>According to the Food and Drug Administration (FDA):
“[G]eneric drugs…are just as safe and just as effective as their brand-name counterparts, and they are a cost-effective way of achieving substantial savings.”
“[A] generic drug is identical or bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”
Generic drugs contain the same active ingredients, in the very same strength, as brand-name drugs. When a medicine is first developed, the pharmaceutical company that discovers and markets it receives a patent on its new drug. The patent usually lasts for 20 years, to give the originating company a chance to recoup its research investment. After the patent expires, a generic version of the drug may become available. Generics are marketed under the drug’s chemical, or "generic," name and meet the same FDA quality and effectiveness standards as the original.
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Generic pharmaceutical manufacturers must prove to the FDA that their version of a drug:
contains the same active ingredient;
is identical in strength,
dosage form, and route of administration;
has the same indications, dosing, and labeling;
provides the same efficacy and safety profile to patients ("bioequivalent")
>Are generic drugs safe?
Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic drug manufacturers to:
meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer; and
follow the same strict "Good Manufacturing Practices" rules.
>Why are generics cheaper?
Some brand-name manufacturers charge customers higher prices in the United States than they do in other countries, where drug prices are regulated. Drug research is costly, and patent protection gives brand-name manufacturers at least 20 years to recover those costs — costs that generic manufacturers do not have. Brand-name manufacturers collectively spend billions of dollars in marketing new drugs to doctors and the public; they send their representatives to visit with doctors in their offices; and they pay for physicians’ trips to meetings and conferences to talk about their drugs with other doctors. Generic manufacturers rarely spend money on advertising and marketing — another important way they keep their costs down
>Which country manufactures the most generic drugs?
India dominates the generic drugs market; it exported $17.3 billion worth of drugs — nearly 20 per cent of the global market — in 2017-18. It exports to the US, South Africa, Russia, the UK, Brazil, Nigeria and the European Union, among others. India’s ability to produce affordable generic drugs has led to its reputation as the “pharmacy of the world”.
>Are Indian generic drugs as effective as those manufactured in the US or Europe?
Dr Arindam Basu, professor of epidemiology and evidence-based health at the University of Canterbury in New Zealand, believes that as medications are expected to go through quality control and evaluation by drug regulators such as the FDA, it is reasonable to believe that generic drugs manufactured in India are as effective as those manufactured in the US. According to a systematic review and meta analysis of 38 studies in the Journal of American Medical Association, “there is no evidence that supports the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs”. However, in her book Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma, US-based investigative journalist Katherine Eban alleged that many Indian generic drug manufacturers compromise on quality encouraged by lax drug regulations in the country. Her investigation was based on 20,000 FDA documents and interviews with over 240 people, including whistleblowers working in Indian drug companies. The Indian drug manufacturers as well as the government have vehemently denied her account.
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