The generic dilemma

Patient healthcare expenditure is increasing worldwide due to brand-name drugs which comprise out-of-pocket expenses that are 80% of total healthcare expenditures.[1] The situation is more complex in India where 70% of the population is rural. The central and state governments’ budgeted expenditure on healthcare touched 2.1% of GDP in FY23 and 2.2% in FY22, against 1.6% in FY21, as per the Economic Survey 2022–23. Despite this increase in allocation, the out-of-pocket expenditure (OOPE) as a percentage of total health expenditure still stands at a considerable 48.2%; though a decline substantially from 64.2% in FY14. Such excessive reliance on OOPE creates a disproportionate burden on low-income individuals, accentuating income inequality and the medical poverty trap.[2] Nearly 40% to 50% of OOPE is spent on medicines, 10% on diagnostic tests, and 13% on doctor consultations.[3,4] A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.[5] Generic product utilization is often encouraged to curb the cost of medicine due to lower prices, leading to substantial savings in healthcare expenditure.[5,6] USA, the first country to implement a generic drug implementation policy, achieved an 89% share of generic drugs in 2016 and this reduced the medical insurance expenditure by US$ 67.7 billion.[7] Japan, Canada, Australia, and European countries, as well as low & middle-income countries such as Philippines, had similar experiences regarding generic drug use.[8,9] All these countries have either made it compulsory to prescribe drugs with active substance names or passed laws for mandatory generic substitution.[10] India is considered as the largest provider of generic medicines worldwide. By volume it occupies about 20% share of global supply including supplies of over 50% of demand for various vaccines worldwide, catering to 40% of generic demand in the United States and 25% of all medicines in the United Kingdom. India produces about 60,000 generic brands for about 60 different therapeutic categories including manufacturing of more than 500 different Active Pharmaceutical Ingredients.[11] Despite such a credible world presence, the road to the introduction of generics in India for the general population has encountered multiple stumbling blocks. With the objective of making quality generic medicines available at affordable prices to all, the Jan Aushadhi Scheme initiated by the Government of India in November 2008 was relaunched by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers as Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) in 2015. Under the scheme, dedicated outlets [Janaushadhi Kendras] are opened to provide generic medicines at affordable prices. As of March 31, 2023, 9303 outlets are functional across the country. The product basket comprises 1800 drugs and 285 surgical items. Though a laudable attempt on the part of the government, the numbers are negligible in comparison to about nine lakh pharmacies spread across the country. These retail pharmacies are still the dominant medical distribution channels thus accounting for the OOPE by patients on medicines. The Medical Council of India’s ethics code for doctors made generic prescriptions mandatory in October 2016, though it was never actively enforced. The effort to reign in the pharma companies through the Uniform Code of Pharmaceutical Marketing practice, designed by the Union Government to prevent unethical practices by pharma companies, continues to be held in abeyance due to an adamant pharma lobby and indecisiveness on the part of the government. Most recently, the National Medical Commission; the regulatory body that replaced the Medical Council of India on 25 September 2020; addressed the matter again and a notification issued on August 2, 2023 said that, “Every Registered Medical Practitioner should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.” The order was again put on hold after the Union Ministry of Health held a meeting to discuss the guidelines with various stakeholders, including the Indian Medical Association and the Indian Pharmaceutical Association, who flagged concerns with the guidelines. The dilemma on the part of the practitioners will continue till all the other stakeholders, the government, and the pharma companies address the underlying concerns. What needs to be emphasized is that generic prescriptions hold the key to establishing a robust health delivery system in a populous country like India that continues to be on the Third World list of economic development. The field of ophthalmology in India faces a complex and multifaceted dilemma with regard to prescribing generic medicines. On one hand, generic medicines offer cost-effective alternatives, potentially increasing accessibility to essential eye care for the largely underprivileged population. On the other hand, ophthalmic conditions often require precise and customized treatments, raising concerns about the efficacy and safety of generic substitutes. The Challenges Precision and variation Ophthalmology demands precision in treatment due to the sensitivity of ocular tissues. Generic medicines may vary in their formulation, leading to concerns about inconsistent therapeutic effects and adverse reactions. Generic drugs are different from branded drugs in terms of inactive ingredients (buffer, excipients, and preservative) and thus, the side effects may be different.[12] Studies have reported different pH, osmolarity, concentration of the drug, drop size, higher particulate matter in generic drugs compared to brand, and a decrease in their efficacy when stored at a higher temperatures of 25°C–50°C.[13,14] Lack of standardization India’s pharmaceutical industry is vast and diverse, resulting in variations in the quality and reliability of generic eye medications. This lack of standardization can be a cause for concern. Indian regulatory framework does not provide unrestricted opportunities for all pharmaceutical companies as the quality system, infrastructure, and requirements to make sure that every generic drug is of the same quality and has passed the same quality system are not there yet in India.[15] Patient trust and compliance Patients may be hesitant to accept generic substitutes, fearing compromised quality. This mistrust can lead to noncompliance, potentially exacerbating eye conditions. Patients tend to prefer branded medications and many do not consider generic medicines equivalent to branded products. There is also a belief that branded products have greater potency and fewer side effects.[16] The packaging of generic drops is also a reason for poor patient adherence to usage. Whereas the packaging of innovator products is carefully designed and evaluated in clinical trials, aiming to identify issues with bottle design, the same is not true of generic eye drops. Several studies have shown considerable variation in the force required to squeeze different bottles and successfully release a drop.[17] Regulatory issues While India has stringent regulations for generic drug approval, enforcement can be a challenge. This raises questions about the quality control of generic ophthalmic drugs. Since testing for bioequivalence and therapeutic equivalence is not feasible with ophthalmic drugs, generic formulations only have to demonstrate pharmaceutical equivalence. These drugs get approval if active and inactive ingredients are within ±5% of the level found in innovator formulation.[18,19] Market logistics Generics being low priced and financially unattractive for manufacturers result in shortages often due to disruption in the supply chain. In many cases, manufacturers had discontinued the production of medications due to loss of profitability. The driving down of cost to the lowest possible price disincentivizes investment by manufacturers which may increase the risk of manufacturing problems or prompt them to leave the market, and shortages were compounded by logistical and regulatory hurdles being too great for other companies to increase production during a shortage.[20] Retailer control The biggest challenge to shift toward generic prescription is that we will be moving from the doctor’s control to the hands of retailers, which will be a big risk. The risk of this shift in control to retailers would mean that they would push only those products that give higher margins and not quality products necessarily and this could over a longer period reduce prices.[21] Benefits Cost-Effectiveness: Generic medicines are often more affordable than brand-name counterparts, making them accessible to a broader segment of the population, particularly in a country like India with diverse economic backgrounds. Percentage difference in the mean costs of branded and generic medicine varied from <10% to >70%.[22] Increased access Generic medications can help bridge the gap in access to essential eye care in rural and underserved areas, where the cost of branded drugs may be prohibitive. Studies indicate that switching from branded-generic medicine to unbranded generic medicines would lead to substantial cost savings for medicine consumers. Estimates suggest that unbranded generic substitution would reduce pharmaceutical expenditure by 6%–1129% of patient’s spending.[23] Competition and innovation The presence of generic alternatives can encourage competition and drive innovation in the pharmaceutical industry, potentially leading to improved formulations and lower prices for ophthalmic drugs. A strategy of delivering the highest quality at the lowest cost has enabled the Indian pharma industry to bring affordable medicines to patients in the country and other developing ones at price points that make them affordable and thus accessible. Generic producers in India drastically brought down the prices of vaccines and life-saving drugs used to treat diseases such as HIV, TB, and diabetes over the last couple of decades.[24] Global experience Several developed countries successfully incorporated generic medicines in ophthalmology, demonstrating that it is possible to strike a balance between cost-effectiveness and quality.[7-10] Mitigating the Dilemma Improved regulation Strengthening regulatory oversight and ensuring consistent quality standards for generic ophthalmic drugs is crucial to building trust among healthcare providers and patients. There is a need for major pharmaceutical policy reforms to promote generic medicines in a big way. Besides, the Central Drugs Standard Control Organisation must ensure that generic medicines available in the Indian pharmaceutical market are bioequivalent and those qualifying bioequivalence tests should be listed along with their branded counterparts and prices on a public or PMBJP portal.[23] Currently, only 14 ophthalmic formulations exist in the Jan Aushadhi Pariyojna list. More formulations need to be included to allow flexibility in prescribing to the clinicians. Physician education Ophthalmologists should be well-informed about the efficacy and safety profiles of generic medicines, allowing them to make informed decisions when prescribing. To have a better understanding about generic drug products, physicians must be well-informed about them during their academic career which will significantly impact the healthcare budget. Further, awareness programs about generic medicines should be conducted by government health authorities to rationalize the prescribing practice and to improve prescriber as well as consumer understanding. In addition, standard guidelines on generic drug substitution policy should be drafted to minimize healthcare expenditure.[25] Patient education Raising awareness among patients about the benefits and potential risks of generic medications can help build confidence in these alternatives. An open and frank physician-patient discussion about disease type, the need of regular follow-up, and the cost of life-long therapy may influence compliance and adherence and is essential for any therapeutic decision-making.[26] Compliance and adherence may paradoxically increase, especially in poor patients who cannot afford costly medications.[27] Research and data Continuous research and data collection on the effectiveness and safety of generic ophthalmic drugs can provide evidence-based guidance to healthcare professionals. The critical issues that affect the quality of generic drugs are purity, potency, stability, and drug release, and these should be controlled within an appropriate limit, range, or distribution to ensure the desired drug quality.[28] Conclusion The dilemma of prescribing generic medicines in ophthalmology in India is a complex issue that requires a balanced approach. While cost-effectiveness and increased access to care are significant advantages, concerns about quality, precision, clinicians’ trust, and patient beliefs must be addressed. Through improved regulation, education, and research, India can navigate this dilemma, ensuring that generic medicines play a valuable role in expanding eye care accessibility without compromising safety and efficacy. Experts who formulate medical education curriculum would have to address this lacuna to ensure that future practicing physicians are well-versed and comfortable in prescribing generic drugs[29] Godman et al. have proposed a 4 “E” methodology for promoting generic drug utilization and development in Europe, and the same can be replicated in India. The 4 “E” include: (i) “Education”—design programs to influence generic prescribing by disseminating educational materials; (ii) “Engineering”—Focus on organizational interventions to evolve agreements on the price and volume of existing drugs in relation to disease management programs; (iii) “Economics”—Increase generic drug utilization through the use of positive and negative incentives for physicians and patients; (iv) “Enforcement”—Initiate regulatory or law enforcement methods which may include mandatory generic substitution laws to which pharmacists must adhere.[30] Taking into account the 140 billion strong Indian population and the poor affordability of the majority; generic prescriptions would catalyze a paradigm shift in the accessibility and penetration of healthcare delivery to all. The shift to generic prescribing has great potential for reducing healthcare-related costs; however, it is important that the limitations of generic medications are understood and addressed.[16] Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

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