The Supreme Court on Thursday stated that doctors nationwide should be required to prescribe only generic medicines instead of branded ones. The top court was hearing a Public Interest Litigation (PIL) seeking the stringent regulation of the marketing and promotion of drugs by pharmaceutical firms.
This observation came during the hearing of a petition filed by the Federation of Medical & Sales Representatives Associations of India (FMSRAI) and others. The plea emphasised that large sums of money are spent on sales and promotional activities aimed at influencing doctors to increase prescription volumes.
A three-judge Bench, headed by Justice Vikram Nath and including Justices Sanjay Karol and Sandeep Mehta, remarked, “We believe that doctors should be mandated to prescribe only generic medicines. That will align with the relief you are seeking. In Rajasthan, an executive instruction already requires all medical professionals to prescribe only generic drugs.”
The petitioners had questioned the effectiveness of the existing voluntary regulatory framework and claimed that the pharmaceutical industry persists in unethical marketing practices.
The next hearing in the case is set to take place in July.
What are generic drugs?
A generic drug is a medication designed to be equivalent to an existing brand-name drug in terms of dosage form, safety, strength, method of administration, quality, performance, and intended use. This means a generic drug functions and offers the same clinical benefits as its branded version. In simple terms, a generic drug can be used as a direct substitute for its brand-name counterpart.
In 1970, the Indira Gandhi-led government passed a law that prohibited the patenting of medical products in India. The Patent Act of 1970 authorised the Indian Patents Office to compel patent holders to grant licences to other manufacturers at lower costs if the patent was not serving a social purpose. This marked a turning point for the Indian pharmaceutical industry. India is notably the world’s leading producer and exporter of generic medicines.
IMA opposes govt push for generic drug prescriptions
In 2023, the Centre’s National Medical Commission (NMC), in its ‘Regulations Relating to the Professional Conduct of Registered Medical Practitioners’, mandated that all doctors must prescribe generic medicines, warning that non-compliance could result in penalties, including suspension of their licence to practise.
The Indian Medical Association (IMA) opposed this directive, questioning why the government continues to license branded medicines if it intends to promote generic drugs. The NMC had to put on hold its new guidelines that prescribe generic drugs due to the backlash from the IMA.
The IMA is the apex body of Indian medical professionals, with around 400,000 doctors.
