Aatrishnu Halder
The Out of Pocket Expenditures (OOPE) on health is one of the primary barriers impeding a sustained access to quality healthcare in India. While the National Health Accounts Estimates for India (2021-22) reports a reduction in OOPE as percent of Total Health Expenditure (THE) from 64.2 percent in 2013-14 to 39.4 percent in 2021-22, a concerning trend is observed in the rise in the Per Capita OOPE (Rs.) at current prices from Rs.2097 in 2017-18 to Rs.2600 in 2021-22 (National Health Systems Resource Centre, 2024).
Medicinal costs constitute a major component of OOPE. Generic medicines emerge as an affordability enabling solution to further drive down such expenditure. Generic medicines are therapeutically equivalent to innovator products in terms of active ingredient, strength, dosage form, and intended use, and are approved based on pharmaceutical equivalence and bioequivalence, rather than requiring repeat clinical trials. This regulatory pathway enables substantial cost savings while maintaining standards of safety and efficacy (Ali & Sinha, 2024; Manak & Inder, 2025).
However, despite regulatory safeguards and low NSQ rates within the scheme, uptake of generic medicines remains uneven, particularly in urban low-income settings. Access to affordable medicines remains a critical concern in India, particularly for economically vulnerable populations residing in urban slums.
What do credible literature about the equivalence and perception on generic medicines say?
Clinical studies have shown that generic drugs and their branded counterparts don’t demonstrate any meaningful difference in terms of therapeutic outcomes. Das et al. (2017) performed an experiment which involved random sampling of patients in Out-Patient-Departments (OPDs) of government hospitals wherein one group was given branded medicines and another with generic versions. Applying the Drug Attitude Inventory (DAI-10) method, the findings revealed that both the groups had an identical mean score of 6.3, implying no significant difference exists between branded and generic drugs in terms of quality (Das et al., 2017).
In the Indian context, research has demonstrated the equivalent quality of generic drugs, including those from Jan Aushadhi Kendras. Singhal et al. (2010) tested the generic versions of four common. drugs viz. Alprazolam, cetirizine, ciprofloxacin, fluoxetine from Jan Aushadhi Kendras against leading brands and found the samples to pass the critical tests of identification, chemical composition, weight uniformity, and dissolution. Another research evaluating the quality of generic versions of alprazolam, cetirizine, ciprofloxacin, fluoxetine, and lansoprazole found them to be identical to branded counterparts and attributed the price differentials to marketing strategies rather than to differences quality or therapeutic value (Kotwani et al., 2011).
Studies focusing on sensitive therapeutic areas offer additional nuance. Ting et al. (2015) evaluated the bioequivalence and clinical outcome of a generic, lamotrigine, with a brand name drug, Lamictal, used in ‘generic-brittle’ patients who have epilepsy and are at a high risk for complications; this study found that the generic drug fulfilled both standard and narrow therapeutic index (NTI) bioequivalence criteria and there was no systematic difference in seizure frequency or adverse events (Ting et al., 2015).
A strong theme in the literature is that awareness is often incomplete. Manjula Bai (2021) found limited public awareness of the Pradhan Mantri Bharatiya Janaushadi Kendra scheme and recommended stronger publicity and consumer education. Johnson et al. (2020) reported similarly low awareness in Bangalore South: most respondents did not know about the nearby Jan Aushadhi Kendra, although almost all wanted more awareness through mass media. Vayalambron and Sishina (2024) also found that a sizeable share of consumers lacked awareness of Jan Aushadhi Kendras, even though many were already using generic medicines because of cost.
More direct patient-level evidence comes from Charan et al. (2019), who found that only 22.9% of patients had heard about generic medicines. Among those who had heard of them, just 38% had used them in the previous six months, while 65.8% agreed that generics are safe, and only 36.7% believed they are as effective as branded drugs. The most common reason for non-use was distrust of efficacy. Age and education were positive predictors of awareness, further showing that knowledge is socially patterned rather than evenly distributed.
Direct observations from the urban slum population of Hyderabad about their acceptance level, perception on generic medicines:
The healthcare infrastructure of urban slums within the Greater Hyderabad Municipal Corporation (GHMC) is shaped not only by epidemiological factors but also by institutional arrangements and information asymmetry. The settlements include people mainly working in informal sectors, such as daily wage earners, auto drivers, construction workers, etc., and have constrained access to the equitable healthcare system, thereby burdening them with excessive Out-of-Pocket Health Expenditure (OOPE).
One of the notable findings from the fieldwork is that 72% of the respondents had lack of knowledge about the utility and therapeutically equivalent of generic medicines which hinders their decisions on informed choices about lower cost medicines. Although 67% of the respondents have shown interest in trying generic medicines if and only recommended by doctors.
Medicines as shaped by doctors and pharmacies:
There is a strong influence of medical professionals on the medicinal choices as doctors were identified as the final decision maker in 71 % of the reported cases involving people with serious illnesses, and also, 93% of the respondents identified doctors in determining their medicinal choices. However, 74% of the medicine purchases for episodic illnesses and 73% for chronic conditions.
Around 27% of surveyed households reported monthly incomes below Rs10,000 while 37% reported monthly medicine expenditure between Rs 1,500- Rs 2,000. Among the respondents, 42 % of the people reported financial difficulty due to medicine expenditure.
Trust- the primary factor of determining the level of generic medicines uptake:
Trust plays an important factor in determining whether a person would use generic medicines over its branded counterparts. Only 9% of the respondents consider generic medicines as therapeutically equivalent to its branded version. Most importantly, 91% identified a doctor’s recommendation as the primary determinant for increasing the number of generic medicines uptakes.
Policy Implications:
Public awareness campaigns should clearly demonstrate about the quality equivalence of the generic medicines through vernacular languages based on the social context, while doctors and medical practitioners should actively prescribe the generic medicines in the prescriptions while nudging people to go for the cheaper alternatives which provide the same therapeutic outcomes.
References:
Ali, A., & Sinha, K. (2024). Regulatory landscape for generic drugs in India: Assessing quality, safety, and efficacy standards. Biotechnology Law Report, 43(3), 131–141. https://doi.org/10.1089/blr.2024.29101.phc
Charan, J., Saxena, D., Chaudhri, M., Dutta, S., Kaur, R. J., & Bhardwaj, P. (2021). Opinion of primary care physicians regarding prescription of generic drugs: A cross-sectional study. Journal of Family Medicine and Primary Care, 10, 1390–1398.
Das, M., Choudhury, S., Maity, S., Hazra, A., Pradhan, T., Pal, A., & Roy, R. K. (2017). Generic versus branded medicines: An observational study among patients with chronic diseases
Kotwani, A., Singal, G., & Nanda, A. (2011). A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India.
Manak, S., & Inder, D. (2025). Generic drugs in India: Regulations, challenges, and reforms: An medicinesfor-whose-benefit.pdf
Singhal, G. L., Kotwani, A., Nanda, A. (2010). JAN AUSHADHI STORES IN INDIA AND
Ting, T. Y., Jiang, W., Lionberger, R., Wong, J., Jones, J. W., Kane, M. A., Krumholz, A., Temple, R., & Polli, J. E. (2015). Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard. Epilepsia, 56(9), 1415–1424. https://doi.org/10.1111/epi.13095
Vayalambron, L., & Sishina, O. C. (2024). An analysis of consumer awareness regarding Jan Aushadhi Kendras. SEEJPH, 2024, 222–225.
About the Contributor
Aatrishnu Halder holds an MA in Public Policy and Governance from the Tata Institute of Social Sciences (TISS), Hyderabad. He is associated with Vaaradhi Trust and has an interest in public policy research, governance, and development-related issues. His academic background and professional engagement reflect a focus on contemporary policy challenges and social development.
Disclaimer: All views expressed in the article belong solely to the author and not necessarily to the organisation.
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Acknowledgement
This article was posted by Pritha Chowdhury, a research intern at IMPRI.
