There is generally a consensus in the world that generic medicines are much cheaper as compared to branded medicines and are equally effective. There should be no debate on use of generic medicines. In the United States almost 80% of prescription drugs sold in the market are generics. Generic drugs have the same active ingredients, strength, indications or use, side effects and testing standards. Yet, the price of generic medicines is much lower as compared to their branded counterparts. In most cases generic medicines are two to three times cheaper as compared to branded medicines.
Why are Generic Medicines cheaperIJ
When a new medicine is made for the first time a company has to spend a lot of money on research and development. After development of the drug time consuming and expensive tests are conducted to ensure its effectiveness and safety. Companies need to recover this cost in order to continue to produce newer and more effective drugs. For this reason the company which develops a new drug is granted a patent on it for a few years. During this period no other company is allowed to manufacture this drug and the company which developed it can recover its cost. Once the period of patent is over any company can manufacture the drug and seek licence after proving its efficacy and safety. These drugs are then labelled by their generic names and are sold at much lower prices because the company manufacturing them did not invest in research and development. The prices of generic medicines are lower also because many companies manufacture the same medicine and there is industrial competition between them. The lower price does not mean lower efficacy or lower safety because drugs are licensed only after rigorous testing by the Drug Controller of India.
Are there differences between generic and branded medicinesIJ
The active ingredients of generic medicines are the same as that of branded medicines. However inactive ingredients like colouring agents, flavours, fillers etc. may be different. Generic medicines may therefore look different from their branded counterparts. However they work alike. Generic medicines are required to achieve approximately the same blood concentration as branded medicines. The difference allowed is roughly 20%. Generic Medicines are therefore equally effective.
What situations require special considerations while prescribing generic medicinesIJ
Some drugs have a narrow margin between the effective blood concentration and toxic blood concentration. These are known as NTI (narrow therapeutic index) drugs. Examples of such drugs include warferin (used as a blood thinner), digoxin (used in treating heart conditions), theophylline (used in asthma) etc. Closer monitoring of patients may be required while using generic version of such drugs.
Current legal Provisions
Medical Council of India amended Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, on September 21 last year. This clause now reads: “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”. There is no other legal provision at present which mandates prescription of generic medicines. Doctors can prescribe whichever medicine they consider best for their patients. Pharmacists have no authority to dispense medicine of any other brand name of generic medicine if the doctor has prescribed medicine of a particular brand.
Why doctors do not prescribe generic medicines in IndiaIJ
Doctors are taught only generic names of medicines in Medical Colleges therefore it should easy to prescribe generic medicines. However doctors mostly prescribe branded medicines in India. This happens because newer medicines are discovered and marketed everyday and information about these medicines is shared with doctors through medical representatives of pharmaceutical companies, who promote their brands. Some doctors wrongly believe that branded medicines are superior to generics. There have been accusations that doctors get incentives from pharmaceutical companies for promotion of their brands. However, these accusations are in most cases false and unfounded.
Pradhanmantri janaushadhi Yojna
This is an ambitious scheme of Government of India for making generic medicines available to all at reasonable prices through Jan aushadhi stores. The scheme had started in Chittaur district of Rajasthan as an innovative Project by one young district collector – Samit Sharma, for which he got the Prime Minister’s Award for excellence in Public Administration. The scheme has now been adopted by Government of India and has been extended to the whole of country. At present the scheme suffers from several challenges. Too few jan aushadhi stores exist so that people are not able to access them easily. Moreover most jan aushadhi stores do not have all types of medicines. In my view instead of opening special stores for cheap medicines, Government should concentrate on availability of cheap generic medicine in all medical stores.
Suggestions for promoting generic medicines
Forcing doctors to write only generic medicines is neither useful not necessary. We understand that generic medicines are cheaper because manufacturers of generic medicines do not have to spend money on development and promotion. It has been suggested that after the period of patent is over Government may withdraw the licence for manufacture of branded medicines and allow manufacture of generic medicines only along with putting a cap on the price of such medicines. However if this is implemented the entire pharmaceutical industry will be up in arms against the Government. It may also result in some essential medicines not being manufactured at all because of low profit margins. Moreover such a course of action also takes away the might of choice of consumers. A better course of action would be to amend the law to allow pharmacists to substitute branded medicines with generic medicines if requested by the patient while filling a prescription. It should be the duty of every pharmacist to inform the patient about all alternate generic medicines available with him along with their prices so that the patient can make an informed choice. The only exception should be if the doctor wants medicine of only a particular brand to be taken by the patient in which case he should write “DO NOT SUBSTITUTE” on the prescription. This is will take away the power of choosing the brand from the doctor and empower the patient to make a choice. This will also obviate the need for the doctor to remember generic names and end unnecessary opposition to generic medicines by the doctor community.
The writer is a senior bureaucrat with the C’garh Government.Views expressed in the column are personal.