New Delhi: With the aim of preventing unethical marketing and ensuring responsible promotion of pharmaceutical products by regulating interactions between doctors / registered medical practitioners (RMPs) and representatives of pharmaceutical companies, the Department of Pharmaceuticals, on 12.3.2024, has issued the Uniform Code of Pharmaceuticals Marketing Practices 2024.
The code outlines guidelines regarding promotion of drugs among doctors/RMPs. Pharmaceutical companies are accountable for the actions of their medical representatives and other employees. The code prohibits provision of gifts, monetary benefits and hospitality to doctors and their family members by pharmaceutical companies. It includes requirements for pharmaceutical companies to self-declare adherence to the code and disclose expenditures related to conferences, seminars and workshops organised for continuing medical education and continuing professional development. Companies may undergo independent, random or risk-based audits. The code establishes a two-layer complaint adjudication process, with appeals handled by the Department of Pharmaceuticals.
Penalties under the code include the following :
- Reprimand to the pharmaceutical entity and publication of full details thereof.
- Recovery of money or items given in violation of the code by the pharmaceutical entity from the persons concerned and notification of the action taken to the Ethics Committee under the code.
- Issuance of a corrective statement in the media, if promotional material issued therein does not comply with the requirements specified in the code.
- Pharmaceutical companies may face action under existing laws by relevant government departments, based on violations detected during administration of the code.
Further, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 made under the Indian Medical Council Act, 1956 provides the code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.
Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 provides that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is rational prescription and use of drug. Further, the Medical Council of India issued circulars dated 22.11.2012, 18.1.2013 and 21.4.2017 directing all registered medical practitioners to comply with the aforesaid provisions.
The National Medical Commission Act, 2019 empowers the appropriate State Medical Councils or the Ethics and Medical Registration Board of the National Medical Commission to take disciplinary action against a doctor for violation of the provisions of the aforesaid regulations. Further, States have been advised to ensure prescription of generic drugs and conduct regular prescription audits in public health facilities.
This information was given by the Union Minister of State for Chemicals and Fertilizers Smt Anupriya Patel in Rajya Sabha in a written reply to a question.
