As the usage of branded and/or, generic drugs is a burning issue since last many years, hence, I decided to share few points among the viewers of my website.
In this article, I have tried to explore the difference, similarity, merits, demerits, practical constraints, confusions, reasons, feasibility etc to use generic or, branded medicines.
There is a common advice that we should buy only generic medicines because the contents are same in generic & branded medicine and secondly, it is being cheaper also, but, are we aware of real storey behind it? Probably NO. like why they are cheaper and if so, then, why branded drugs are available in market, who is responsible for all this etc etc..
The Generic medicines and Branded medicines both are exactly same with respect to their usage, ingredients, indications, side effects, contra indications, special precautions, risks etc.
- The generic medicines are available in market only after expiry of ‘patent’ protection to the manufacturer of branded medicine. It is NOT necessary that every branded drug has a generic drug also.
- A huge investment is made by the manufacturer of branded medicine in various research works, inventing processes and on educating the doctors (for drug promotion) which many times extends to gifts and free holidays and even foreign trips also and the manufacturer of generic drug avail an enormous economic advantage for these medicines which is why their drugs are much cheaper.
- On the other hand, the doctors are advised to prescribe only generic medicines so that even a poor person may buy it.
- Once any generic drug enters in market, the prices of both branded drug and generic drug declines drastically due to competition.
- The supply of generic drugs is governed by regulations in countries where they are dispensed. In most of the countries, specially in European Union and the United States, the patent protection prolongs upto 20 years and it may be further extended for another 5 years.
- The retail pharmacists have very less incentive in generic drugs as compared to branded drugs. However, there are certain branded drugs also whose sale and profit margin is very low.
- The retail pharmacies have interest in selling only fast moving products whether it is branded or, generic, does not matter but, the main focus is that the margin of profit must be high.
- Indian Government had declared a list of pharmacies in 2008, called ‘Jan Aushadhi’ to supply cheaper generic medicines. Only few stores could have been operational in last 9 years and most of them have stock outs & other problems.
- Presently, there are about 7 lac retail pharmacy shops in India and many rural areas are still deprived of it.
- The ‘Jan Aushadhi’, available in market, are lesser than 10,000. A person has to rush up any of these few Jan Aushadhi stores in city, facing heavy traffic while, travelling from village to the nearby town in order to save merely few rupees. This is useful only for a person, buying medicines for 3 to 6 months for a chronic condition e.g: diabetes, hypertension etc.
- The total worth of Indian pharmaceutical market is about Rs: one lakh crore out of which, the market, captured by generic medicines, is about Rs:10,000 crore i.e:10% of the total pharmaceutical market.
- The medicines, covered under the national list of essential medicines-2015, remains under price control and its value is as low as 12% of the total market of Rs one lakh crore.
- Further, the market for useful medicines is only 4% of the total market value which have been put under price control by the government under Para 19 of the Drug Price Control Order (DPCO) – 2013.
- It is observed that minimum 90% of the Indian pharmaceutical market is captured by branded products including drugs.
- In this situation, if government frames a rule that doctors must prescribe only generic medicines, many patients may die in absence of getting those medicines from retail shops.
- The pharmacist, as per the prevailing law, cannot change a generic drug with a branded and vice versa.
- The country’s top most medical regulator (MCI) has warned the doctors of action if they fail to adhere to its guideline on prescribing the drugs only in generic names and writing prescriptions legibly. The MCI has directed medical practitioners to give the rational prescription, failing which a disciplinary action would be taken if they fail to obey these instructions.
- The MCI reviewed its 2016 directions and emphasized for a legal framework to ensure that doctors prescribe only low cost generic medicines to the patients.
- MCI pursued the medical community regarding its 2016 notification and amended the clause 1.5 of the MCI Regulations, 2002, making it compulsory for doctors to prescribe medicines by their generic names instead of brand names.
- Recently, while inaugurating a multi-speciality hospital in Surat, Modi had said that the doctors write prescriptions in such a way that the poor people do not understand their handwriting and they end up buying medicines from the private stores at high prices.
- The government is now revising the National List of Essential Medicines-2015 to include more medicines. The Jan Aushadhi programme is also emerging in market fastly.
After the expiry of patents, other manufacturers can submit an application for abbreviated new drug (ANDA) to the FDA for approval to market a generic version of the brand-name drug.
The generic drugs are as safe as branded drugs. The FDA first approves the generic drugs. The FDA requires that generic drugs must be as high in quality, and as strong, pure and stable as brand-name drugs.
When a generic drug is approved and marketed, the cost may remain high (although less than the brand name drug) for initial 6 months because the FDA gives the first generic manufacturer an exclusive period of 180 days which is assigned to the generic manufacturer to file an application for abbreviated new drug.
During this exclusive period when there is no any other competitive drug available in market, the manufacturer may charge higher prices.
If more than one generic manufacturer files their ANDA at the FDA on the same day, then, these companies will have to share 180 days exclusivity which might cause the decline of prices.
It is not necessary that all branded drugs have generic drug also. The patents of new drugs are generally protected for 20 years after FDA filing. However, it may take many years to research and get the brand name drug to market. When the patent period is nearer to expire, the other drug companies apply to the FDA for approval to start selling the generic version of the drug.
A generic drug may be approved temporarily by FDA before the expiry of patent period and many companies can manufacture and sell generic versions of the brand name product.
The generic drugs and proprietary brand names may be searched through the Electronic Orange Book on the FDA.
During the period when the generic products has been approved but, not appearing in the ‘Orange Book’, the patient may consult the most recent monthly FDA generic approvals, called ‘First Generic Drug Approvals’.
It is an exact copy of the brand name version authorized by the original patent holder of the drug product. The authorized generic is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is exactly same as the branded product in appearance (shape, color, markings) and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.
For example, Atorvastatin calcium by Greenstone is an authorized generic and exactly the same drug as the Lipitor brand cholesterol medication by Pfizer. The Greenstone company is a subsidiary of Pfizer. The cost of authorized generics must be low and similar to other generics at the pharmacy.
Biosimilar and a Generic drug:
A biosimilar drug is not considered as generic drug in the same way that a traditional drug is not considered as a generic drug.
Narrow Therapeutic Index (NTI) drugs:
These are those drugs in which a small difference in dose or blood concentration may cause serious therapeutic failures and/or adverse drug reactions which may be even life-threatening. Source to get information about Generic drugs:
A doctor or, pharmacist are the best source to get the information about generic drugs. A generic drug may not look like the branded drug. For this purpose, the drugs.com may be referred and FDA’s website: http://www.fda.gov/Drugs’ may also be referred.