Generic Drug Dispute

What is a Generic Drug?

United States Food and Drugs Administration which regulates drugs, gives license, defines Generic drug as a drug product that is comparable to branded drug product in dosage, form, strength, route of administration, quality and performance, characteristics and intended use.

Non-proprietary name or generic name is the name for the active ingredient in the medicine that is decided by an expert committee and is understood internationally thus, paracetamol/acetaminophen is the non-proprietary name (generic name) while Crocin/Metacin/Meftal/Tylenol etc. are brand names.  All generic drugs have a brand name as well as a non-proprietary name but all drugs having a non-proprietary name (generic name) may not be generic drugs.

For example Amaze- Bio Pharma is a very famous, big and established pharmaceutical Company having a strong research and development , biotechnological department, best scientists. Lets a virus named E-bola which is most prevalent these days and has no antidote available for the same  but Amaze-Bio Pharma came  up with an antidote a chemical component named Bauravol for the same, through its research and technology. This chemical named Bauravol started to be sold in the name of Bola Lol by the Amaze- Bio Pharma. Other components who now know the chemical component for curing E-Bola cannot use such chemical and sell it under their brand-name. In this case exclusive right has been given to Amaze- Bio Pharma for a particular period of time i.e. 20 years and this particular company can only sell such chemical component i.e. Bauravol and can commercially exploit in their own way and can sell it in whatsoever price the company decides. The patent protection is given so that the company who has came up with the chemical would be able to recover costs of Research an development, fees of scientists , cost of clinical tests, etc for coming up with such chemical.

After completion of or expiry of patent the following chemical becomes Generic and now any of the company can use such chemical also know as generic salt to make and sell it in any name under their own brand name. Once any chemical or active ingredient becomes generic the price reduces as thee is no cost incurred on Research and development, clinical trial, etc by such companies who ate selling it under their brand name with same active ingredient like that of the Brand name drug .

In India generic drug is only made due to lack advance technology and resources to make chemical component thus a generic salt is sold under different brands, the generic drug  and brand-name drug should not be completely similar , it should be combined different other chemical components.

What is the Dispute regarding generic drugs?

In India Generic drugs are more cheaper than that of Brand-name drugs as brand name is attached to it and brands sell the same chemical component at different prices. Recently in the year of 2017 Prime Minister of India Mr. Narendra Modi delivered a speech at Surat whereby he suggested Doctors to prescribe generic drugs that is the generic salt instead of Branded drugs so that the poor section of the society could be benefited out of it and he mentioned that it is very soon going to be implemented by the government and government shall come up with a rule to mandate doctors to prescribe Generic drugs.

Also the Medical Council of India strictly mentioned that the Doctors should only and only prescribe generic drugs otherwise strict action would be taken against the doctors . Doctors are quiet upset with such order  as it was not the first time where the Medical Council of India has ordered it. Earlier on September 21, 2016 Medical Council of India notified an amendment in clause 1.5 of Indian Medical Council ( Professional Conduct, Etiquette, Ethics) Regulations, 2002. This clause ids read as follows- "Every Physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs."

Also the UPA government had from time to time issued circulars and instructions to government hospitals and dispensaries under Central Government Health Scheme to " prescribe generic medicines" to the " maximum extent possible". In December 2012 the UPA government has issued a 'statutory directions' to state governments under sections of Drugs and Cosmetics Act, 1940 to ' gnat or renew' license to manufacture for "sale or distribution of drugs in proper or generic names only. This was intended to build a mechanism for wider use of generic drugs.

Most recently a country wide campaign has been under way to ensure availability of generic medicines  under Pradhan Mantri Bharatiya Janaushadi  Pariyogna under which several around 861 Janaushadi center were opened where generic drugs were made available.

Controversy

Controversy or the dispute is regarding about what a doctor should prescribe .Whether Doctor will prescribe the generic drug ( salt/ molecule) exampleas stated in above example is Bauravol or should he prescribe the brand-name drug which is sold by different companies by different names after the expiry of patent. For example- Combiflam which is the medicine which was initially made by the Sanofi which is a french based Pharmaceutical Company. The active ingredient of  Combiflam is Ibuprofen+ Paracetamol. In this case what doctor should prescribe whether Combiflam which is a brand- name or Ibuprofen+ Paracetamol which is a generic salt made by n number of Companies. This is in a way taking away the power from hands of doctors, it might be possible that there is a particular brand-name which are trusted by doctors to be the best through their years of practice but now Doctors can't prescribe it.

Doctors can't prescribe for Combiflam as government has prohibited doctors from prescribing Brand- name   drug but to write generic drug. If Doctors prescribe suppose Centrezine which is produces by many companies and leaves it to patient whether which one( which company) he will buy if the patient buys most cheapest one  belonging to the local company which has a poor quality control then this any cause the patient to fell ill and liability shifts on the doctors. In a way we can say that power is snatched from hands of doctors and given to the Chemists and now the drug manufacturers will try to influence the chemists by giving them some commission so that they would recommend their manufactured medicine or the brand-name to the patients as the patients specially in India has little or no knowledge of medical science or medicines.

Doctors can any way circumvent or escape the liability  of prescribing generic medicines like on prescription he wrote a generic drug but says the patient to buy this generic salt of a particular brand-name.

A part from this is a complete injustice towards doctors. The differentiation of doctors as to who is a good doctor and who is a bad/average doctor will reduce because every doctor is going to prescribe the same generic salt and then what will be the differentiation.

Issues

• Not more than 1% of generic drugs sold in India undergo quality tests so there is no guarantee that the medicine one will taking will be effective
• The big brand-name producing medicines have the pressure of having a good quality checks because its a question of their goodwill  in the market but the local small generic drugs seller have no such pressure and have no such reputation to maintain, a generic seller is selling for low price for maximum profit hence there will be no quality control
• The choice of which generic drug to provide is on chemist and generally and we can see in India the one who is selling medicines are untrained and sell that medicine which has maximum margin.
• When there are combination of different chemicals in a drug then practically it is not possible on part of Doctor to remember all the generic slat components apart from that requirements of each patient is different thus it is not possible to remember and write all generic names in the prescription.

Solution

As such there is no solution as there is some kind of loophole in each solution.

The solution can be by putting a price cap on each generic drug but if it would be of same price cap then on e with quality control and the one with no quality control are kept on the same plane as a result of one making quality-controlled drugs will stop making it and thus putting a price cap is not going to work.