A generic drug, as defined by FDA, is a
-drug identical to a brand name drug in dosage form,
-safety, strength, route of administration, quality, performance characteristics, and
So Generic drugs are copies of innovator or brand-name prescription drugs and Generic drug developers do not have to repeat these studies, resulting in much less expensive development programs and more affordable access to treatments for many patients and consumers. Although, the generic medicines industry is moving beyond making copies to developing patent-expired products, with new formulations, dosages and delivery methods
Beginning of Generics- Definition and Legislative History
Generic drugs emerged in the middle of 1960s with regulatory changes resulting from the tragedy of women who used thalidomide during pregnancy. Shortly after, it became a choice drug among women to treat morning sickness.
In 1961, congenital disabilities were found in more than 12,000 children associated with thalidomide use and later that year, thalidomide was withdrawn from the market.
After 1962, FDA established a new mechanism for proving safety and efficacy by allowing the “literature-based” New Drug Application. Based on this, submission of published data regarding a branded product’s safety and efficacy by a generic product’s manufacturer was permitted.
Generic drugs industry Scenario- Regulations and Reforms
The regulations and laws governing the approval of generic drugs are somewhat the same around the world, with very few differences in developing countries in terms of regulatory structures, lobbying powers of special‐interest groups, patent‐litigation systems, political economies of health care systems, and perceptions of generics among patients and health care professionals. There are different legal requirements in different jurisdictions that define the criteria of what a generic medicine is. However, the main principles is same, underpinning the safe and effective use of generic drugs is the concept of bioequivalence.
Scientific and Regulatory Collaboration has moved the needle to create new approaches to support timely assessment and approval of many generic drug products
The Generics Act of 1988 (Republic Act No. 6675) declares the policy to promote, require and ensure the production of adequate supply, use and acceptance of drugs (including for animal use) identified by their generic names. Its main objective was
- to promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs;
- to ensure the adequate supply of drugs with generic names at the lowest possible cost;
- to encourage the extensive use of drugs with generic names through a national system of procurement and distribution; to emphasize the scientific basis for the use of drugs; and
- to promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions.
Enacted in 1984, the Hatch–Waxman Act, also known as Drug Price Competition and Patent Term Restoration Act, standardized the procedures for recognizing generic drugs. The food and drug administration (FDA) within the U.S. Department of Health and Human Services regulates the drug approval system in United States.
In 2007, the FDA launched the Generic Initiative for Value and Efficiency (GIVE): an effort to modernize and streamline the generic drug approval process and to increase the number and variety of generic products available. The new requirement was an abbreviated new drug application (ANDA) to be submitted by the pharmaceutical companies to the regulatory authorities for getting the approval to market a generic drug.
European Union (EU)
The legislation in EU is more complex than in the US, with each member state having a competent authority in addition to the European Medicines Agency [EMA], which oversees EU-wide authorisation of medicines. Historical legacies and the need for compromise go a long way toward explaining the institutional complexity of the EU to accommodate all member states, EU legislation typically allows for numerous exceptions, exemptions, derogations, transitional periods, and other forms of discretion left to the member states.
The “Patent Amendment Act” of 2005 made it illegal to reverse engineer or copy patented medications after January 1, 1995. The Act only permitted off-patent generic pharmaceuticals and generic copies of medications patented before 1995 to be sold in India.
In 2008, the Government of India, through the Department of Pharmaceuticals, started a new initiative, “Jan Aushadhi” means “Medicine for People”). This program envisaged making unbranded quality medicines available to poor people in the country at a reasonable and affordable price through retail outlets’ setups with the government’s help.
According to a proposal made by the Medical Council of India in an amendment to the code of conduct for doctors in October 2016, every practitioner should prescribe drugs with intelligible generic names.
Can a generic of a brand-name drug market immediately after the brand-name drug is approved?
When approved, the brand drug often receives patents and other protections, giving them time to recover the cost of discovering and developing the drug. Patent terms are set by statute for a new patent is 20 years from the date on which the application for the patent. Many other factors can affect the duration of a patent before it can enter generic drug market.
Although there is a continuous process of harmonization taking place worldwide, we still see a huge challenge, which is yet to be overcome by the Pharmaceutical industry in the case of generic drug development and filing due to the heterogeneity in the regulatory landscape of the various countries. Currently, the Indian pharmaceutical industry is currently the world’s 3rd largest by volume and 14th most significant in value. Major fragment of Indian pharmaceutical industry is generic drug, vaccine, biosimilar, contract research and manufacturing. Generic drugs are currently the highest in India’s pharmaceutical industry, accounting for 70% of market share by revenues.
Teva Pharmaceutical Industries Ltd, based in Jerusalem, Israel, is the world’s leading generic drug maker, yet it’s also active in ventures that include APIs. The business has 43,000 employees globally. The company has its commercial footprints in 37 international markets, including Europe, Latin America, Asia-Pacific, Russia, the Middle East, and Japan.
Mylan N.V, based in US is a leading global healthcare company primarily engaged in developing and manufacturing intermediates, bulk actives, and oral dosages