What is a generic drug?
All drugs start as branded drugs. Pharmaceutical companies spend a large amount of money in research and development of new drugs. In order to recover these costs (average USD 1.2 billion for each drug), the drugs are patented by the companies, which developed it, to prevent anyone else from selling the drug for a defined period of time (e.g. 10-15 years). After this patent period is over the patent expires and other companies can make and sell this drug, now called generic. The generic drugs may be prescribed in two ways i.e. as generic (only generic name ) or generic brand (generic drug with manufacturer name in bracket). Generic drugs are in no way inferior, it is the same drug but at a later stage in the life cycle of a drug. A generic drug may be made and sold by a different company and may have different colour, packaging and inactive ingredients but the active ingredient is the same.
The Governments all over the world promote Generic Drugs to bring down the expenditure on healthcare:
In India annually, about 32 million people get pushed below poverty line because of expenditure on medical care. About two thirds of this expenditure is on medicines, making it a major reason of poverty in India (NHSRC estimates). Generic medicines are cheaper than brand-name drugs, hence will substantially reduce expenditure on health. In the US, the generic drugs that draw a large number of manufacturers average the cost falls to about 20% (US FDA).
The world has and is moving towards generic drugs. Let us take examples of two countries, US and Canada. In the US, generic and over-the-counter drugs account for about 80 percent of the sale. In the 2009, the main suppliers of generic drugs (about 40%) in the US were India and China.
(https://www.scientificamerican.com/article/are-generic-drugs-bad-for-you/ 01 May 2017).
In Canada (2011 Canadian Medical Association Journal ) generic drugs accounted for more than three-quarters of all prescriptions, but accounted for only 20% of spending on pharmaceuticals.
The Medical Council of India and the Indian Government have recently accelerated their efforts to promote prescription and the use of generic drugs to bring health care within reach of India’s poor. Government is committed to achieve Universal Healthcare and move towards right to health as stated in the recently released 2017 Health Policy. Promoting generic drugs nationally builds on the rich experience across states especially Rajasthan and Tamil Nadu who are pioneers in introducing generic drugs in public health system. In medical colleges, future doctors are taught about pharmacological compounds (generic drugs) only. They later learn about branded drugs from representatives or promotional activities of the pharmaceutical companies.
According to USFDA :
Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.
Who loses and who gains with promotion of generic drugs?
It is important to understand who gains and who loses by promotion of generic medicines and to understand the position being taken by different stakeholders in the current debate on generic drugs in India. The challenges and benefits from promotion of generic drugs are summarized in the Table below:
Table: Challenges and benefits from promotion of generic drugs
The Government must address the concerns about promotion of generic drugs:
Despite convincing scientific evidence that generic drugs are equivalent to branded medicines, there remains an undercurrent of fear towards generics in India. Even with very effective quality control in countries like the US, there have been concerns. A study in the US found that of 43 editorials in scientific journals, 53% expressed negative views concerning generic substitutions for branded cardiovascular disease pharmaceuticals (Kesselheim et al 2008 JAMA) mostly due to advertising by brand companies against generic drugs and some generic drug scandals. In India, the main concern raised by professional bodies is that the quality regulatory mechanism is weak. This may adversely impact on health outcomes.
Large generic manufacturers which have made India “the pharmacy of the world” meet international standards of quality control, but the manufacturers catering to the domestic market may not. Corruption and inducements that often lead to substandard drugs being sold in the market remains a major concern. Another concern is that the choice of manufacturer of generic drugs will shift to the chemist from the doctor which may affect quality of care if the medicine is substandard. The government needs to strengthen regulatory mechanisms and address corruption and inducements to assure availability of quality generic drugs to the public nationally. The pharmaceutical industry needs encourage all manufacturers to adopt Good Manufacturing Practices, voluntarily or through legal enforcement.
The recent decisions by the Medical Council of India and the government to promote generic drugs is welcome and will increase availability of medicines at affordable cost and contribute to reducing poverty. The concerns of the Indian Medical Association and other professional bodies regarding quality of generic drugs need to be seriously addressed by the government. It is important for the professional bodies to collaborate with the government in improving access to affordable quality medical treatment including medicines. There is a need for the government to engage all stakeholders along in its noble efforts to improve access, affordability, timeliness of high quality medical care to reach Universal Health Care and move towards right to health in the country.
Courtesy: Dr Sanjiv Kumar, Economic Times
Dr Sanjay Kumar is
– Director, International Institute of Health Management Research, New Delhi
– Professor Leadership, Global Health & Program Management, CLEN Institute of Global Health, New Delhi,
– Formerly Executive Director, National Health Systems Resource Centre, Min of Health & FW, Govt of India,