Compliance with Generic Drug Prescription Regulations

Union Minister’s Statement in Rajya Sabha

New Delhi: The Union Minister of State for Health, Smt Anupriya Patel, recently addressed the Rajya Sabha, emphasizing that doctors must follow guidelines set by the former Medical Council of India (MCI), the Directorate General of Health Services (DGHS), and other relevant bodies concerning the prescription of generic drug names in clear handwriting.

Parliamentary Inquiry on Prescription Practices

Parliament member Shri Shaktisinh Gohil inquired with the Health Ministry about the actions taken by the National Medical Commission (NMC) and the Ethics & Medical Registration Board (EMRB) to enforce Regulation 1.5 of the Medical Council of India (Professional Conduct, Etiquette and Ethics) Regulations, 2002. He posed several questions, including whether failing to prescribe medications by their generic names constitutes professional misconduct, the reasons for the persistent violations over the last 23 years, and details of any issued circulars, directives, or advisories. Additionally, he sought information about the number of registered medical practitioners (RMPs) found guilty and the disciplinary measures enacted.

Minister Patel’s Response

In her response, Minister Patel clarified that Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 requires all physicians to prescribe drugs using their generic names in a legible manner, preferably in capital letters, while promoting rational drug use. She highlighted that the former MCI had issued circulars urging all Registered Medical Practitioners to comply with these mandates.

Directive from the Directorate General of Health Services

Minister Patel further noted that the DGHS has mandated all Central Government hospitals to prescribe only generic medicines. Similar directives were conveyed to doctors participating in the Central Government Health Scheme (CGHS) and Wellness Centres to ensure that prescriptions are made clearly using generic names.

Empowerment of State Medical Councils

The Minister pointed out that the National Medical Commission Act of 2019 grants the State Medical Council (SMC) or the EMRB of the NMC authority to take disciplinary action against any registered medical practitioner for professional or ethical misconduct.

Monitoring Prescription Practices

Recently, Medic Helpline reported that the NMC acknowledged the necessity for improved monitoring of prescription practices across all medical colleges. Consequently, the NMC has instructed all medical colleges in India to establish Sub-Committees under the Drugs and Therapeutics Committee (DTC) to supervise prescriptions and ensure adherence to legal, regulatory, and ethical standards.

Recent Guidelines on Prescription Conduct

In 2023, the NMC issued the Registered Medical Practitioner RMP (Professional Conduct) Regulations, 2023, which delineated comprehensive guidelines on prescription practices. These regulations underscored the significance of generic prescriptions and categorized violations as punishable offenses, potentially resulting in a license suspension of up to 30 days. However, it is important to note that these regulations have been temporarily halted.

Related Updates

The NMC has also mandated medical colleges to establish prescription monitoring committees and integrate the significance of legible prescribing into their educational curricula.