Are generic medicines as effective as brand-name drugs? . Dr. Sanjiv Kumar, director, International Institute of Health Management Research, and former executive director, National Health Systems Resource Centre, Ministry of Health and Family Welfare, talks about generic versus branded drugs and how all stakeholders should agree that generic drugs, while being good, need to come under strict quality control to actually benefit patients.
Why are generic drugs so vital for India?
In India, annually an estimated 32 million to 94 million people (Goyanka R, Garg C Charu, Prasad S. - report submitted for publication) get pushed below the poverty line because of expenditure on medical care. About two-thirds of this expenditure is on medicines, making it a major reason for poverty in India (National Health Systems Resource Centre's estimates).
Generic medicines are cheaper than brand-name drugs, hence will substantially reduce the expenditure on health. 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% of the sale. In 2009, the main suppliers of generic drugs (about 40%) in the US were India and China.
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 healthcare within the reach of the country’s poor.
The government is committed to achieve ‘universal health care’ and move towards right to health as stated in the recently released 2017 National Health Policy. Promoting generic drugs nationally builds on the rich experience across States, especially Rajasthan and Tamil Nadu, which 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.
How do generic drugs work?
Generic drugs are important options that allow greater access to healthcare. They are copies of brand-name drugs and are same in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Generic drugs are in no way inferior. They are 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 a different colour, packaging and inactive ingredients but the active ingredients are the same.
What are the major 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 it 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 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 health outcomes.
What are the major challenges in this sector?
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. The pharmaceutical industry needs to encourage all manufacturers to adopt good manufacturing practices, voluntarily or through legal enforcement.
Is it enough to promote generic medicines? Doesn’t quality of drug matter?
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 the quality of generic drugs need to be addressed seriously 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 in its efforts to improve access, affordability, timeliness of high-quality medical care to reach ‘universal health care’ and move towards right to health
