Doctors In India Can Now Only Prescribe Generic Medicines, Here's Why It Might Not Be A Good Thing

If you have ever been to a pharmacy, there is a good chance that you have encountered a scenario where the pharmacist told you that some medicine on your prescription is unavailable, but they can give you the same drug but from a different brand, which is also cheaper.

And you likely bought the alternative offered by the pharmacist because it is the same and less expensive drug.

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What you just bought is called generic medicine, and going forward, it will be the standard practice for doctors across India.

NMC makes prescription of generic medicines mandatory

That is because the National Medical Council (NMC) has mandated that now doctors can prescribe only generic medicines.

According to the new NMC guidelines, all doctors will mandatorily be required to prescribe generic drugs failing which they will be penalised and even their license to practice may also be suspended for a particular period.

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The NMC, in its notified 'Regulations relating to Professional Conduct of Registered Medical Practitioners," also asked doctors to avoid prescribing branded generic drugs.

The regulations notified on August 2 stated, "India's out-of-pocket spending on medications accounts for a major proportion of public spending on health care. Further, generic medicines are 30 per cent to 80 per cent cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care."

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Under the regulations' generic medicine and prescription guidelines, the NMC defined generic drugs as a "drug product that is comparable to brand/reference listed product in dosage in dosage form, strength, route of administration, quality and performance characteristics, and intended use."

What are generic medicines?

According to the USFDA, a generic drug or generic medicine is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

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IMA oppose MNC notification

But the move to force doctors to prescribe only generic medicines is facing pushback from the medical community.

The Indian Medical Association (IMA) equated the move to running trains without tracks.

"The ill-advised steps taken by NMC on the issue of generic drugs is an emergency. The regulation is mandatory for doctors to prescribe only generic drugs. It is a matter of great concern for IMA since this directly impacts patients' care and safety. Generic promotion needs to be genuine. Running trains without tracks is how the present promotion of generic drugs by NMC appears to be," the IMA said in a statement.

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The IMA further said that if serious about implementing generic drugs, the government should give licence only to generics and not to any branded drugs while ensuring quality of generic drugs.

"If doctors are not allowed to prescribe branded drugs, then why such drugs should be licensed at all, given that modern medicine drugs can be dispensed only on the prescription of doctors of this system," IMA said.

Why are generic medicines not the same as branded drugs?

One of the major issues, doctors and health experts point out about generic medicines is quality.

Since pharma companies invent medicines, they go through various stages of quality and safety checks before they are approved. In most cases, the inventing pharma company also gets a patent for the same.

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But after the patent expires, other pharma companies are also allowed to make the same drug using the same formulation, at which point it becomes a generic drug.

Since the non-patented pharma company did not have to invest in R&D, they can sell them at a lower price than the inventor.

Generic drugs don't go through same quality checks

Also, since the generic drug manufacturer is following the original company's formula, they only have to provide evidence that their drug is similar and does not have to do trials to show the drug is effective.

"The problem is the Indian regulators (unlike regulators in rest of the world) do not require bioequivalence studies to be done before companies get a licence to sell the drug. So essentially, we have no way of knowing whether the drug being marketed in India has the same quantity, quality, impurities etc, when compared to the patented drug. We have to just rely on the Indian Pharma company's word (with no data) that the generic drug they are selling is as good as the original patented drug," Soumitra Pathare, the Director of Centre for Mental Health Law & Policy, said in a series of tweets.

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