twenty thousand rupees]:”[12]
This makes the rule very weak as it is a residuary clause which does not address the specific offense of selling prescription medicines over the counter. Moreover, the penalties mentioned in the above provision are not stringent enough to have a deterring effect among pharmacists and medical professionals. Inconsistent and superficial inspections and non-existent maintenance of records despite regulatory requirements to do so further worsen the situation. The available data regarding antibiotic resistance in India is also very inconsistent and not well recorded which shows us that the current system of surveillance and regulation of the sales of antimicrobial drugs, if solid on paper, are implemented poorly. When we compare such legislations to the ones in countries like USA, we observe that the Food and Drugs Administration (FDA) publishes guidelines and rules that must be followed in the United States when it comes to the prescription and sale of antibiotics. Barring a few exceptions, no antibiotic medicine in the United States can be sold without a valid prescription from a practicing medical professional. Selling antibiotics without a prescription in the United States can result in both civil and criminal penalties. The exact punishment for selling antibiotics without a prescription will depend on the specific circumstances of the case and the jurisdiction in which the offense occurred. The FDA has the authority to take action against companies and individuals who violate federal laws and regulations regarding the distribution of drugs and can take various enforcement actions such as product seizures, fines, and even criminal prosecution. Additionally, state and local law enforcement agencies may also take action against individuals or businesses that sell antibiotics without a prescription, including fines or imprisonment[13]. Despite variations in laws between different states in the USA, the overall implementation of control over antibiotic dispensing across the country is relatively well maintained and consistent.
But do these measures translate to a lower number of cases of antibiotic resistance? The Centre for Disease Control (CDC), USA estimates that about 2.8 million Americans are infected with a drug-resistant disease every year and about 35,000 deaths occur annually as a direct result of this issue[14]. The CDC reports suggest that this happens as a result of improper consumption of the drug and lack of awareness regarding the dangers of irregular dosages of the drug. The United States Congress recently introduced a bill to create the Strategies To Address Antimicrobial Resistance (STAAR) Act in 2019[15] but it has had an extraordinarily trivial effect in the current situation so far. This shows us that although strong policies can help in collecting data, regulating the manufacturing, and keeping tab on the sales of such drugs, it is not enough to curb the effects of this ‘silent pandemic.’
Looking ahead
The Government of India has already initiated discussions about this issue and has started to act towards a potential solution. The NCDC, back in 2012, had introduced an antibiotic stewardship strategy called the National Programme on Anti-Microbial Resistance Containment which aims to introduce better surveillance and collection of data regarding drug resistant infections. This programme also visions the introduction of practices that promote the rational use of antimicrobial medications. Apart from the measures the Government of India is currently taking, I believe it is necessary to create a more accessible, centralised database that can track the sale of antibiotics. The requirement for maintenance of manual registers of the sale of antibiotics as well as other controlled drugs in every pharmacy is a tedious process and does not lend itself to consolidation and tracking. India is in the midst of a technological and IT revolution, and we have the capabilities to connect pharmacies across the country through the growing telecommunication network. Note that more and more small businesses even in rural areas have now adopted UPI as a mode of payment – the same connectivity tools through the mobile telecommunication network can be used to facilitate creation of a centralised database on sale of antibiotics. This is feasible as (1) most Indian pharmacies, at least in urban and semi-urban areas have a computerized billing system from which data on sale of Schedule H and H1 drugs may be uploaded onto a database that is centralized, at least at State level. This approach can prove to be highly effective as it also gives us an insight into the trends around the inventory and sale of antibiotics across the nation, which can help us understand if antibiotics are being dispensed over the counter. The data will include the details of the dispensing pharmacy, patient, prescribing doctor – all of which would enable useful analysis and provide pointers to ‘leakage’ through sale of antibiotics without prescription.
On the other hand, there is also a need for stringent policies to be put in place, specifically addressing antibiotics. The vague and unorganised system of regulation makes the implementation of policies patchy and ineffective. State governments must follow stricter standards when it comes to the guidelines pharmacies are expected to follow. The state of Kerala is a leading example in this scenario, where the Kerala Antimicrobial Resistance Strategic Action Plan (KARSAP) was initiated- the first of its kind in India. This plan was introduced in 2018 and worked towards the Awareness and Understanding, Infection Prevention and Control and Optimising use of antibiotics[16]. In order to achieve antibiotic literacy in the state, Health Minister Veena George also mentioned that no antibiotics will be sold without a prescription and action will be taken against the pharmacists who break the rule[17]. The Government must also work towards making the availability of cheap and accessible medical advice by establishing more local dispensaries and hospitals that can cater to the masses living in remote areas. The Pharmacy Act of 1948 outlines the qualifications and knowledge requirements needed to establish and operate a pharmacy. A sensitization course must be introduced into the curriculum in order to spread awareness about the dangers of irresponsible consumption of such medications. Such courses must be regularly conducted for doctors by the Indian Medical Association and must also be conducted in educational institutions to instil responsible medical practices. Creation of awareness among common people through educational institutions, market associations, social institutions and social media would also play a part in addressing this critical issue.
Antibiotic resistance and ‘superbugs’ are a significant threat to human health, no less than pandemics like COVID – just that they are slow and less visible – but equally dangerous. The time to act is NOW.
[1] Annie J Browne et al., Global antibiotic consumption and usage in humans, 2000–18: a spatial modelling study, 5 The Lancet Planetary Health e893–e904 (2021).
[2] Supra 1
[3] World Health Organization, Antibiotic Resistance, World Health Organization (2020), https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance.
[4] Eili Y Klein et al., Tracking global trends in the effectiveness of antibiotic therapy using the Drug Resistance Index, 4 BMJ Global Health e001315 (2019).
[5] National Guidelines for Infection Prevention and Control in Healthcare Facilities, MoHFW 2020 Training Modules :: National Centre for Disease Control (NCDC), Ncdc.gov.in (2020), https://ncdc.gov.in/index1.php?lang=1&level=2&sublinkid=1019&lid=794 (last visited Jan 23, 2023).
[6] Sakthivel Selvaraj, Habib Hasan Farooqui & Anup Karan, Quantifying the financial burden of households’ out-of-pocket payments on medicines in India: a repeated cross-sectional analysis of National Sample Survey data, 1994–2014, 8 BMJ Open e018020 (2018), https://bmjopen.bmj.com/content/8/5/e018020.
[7] Supra 6
[8] National Health Accounts Estimates for India, https://main.mohfw.gov.in/sites/default/files/89498311221471416058.pdf.
[9] Mishra Divya et al., Self-Medication Among Adults in Urban Udupi Taluk, Southern India, 6 International Journal of Medicine and Public Health 126–129 (2016), http://ijmedph.org/article/469 (last visited Oct 31, 2020).
[10] Antibiotic Resistance Is Not Theoretical: It’s Here and Getting Worse, pew.org, https://www.pewtrusts.org/en/research-and-analysis/articles/2020/09/02/antibiotic-resistance-is-not-theoretical-its-here-and-getting-worse (last visited Jan 23, 2023).
[11] Institute of Medicine (US), Drug-Resistant TB in India (2012), https://www.ncbi.nlm.nih.gov/books/NBK100386/.
[12] GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) THE DRUGS AND COSMETICS ACT AND RULES THE DRUGS AND COSMETICS ACT, 1940 (23 OF 1940) THE DRUGS AND COSMETICS RULES, 1945, https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf.
[13] Office of the Commissioner, Medical Countermeasures Initiative (MCMi), FDA (2021), https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/medical-countermeasures-initiative-mcmi.
[14] Office of the Commissioner, Antimicrobial Resistance Info, U.S. Food and Drug Administration (2019), https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda.
[15] Sherrod Brown, Text – S.3291 – 117th Congress (2021-2022): STAAR Act, http://www.congress.gov (2021), https://www.congress.gov/bill/117th-congress/senate-bill/3291/text.
[16] Kerala Antimicrobial Resistance Strategic Action Plan, ncdc.gov.in, https://ncdc.gov.in/WriteReadData/l892s/35158354141579866436.pdf.
[17] No antibiotics without prescription in Kerala, The Hindu, December 22, 2022, https://www.thehindu.com/news/national/kerala/no-antibiotics-without-prescription-in-kerala/article66289915.ece (last visited Jan 23, 2023).
Author: Aarush Venkatesh
Juris Centre 