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Generic Medicine

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What are the generic drugs ?

Generic drugs have the same active ingredients (bulk drugs) in the same dose and dosage form as branded drugs already approved by food and Drug Administration. Generic drugs are copies of branded drugs that have exactly same dosages, intended use, effects, and side-effects, route of administration, safety, and strength as original branded drugs. In other words their pharmacological and their therapeutic effects are same as branded drugs. Bioavailability of generic drug is same as branded drug and they are bioequivalent. Broadly Generic drugs Refer to any drug marketed under its chemical name without advertising.

What are the brand name drugs ?

A brand name drug is a medicine that is discovered, developed and marketed by a pharmaceutical company. After the discovery of new drug the company files for a patent to protect against other companies making copies and selling the drug. At this point drug has two names generic name and a brand name to stand out in the market place. Several years of research, costly scientific development and many clinical studies are carried out before drug control authorities approved these pioneer drugs for marketing. This is a costly affair.

What are the apparent differences between generic and branded drugs ?

They may look different. They could have different sizes, shapes, colours. They may have different recipients, they may have different manufacturers. The generic medicines cost less Than the branded medicines.

Why Generic medicines are less costly ?

Generic manufacturers do not have significant research and development expenses; do not spend in costly advertising, marketing and sales promotion expenses or clinical trial expenses. They do not spend on decorative costly packing materials, but only use protective packing materials. When branded drug product patent expires, generic manufacturers compete by offering lower prices, without compromising quality, efficacy and bioavailability. For Generic Drug, companies incur fewer costs in creating generic drugs, only the cost to manufacture, and not the entire cost of research, development and clinical trials and discovery. Generic manufacturers also do not bear the burden of proving the safety and efficacy of drugs through clinical trials. Only bioequivalence studies are adequate. Hence generic medicines are less costly.

Are generic drugs manufactured by the same companies that make brand name drugs ?

There are a number of Indian Companies who manufacture both branded and generic drugs. They promote branded drugs in India but market the generic drugs in developed nations like USA, UK and other countries.

Can I purchase Generic medicines without prescription ?

We honor only doctor’s prescription. Decision to choose branded drugs or generic drugs involves you and your doctor only

Are generic medicines really as good as their original branded drugs ?

When a generic drug is approved, it has to meet standards established by FDA with respect to identity, strength, quality, purity and potency. Through review of bioequivalence data, the companies have to assure of “the performance of generic drugs is comparable to pioneer drugs”. In India after introduction of new drug by pioneer company within four years after this introduction, other companies have to conduct stability studies and carryout bioequivalence study of these products, get approval from M/s Drug Control India and subsequently get manufacturing license from local state FDA before starting production and marketing. After four years, this bioequivalence study is not required. Most of the time, this drug formulation becomes official in Indian Pharmacopoeia or British Pharmacopoeia or USP or JP or International Pharmacopoeia etc. and comparative dissolution studies and compliance with specifications either given in Pharmacopoeias or FDA approved specifications and stability data are adequate to get FDA permission for manufacture and marketing generic drugs. Generic Drugs and Branded drugs are manufactured in the same fashion, following validated manufacturing processes, complying with Good Manufacturing practices and schedule "M" requirements, using same bulk drugs complying with Pharmacopoeias standards or FDA approved standards, tested and released by Quality control Laboratory but packed differently. FDA considers Generic Drugs to be identical, bioequivalent, to branded drugs in dosage form, safety, efficacy, route of administration Quality performance and intended use. We procure generic drugs from manufacturers having WHO GMP or at least state GMP Certificates. Generic medicines are as good as branded medicines

If Brand name drugs and generics have the same active ingredients why they look different ?

Active Ingredients will be same but percipients, colour, shape, size will be different however they will bioequivalent to branded drugs. Their looks will be different. Packing though protective will be different and less decorative.

Are these generic sold as loose ?

We honor only doctor’s prescription. Decision to choose branded drugs or generic drugs involves you and your doctor only

Does shelf life of generic medicines differ from branded drugs ?

Shelf life of medicines depends on many factors. Different manufactures may give different expiry based on their stability studies. In India, Manufacturers have to comply with “Schedule P of Drug and cosmetic rules 1945,” which give life period and conditions of storage of drugs for antibiotics and vitamins etc

Is packing important for medicines ?

Pharmaceutical packages are desired to provide not only a means of transport and brand identification but to Serve more Significant functions such as providing adequate protection and to ensure the stability of the product while in distribution and storage. Onus of maintaining a product in desired quality and quantity till it is consumed lies with packaging. A designer of packing material has to ensure that formulation in a pack will stand all the climatic conditions during its certified shelf life. Drugs and Cosmetics (Sixth amendment) Rules (1988) have given the requirement for product containers, closures, Labels and other packaging material. Generic names are to be printed prominently above brand names on the tables of medicines.

Why doctors will write Generic drugs ?

A generic drug is the basic information while studying. They do not know the brands. But when they become doctor they have been tempted to write the brands. As per medical ethics and conducts (section 1.7) while writing prescription they have to write generic drugs only.

Any threat from existing medicals or Medical Association ?

No. Very important thing we have to consider here that almost 95% medicals are attached to the doctors. Whenever there is an emergency, the patient will not search for Swast Aushadhi Seva. He will go to the doctor and the medical for treatment. As well as generally doctors are writing advance molecule drugs which are not available in Generic, SO they do not need to worry. As well as government is continuously taking follow up for opening new Generic medicine store which is the prime objective of Central and State Government. So we need not worry about it.