Explained: Why doctors are opposing govt's directive on prescription of generic medicines

A wave of protest and opposition is spiraling within the medical fraternity across the country over the National Medical Commission's (NMC) recent directive to doctors to exclusively prescribe generic medicines to patients.

As the debate rages on, doctors, medical associations, and healthcare bodies have united their voices, urgently appealing to both Union Health Minister Mansukh Mandaviya and Prime Minister Narendra Modi to reconsider and rescind the rule.

In the past week, at least three organizations have reached out to the government, urging a reevaluation and withdrawal of the directive. Following the Indian Medical Association's lead in opposing the policy change, the Association of Physicians of India — a body of consultant physicians — and the Medico-Legal Society of India have also written to Mandaviya and Modi, presenting their arguments against the directive.

The new rule explained

On August 2, the NMC imposed a directive mandating doctors to prescribe generic drugs instead of branded equivalents. In case of non-compliance, they can be penalised. For breaches, doctors could also receive warnings and mandatory participation in workshops and training sessions. Persistent violations of the directive could further lead to the suspension of their licenses, as per an official notification by the NMC.

Generic medicines are the unbranded versions of drugs that have identical dosages, usage, side effects, administration routes, risks, safety, and potency as their branded counterparts. For instance, while Crocin and Dolo 650 are branded versions of a pain and fever reliever, their generic name is paracetamol.

Under NMC's guidelines for generic medicine prescriptions, these medicines are defined as products equivalent to their brand/reference-listed counterparts in terms of dosage form, strength, administration route, quality, performance characteristics, and intended use.

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To ensure clarity and minimise misinterpretation, the NMC recommends that prescriptions be legible, preferably written in all capital letters. Typewritten and printed prescriptions are encouraged to prevent errors. The NMC has also supplied a prescription template for doctors to use in rational prescription writing.

However, apprehensions have arisen regarding the efficacy and quality of these generic drugs. Critics who are majorly medical professionals and academicians in medical education institutions argue that their effectiveness and reliability may be compromised due to a lack of standardized testing and approval procedures. They further contend that branded drugs offer greater assurance of quality.

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Brewing debate over generic versus branded

Generally known, despite concerns about generic medications, their affordability remains a significant advantage. Their lower prices result from the absence of patent protection and marketing expenses, making healthcare more accessible to the masses. This shift in prescription practices could hold particular significance for chronic patients burdened by medical costs, the government holds.

As anticipated, insurance companies could also save substantially, as high-priced branded drugs contribute significantly to elevated healthcare premiums.  IMA has however argued that the directive to prescribe specific groups of drugs undermines comprehensive medical care and weakens medical professionals' autonomy.  Despite being supportive of the intention behind the promotion of generic drugs, doctors have expressed apprehensions that the new directive could compromise the quality of care they can provide.

The mandate aims to make healthcare more affordable and grant greater access to essential medications for economically disadvantaged populations. “The directive appears to shift decision-making power from medical practitioners to pharmacists or individuals in pharmacy settings. This shift may not align with the patients' best interests, as it places a crucial treatment decision in the hands of non-medical personnel,” Dr Sharad Kumar Agarwal, National President, and Dr Anilkumar J Nayak, Secretary General, IMA jointly said.

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 According to the Medico Legal Society of India, the directive to prescribe generic medicines is under scrutiny for potential violation of citizens' fundamental rights under Article 21 of the Indian Constitution. Several legal cases have established that individuals possess the right to make decisions about their bodies and medical treatment without unwarranted state interference.

While the IMA said less than 0.1 per cent of the drugs manufactured in India are tested for quality, the medico legal society warned that concerns arise due to potential compromise in quality control of generic drugs, leading to uncertain efficacy and liability for doctors. The NMC's lack of control over drug quality and pharmacy practices further adds to the debate. Doctors have said that the availability of medicines in the Indian market is a challenge.

“Samples are not tested, and quality is not assured. The pharmaceutical sector is highly regulated in India but testing available medicines is complex. Samples and templates lack quality testing. The pharmaceutical sector and chemist shops lack regulation. While doctors prescribe, chemists can provide any medicine. There's no regulation that the NMC can impose on chemists,” said Dr Rajeev Sood, Vice Chancellor of Baba Farid University of Health Sciences, Faridkot, Government of Punjab medical educational institution.

What is the solution?

Dr Sood, also the former Dean of PGIMER-Ram Manohar Lohia hospital in New Delhi and a member of apex medical organizations in India, further explained that additionally, each company produces multiple versions: a premium brand, a second-tier cheaper option, and a third generic and more affordable one. However, companies often prioritize the premium brand. Thus, simultaneous regulation of the sector and pharmacists is crucial. It's not effective to impose these guidelines solely on doctors without including the entire industry, he said.

He cited instances that exist where patients receive compromised quality. Certain life-saving medicines are costly. When patients visit chemists, they might receive any medicine available, he said, adding that after approvals, prices should be controlled.

"Pricing should occur at the manufacturing level. Opting for a route where doctors only prescribe generics and chemists have autonomy can lead to issues. Chemists who create their own drugs compromise quality. Some patients report not benefiting from generic medicines. Offering generic medicine is positive, but addressing quality, distribution, and chemist regulation is essential. The current system permits compromised quality to infiltrate the market,” said Dr Sood.

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Experts have said that India has traditionally favored branded generics, and transitioning to generics might not be straightforward. “For instance, doctors might face challenges prescribing generics in combination molecules or nutraceuticals. Moreover, a shift in influence from doctors to retailers is possible, as retailers could prioritise brands with higher margins when dealing with generics," explained Hari Natrajan, Founder and Managing Partner at Pronto Consult, a consulting firm working across sectors, including healthcare. "Recently, there has been a noticeable rise in patients purchasing from Jan Aushadi outlets nationwide. This trend is expected to continue with the establishment of new stores, leading to greater adoption of generics as envisioned by the Government of India," he added.

The API has argued that a patient-centric approach requires doctors to have the flexibility to prescribe medications that suit individual patients' needs, considering factors like allergies, tolerances, and specific medical conditions, the doctors associations have said.

"We advocate for a more flexible stance that encourages the prescription of generic drugs while allowing medical judgment to prevail in cases where brand-specific medications are medically justified. We urge the Ministry/Department to consider our concerns and resentments with an open mind," said Dr Girish Mathur, President of the Association of Physicians of India (API).

"Rather than taking the NMC route the Government should take the Pharma route and ban all the branded drugs. The government allows several categories like Branded, Branded Generic, and Generic and permits pharmaceutical companies to sell the same product at different prices. Such loopholes in law should be plugged," Dr Sharad Kumar Agarwal, National President and Dr Anilkumar J Nayak, Secretary General, IMA jointly said.