Doctors tell the Central government to stop making them look like criminals, call for ensuring generic-drug quality, availability, and knowledge.
Doctors tells government to stop making them look like criminals, first ensure quality,availability, knowledge of generic drugs is in place! (wikimedia commons)
The recent notification by the National Medical Commission (NMC) urging doctors to prescribe generic drugs has ignited a debate over the feasibility of such a significant shift in India’s healthcare system.
While the intent behind the move — to reduce healthcare costs and enhance access to quality care — is laudable, several complex challenges appear to threaten the smooth implementation of the directive.
On 2 August, the NMC released a comprehensive set of guidelines aimed at reshaping prescription practices.
It mandated that registered medical practitioners prescribe medications using “generic”, “non-proprietary”, or “pharmacological” names.
This approach, the NMC said, would ensure transparency and promote the use of cost-effective alternatives.
The guideline also mentioned punitive measures against those violating the directive.
A doctor would be warned to be careful about the regulations or instructed to attend a workshop or academic programme on ethics, personal and social relations, and/or professional training.
The regulation also warned of suspending the licences of repeat violators for a specific period.
The NMC guidelines have also worried the Indian Medical Association (IMA), the apex body of Indian medical professionals. It felt the decision would directly impact patient care and safety.
IMA, while criticising the NMC’s hasty decision, termed the promotion of generic drugs “running trains without tracks”.
The association asserted that the ethical responsibility of prescription should remain with the medical practitioner rather than be shifted to pharmacists or chemists.
It warned against compromising patient care for the sake of cost-cutting and emphasised the importance of genuine promotion of generic drugs.
In a statement, the IMA highlighted the inconsistency of allowing branded drugs to be licensed while preventing doctors from prescribing them. It called for a quality-centric approach, suggesting that licences should solely cover generic drugs to ensure patient safety.
The association also called for a balance between making quality brands available and empowering doctors to make informed prescription choices.
Raising concerns over the uncertainty surrounding the quality of generic drugs due to weak quality control measures in the country, the association demanded transition to generic drugs be postponed until the government could guarantee the quality of all drugs in the market. “Patient care and safety are non-negotiable,” the IMA said.
In response to NMC’s insistence on generic prescriptions, the IMA proposed a unified approach where all pharmaceutical companies manufacture drugs without brand names, thereby eliminating the need for brand-specific prescriptions.
The association underscored that this shift should be accompanied by stringent quality checks on generic drugs, or else the responsibility should lie with the NMC and the government.
The IMA also called for the deferral of the regulation for wider consultations by the government of India, emphasising the need for a comprehensive and considered approach. The association demanded the urgent intervention of the Union government and NMC in this matter.
IMA Press Release dated 14.08.2023 pic.twitter.com/QX3y5YmxDJ
— Indian Medical Association (@IMAIndiaOrg) August 14, 2023
The NMC stated that India’s out-of-pocket spending on medications accounted for a major proportion of public spending on healthcare.
“Generic medicines are 30-80 percent cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care,” the NMC notification said.
The commission clearly distinguished generic medicines and branded generic drugs.
“Generic medicines are defined as drug products that closely match brand/reference listed products in various aspects such as dosage form, strength, route of administration, quality and performance characteristics, and intended use,” the council said.
“Branded generic drugs, on the other hand, are formulations that have come off patent and are produced by different companies under distinct brand names,” the guidelines said.
In simpler terms, it referred to the name of the main chemical ingredient in the tablet or injection.
The guideline also said that doctors should prescribe generic medicines available in the market and accessible to patients.
It may be noted that generic drugs are available at the Jan Aushadi Kendras and other generic pharmacy outlets. The NMC guidelines asked doctors to encourage patients to purchase from these outlets.
Doctors said they were concerned about drug quality, patient trust, accessibility, regulatory clarity, industry influence, and the need for additional education.
One significant concern stemmed from doctors’ apprehensions regarding the quality and efficacy of generic medicines.
While regulatory bodies have been striving to maintain standards, there was a certain degree of scepticism among medical practitioners about the consistency and reliability of these alternatives.
Doctors, holding the patient’s well-being as their utmost priority, expressed fear that prescribing medications with potential variances in effectiveness might compromise treatment outcomes.
Speaking to South First, nephrologist and transplant physician at the Bengaluru-based Trustwell Hospitals, Dr Arvind Canchi, offered a thought-provoking analysis of the NMC’s endorsement of generic medicines.
Emphasising the importance of maintaining consistent quality, Canchi acknowledged the potential benefits of generic drugs, but raised critical questions about their efficacy and reliability.
“The problem with the use of generic drugs is that the quality of these drugs should be equal in all respects,” explained Canchi, who is also the chairperson of the Indian Society of Nephrology Social Media Team.
He emphasised that the equivalence extended beyond mere cost considerations, encompassing factors such as absorption, drug content, and overall quality.
For generic drugs to be considered viable, they should meet rigorous standards across brands and remain comparable to their branded counterparts.
Canchi’s concern was not merely theoretical. He explained that while generic drugs might present an affordable and easily accessible solution, they should adhere to established standards to ensure efficacy and reliability.
“This is particularly pertinent in cases where patients are reliant on consistent drug potency for life-saving treatments,” he said.
Drawing upon his expertise, the nephrologist provided a real-world example in the context of kidney transplant patients. He explained doctors’ complexities when choosing between branded and generic drugs for immunosuppressive regimens.
The efficacy of these drugs would directly impact the success of a transplant, making the need for consistent quality and potency paramount.
“What if a patient is currently prescribed branded medication, such as Neuoral (cyclosporin), Pangraph, Prograph (tacrolimus), or Celcept (mycophenolate mofetil)? Are various other generic options available? If there is a reliable method to measure the drug content within the capsule and ascertain its effectiveness with the generics, then the generics could be considered for use,” he said.
In cases where quantification and assurance of efficacy were lacking, and if a patient opted for a generic medication with uncertain efficacy, there would be a risk of compromising the transplant kidney’s well-being, he explained.
The disparity between the effects of the generic drug and the established branded drug underscored a critical consideration that demanded thorough contemplation and decision-making.
Canchi posed a poignant question: “What about impurities within the generics?” He stressed the necessity for robust guidelines and testing mechanisms to monitor the content and efficacy of generic drugs.
While acknowledging the potential benefits of cost-effective alternatives, he also said that the Central Drugs Standard Control Organisation (CDSCO) and Drug Controller General of India (DGCI) must establish stringent protocols to ensure patient safety.
The nephrologist’s concerns extended to critical care scenarios as well. Canchi outlined scenarios where doctors treat life-threatening conditions such as sepsis. In such instances that call for swift action, the reliability of a drug would be of paramount importance.
The consequences of inadequate or uncertain drug efficacy could prove fatal, placing the onus on medical practitioners.
Private Hospitals And Nursing Association (PHANA) former president Dr Prasanna HM raised another concern.
“It is impossible to implement this guideline as long as 100 percent of our drugs have passed the quality standards, while 90 percent of generic drugs in India have failed the test,” he pointed out.
Prasanna said patients would be at the mercy of pharmacists. “The chemist will be deciding the medicine or brand,” he said.
Raising similar concerns, former IMA Cochin chapter president Dr Rajeev Jayadevan illustrated the point, drawing from his experience in several countries.
“Take the United States, for instance. When I prescribe a generic medication there, I am assured that the patient will receive a pill containing the precise compound in the correct quantity and format, optimised for effective absorption, devoid of any contaminants. This eliminates the need for me to specifically seek a trustworthy brand,” he said.
To further illustrate the point, he cited the example of shopping for a mobile phone. “While one could opt for a cheap phone from an unknown manufacturer, most buyers would prefer a reliable phone that doesn’t fail during times of need. That’s why people gravitate towards manufacturers known for producing durable, high-quality phones,” he said.
“Similarly, in developed nations, strict quality control measures and penalties for deviations from standards ensure that all available medicines — whether over-the-counter or prescription — adhere to the same rigorous standards. Unfortunately, such uniformity is not a reality in India,” he added.
“When a patient seeks my expertise, my concern is about their swift recovery. Subsequently, the medications I prescribe must meet the highest standards to yield the desired outcomes. However, in India, the certainty of a universal quality seal, which guarantees consistent standards for all medications does not exist,” he further said.
Jayadevan emphasised that once such an assurance mechanism has been put in place, medical practitioners would readily embrace generic prescriptions, streamlining the decision-making process by obviating the need to recall an array of brand names.
Dr Rohan Krishna, president of FAIMA (Federation of All India Medical Association) took to X, after finding the NMC directive comical.
He pointed out a glaring incongruity: Despite the NMC guideline mandating the prescription of generic drugs, these drugs were rarely available in government hospitals.
Krishna also pointed at a fundamental premise: If the doctors were to be penalised for not prescribing generic drugs, then the onus would lie on the government to ensure the availability of these medicines.
Docs to be punished for not writing generic medicines???
Punished???
A doc undergoes minimum 10 yrs of aggressive training before he earns d ryt to prescribe medicine.
99.99 % of docs r honest and have no relationship with pharma companies whereas there is a big question mark… pic.twitter.com/lUUptHZumk— Dr. Rohan Krishnan (@DrRohanKrishna3) August 13, 2023
He also shed light on the collaborative arrangement between private companies and the government for the production of these medicines.
However, this collaboration has not been without concerns. Questions have been raised over the quality of these drugs. There were instances of substandard drugs reaching the patient.
Krishna also raised an important query. “Is it fair to hold doctors accountable and penalise them for not prescribing generic medicines, especially when there are legitimate doubts surrounding the quality and effectiveness of these drugs?” He also questioned why the doctors were being made to look like criminals.
The clause to initiate punitive measures has surprised the doctors. Krishna emphasised the rigorous and prolonged training that doctors undergo before prescribing medicines. This background underscored the professional integrity of the majority of doctors, maintaining an ethical distance from pharmaceutical companies.
On the flip side, doctors were apprehensive of the quality of generic drugs produced by private companies and the transparency of the tendering process.
Another renowned transplant nephrologist from Aster Hospital, Dr Sundar Sankaran, said, “As a transplant nephrologist I am not sure if this is a wise decision.”
He called for a wider discussion on the issue and a fresh set of guidelines.
As a Transplant Nephrologist, I am not sure if this is a wise decision
In my experience in Transplant the therapeutic window of the Life saving drugs like Tacrolimus and cyclosporine are low and all generic brands are not same
It will now be pharmacies deciding the generic brands… https://t.co/8E691kiCiZ— Sundar Sankaran (@sundar_s1955) August 13, 2023
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