GENERIC DRUGS

A generic drug is pharmaceutical drug that is equivalent to a brand nameproduct in dosage, strength, route of administration, quality, performance, and intended use. They are labeled with the name of the manufacturer and a generic nonproprietary name such as United States Adopted Name or international nonproprietary name of the drug. A generic drug must contain the same active ingredient as the original brand formulation. Biopharmaceutical such as monoclonal antibiotics differ from small molecule drugs.

In most cases, generic products become available after the patent protections afforded to a drug’s original developer expire. Once generic drugs enter the market, companies must submit an abbreviated new drug application (ANDA) for approval to market a genetic product. The Drugs Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDA’s possible by creating a compromise in the drug industry. New Drugs are developed under patent protection. When Patent of exclusivity expires, manufacturer can apply to the FDA to sell generic versions.

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drugs. To gain FDA approval, a generic drug must: • Contain the same active ingredient as the innovator drug(inactive ingredients may vary) • Be identical in strength, dosage form, and route of administration • Have the same use indications • Be bioequivalent • Meet the same batch requirements for identity, strength, purity, and quality • Be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products

GENERIC DRUGS V/S BRANDED DRUGS

Every medicine has an approved generic name. If it is made by several companies, each will also give the medicine a brand (trade) name. So one medicine may have a generic name and also have one or more branded name

GENERIC NAME-

Each medicine has an approved name called the generic name. A group of medicines that have similar actions often have similar –sounding generic names.

For example, phenoxymethylpenicillin, ampicillin, amoxicillin, and flucloxacillin are in one group of antibiotics.

BRANDED (TRADE) NAME-

Many medicines also have one or more brand names. This is chosen by the company that makes it. Several companies may make the same generic medicine, each with their own brand name.

For example, paracetamol is a generic name. There are several companies that make this with brad names such as Panadol, Calpol, etc

The colour, size, shape, etc, of brand of the same medicine may vary depending on company making it.

COMBINATION PRODUCTS

Some tablets or pills contain combination of medicines. Combination product are often marketed and sold with a brand (trade) name. However, the individual ingredient (the individual medicines that are combined into the one tablet or pill) will be listed in small print on the packet.

For example, a popular painkiller has a brand name of Solpadol. This contains

two generic medicine- paracetamol and codeine.

GENERIC PRESCRIBING

Doctors are encouraged to prescribe by using the generic name. This is because:

The generic name is the one doctors are trained to use. There are sometimes many brand (trade) names for one medicine.

Generic medicines are often cheaper for the NHS. A few medicines are always prescribed by the specific brand. This is because there are differences in amount you end up having in your body between the different brands.

Examples of theses medicines are:

Some epilepsy medicines, such

Lamotrigine

Theophylline

Diltiazem

Nifedipine

Lithium

Mesalazine

WHY GENERIC MEDICINES ARE CHEAPER THAN THE BRANDED MEDICINE?

‘’Generic makers don’t face the same cost as manufacturer of brand-name maker often invented the drugs, a process that can cost hundreds of millions of dollars. That is an enormous economic advantages for these companies, which is why their drugs can be much cheaper.’’

A generic drugs has a similar chemical composition or drug formulations as of brand name counterpart that act on the body with the same strength and absorption process as that of the brandname drug. So, the generic version of a drug is the bioequivalent of its brandname counterpart, meaning there is either no considerable variation between the two drugs in terms of the rate and extent of absorption.

Most of the reason for why generic drugs are less expensive than branded drugs: • Research and development-drugs research is costly and creation of a drug can consume many years-cost that generic manufacturer do not have. Generic drug manufacturer doesn’t have to bear this cost. For generic drug manufacturers the clinical formula is known, the clinical trials are complete, and these are investing only on the production of the medicines. • Marketing-Brand-name manufacturers spend money in marketing new drugs to doctors and public. Generic-name manufacturers rarely spend money on advertising and marketing

• Competitions- generic drug producers also keeps the costs down. Once generic drugs are approved, multiple companies begin producing and selling the drugs. GOVERNMENT INITIATIVE IN DEVELOPING GENERIC DRUGS Over the year India, has developed a strong capability in producing quality branded and generic medicines in most of the therapeutic categories, evolving from an mere Rs.1,500 crores industries in 1980 to a more than Rs 1,19,000 crores industry in 2012.For a large population of poor people in the

country, find it difficult to afford the more expensive branded category of medicines. Accordingly, ensuring availability of quality medicines at affordable prices to all has been a objective to Government. Some of the steps taken to enable this are: • Price control of Scheduled Drugs through the National Pharmaceutical pricing authority (NPPA). • Price regulation of Non Schedule drugs. • Uniform VAT Of 4% on medicines.

• Reduction in Excise duty from 16% to 4% further and in addition to above low rate of 4%VAT on medicine in the country.

PM MODI PROPOSAL ON GENERIC MEDICINE

Modi’s proposal is seen as an attempt to bring expensive drugs to poor Indians, and also as a not-so subtle swipe to regulate the doctor drug company nexus considered to be one of the reason patients have to pay more for the medical expenses. Modi’s latest salvo has resurrected the ghost for Rs 17,000 crore Indian Pharma market dominated by branded generics.

In India, the requirement of BE study is a grey area.

The BE study is a standard requirement in most regulated markets like Europe and USA, where doctors also prescribe medicines by their generic names for products out of patent.

According to, public health activist this is how India should move forward as far as medicine are concerned. ‘’This will be path-breaking move if it comes through. The government needs to ensure chemist do not stock highly expensive medicines and state drug regulators should ensure quality,’’.