Explained: Why directives to Indian doctors to prescribe generic medications have been put on hold

The Union Health Ministry asked the NMC to modify the Registered Medical Practitioner (Professional Conduct) Regulations, 2023, only weeks after releasing it earlier this month. The regulations, which also made other modifications, included a provision that would penalise doctors for not prescribing generic medications. The move comes two days after members of the Indian Medical Association (IMA), which represents the nation’s largest network of doctors, and the Indian Pharmaceutical Association, which is made up of some of the biggest pharmaceutical companies in the nation, approached the Centre and spoke with Health Minister Mansukh Mandaviya, according to ThePrint. Also read: 'No brands, prescribe only generic drugs': India's diktat to doctors Massive opposition The NMC was informed that doctors have been protesting its directives ever since it was released. The doctors contended that India’s poor generic drug quality control laws would put patients in danger from these regulations. Branded medications, according to them, give a higher level of quality assurance. The IMA strongly disagreed with the restrictions, particularly the provision that warned doctors against prescribing anything other than generic, non-proprietary, or pharmacological names for medications. It claimed that the order to prescribe generic medications undermines comprehensive medical care and erodes the autonomy of medical professionals. According to Business Today, IMA’s National President Dr Sharad Kumar Agarwal and Secretary General Dr Anilkumar J Nayak said that the directive appeared to shift decision-making power from medical practitioners to pharmacists or individuals in pharmacy settings. Dr Rajeev Sood, Vice Chancellor of Baba Farid University of Health Sciences, Faridkot, too opposed the order, saying, “The pharmaceutical sector is highly regulated in India but testing available medicines is complex. Samples and templates lack quality testing. The pharmaceutical sector and chemists shops lack regulation. While doctors prescribe, chemists can provide any medicine.” “We heard the issues raised by doctors and drugmakers in this regard and concur that it may not be practical to only prescribe generic medicine in all cases mandatorily. In some cases, for instance, a drug may have multiple ingredients and it is not practical for doctors to write lengthy prescriptions,” a senior ministry official told ThePrint. The outlet quoted another ministry official as saying, “The NMC has been asked to make changes in the regulations on various issues, including the clause involving generic drugs, and we have asked them to allow doctors to at least prescribe branded generics.” Also read: Doctors to be penalised for not prescribing generic drugs, says new NMC regulation The controversial regulations In accordance with the RMP (Professional Conduct) Regulations, 2023, all licenced medical professionals “should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.” Additionally, the regulations instruct physicians to discourage the prescription of “branded” generic medications and to encourage patients to buy their medications from one of the 9,303 Jan Aushadhi Kendras established by the Centre or from other generic pharmacy shops. “Generic medicines are 30 to 80 per cent cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care,” it said. A doctor who violates the rules may receive a warning to be more cautious or be required to attend a workshop or academic programme on ethics, personal and social relationships, and/or professional development. The regulations stated that if there are many violations, the doctor’s licence to practise may be suspended for a specific amount of time. Prescriptions should be readable and preferably written in all caps to prevent misunderstanding, according to the NMC. To reduce errors, it advised typing and printing prescriptions whenever possible. The NMC has also made available a template that can be used to write logical prescriptions. Only generic medications that are sold and easily accessible to people should be prescribed by doctors. According to the NMC regulation, they should also lobby for local pharmacies and hospitals to offer generic medications. Additionally, according to India Today, a Public Interest Litigation (PIL) was submitted to the Supreme Court in an effort to impose strict disciplinary measures on licenced physicians who don’t recommend generic versions of branded medications. Also read: Explained: How desperate Chinese are illegally procuring India-made meds amid COVID scare Generic drugs The NMC defines generic medications as “drug products that are comparable to brand/reference listed products in dosage form, strength, route of administration, quality and performance characteristics, and intended use” under the generic medicine and prescription guidelines of rules. Both a brand name and an official international non-proprietary name (INPN) may be used to market these medications. The INPN is the accepted generic name for a drug, however in India — one of the world’s major producers of generic medications — these medications are typically offered as branded generics. A branded generic medicine, on the other hand, is one that has lost its patent, is made by a pharmaceutical company, and is marketed by a different company. These drugs may be less costly than the branded patent version but costlier than the bulk-manufactured generic version of the drug. There is less regulatory control over the prices of branded generic drugs. With inputs from agencies