India’s largest professional medical body, the Indian Medical Association, has opposed the government’s suggestion that doctors should write generic names of drugs while prescribing medicines. Prime Minister Narendra Modi announced on April 17 that the government was considering such a rule, following which the Medical Council of India issued a circular reiterating its September 2016 notification, which already states that a doctor is expected to “prescribe drugs with generic names”.
But the Indian Medical Association is finding this hard to swallow. “Not writing a brand name is like asking people to vote but without mentioning the names, BJP or Congress,” said Dr KK Aggarwal, president of the association, which has close to 2.75 lakh members.
Generic drugs are those for which the patent has expired and may be branded or unbranded. Unbranded generics are referred to and sold under their International Non-proprietary names – the names that doctors are now expected to use when writing prescriptions. The government’s purported aim for the move is to ensure that patients are being given affordable medicines. Original branded medicines sold by large pharmaceutical companies are more expensive because they are marketed more extensively. Generic drugs are may be manufactured by smaller companies at lower costs and may have lower prices. Generic drugs have the same formulations as original drugs, as well as the same effect and can be as safe as branded drugs.
More than 90% of the medicine market in India is made up of branded generics. Members of the medical community and health activists have said that the government must move to reduce the profit margins on branded generics instead of trying to regulate doctors’ prescriptions.
Said uro-gynaecologist Dr Aparna Hegde: “Profits resulting from prescriptions most often benefit the pharmacist and/or the hospital and not the doctor because often it is former who decide which drug is given to the patient based on their available stock irrespective of the brand prescribed by the doctor. This practice of substitution [where a pharmacist may decide which drug to give] can be dangerous if maximising profits underlies the choice of the drugs stocked.”
Hegde is concerned about the quality generic drugs, especially non-branded generic drugs, given India’s poor drug regulatory systems.
Dr S Utture, elected member of Maharashtra Medical Council, said that the need to prescribe branded generic drugs arises because doctors have little faith in the non-branded generics. “The problem is that we have a very weak Food and Drug Authority,” he said. “If the FDA ensures that the non-branded drugs have the same bio availability [the amount of drug absorbed in the blood stream] as branded generics, there would be no problem.”
In a recent article on Scroll.in, S Srinivasan who runs Low Cost Standard Therapeutics, which manufactures essential medicines for rural and urban poor, wrote that the quality of a medicine does not necessarily depend on whether it is an expensive branded medicine or a less-expensive generic one. But much of the price of a branded medicine may be to cover the marketing costs to the manufacturer that might include special attention to doctors like gifts and paid holidays.
But instead of regulating doctors’ prescription habits, the Indian Medical Association wants the government to disallow differential pricing of the same drug under different brand names. “The judgment to prescribe a drug and the format lies with the registered medical practitioner,” said Aggarwal, calling this right to make such a judgment sacrosanct.
The Medical Council of India certainly does not think so. The council had tried to get doctors to write generic names in prescriptions last September when it amended its regulations.
Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs.
The above Clause – 1.5 is substituted in terms of Notification published in the Gazette of India on 08.10.2016 as under.
“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”— September 2016 amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002
“The amendment clearly says ‘should’ prescribe medicines with generic names and not ‘shall’, which clearly means that it is a doctors’ discretion,” countered Aggarwal.
He insisted that the association’s members may prescribe the medicines using their generic names but will continue to “put the brand name in the brackets”.