Challenges And Outcomes Of Pharmaceutical Price Controls In LMICS - Insights From India’s Drug Pricing Policy

Author: LawSphereX

Category: General Law

Published: 2026-08-23T18:44:59.628Z

Updated: 2026-08-30T07:10:06.423Z

CHALLENGES

AND OUTCOMES OF PHARMACEUTICAL PRICE CONTROLS IN LMICS: INSIGHTS FROM INDIA’S DRUG PRICING POLICY Regan Kalate, Ph. D. Research Scholar, Dept. of Laws, Himachal Pradesh University, Summerhill, Shimla, Himachal Pradesh, India.

ABSTRACT

Medicines represent a large portion of healthcare spending, and many people struggle to afford essential treatments for non-communicable diseases (NCDs). In India, the National Pharmaceutical Pricing Authority (NPPA) manages drug prices through the National Pharmaceutical Pricing Policy (NPPP) and Drug Price Control Orders (DPCO). The NPPA sets ceiling prices for essential medicines included in the National List of Essential Medicines (NLEM) to ensure affordability. The DPCO, revised in 2013, covers a wide range of drugs and establishes maximum retail prices (MRPs). Globally, different pricing mechanisms are employed: the UK and Canada use value-based pricing, Germany and France use reference pricing, while the US relies on market dynamics.

India’s approach focuses on setting price ceilings to manage drug costs, despite having relatively low health expenditures compared to substantial subsidies in other sectors. Price controls can enhance medicine affordability but may also disrupt supply and innovation. Research shows that while essential drug prices have decreased, the effects on market dynamics are mixed. Evidence indicates that price controls might lead to reduced sales and market exits by low-cost producers, potentially causing shortages and decreased access. Price controls can shift market share towards multinational companies, which may affect the availability of affordable drugs. While price controls have reduced costs for some drugs, they may also lead to market instability and shortages, particularly impacting rural areas.

Effective drug price regulation in LMICs and India requires a balanced approach, addressing affordability while considering the impacts on innovation and market stability. Policymakers need to ensure that regulations do not inadvertently disrupt access to essential medicines or undermine the healthcare system. Comprehensive strategies that include health system reforms, better health literacy, and collaboration among stakeholders are crucial to improving healthcare access and ensuring equitable distribution of medicines.

Keywords: Low- and Middle-Income Countries (LMICs), Drug Prices, National Pharmaceutical Pricing Authority (NPPA), National Pharmaceutical Pricing Policy (NPPP), Drug Price Control Orders (DPCO), National List of Essential Medicines (NLEM), Price Control Mechanisms, Pharmaceutical Industry, Essential Medicines, Pharmaceutical Regulation, Non-Communicable Diseases (NCDs). Introduction Low-income households in low- and middle-income countries (LMICs) are especially burdened by drug prices, as they not only have limited income and savings but also depend heavily on medication for healthcare due to inadequate access to medical facilities and trained professionals.

While, medicines account for approximately 30% of total public and private healthcare expenditures in low- and middle-income countries but they constitute 20– 60% of total healthcare expenditure, and nearly 90% of the population pays for medicines out of pocket. 1 A significant portion of the population in low- and middle income countries (LMICs) has been found to be unable to afford the monthly treatment costs for medicines required for three common non-communicable diseases (NCDs) when purchasing from the private sector. 2 National Pharmaceutical Pricing Authority (NPPA) The National Pharmaceutical Pricing Policy (NPPP) governs price control, while the Drug Price Control Orders (DPCO), issued by the Ministry of Chemicals and Fertilizers, enforce these controls, with the Ministry serving as the primary administrative authority for pharmaceutical companies.

The functions of the Authority include implementing and enforcing the provisions of the Drugs (Prices Control) Order according to its delegated powers, handling legal matters arising from its decisions, monitoring drug availability, identifying shortages and taking corrective actions, collecting and maintaining data on production, exports, imports, market share, and profitability for bulk drugs and formulations, undertaking or sponsoring relevant studies on drug pricing, recruiting and appointing staff according to government rules, advising the Central Government on changes or revisions to drug policy, and assisting the Central Government with parliamentary matters related to drug pricing.

3 Government Pricing Mechanisms The Indian government regulates drug prices primarily through the National Pharmaceutical Pricing Authority (NPPA) under the National Pharmaceutical Pricing Policy (NPPP) and the Drug Price Control Orders (DPCO). The advent of drug price regulation began post-World War II due to rising pharmaceutical costs, leading policymakers to balance innovation and affordability, with countries adopting diverse approaches based on their healthcare systems and contexts: the UK and Canada use value-based pricing, Germany and France employ reference pricing, and the US relies mainly on market dynamics with some public healthcare constraints. 4 In India, although government health expenditures are similar to those of comparable countries when considered as a proportion of total government spending, they are relatively low in relation to GDP, amounting to $21 billion or 0.

96% of GDP in 2016, and are overshadowed by large subsidies for food, fertilizer, and petroleum, which collectively exceed the direct health expenditures by the state and central governments. 5 Thus, Indian Government does not give any direct benefit to the pharmaceutical companies for controlling the prices of medicines, rather, to regulate medicine prices in India, the Government enforces a price cap, where the maximum retail price (MRP) represents the highest allowable price that can be charged for a product sold in the country, as determined by the manufacturer. In India, even, all retail products must display a maximum retail price (MRP) and shops cannot charge above it, illegal overcharging often occurs in remote areas, tourist spots, and where products are scarce.

The National Pharmaceutical Pricing Authority (NPPA) publishes maximum ceiling prices for medicines, with the National List of Essential Medicines (NLEM) determining which medicines fall under price control through the Drug Price Control Orders (DPCO).

Drug Price Control Orders (DPCO) National governments use a variety of policy instruments to address market imperfections and control medicine prices and expenditures, often employing price regulation methods such as controlling mark-ups, reference pricing, price negotiations, cost-plus-based pricing, value- based pricing, pricing through tenders, and pooled procurement; the choice of which approach to use is typically based on a careful assessment of national priorities, health financing mechanisms, the regulatory landscape, and the health system context, with most countries implementing a combination of these instruments to balance health policy objectives with industrial policy goals. 6 The central idea behind drug price regulation is to manage medicine prices through various mechanisms to ensure their affordability and availability.

In India, drug prices are regulated by Drug Price Control Orders (DPCO) issued under the Indian Essential Commodities Act of 1955, and this system is overseen by the National Pharmaceutical Pricing Policy (NPPP), which also led to the formulation of a National List of Essential Medicines (NLEM). The Drug Price Control Order (DPCO) is a key regulatory mechanism in India designed to control the prices of essential medicines. The Drug Price Control Orders (DPCO) are instrumental in regulating the prices of life-saving drugs that are crucial in the current healthcare landscape, as they encompass all essential medications and establish a ceiling price, ensuring that drug prices do not exceed the limits set by the DPCO.

The term "scheduled drugs" has been updated to "scheduled formulations” in response to recent developments in the pharmaceutical sector,7 thus, price controls are applied to "Scheduled drugs" or "Scheduled formulations," which, since 2013, include "Essential Medicines" identified by the Government through the National List of Essential Medicines (NLEM) under Schedule-I of DPCO; however, this does not imply that all drugs under price control are essential medicines, and according to Para 19 of the DPCO-2013, the Government has the authority, in extraordinary circumstances and in the public interest, to set ceiling or retail prices for any drug, whether scheduled, non-scheduled, or a new drug, for any duration it deems appropriate, while price exchanges among competitors can also breach antitrust laws.

8 Consequently, Schedule I of the DPCO-2013 currently corresponds to the NLEM-2022 list, making it the most recent in the series and any formulation containing a combination of drugs listed in the NLEM can be subject to price fixation. 9 Since 1970, the National Pharmaceutical Pricing Authority has introduced a series of Drug Prices Control Orders to regulate the prices of essential medicines in India. 10 Following the introduction of the Drug Price Control Orders (DPCO) in 1995, a revised version was implemented in 2013; while DPCO 1995 covered approximately 74 bulk drugs, DPCO

2013 encompasses nearly 652 drugs, meaning that all medicines currently regulated by DPCO

fall under the provisions of DPCO 2013. 11 In May 2013, India's Department of Pharmaceuticals (DoP) brought 348 specific formulations from the National List of Essential Medicines (NLEM) under price control through the Drug Price Control Order (DPCO) 2013, aiming to ensure affordable access to essential medicines for the poor while fostering innovation and growth in the pharmaceutical industry, with the National Pharmaceutical Pricing Authority (NPPA) authorized to regulate and monitor medicine prices, and firms required to implement the new prices by June 2013, with the order taking effect in July 2013,12 Before the 2013 legislation, India already had price controls in place on 95 active pharmaceutical ingredients, commonly referred to as "bulk drugs.

"13 The government's efforts to reform and expand pharmaceutical price controls faced strong opposition from the local pharmaceutical industry, and with good reason—when the Indian government announced plans to impose price controls on essential medicines in 2006, the stock prices of local pharmaceutical firms plummeted. 14 The legislation empowered the government to impose price ceilings on drug formulations listed in India’s National List of Essential Medicines. The primary aim of establishing the Drug Price Control Orders (DPCO) was to ensure that essential and life-saving medications are available at minimal prices to all segments of society, particularly for those who need proper medication but cannot afford it.

The DPCO 2013 set price ceilings for regulated drugs using a market-based mechanism, calculating the ceiling as the simple average of prices for brands with at least 1% market share, with higher-priced brands required to reduce prices, and annual price increases for regulated drugs limited to the wholesale price index, unregulated drugs allowed a 10% annual increase, a 16% retailer margin fixed, firms permitted to exit a category only with six months' notice, and the NPPA authorized to mandate continued production for up to 12 months while monitoring drug production and availability.

15 The ceiling price represents the maximum price set by the government for drugs, and there is also a 'National List of Essential Medicines (NLEM),' which is a comprehensive list of essential medications, currently including over 348 drugs and expanding regularly to accommodate new and lifestyle-related diseases and their treatments,16 however, the National List of Essential Medicines, released in September 2022, includes 384 drugs and covers over 1,000 formulations across 27 therapeutic categories.

17 Moreover, not all drugs under price control are essential medicines, as Para 19 of the DPCO-2013 empowers the Government, in extraordinary circumstances and in the public interest, to fix or revise the ceiling or retail price of any drug, whether scheduled, non-scheduled, or new, for any period it deems fit, regardless of the annual wholesale price index, with price controls applying equally to both generic and branded drugs.

18 Impact of Drug Price Control Orders Drug price regulation affects patient access to medicines in complex and context-specific ways, as direct price controls can improve affordability and accessibility but may disrupt drug supply, this is especially true for less commonly used or complex medicines, creating market instabilities that may negatively impact patient access to essential medicines, making direct price controls potentially counterproductive in the long term, while indirect price control methods can be complicated and potentially limit innovation; therefore, addressing persistent access disparities requires a comprehensive strategy that includes health system reforms, better health literacy, and collaborative efforts.

19 The implementation of price regulation involves multiple stakeholders, including pharmaceutical firms, physicians, patients, and retailers, each of whom responds differently to the regulatory measures. At present, price regulation focuses on the supply side of the market by controlling manufacturer prices and their profit margins.

Initially, the Drug Price Control Order (DPCO) has lowered the costs of essential drugs, reducing overall healthcare expenses in India and improving accessibility for middle-income groups, exemplified by the recent regulation of prices for 92 drugs by the NPPA; companies like Mankind Pharma, which sell below the ceiling price, have seen increased profit margins, while the shift from manufacturing costbased pricing in DPCO 1995 to market-based pricing in DPCO 2013 benefits patients and manufacturers alike by making long-term essential medications more affordable.

20 Previous research from India on the antihyperlipidemic drug atorvastatin, which was regulated under DPCO 2013, indicated that placing the drug under price control led to an improvement in its relative sales within the country,21but later studies suggests that after DPCO 2013 was introduced, sales of antibiotics under the regulation dropped immediately by 3. 7% (though this change was not statistically significant), with a continued but insignificant decline of 0. 3% over time compared to before the intervention; however, in terms of 'average monthly market share, there was a sharp and significant decrease of 579% initially, followed by a small and statistically insignificant increase of 9. 5% over time compared to the period before the policy.

22 In a study, though being confined to a specific segment of the Indian anticancer drug market, using monthly sales audit data from 2012 to 2015 provided by Intercontinental Medical Statistics (IMS) Health, it was found that 22. 3% (n=347) of 1556 anticancer drug packs were price controlled; the policy led to an immediate monthly reduction of 27. 3% (95% CI -38. 6%, -13. 9%; p=0. 001) and a long-term monthly reduction of 0. 7% (95% CI -1. 6%, 0. 3%; p=0. 16) in the utilization of these price-controlled formulations, with their utilization being 5. 03 thousand standard units lower than expected in the final study month without the policy.

23 Some Indian studies provide detailed insights into how producers react to price controls in branded generics markets; specifically, while price ceilings can successfully reduce overall pharmaceutical prices, they may inadvertently cause low-priced products to be withdrawn from the market, thereby potentially diminishing consumer welfare for those who depend on these affordable medications; furthermore, despite the appearance that price ceilings cut pharmaceutical costs without harming local businesses, they often result in a shift of market share toward multinational companies, putting local firms at a disadvantage, and evidence suggests that lower-priced medicines are frequently of lower quality, meaning that the increased market share of multinational firms could lead to health issues that outweigh the advantages of lower prices.

24 Further, studies indicate that a reduction in the detailing of regulated drugs may lead to a decrease in their prescriptions, thus lowering price ceilings through regulation negatively impacts profit margins, though, Government regulations generally motivated by the intention to enhance overall population welfare, are often implemented without fully assessing their impact on all stakeholders, as demonstrated by the instance in India where price caps on pharmaceuticals, while reducing profit margins, inadvertently lessened companies' incentive to market these regulated drugs, ultimately leading to a decline in sales.

25 Some studies suggest that the legislation's impact on consumer welfare is mixed: while the mandated price cuts led to similar price reductions in related products and increased market share for high-quality items, they also resulted in the exit of low-cost producers and decreased sales in markets with stricter price controls, potentially causing shortages of essential medications that could disproportionately affect rural and cost-conscious consumers, further worsening access to medicine.

26 Firms may circumvent price ceilings by altering or adding formulations of regulated drugs—such as shifting their focus to marketing combinations like Atenolol/Amlodipine instead of the individual molecules under price control—and, in the long term, may discontinue production of the controlled drugs altogether, transitioning to other molecules within the same therapeutic class, thereby rendering the price control ineffective. 27 Similarly, reducing margins for pharmacists is likely to be counterproductive, as it diminishes their incentive to stock those drugs, which could prompt pharmaceutical firms to shift their marketing efforts towards more profitable drugs and categories, potentially resulting in higher prices for patients or, even worse, leading firms to exit the essential medicines market altogether.

28 Thus the significant concern associated with the introduction of price controls is the potential for producer exit from the market. To address this concern, India required companies to notify and obtain approval before withdrawing a price-controlled product from the market, a measure that may have prevented the anticipated exit of multinational firms, which did not leave the Indian market at an increased rate following the price control legislation, at least in the short term. 29 Placing entire therapeutic categories under price control could resolve the issue of selective detailing, but it may also lead to significantly reduced investments in new drug launches within that class, which could be harmful in the long term.

One of the most significant effects of the control has been the rollback of prices for numerous brands to align with regulatory limits, which narrowed the price gap between lower and higher-end brands, disproportionately affecting small Indian manufacturers who were most impacted by the reduced-price differentials. 30 Some governments, including the Indian government, have proposed selling drugs under their generic names to cut marketing costs and lower prices; nevertheless, from a firm's perspective, the absence of price competition only heightens the significance of brand oriented competition.

31 Drug price regulation affects branded drugs more profoundly due to their higher prices, driven by research, development, and marketing costs, while promoting generics can enhance patient access by offering cheaper alternatives; however, an overreliance on generics may undermine patient adherence due to concerns about efficacy or quality and could also deter investment in new drug research, potentially affecting access to innovative treatments in the future. 32 Overall, while DPCO aims to make medicines more affordable, it requires careful management to balance affordability with maintaining a stable and innovative pharmaceutical market. Essential Medicines List (EML) and Price Capping The idea of essential medicines began as a conceptual policy framework and was formalized into the Essential Medicines List (EML) in 1977, with subsequent revisions occurring every two years.

33 The WHO Model Essential Medicines List (EML) serves as a guide for countries to develop and update their national EMLs, improving medicine procurement, supply, and prescription practices. 34 India’s National List of Essential Medicines is also derived from the World Health Organization (WHO)’s List of Essential Medicines, with modifications to suit local market conditions, and like the WHO list, it typically includes only specific formulations of a given molecule. For example, the National List of Essential Medicines includes the 250mg and 500mg dosages of the widely used antibiotic amoxicillin, but it excludes the 125mg dosage, which is also commonly used.

The criteria for selecting essential medicines involve meeting priority public health needs, proving efficacy and safety, ensuring cost-effectiveness, adhering to treatment guidelines, maintaining stability under standard storage, obtaining approval from regulatory bodies such as the DCGI, and being adaptable to local health requirements and emerging conditions. 35 In India, the first National Essential Medicines List (NEML) was created in 1996 and has been revised in 2003, 2011, 2015, and most recently in 2022, to ensure the consistent availability of essential medicines in appropriate forms, adequate quantities, with guaranteed quality, and at affordable prices.

However, several researches have highlighted significant challenges in the availability and utilization of essential medicines in India, revealing inadequate supplies across various states, with stock-outs ranging from 4 to 14 weeks, indicating governance and procurement issues. 36 Delays in updating the National List of Essential Medicines (NLEM) can obstruct access to vital medications, affecting patient care and affordability, particularly in resource-limited settings. 37 Research shows that more than half of prescriptions include drugs not listed in the NLEM, which can result in higher costs and reduced treatment effectiveness.

38 Programs such as the Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) strive to improve access to affordable generic medicines, yet issues like restricted drug availability and frequent stock-outs highlight the need for policy reforms to better procurement and distribution of essential drugs.

39 Conclusion Companies with the majority of their product prices above the ceiling are experiencing significant declines in profit margins, as detailed in the report, and with the pharmaceutical sector's growth and increasing competition, these companies must adapt to a constantly evolving market; however, ceiling prices and the Drug Price Control Orders (DPCO) may pose substantial obstacles, potentially causing companies to lose interest in the Indian market, leading to economic instability, and deterring companies from expanding into the essential drugs market in India due to stringent pricing regulations.

Some researchers have noted that the adverse effects of price control on a company could be mitigated by boosting the production and sales of other products, such as animal health products, family products, and laboratory chemicals, which are not subject to drug price control regulations. 40 However, the ability to swiftly shift into high-volume production or new markets varies among organizations, depending largely on the structure of their product line and their capacity to penetrate mass markets.

The researchers have noted shifts in pharmaceutical companies following the imposition of price controls, suggesting that companies should, first, minimize regulatory exposure by diversifying into product lines that are relatively free from governmental controls, as such controls are acceptable if they serve the larger societal good and companies can offset economic losses by expanding into uncontrolled categories; second, they should focus on maximizing sales volume by targeting mass markets or bulk-buying segments; and third, they should prioritize marketing cost-effectiveness in strategy selection, operations, target groups, and market territories. 41 Ultimately, studies that have stood the test of time suggest that regulatory measures should carefully consider the broader impacts on the healthcare ecosystem to prevent unintended negative outcomes for vulnerable populations.

42 Indirect price control methods like reference pricing and value-based pricing, intended to foster competition, can be complicated by administrative issues and may hinder pharmaceutical innovation, and despite extensive drug price regulation, access to essential medicines remains uneven, underscoring the need for a comprehensive strategy that includes health system reforms, better health literacy, and improved stakeholder collaboration.

The impact of drug price regulation on patient access to medicines is complex and influenced by various factors, as revealed by above discussed studies across different geographic and medicine specific zones. Therefore, to tackle this matter cosmetically, the policymakers need to balance the economic impact of drug price regulation with its potential long-term effects on pharmaceutical innovation, drug availability, and patient access, ensuring both affordability and incentives for developing new treatments. They must collaborate with the healthcare professionals, and other stakeholders to create comprehensive strategies that address challenges in healthcare by reforming systems for equitable access, enhancing health literacy, and fostering sector-wide collaboration.

ENDNOTES

1 Selvaraj, Sakthivel, et al. , Evaluating the Impact of Price Regulation (Drug Price Control Order 2013) on Antibiotic Sales in India: A Quasi-Experimental Analysis, 2008-2018. ” Journal of Pharmaceutical Policy and Practice (22 Oct. 2022), vol. 15, No. 1, https://doi. org/10. 1186/s40545-022-00466-4. 2 Khatib R, McKee M, Shannon H, Chow C, Rangarajan S, Teo K, et al. , Availability and Affordability of Cardiovascular Disease Medicines and Their Effect on Use in High-Income, Middle-Income, and Low-Income Countries: An Analysis of the Pure Study Data. Lancet 61–9, (2016), 387(10013). 3 Abdul Hamid, Shubam Segal, Tanvay Jaithliya, Jayesh Gadhiya, Zakarya Noorani and Gaurav Kumar Sharma, Drug Price Control Orders (DPCO), European Journal of Biomedical and Pharmaceutical Sciences, 945-956 (2018), Vol. 5, Issue 5.

4 Ashiwaju B I, Orikpete O F, Alade E Y, Raji A, Adesanya A O, Nwankwo T C, Impact of Drug Price Regulation on Patient Access to Medicines: A Systematic Review, Matrix Science Pharma, 112-118 (October-December

2023) Volume 7, Issue 4.

5 Summan A, Stacey N, Hofman K, Laxminarayan R., Fiscal Instruments for Health in India, in: Jamison DT, Gelband H, Horton S, Jha P, Laxminarayan R, Mock CN, Nugent R, editors, Disease Control Priorities: Improving Health and Reducing Poverty, 3rd ed. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2017 Nov 27. Chapter 19. PMID: 30212167.

6 Supra Note 1.

7 Kolte, A., Mal, H., Fulambrikar, M. and Jagtap, A, Impact of Price Control on Pharmaceutical Sector with Reference to India, Int. J. Intelligent Enterprise 90-104 (2021) Vol. 8, No. 1.

8 Supra Note 3.

9Ibid. 10 Sharma B, Mehta A, Farooqui H. H. et al., Impact of the Drug Prices Control Order (2013) on the Utilization of Anticancer Medicines in India: An Interrupted Time-Series Analysis, Cureus (June 27, 2022), 14(6): e26367. DOI 10.7759/cureus.26367

11 Supra Note 7.

12 Saravana Jaikumar, et al., Do No Harm? Unintended Consequences of Pharmaceutical Price Regulation in India, Social Science Research Network, (1st Jan 2023), papers. Ssrn.com/sol3/papers.cfm?abstract_id=4656364, https://doi.org/10.2139/ssrn.4656364.

13 Emma Boswell Dean, Who Benefits from Pharmaceutical Price Controls? Evidence from India, SSRN

Working Paper 4509963 (1 Jan. 2023), https://doi.org/10.2139/ssrn.4509963. or https://ssrn.com/abstract=4509963. 14 Aggarwal, A., India pharmaceuticals sector, Credit Suisse; as cited Ibid.

15 Supra Note 12.

16 Majumdar, J.S., Corporatization of the Healthcare System, Theoretical Quarterly of Communist Party of India, (Marxist), Marxist 2-8 (July-September 2018), Vol. XXXIV, Issue 3. Central Drugs Control Organisation, “Essential Medicines.” Visited at https://cdsco.gov.in/opencms/opencms/en/consumer/Essential-Medicines/Cdsco.gov.in on 24th Aug. 2024. 18 The internal guideline issued on May 29, 2014, under Para 19 of the DPCO, which detailed how to fix or revise prices for non-scheduled formulations based on inter-brand price differentials and establish launch prices for new non-scheduled formulations, was withdrawn on September 22, 2014; however, this does not affect the Government’s authority under Para 19 of the DPCO-2013 to set prices for non-scheduled formulations, as the guideline was perceived to exceed the scope of Para 19.

19 Supra Note 4.

20 Supra Note 7.

21 Selvaraj S, Farooqui HH, Karan A. 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. BMJ Open. 2018;8(5): e018020. 22 Selvaraj, Sakthivel, et al., Evaluating the Impact of Price Regulation (Drug Price Control Order 2013) on Antibiotic Sales in India: A Quasi-Experimental Analysis, 2008-2018, Journal of Pharmaceutical Policy and Practice (22 Oct. 2022), Vol. 15, No. 1, https://doi.org/10.1186/s40545-022-00466-4.

23 Supra Note 10.

24 Supra Note 13.

25 Supra Note 12.

26 Supra Note 13.

27 Supra Note 12.

28 Ibid.

29 Supra Note 13.

30 Venkatakrishna V. Bellur, Radharao Chaganti, Rajeswararao Chaganti and Saraswati R Singh, Strategic Adaptations to Price Controls: The Case of Indian Drug Industry, Academy of Marketing Science, Journal of the Academy of Marketing Science Winter 143-159 (1985), Vol. 13, No. 1.

31 Ibid.

32 Supra Note 4.

33 Pallavi Jha, Sneha Ambwani, Surjit Singh, Pankaj Bhardwaj, Shobhan Babu Varthya and Jaykaran Charan, Availability of the Essential Medicines is Community Pharmacies: A Cross-Sectional Study, Journal of Pharmacology and Pharmacotherapeutics 92 –94 (2022) Vol. 13(1). 34 Gautam Satheesh, M. K. Unnikrishnan, Vivekanand Jha, Abdul Salam, India’s Latest Essential Medicines List: Gaps, Strengths and Opportunities in Evidence-Based Decision Making, British Medical Journal Evidence Based Medicines (01-Feb-2023). 35 Arpit Parmar, Santanu Nath, Susanta Kumar Padhy, List of Essential Psychotherapeutic Medicines 2019 of India: When Science Was Left Behind, Indian Journal Pharmacy (March-April 2022), Vol. 64, Issue 2; and also, Harmeet Singh Rehan, Indranil Banerjee, Umesh D. Suranagi, Are We Moving Towards a New Definition of Essential Medicines?

Journal of Pharmacology and Pharmacotherapeutics (October-December 2015), Vol. 6, Issue 4.

36 Medha Wadhwa, Poonam Trivedi, Devang Raval, Somen Saha, Hitesh Prajapati, Rupal Gautam, K V

Jagadeesh, Kavitha Rajshekhar, Factors Affecting the Availability and Utilization of Essential Medicines in India: A Systematic Review, Journal of Pharmacy and Bioallied Sciences (April 2024).

37 Supra Note 34.

38 Ratinder Jhaj, et al., Use of Drugs Not Listed in the National List of Essential Medicines: Findings from a Prescription Analysis by the Indian Council of Medical Research-Rational Use of Medicines Centres Network in Tertiary Care Hospitals Across India, Indian Journal of Pharmacy (November 2022). 39 Sonam Lavtepatil and Soumitra Ghosh, Improving Access to Medicines by Popularizing Generics: A Study of ‘India’s People’s Medicine’ Scheme in Two Districts of Maharashtra, BMC Health Services Research Health (2022).

40 Supra Note 30.

41 Supra Note 30.

42 Supra Note 12.