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31 August 2023Big PharmaLiz Hockley

India regulator U-turns on controversial generics-only policy

National Medical Commission has put new regulations on hold that would have made prescribing generics mandatory | Move comes after pressure from doctors’ organisation and pharma firms.

India’s National Medical Commission (NMC) has put controversial new guidelines on hold just weeks after they were published, which would have compelled doctors to prescribe only generic versions of drugs.

The NMC said on Wednesday last week (August 23) that its Registered Medical Practitioner (Professional Conduct) Regulations 2023 “shall not be operative and effective till further Gazette Notification on the subject”, and that the Professional Conduct, Etiquette and Ethics Regulations 2002 were immediately effective instead. The regulations had been published on August 2.

The U-turn came following a meeting held on Monday (August 21), when India’s Minister of Health Mansukh Mandaviya heard concerns from stakeholders including the Indian Medical Association (IMA), which represents doctors, and the Indian Pharmaceutical Alliance (IPA), about the regulations.

Doctors argued that generic medications were not subject to the same standards and approval procedures as branded drugs, and questioned their effectiveness. They said the new rule would shift decision-making power away from physicians and into the hands of pharmacists, which was not in patients’ best interests.

In a statement, the IMC said: “If doctors are not allowed to prescribe branded drugs, why should such drugs be licensed at all, given that modern medicines can be dispensed only on prescription of doctors?”

The NMC had said that generic medicines were 30% to 80% cheaper on average than branded ones, and therefore the proposal could improve access to healthcare. But pharmaceutical firms and medical professionals contested that making them mandatory would compel pharmacists to push generics that had high profit margins, negatively impacting manufacturers of quality branded generics.

They also highlighted potential quality issues with combination drugs if only generics were prescribed due to a lack of specific standards for these medications, the Indian Express reported.

Along with making generics mandatory, the new regulations included directives on medical education and social media usage. They also banned doctors from attending events sponsored by pharmaceutical companies.

Those opposed to the guidelines had said they gave the NMC and state medical council powers “equivalent to a civil court”.

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