The National Medical Commission (NMC) has decided to temporarily suspend its recent directives that required doctors to prescribe only generic drugs. These directives, officially released on August 2 under the title “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023”, faced significant opposition from various stakeholders, including the Indian Medical Association (IMA) and the Indian Pharmaceutical Alliance (IPA). Even the Central Drugs Standard Drug Control Organisation (CDSCO), India’s primary drug regulatory authority, raised concerns about the language used in the official notification.
Suspension Amid Controversy: NMC Guidelines and Ministry of Health’s Intervention
This suspension follows a meeting convened by the Ministry of Health, involving stakeholders like the IMA and IPA, who expressed their reservations about the directives.
The announcement states, “The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby temporarily suspended immediately… The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, will take immediate effect.”
Aside from the generic medication provision, the NMC guidelines covered areas like continuous medical education, social media usage, maintaining a dynamic roster of physicians, and prohibiting doctors from participating in events sponsored by pharmaceutical companies.
During the Ministry of Health meeting, concerns were raised that the directives granted the NMC and state medical councils powers similar to a civil court, a role usually reserved for Parliament. Participants also voiced concerns about disparities in drug quality, especially for non-branded generics.
Debates and Challenges: Evaluating NMC Directives and the Future
Participants suggested suspending the directives until the implementation of World Health Organization good manufacturing practices. They argued that mandating exclusive prescription of generic drugs might lead to pharmacies selling them at high profit margins, possibly discouraging high-quality branded generics.
Issues with combination drugs were also raised, as the Indian Pharmacopoeia lacks specific standards for them. Restricting the sale to generic versions of combination drugs could raise quality concerns.
The CDSCO raised concerns about ‘List O’, a group of “over the counter” medications recommended on teleconsultation platforms. The NMC’s August 2 notification included 14 therapeutic categories in List O. However, CDSCO believed some categories might have drugs that shouldn’t be distributed this way under the Drugs and Cosmetics Act.
Regarding restrictions on doctors’ participation in industry-sponsored events, a committee has been formed, including Dr. VK Paul from Niti Aayog, to streamline industry sponsorships. The committee’s report is awaited and is expected to allow such conferences with certain limitations.
In conclusion, the NMC’s decision to suspend the directives temporarily aims to address concerns raised by stakeholders and ensure a balanced approach to medical regulations.
