IMA opposes NMC move to mandate doctors to prescribe only generic medicines

The Indian Medical Association (IMA), the apex body of Indian medical professionals with around 400,000 doctors, has expressed concerns about the National Medical Council (NMC) move to mandate doctors to prescribe only generic medicines. In fact, the IMA has sought a deferment of the regulation for 'wider consultations' by the Centre.

The NMC is a government body that regulates medical education and medical professionals.

The IMA, which has a presence across 32 states and 1,760 local branches across India, said that the 'ill-advised' step taken by the NMC on the issue of generic drugs is an 'emergency'. India is a branded generic drugs market where pharmaceutical companies sell copy-cat drugs (those that are off patent) under different brands. This means the same molecule can be sold under different brand names.

In its 'Regulations relating to Professional Conduct of Registered Medical Practitioners' released recently on August 2, the NMC has said: “Every registered medical practitioner (RMP) should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.”

The IMA said in a statement on Monday that “It is a matter of great concern for IMA since this directly impacts patients’ care and safety. Generic promotion needs to be genuine.” It said that the biggest impediment for generic drugs is assurance of quality. “The quality control in the nation being very weak, there's practically no guarantee of the quality of drugs and prescribing drugs without assured quality would be detrimental to patient health. Less than 0.1 per cent of the drugs manufactured in India are tested for quality,” the IMA said.

It added further that this measure just shifts the choice from a medical practitioner who is primarily concerned, trained, and responsible for the patients’ health to a chemist or person sitting in a chemist shop, who is selling drugs.

“This naturally wouldn't be in the best interest of the patient. If doctors are not allowed to prescribe branded drugs, then why should such drugs be licensed at all, given that modern medicine drugs can be dispensed only on prescription of doctors of this system,” the statement said.

Once doctors start prescribing only generic medicines or molecule names, then the chemist can offer the cheapest option available to patients, thereby reducing patient costs. Industry insiders also feel that the move is a step towards implementing and codifying the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), which is currently a voluntary set of guidelines preventing pharmaceutical companies from giving freebies to doctors.

The IMA felt that if the Centre is serious about implementing generic drugs, then it should not give licences to branded drugs at all, and at the same time ensure the quality of generic drugs.

“Making quality brands available in the market but disallowing doctors who are responsible for patients’ health, from prescribing them seems dubious. The onus of exercising the choice shifts from the doctor to the medical shop,” the doctors’ body said.

It also said that the government allows several categories like Branded, Branded Generic and Generic and permits the Pharmaceutical Companies to sell the same product at different prices. “Such loopholes in law should be plugged. IMA demands a foolproof system of quality assurance before switching over to Generic drugs. IMA had been demanding for long that only good quality drugs should be made available in the country and prices should be uniform and affordable,” it said.

IMA urged the Centre to have 'one drug, one quality, one price' system whereby all brands should be either sold at the same price, which should be controlled or banned, and only generics allowed while ensuring the highest quality of these drugs. It has asked for deferring the Regulation and the Centre and the NMC to intervene in the matter.

Interestingly, the chemists' lobby is not happy with the move to prescribe only generic drugs too.

Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists (AIOCD), an umbrella organisation of chemists in the country, said: “We find some challenges and concerns with this government’s decision for generics. There’s concern about potential monopolies by big companies in the future.” He expressed concern about quality. “Substandard stuff has been found even among branded drugs sometimes.” Singhal said making generics optional could help prevent monopolies and protect patient rights. However, this approach might also impact the pharmaceutical industry and the availability of branded drugs. The revenue of the pharma industry may decrease, and this could affect research and development. And some patients might worry about the effectiveness of generic drugs, he added.