What are Generic Drugs:
Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts and it works in the same way and provides the same clinical benefit as its brand-name version.
What are Branded Drugs:
Branded drugs are the drugs that have a trade name and is protected by a patent (can be produced and sold only by the company holding the patent) and when the patent protection for a brand-name drug expires generic versions of the drug can be offered for sale if the FDA agrees.
Branded medicines are medicines which have a name given to them by a company for the purpose of advertising. Branded medicines may be the original medicine developed by a company or several companies may make the same generic medicine, to which each company gives its own brand name.
Why Generic Drugs are cheaper:
Generic makers don’t face the same costs as manufacturers of brand-name drugs. That is because the brand-name maker often invented the drug, a process that can cost hundreds of millions of dollars. That is an enormous economic advantage for these companies, which is why their drugs can be much cheaper.
Are Generic Drugs are Safe & same as Branded Drugs:
Yes. The FDA (Foods & Drugs Administration) requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
Why Branded Drugs are so expensive than Generic drugs:
According to the FDA, generic medications can cost, on average, 80 to 85 percent less than the brand-name equivalents. Brand-name drugs are typically more expensive because of the higher initial costs to develop, market, and sell a brand-new drug. A pharmaceutical company that develops a brand-name drug will file for a patent that prohibits other manufacturers from producing and selling the medication for a set time period.
Example of Generic & Branded Drugs:
An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug is Lopressor.
Generic drugs must meet high standards to receive FDA approval:
FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:
- The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
- The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical).
- The inactive ingredients of the generic medicine are acceptable.
- The generic medicine is manufactured under the same strict standards as the brand-name medicine.
- The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine’s label.
Do Generic drugs need Clinical Trial:
Today, more than 8 in 10 prescriptions filled in the United States are for generic drugs. … Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, generics are usually substantially less expensive than brand-name drugs.
Use of Generic medicines in India:
Generic medicines in India have received a new impetus with Prime Minister Modi himself advocating the usage of these medicines. Doctors will now be required to prescribe generic formulations of medicines, as opposed to specific brands. The Prime Minister has announced that prescription of medicines by their generic names will be mandatory.
With increasing pressure from the “Big Pharma” companies in developed countries, Indian generic manufacturers must now operate under a markedly restrictive intellectual property rights (IPR) regime. The new policy can ensure that—at least in the Indian market—generic manufacturers retain an advantage. Big Pharma’s access to Indian consumers will have to be routed through generic companies using channels such as voluntary licensing.
Generic medicine Experiments in India:
The Tamil Nadu and Rajasthan governments procure generic name medicines at extremely competitive prices year after year, and crores of drugs are in use in their public health systems, thanks to the quality assurance systems in place.The success of the drug procurement system in these two states should counter the defeatist narrative that insists that generic medicines can never be good.This is not to underestimate the challenges in ensuring quality generic medicines countrywide, but the critics from the medical profession are doing the poor patient enormous disservice by swallowing the disinformation from the pharmaceutical industry about the general lack of bioavailability of generics as compared to brands.
When a pharma company invest & develop any new drug & earn patent rights for it, then is called branded drug(BD). The duplicates of branded drugs are known as generic drugs. They have following differences:
Production: Only Company with patent rights are allowed to manufacture Branded Drug. Once patent lapses, other companies are allowed to produce generic drugs.
Cost: Unlike generic drugs, branded drugs incur high cost due to high investment research & development.
Ingredients: The active ingredient (the one which cure the disease) of both drugs are same but the differs in colour, shape or taste
Affordable, effective & easy drug access important for “universal healthcare”. So, India has decided to bring a law for doctors to prescribe generic medicines which have certain issues:
- Implementation: Lower awareness and corruption have given rise nexus between Doctors chemists & pharma sector. So, public awareness via digital media along surveillance mechanism to curb nexus
- International pressure: Big western pharmaceutical lobbies may back stringent IPR rigme & compulsory licensing. They may blame India to breach TRIPS agreement and drag into WTO. But recent UN report has given precedence to human rights over patent rights which support India’s move for affordable generic price to improve health care
- Supply side challenge: India is import driven country for active pharmaceutical ingredient and already facing challenge of substandard quality of generic drugs. Along with this current move may reduce FDI inflow in pharm sector and slowdown research & development in domestic pharma companies. However, India has taken steps like ‘India Pharma & India Medical Device 2017’ and new IPR policy that offer incentive & ease of doing business in India. India should adopt stricter accreditation and inspection rules for generic drugs
Jan Aushadhi Scheme :
- The Government has launched ‘Jan Aushadhi Scheme’ to make available quality generic medicines at affordable prices to all, especially the poor, throughout the country, through outlets known as Jan Aushadhi Stores (JASs).
- Under the Jan Aushadhi Scheme, the State Governments are required to provide space in Government Hospital premises or any other suitable locations for the running of the Jan Aushadhi Stores (JAS).
- Bureau of Pharma PSUs of India (BPPI) is to provide one-time assistance of Rs.2.50 lakhs as furnishing and establishment costs, start up cost for setting up a Jan Aushadhi Outlet.
- Any NGO/Charitable Society/Institution/Self Help Group with experience of minimum 3 years of successful operation in welfare activities, can also open the Jan Aushadhi store outside the hospital premises. A margin of 16% on the sale price is built in the MRP of each drug.
- In addition, the JAS are eligible for incentive linked to sale of medicines @ 10% of monthly sales amount, subject to a ceiling of Rs.10,000/- pm for a period of first 12 months. In case of Stores opened in North Eastern States and other difficult areas i.e., Naxal affected areas/Tribal areas etc., the rate of incentive is15% of monthly sale amount, subject to a ceiling of Rs.15,000/- per month.
- At present more than 175 Jan Aushadhi Stores have been opened across various States/UTs. JAS are opened on the locations as requested by the entity intending to open. The steps are also taken to open Jan Aushadhi stores in all AIIMS, prominent Hospitals, Medical Colleges under the Ministry of Health & Family Welfare.
Indian Government Initiative:
- 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 prescribe drugs with generic names legibly … and he/she shall ensure that there is a rational prescription and use of drugs.”
- How the MCI is going to ensure rational prescription and use, without a framework to measure the same, should be looked into seriously.
- Rational use and prescription depends on the doctor, the pharmacist, the regulator, and the consumer.
- Some minimum prerequisites for rational use are: prescription-only medicines (Schedules G, H, H1 and X) must not be available freely over the counter; doctors and their professional bodies along with regulators must ensure there is no misuse of antibiotics and critical drugs; and the removal of all irrational/harmful/useless medicines, both FDCs and unscientific single ingredients, must be ensured.
- Practical guidelines for rational use and prescription audit of medicines must be developed and implemented seriously by all doctors. Branding of off-patent drugs needs to be discouraged as is the practice in well-regulated countries.
- A time bound plan to make generic prescriptions mandatory will also prepare Indian pharma’s vast supply chain of 800,000 wholesalers and retailers to get used to the new initiative progressively. India’s 800,000 retailers have thrived because it is a profitable high-margin business.
- In the comparative analysis of generic drugs over the Branded drugs, the analysis were made based on how they were developed. Branded drugs take lots of time to get approved as the new substance drug undergoes lots of testings (pre clinical as well as clinical testings). Also, the analysis was made based on the costs. Branded drugs are more expensive as seen in the cost estimate above. Generic drugs are cheaper option especially for long term treatments.
- People are not aware of word “generic medicine” because they do not know what the word “generic” means. Many think its some different system of medicine – just like ayurveda, homeopathy, allopathy, unani, etc – they think a new system of medicine has been discovered and approved. So awareness among the people about generic drugs is more important & should be increased in order to get the medicines in cheaper rates.
- Ministry of Health & Family Welfare of India & Health department of the respective states should watch that whether Jan Aushadhi sceheme is implemented in all the states & people are getting its benefit or not.
- Every physician should prescribe drugs with generic names legibly and he/she shall ensure that there is a rational prescription and use of drugs.