Introduction
A generic drug is a pharmaceutical drug that does not use the name of the company but is labelled with the name of the manufacturers. It contains the same chemical substance as a patented drug has, created to be the same in dosage form, safety, strength, quality, and performance, etc. However, these drugs contain the same active pharmaceutical ingredient (API), as mentioned in branded counterparts. These are named using standardised affixes that distinguish drugs between and within classes, and suggest their action. They are developed either by a generic drug company or the original manufacture after the original product is expired. In most countries, the duration of patent is 20 years. However, many countries and regions, such as the European Union and the United States, may extend it for five years, provided specific goals are met.
Manufacturing of Generic Drugs
In 1984, the Drug Price Completion and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act) was passed in the United States to encourage the manufacture of generic drugs. The pharmaceutical companies submitted an abbreviated new drug application (ANDA) to the regulatory authorities for getting the approval. Generic drug manufacturers do not have to spend extra money for drug discovery and clinical or pre-clinical tests. Therefore, generic drugs are available at a lower cost compared to branded ones. They are not cheaper because they are lower in quality.
In general, generic drug manufacturers have to prove that the formulations of their drugs must be equivalent to those of branded ones. This bioequivalence should not necessarily be 100 per cent same, pharmaceutically. Chemically, there may be certain differences, but generic drugs must be a pharmaceutical alternative, i.e., the therapeutic effect should be the same. A generic drug is a bioequivalent if its pharmacokinetic parameters of area under the curve (AUC), and maximum concentration (Cmax) are within a 90 per cent confidence interval of 80–125 per cent. Most approved generic drugs consisting of small molecules are well within this limit. As for complex drugs, demonstrating pharmacodynamic is more challenging like inhalers, liposomal preparations, etc. As per the US Food and Drug Administration (FDA), the difference between absorption of branded drugs and generic ones is on average 3.5 per cent, compared to the difference between two batches of a branded-name drug.
* Manufacturing of Generics in India In the early 1960s, the Government of India began encouraging more drug manufacturing. The Patents Act, 1970 removed composition patents for foods and drugs and kept process patents; the period was shortened to 5–7 years. Consequently, a niche was created in the Indian and global market, which the Indian companies filled by reverse-engineering new processes for manufacturing low-cost drugs. As per the code of ethics, issued in 2002, the Medical Council of India (MCA) calls for physicians to prescribe drugs by their generic names only.
* Jan Aushadhi Stores The Government of India started in 2008 a new initiative, called ‘Jan Aushadhi’ in order to make standard generic medicines available to poor people in the country at a reasonable and affordable price at retail outlets. The Department of Pharmaceuticals has taken ownership of setting up Jan Aushadhi Stores, which are pharmacies selling only generic drugs to the extent possible giving preference to pharmaceutical public sector undertakings too. About 3,200 Jan Aushadhi stores were operating in more than 33 States/UTs in 2018. However, many more such stores need to be set up.
The Medical Council of India (MCI), in an amendment to the Code of Conduct for doctors in October 2016, has recommended that every physician should subscribe drugs with generic names legible. Doctors should ensure that there is a rational prescription which promotes the use of generic drugs.
* Some Other Related Products Besides generics, there are some other closely related products other than branded drugs. They are as follows:
(i) Biosimilars Biosimilars have active pharmaceutical ingredients that are almost identical to the original products. They are not equal to generic drugs as the active ingredients are different from those of their reference products and are typically regulated under an extended set of rules.
(ii) Branded Generics Branded generics are products that are either a novel dosage form of off-patent products or a molecule copy of an off-patent product with a trade name. Since it can involve some research and development, they may be somewhat expensive. It must be bioequivalent to the original brand product and can be manufactured either by a generic drug company or the original manufacturer after the patent expires.
(iii) Authorised Generics An authorised generic is an exact copy of the brand name version, which is authorised by the original patent-holder. It is a prescription drug produced by a brand company under a New Drug Application (NDA). Marketed as generic under a private level, it is identical to the branded product in shape, marketing, colour, etc. It also has the same inactive ingredients as the branded drugs do.
Generic drugs differ in the manufacturing process, colour, taste, formulation, recipients, and packaging, etc. But in benefits and risks, they are similar to branded drugs. Every brand name drug does not necessarily have a generic version, because some generic products may be unprofitable or too difficult to manufacture.
Information about generic drugs may be obtained from doctors or pharmacists. Be aware that generics may not look similar from refill to refill because of different manufacturers of the same drug.
Economy in Generic Drugs
India is a leading country in the world of generic drugs, exporting about US $ 17.3 billion worth of drugs in 2017–18. India exports generic drugs to the United States and the European Union. Thailand has imported millions of doses of a generic version of the blood-thinning drug Planix from India at a cost of US$ 0.03 per dose.
About 84 per cent prescriptions were filled generics in 2012. After two years, generic drugs led to US$ 254 billion in healthcare savings. The industry began transitioning to the end of an era of giant patent cliffs in the mid-2010s. In 2018, patented drugs were set to come off patents with sales of around US$ 28 billion.
Criticism of Generic Drugs
Since generic drugs are typically 30–80 per cent cheaper than the branded ones, critics say that the use of generic drugs may result in prolonging illness or failure of therapeutic effect. So, generic drugs may not be as good as branded drugs. Questions are also raised pertaining to purity, potency, stability, and drug release, which are not controlled within an appropriate limit, range or distribution.
Another reason for the lack of confidence in generic drugs is the absence of stringent regulatory requirements for the quantity of the drug, and the permissible impurities in them. Some doctors have accepted that they suspect some generic drugs, such as warfarin (Coumadin), which has a narrow therapeutic window and requires frequent blood tests to make sure the patient does not have a toxic level.
A series of scandals around the world shook public confidence in the late 1980s when several instances of fraudulently obtaining bioequivalence data were found. The companies used branded drugs in their tests instead of their own products. Corruption was also found at the FDA where employees were found accepting bribes to approve some generic companies.
As per some reports, a large number of generic drugs, manufactured in India for India, are actually ineffective and a few even harmful. According to Katherine Eban, author of the book Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma, fraud and treachery are deeply entrenched in much of the Indian generic industry. She raises some troubling questions about some of the big names like Dr. Reddy’s, Ranbaxy, Wockhardt, Glenmark, and RPG Life Sciences. In 2013, Ranbaxy paid $500 million in fines in a well-covered court case in America for seven charges of selling adulterated drugs. Testing the drugs for India was just a waste of time because no regulators ever looked at the data.
The book is full of hair-raising accounts from fraud to insanitary conditions to poor standards of manufacturing to fake tests for microbes and bacteria.
Suggestions
To solve this problem, the government should bring legislation to ensure compliance in generic drug manufacturing and testing. Undergraduate medical students learn about the concept of generic drugs, but their importance in reducing patients’ expenses is not emphasised during their further training. So, experts who frame medical education curriculum should emphasise on this aspect so that practising physicians are comfortable in prescribing generic drugs. Pharmacies and drug stores, except government-run hospitals, hardly stock generic drugs. Regulatory measures should be made stringent regarding generic drugs so that confidence and the habit of prescribing generic drugs may be developed; also, myths, fears, doubts, or false ideas may be dispelled. Availability of generic drugs is ensured at every store. Physicians can be able to commence patients only after real-time effectiveness is documented and published. The regulator should maintain high standards for safety, efficacy, and equality in the review of generic drugs.
For effective use of generic drugs, sponsors, healthcare providers, and regulators need to work together effectively.
Best Sellers in Office Products
Best Sellers in Apps for Android