Disciplinary Action against Doctors over failure to prescribe generic medicines: Supreme Court seeks response from Centre, NMC

New Delhi: Hearing a petition seeking disciplinary actions against doctors who fail to prescribe generic medicines to their patients, the Supreme Court has sought a response from the Centre, all state governments, the Ethics and Medical Registration Board of the National Medical Commission (NMC) and others in the matter.

According to recent media accounts, the apex court bench of Chief Justice of India D.Y. Chandrachud, Justices J.B. Pardiwala and Manoj Misra was moved by a petition that sought disciplinary actions against doctors who fail to prescribe generic medicines, as well as directions to the National Pharmaceuticals Pricing Authority to fix the Maximum Retail Price (MRP) of Non Scheduled formulations and off-patented generic medicines. The petitioner also sought surprise checks on prescriptions to ensure compliance with generic drug regulations; to prohibit the use of trade names/brand names for off-patent drugs, mandating the display of only the manufacturing entity's name and such similar reliefs.

RTI Activist and Environmentalist, Advocate K.C. Jain, the petitioner, apprised the bench that regulations emphasizing the importance of prescribing generic medicines, which were notified back in 2002, remain largely unimplemented in practice. He said that the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, which highlight the significance of prescribing drugs by their generic names, exist solely within legal frameworks.

The plea pointed out that affordability of medicines is a vital factor that contributes to effective healthcare delivery and the realization of the ‘right to health’.

Read also: How to write a Prescription: Check out NMC's Prescription guidelines for doctors

Medical Dialogues had reported about the dictums laid down by the NMC (erstwhile Medical Council of India) in its recently released NMC Registered Medical Practitioner RMP (Professional Conduct) Regulations, 2023 for all doctors to follow.

Dedicating a separate section to "Generic Medicine and Prescription guidelines" that is going to act as a benchmark for doctors to write their prescriptions, the guidelines laid down the various Dos and Don'ts, when it comes to writing prescriptions. The guidelines also gave a template of a model prescription, which may be followed while writing a prescription.

More importantly, the new code of Conduct laid stress on generic prescriptions by doctors only, making violation of the same a punishable offence where punishment can lead to suspension of licence for up to 30 days. Section 8 of the National Medical Commission Registered Medical Practitioner RMP (Professional Conduct) Regulations, 2023.

"Prescribing Generic Medicines: Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1 and/or L2)(Generic Drugs and Prescription guidelines)," stated the regulations.

RMP can prescribe or supply drugs, remedies, or appliances as long as there is no exploitation of the patients. Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug. (L2), the guidelines added.

"India’s out-of-pocket spending on medications accounts for a major proportion of public spending on health care. Further, generic medicines are 30 to 80 % cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care cost and improve access to quality care," the guidelines further stressed.

Any violation of these abovementioned rules will draw action from the authorities in the form of L1 and L2 penalties i.e. a warning or instruction to the doctor or a suspension of the license to practice for up to one month (30 days).

Meanwhile, the Indian Medical Association (IMA) recently demanded deferring the implementation of the National Medical Commission regulations that make it mandatory for doctors to prescribe generic drugs, stating the biggest impediment to such medicines is the uncertainty about their quality.

The IMA stated that less than 0.1 per cent of the drugs manufactured in India are tested for quality. “This step should be deferred till the government can assure the quality of all the drugs released into the market. Patient care and safety are not negotiable,” the association said in a statement.

Read also: Mandatory Generic Prescriptions: IMA demands Deferring implementation of NMC regulations

Now, in the PIL filed under Article 32 of the Constitution, the petitioner stated that it is unfortunate that due to the lack of a robust system in place to enforce these regulations through the initiation of disciplinary proceedings, surprise checks of prescriptions, and regular prescription audits, the regulations remain largely unimplemented in practice, existing solely within legal frameworks.

“Generic drugs, which have the same active ingredients as their branded counterparts but are not marketed under a specific brand name, are often significantly cheaper. The prices of generic medicines (off-patented) can be 50 per cent to 90 per cent lower than those of branded medicines,” stated the petition, as quoted by IANS.

“By prescribing generic drugs, healthcare professionals can help alleviate the financial burden on patients and facilitate their access to vital medications,” the plea further said.

"Cost is a crucial aspect when it comes to accessing medicines. Generic drugs, which have the same active ingredients as their branded counterparts but are not marketed under a specific brand name, are often significantly cheaper. The prices of generic medicines (off-patented) can be 50% to 90% lower than those of branded medicines. This price difference makes generic drugs more affordable and accessible to a broader section of the population", reads the PIL, as quoted by Verdictum

Further, Jain submitted that the EMRB and/or the State Medical Councils have grossly neglected their mandatory duty to enforce adherence to the above Regulations. This has resulted in significant hardship for the underprivileged and economically weaker sections of society, leading to a ‘health crisis’.

Also, it is pleaded that "the glaring absence of provisions for fixing maximum retail prices (MRPs) for non-scheduled formulations, including generic versions of medicines, is arbitrary and grants manufacturers unrestricted and unchecked authority to set any MRP, regardless of the actual manufacturing cost of the medicine."