New Delhi: The Union health ministry has asked the National Medical Commission (NMC) to modify the Registered Medical Practitioner (Professional Conduct) Regulations, 2023 — issued earlier this month — which, among other changes, introduced a provision to penalise doctors for failure to prescribe generic drugs, ThePrint has learnt.
The directive to the NMC came two days after representatives of the Indian Medical Association (IMA) — the largest network of doctors in India — and the Indian Pharmaceutical Association, which represents some of the country’s largest drugmakers, met Health Minister Mansukh Mandaviya.
A drug that goes off-patent becomes a generic medicine and can be made available under an official international nonproprietary name (INPN) or a brand. The INPN is the generic name of a medicine that is accepted the world over but in India, one of the largest producers of generic drugs globally, these medicines are mostly sold in the form of branded generics.
The RMP (Professional Conduct) Regulations, 2023, state that every registered medical practitioner “should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets”.
Further, the regulations ask doctors to avoid prescribing “branded” generic drugs and to encourage patients to purchase drugs either from Jan Aushadhi Kendras — the 9,303 stores set up by the Centre — or from other generic pharmacy outlets.
The IMA vehemently opposed the regulations, especially the clause asking doctors to prescribe drugs only with generic or non-proprietary or pharmacological names, or face penalty. The maximum punishment for violations, according to the NMC regulations issued on 2 August, is suspension of licence for up to 30 days.
“We heard the issues raised by doctors and drugmakers in this regard and concur that it may not be practical to only prescribe generic medicine in all cases mandatorily,” a senior ministry official told ThePrint. “In some cases, for instance, a drug may have multiple ingredients and it is not practical for doctors to write lengthy prescriptions,” the official added.
A second ministry official said, “The NMC has been asked to make changes in the regulations on various issues, including the clause involving generic drugs, and we have asked them to allow doctors to at least prescribe branded generics.”
ThePrint reached Union Health Secretary Sudhansh Pant and NMC spokesperson Dr Yogendra Malik for comment but calls to them went unanswered. This report will be updated if and when a response is received. ThePrint also reached the Indian Pharmaceutical Association over messages but they refused to comment.
However, sources in the Indian Drug Manufacturers Association (IDMA), a network of generic drugmakers, backed the IMA’s demand and termed the regulations “immature”.
“Given the current landscape of marketing and regulatory practices, it may not be possible for doctors to solely prescribe generics,” said a senior IDMA member who did not want to be named.
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‘India’s drug ecosystem simply not ready’
IMA secretary general Dr Anilkumar J. Nayak told ThePrint that the main issue in binding doctors to generic drugs is the lack of quality assurance. He added that while the regulations earlier advised prescribing generic medicine, what has changed now is the penal provision in case of violations.
In September 2016, the Medical Council of India, the former regulator for medical professionals, had amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002, asking doctors to prescribe generic drugs “as far as possible”. The year after that, Prime Minister Narendra Modi declared that the government could make “legal arrangements” to ensure doctors only prescribe generics.
The IMA, however, said such a proposition is not practical for the country.
“India’s drug ecosystem is simply not ready for it,” said Nayak.
A letter to Mandaviya dated 21 August 2023 — co-signed by Nayak and IMA president Dr Sharad Kumar Agarwal — said the clause proposing a penalty for failure to prescribe generic medicines is a matter of great concern for the association since this directly impacts patient care and safety.
It is believed that less than 1 percent of the generic drugs manufactured in India are tested for quality, said the letter, adding that patient safety is non-negotiable for both the government and the medical profession.
The letter stated that while the World Health Organization and Schedule M of the Drugs and Cosmetics Act, 1947, provide for the bioequivalence (BE) and bioavailability (BA) study of a drug to the innovator product to prove its safety, clinical efficacy equivalence and compliance with good manufacturing practices (GMP) on a continuous basis for sustainable supply, only a few categories (of medicines) currently need BA/BE study.
“All generics may not be bioequivalent,” it pointed out, adding that “testing some samples of a batch does not provide assurance of the product quality and safety”. “Batch to batch reproducibility and stability of the product is possible only through a comprehensively designed Quality Management System in a company complying to current GMP standards,” it added.
Dr Rajeev Jayadevan, a Kerala-based IMA member, noted that many off-patent medicines are “sold in India by numerous manufacturers as branded generics”. Despite recent progress, he added, there is still substantial variation in quality among individual manufacturers making the same product in India and quality checks are far from universal.
As a result, rather than just the generic name, doctors prefer to write the actual name of the product that they believe is of the highest quality and has worked for their patients over years of practice, he said.
Jayadevan also emphasised that if only a generic name is mentioned in a prescription, without specifying the brand of the product, the patient is at risk of receiving a low-quality product from the pharmacy.
The reason, he said, is that among multiple available versions of the same product, the sale will be influenced by the highest profit margin rather than quality, reputation or patient feedback on the product.
The NMC, explaining its reason for asking doctors to prescribe generics, has said that India’s out-of-pocket spending on medication accounts for a major proportion of public spending on healthcare.
“Further, generic medicine are 30 to 80 percent cheaper than branded drugs. Hence, prescribing generic medicine may overtly bring down healthcare costs and improve access to quality care,” the NMC regulations said.
Meanwhile, the IMA’s letter to Mandaviya also said that the onus lies on market forces rather than the medical profession. “Market forces rather than the profession will determine the choice (of medicine),” it said.
Its views have been echoed by some groups advocating patient safety. “I believe that patient safety and medicine quality are paramount and should be entrusted to registered medical practitioners, who remain custodians of their patients’ health and accessibility,” said Bejon Kumar Misra, founder of Hyderabad-based Patient Safety & Access Initiative of India.
‘Baby step towards eventual debranding’
Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN), which works to increase access to and improve the rational use of essential medicines, said the NMC regulations are a positive change towards changing the culture in the medical fraternity and introducing more rational prescribing. “It would be a baby step towards eventual debranding of medicine in India, which is still a long way away,” Aisola told ThePrint.
She added that there exists a “very cushy ecosystem in which doctors and pharmaceutical companies function, which thrives on promotion based on inducements to doctors”. The branding of virtually all medicines sold in India, said Aisola, contributes to the making of an ecosystem where there is essentially no competition among companies on the basis of price.
Companies influence doctors by offering inducements, commissions and incentives to prescribe these drugs, she said. “The companies have also been consistently introducing useless or worse, unsafe combinations to drive sales based on differentiating their products from other firms.”
Aisola added that the NMC regulations can “bring about some positive change in the prescription culture where, on many occasions, irrational fixed-dose combinations (FDCs) are prescribed”. “Doctors will be more conscious of what they are asking their patients to consume,” she said.
In any case, Aisola added, the latest regulations clearly say that in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice (of prescribing only generics) can be relaxed.
She, however, also said the country may not be ready for pure generic prescriptions (without mention of any brand names), because the government is yet to put in place required policies and regulatory efforts.
According to Aisola, there are three areas the government and regulators need to look at — weeding out unscientific FDCs and not granting approvals for new irrational/hazardous/unscientific FDCs, lack of quality assurance for generic drugs due to weak regulatory system and enforcement, and lack of any law to regulate pharmaceutical marketing and promotion practices.
Dr Anant Phadke, founding member of the Alliance of Doctors for Ethical Healthcare, said it is logical for doctors to use generic names in prescriptions since their training is carried out in and involves scientific literature that uses these very same generic names.
According to him, the claim that only branded medicines have assured quality is a myth “propagated by big pharma companies through their high-expenditure propaganda”.
“But national drug surveys done on thousands of samples collected from retail chemists across India and subjected to lakhs of tests have repeatedly shown that, during the last 10 years, the proportion of ‘not standard quality or NSQ’ medicine is less than 5 percent,” he said.
Advocating for this number to be brought down to almost zero, Phadke said that, in the absence of this quality assurance, the narrative that only branded medicine have assured quality has acquired some credibility because the Indian drug regulatory system doesn’t ensure that all medicines in the market, irrespective of company, are of assured quality.
(Edited by Amrtansh Arora)
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