DRAFTED BY AVANISH SHARMA
Generic medicine contains the same active pharmaceutical ingredients (API) as the branded version of the same medicine contains. Generic medicine has the same pharmacological effects as the branded version of that medicine; means the efficacy, dosage, effects, and side effects all are the same for both the medicines. Take an example of a generic medicine used for the treatment of type2 diabetes, is “Glimepiride” and it is sold with different brand names as “Amaryl, Zoryl, Glimy” etc. The brand name of medicine depends upon the manufacturer or developer of that medicine but the generic name will always be the same.
Generic medicines are available at much cheaper prices than prices of branded medicines. There is a reason for it, as the manufacturer who develops a new drug requires a lot of expenditure on research and development (R&D) and marketing of the drug. He gets the patent of that drug for 20 years and sells it with his brand name or gets royalty if some other manufacturer uses the same methodology. After the expiry of the patent, any manufacturer having minimum regulatory approval and facility can produce and sell a generic version of the original drug and that manufacturer does not require spending on R&D and marketing of that drug. So generic medicine becomes cheaper in comparison to the branded version of that medicine.
Clause 1.5 of Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002 prescribes that every physician should prescribe drugs with its generic names legibly and preferably in capital letters. The Circular issued in 2017 by the Medical Council of India (MCI) informed all physicians to comply with the above-mentioned rules. There are sufficient rules and regulations for promoting the use of generic medicines but lies with the implementation part of it. Doctors generally prescribe branded versions of a drug and they are very reluctant to prescribe a generic version of that drug. By prescribing branded versions of medicines doctors make huge commissions and this privilege is not with generic medicines. Sometimes doctors themselves do negative campaigning for generic medicines over their efficacy and safety. Sometimes pharma companies do unethical practices such as “evergreening of patents”. Here companies get new patent rights after completion of 20 years of an old patent by just doing little modification in their formula of that drug and making it difficult for generic medicine manufacturers to produce a generic version of that medicine. Generic medicines availability and lack of public awareness about it, are other problems with generic medicines.
Generic medicines affordability makes it optimum for a developing country like India where 21.9 % (2011) people are below the poverty line (BPL) as per Suresh Tendulkar Committee. As per the Finance Commission of India, nearly 70% of the expenditure on health is out of pocket, one of the highest globally, and this pushes about 60 million Indians into poverty each year. The government should make the public aware of generic medicines and make sure strict implementations of medical guidelines dealing with generic medicines.
