Co-Written by Dr. Swati Sapna & Upasna Gaba

medicine

The World Health Organization (WHO) defines generic medicine as “a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.”(1) The US Food and Drug Administration (FDA) states that generic medicines are similar in terms of safety, efficiency, dosage form, route of administration, strength and quality to its corresponding innovator. It is often said to have the same intended use as the revolutionary medication and can vary only in the shape, colour, packaging and types of the excipients used, but not in the active ingredient.(2) Through introducing and implementing generic medicine policies, the use of generic drugs and their introduction into healthcare systems is gaining prominence worldwide.(3) In many parts of the world, replacing brand prescriptions with generics is an accepted trend; however, India has not embraced the practice on a large scale, owing to different factors, such as non-availability, substandard quality and medication counterfeiting. (4)(5) Despite policy changes, the use of generic drugs has remained primarily limited to institutional settings in small pockets of the country.(6)

However, the economic advantages of generic drug use are well-known and unquestioned and could contribute to significant reductions in out-of-pocket expenditures. The prescription of generic medicinal products may lead to increased use, especially by the rural poor, and will therefore help to improve overall health conditions and improve access to medicines.(7)

Prescribing pattern and perceptions regarding generic medicines

To understand the prescribing patterns and perceptions of the doctors as well as consumers with respect to generic medicine use, various studies have been conducted till date. A study conducted at tertiary care teaching hospital, Tamil Nadu, India to examine the drug prescribing trend where 700 prescriptions were analyzed inferred that generic prescribing was appallingly low (6.42 per cent) among the prescribing indicators.(8) Another prescribing pattern study showed that number of medicines prescribed under a generic brand was just 35%.(9)Health practitioners’ prescriptions of branded drugs are believed to be one of the major causes of the high cost of medication.(10)

A study conducted to assess the perceptions regarding generic medicine use inferred that the quality of the generic and the branded medications tested were comparable. Contrary to the findings of the quality survey, patients and health workers were mainly in favour of branded medicines. Along with the other drivers, negative opinions of drug quality lead to the private sector’s selection of more expensive medications. Faith in the health system has emerged as an overarching core theme that guides the local health system’s choice of medicines and suppliers. Issues related to trust and confidence in unbranded generic drugs are not letting them appear in prescriptions, although they are known to be much cheaper and equivalent to branded medicines in efficacy. (11)

Cost-effectiveness of generic medicines

In contrast to the most selling brand, unbranded generic drugs are much affordable and can minimize the cost of treatment in primary care and family practice. When measured using the WHO-HAI (WHO-Health Action International) instrument, the generic drug supply at the neighbourhood pharmacy was 73.3 per cent, and the savings for the final customers were up to 93.1 per cent, relative to the most-selling brand with the same composition.(12) Another study concluded that generic medicines cost is lower when compared to its branded counterpart.(6) In a study the prices of generic medicine scheme (Jan Aushadhi Scheme) were compared to the prices of branded medicine alternatives. Substantial differences were found between the generic medicine scheme price and the cheapest branded corresponding medicine available in the market.(13)

Generic drugs provide an inexpensive alternative to patented branded drugs. Innovative firms have generated complicated legal problems relating to the patent rights of the original product, leading to delays in the marketing of generic medicines. Policymakers need to make generic medicines simpler for patients by guaranteeing adequate quality controls, education of healthcare professionals and patients on the benefits of generic drugs and providing information on drug quality standards to increase the usage and availability of generic drugs. The state must increase the availability and affordability of generic and critical drugs in the market in order to reduce the burden of healthcare costs. Since India is one of the world’s largest producers of generic drugs, the pharmaceutical industry has helped to minimize many nations’ medical costs by exporting them medicines. (14) (15)

Therefore, it can be concluded that doctors` prescription, low price of the drugs, availability of generic medicine store (Jan Aushadhi Store), quality of generic drugs and recommendation from others have a significant impact on acceptance and use generic medicines.

References:

  1. NPrices_Glossary.pdf [Internet]. [cited 2020 Nov 22]. Available from: https://www.who.int/medicines/areas/access/NPrices_Glossary.pdf
  2. Research C for DE and. Generic Drugs: Questions & Answers. FDA [Internet]. 2019 Feb 9 [cited 2020 Nov 22]; Available from: https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
  3. Hassali MA, Alrasheedy AA, McLachlan A, Nguyen TA, AL-Tamimi SK, Ibrahim MIM, et al. The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014 Dec 1;22(6):491–503.
  4. Banahan BF, Kolassa EM. A Physician Survey on Generic Drugs and Substitution of Critical Dose Medications. Arch Intern Med. 1997 Oct 13;157(18):2080–8.
  5. A Cross-Sectional Study to Evaluate the Awareness and Attitudes of Physicians Towards Reducing the Cost of Prescription Drugs, Mumbai | SpringerLink [Internet]. [cited 2020 Nov 22]. Available from: https://link.springer.com/article/10.1007/s40258-014-0080-2
  6. Das M, Choudhury S, Maity S, Hazra A, Pradhan T, Pal A, et al. Generic versus branded medicines: An observational study among patients with chronic diseases attending a public hospital outpatient department. J Nat Sci Biol Med. 2017;8(1):26–31.
  7. Dongre Y, Mahadevappa B, Rohini R. Building access to healthcare in rural India: possibility and feasibility of low‐cost medicine. Int J Pharm Healthc Mark. 2010 Jan 1;4(4):396–407.
  8. Shanmugapriya S, Saravanan T, Rajee SS, Venkatrajan R, Thomas PM. Drug prescription pattern of outpatients in a tertiary care teaching hospital in Tamil Nadu. Perspect Clin Res. 2018 Sep;9(3):133–8.
  9. Patterns of prescription and drug use in ophthalmology in a tertiary hospital in Delhi – Biswas – 2001 – British Journal of Clinical Pharmacology – Wiley Online Library [Internet]. [cited 2020 Nov 22]. Available from: https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2125.2001.00350.x
  10. N. M, K. N, P. D, N. S, Nagaral J, V. R, et al. Analysis of cost between branded medicines and generic medicines in a tertiary care hospital. Int J Basic Clin Pharmacol. 2019 Apr 23;8:1074.
  11. Aivalli PK, Elias MA, Pati MK, Bhanuprakash S, Munegowda C, Shroff ZC, et al. Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India. BMJ Glob Health. 2017;2(Suppl 3):e000644.
  12. McMullan P, Ajay VS, Srinivas R, Bhalla S, Prabhakaran D, Banerjee A. Improving access to medicines via the Health Impact Fund in India: a stakeholder analysis. Glob Health Action. 2018 Jan 1;11(1):1434935.
  13. Mukherjee K. A Cost Analysis of the Jan Aushadhi Scheme in India. Int J Health Policy Manag. 2017 01;6(5):253–6.
  14. Rana P, Roy V. Generic medicines: issues and relevance for global health. Fundam Clin Pharmacol. 2015;29(6):529–42.
  15. Making healthcare affordable: Beliefs and attitude towards Generic Medicines in India – The Financial Express [Internet]. [cited 2020 Nov 22]. Available from: https://www.financialexpress.com/lifestyle/health/making-healthcare-affordable-beliefs-and-attitude-towards-generic-medicines-in-india/1614799/

Dr. Swati Sapna is a dentist and currently a postgraduate student pursuing Masters of Public Health (Epidemiology) at Prasanna School of Public Health, Manipal Academy of Higher Education (MAHE), Manipal, India.

Upasna Gaba is a pharmacist and currently a postgraduate student pursuing Masters of Public Health (Health Policy) at Prasanna School of Public Health, Manipal Academy of Higher Education (MAHE), Manipal, India.


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