Several news organisations since Saturday, 12 August, have reported —supposedly quoting the latest National Medical Commission (NMC) guidelines — that:
It's now mandatory for doctors to prescribe only generic drugs instead of branded drugs.
Failure to do so may lead to their licence being suspended for a certain period of time.
The news reports caused an uproar among the medical fraternity, with doctors debating on social media over generic and branded drugs.
But does the NMC notification, released more than 10 days ago on 2 August, listing regulations relating to the professional conduct of registered medical practitioners, actually say that?
"The notification appears to be mainly advisory than instructive," Dr Ashwini Setya, a Delhi-based gastroenterologist, who was part of an advisory panel that looked over the draft of the NMC guidelines, and recommended changes, told FIT.
NMC Didn't Make 'Prescribing Branded Meds Punishable': Why're Doctors Outraging?
1. What's the Controversy?
Doctors, health policy experts, and other medical practitioners were quick to voice their protest against the guidelines that potentially made prescribing branded medicines a punishable offence.
What exactly are generic and branded drugs? According to the NMC:
Generic drug: A drug product that is comparable to brand/reference listed product in dosage, strength, route of administration, quality and performance characteristics, and intended use.
Branded drugs: A drug which has come off patent and is manufactured by drug companies and sold under different companies' brand names.
For example, paracetamol is a generic drug, but when it's sold under different brand names, each of them becomes a branded drug.
The Indian Medical Association (IMA), on 14 August, released a statement urging the government to defer these rules, saying "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."
"What has happened is, somebody has done a story and everybody is responding to it. Nobody has read the guidelines about what the NMC has actually said."
Dr Sumit Ray, Critical Care Specialist, Holy Family Hospital, Delhi told FITExpand2. Branded vs Generic Drugs: What Does the Notification Actually Say?
The notification lays down recommendations for Registered Medical Practitioners (RMP) when it comes to the prescription of generic drugs as opposed to branded drugs (among other things).
It says:
Avoid prescribing 'branded' generic drugs.
Prescribe drugs with “generic”/“non-proprietary”/“pharmacological” names only.
Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug.
"It says that a generic name should be there. Within brackets, you can write the brand names also," Dr Sumit Ray, Critical Care Specialist, Holy Family Hospital, Delhi, told FIT.
The notification also includes other guidelines to encourage the prescription of generic drugs, like:
Advocate for hospitals and local pharmacies to stock generic drugs.
Prescribe only those generic medicines that are available in the market and accessible.
Encourage patients to purchase drugs from generic pharmacy outlets.
Educate medical students, patients, and the public regarding the equivalence of generic medicine with their branded counterparts.
"It says that these are 'guidelines' to the RMPs," adds Dr Ashwini Setya.
The guidlines also mention certain conditions where the advice may be relaxed, like, "In the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed."
"This is very ambiguous," says Dr Setya. "What are exceptional cases? Who will define exceptional cases?"
"It goes on to say 'prescribe only those generic medicines that are available in the market and accessible to the patient'. What if the patient needs the medication which is not available in the market at that point of time? And how can a doctor ensure or check on the availability of that generic medicine in the market?" he adds.
Does NMC Call For Penalties If a Doctor Prescribes Branded Drugs?
As far as the penalties are concerned, there is no explicit mention of punishments for not prescribing generic medicines or for prescribing branded ones.
"There are five levels of punishment mentioned in the guidelines, where levels 4 and 5 involve suspension of the practitioner's license either temporarily or permanently," Dr Setya explains to FIT.
While not mentioning the generic name can lead to an L1 or L2 punishment, the document doesn't mention any level of punishment for also prescribing branded drugs as well.
Speaking to FIT, Dr Aishwarya Yadav, General Secretary, IMA-JDN, Maharashtra, says the reason the IMA has taken out an official statement against the guidelines is so it doesn't create fear and imbalance in the medical community.
"We feel its better to raise voice now before it becomes a mandate," she says.
Expand3. Generic Vs Branded Drugs: Why Does it Matter?
While generic drugs are less expensive, and eliminate the possibility of the RMP being influenced by a pharma company, several valid questions have been raised regarding the push for the prescription of generic drugs over branded ones (even if it's not a punishable offence).
IMA in its statement, for instance, asks:
"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 prescription of doctors of this system."
There is also the question of if not the RMP, does the chemist get to decide which brand of the drug the patient gets?
"This measure is just shifting the choice from a medical practitioner who is primarily concerned, trained and responsible for the patients’ health...This naturally wouldn't be in the best interest of the patient."
Indian Medical Association"A pharmacist may choose to sell them a more expensive brand. The patient often doesn't know about the alternative brands available and ends up just buying what they're given," says Dr Aishwarya Yadav.
"If it was a public health system, where patient doesn't have to pay, and if it is acquired by the Public Health Services (PHS) and given to the patient, it absolutely makes sense," Dr Ray adds. However, that is not how it goes often.
Expand4. The Root of The Problem
A looming issue that many doctors have raised is that not all brands and generic drugs work well, and they are not all of the same quality.
"The biggest impediment to generic drugs is the uncertainty about their 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," the statement from IMA says.
"Less than 0.1 percent of the drugs manufactured in India are tested for quality. This step should be deferred till the Government can assure the quality of all the drugs released into the market."
Indian Medical Association, in a statementDr Setya agrees, adding, "If all drug manufacturers are following the Good Manufacturing Practices (GMPs) and they are all coming under the checks of the Drugs Controller General of India (DCGI), then you know you're getting uniformly quality medicine. But in the absence of that doctors are left to prescribe on the basis of their own trust in brands through experience."
However, this isn't ideal because "It is based on your qualitative judgment. There is no evidence," says Dr Ray.
So essentially, it all boils down to India's long-standing issue of substandard drug manufacturing practices and a lack of strict regulations governing them.
"There needs to be checks and balances but an individual doctor will find it very difficult to assess which brands are good."
Dr Sumit Ray, Critical Care Specialist, Holy Family Hospital, DelhiDr Ray also raises the question that in such a situation where it's left to the discretion of the RMP, how can one be sure of the motivation behind prescribing a certain brand?
"Is this prescribing practice a bias due to the fact that they fund my trips? or do I have evidence to say that they work? An effective, accountable mechanism is the only one that can check this," he adds.
(At The Quint, we question everything. Play an active role in shaping our journalism by becoming a member today.)
Expand
What's the Controversy?
Doctors, health policy experts, and other medical practitioners were quick to voice their protest against the guidelines that potentially made prescribing branded medicines a punishable offence.
What exactly are generic and branded drugs? According to the NMC:
Generic drug: A drug product that is comparable to brand/reference listed product in dosage, strength, route of administration, quality and performance characteristics, and intended use.
Branded drugs: A drug which has come off patent and is manufactured by drug companies and sold under different companies' brand names.
For example, paracetamol is a generic drug, but when it's sold under different brand names, each of them becomes a branded drug.
The Indian Medical Association (IMA), on 14 August, released a statement urging the government to defer these rules, saying "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."
"What has happened is, somebody has done a story and everybody is responding to it. Nobody has read the guidelines about what the NMC has actually said."Dr Sumit Ray, Critical Care Specialist, Holy Family Hospital, Delhi told FIT
Branded vs Generic Drugs: What Does the Notification Actually Say?
The notification lays down recommendations for Registered Medical Practitioners (RMP) when it comes to the prescription of generic drugs as opposed to branded drugs (among other things).
It says:
Avoid prescribing 'branded' generic drugs.
Prescribe drugs with “generic”/“non-proprietary”/“pharmacological” names only.
Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug.
"It says that a generic name should be there. Within brackets, you can write the brand names also," Dr Sumit Ray, Critical Care Specialist, Holy Family Hospital, Delhi, told FIT.
The notification also includes other guidelines to encourage the prescription of generic drugs, like:
Advocate for hospitals and local pharmacies to stock generic drugs.
Prescribe only those generic medicines that are available in the market and accessible.
Encourage patients to purchase drugs from generic pharmacy outlets.
Educate medical students, patients, and the public regarding the equivalence of generic medicine with their branded counterparts.
"It says that these are 'guidelines' to the RMPs," adds Dr Ashwini Setya.
The guidlines also mention certain conditions where the advice may be relaxed, like, "In the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed."
"This is very ambiguous," says Dr Setya. "What are exceptional cases? Who will define exceptional cases?"
"It goes on to say 'prescribe only those generic medicines that are available in the market and accessible to the patient'. What if the patient needs the medication which is not available in the market at that point of time? And how can a doctor ensure or check on the availability of that generic medicine in the market?" he adds.
Does NMC Call For Penalties If a Doctor Prescribes Branded Drugs?
As far as the penalties are concerned, there is no explicit mention of punishments for not prescribing generic medicines or for prescribing branded ones.
"There are five levels of punishment mentioned in the guidelines, where levels 4 and 5 involve suspension of the practitioner's license either temporarily or permanently," Dr Setya explains to FIT.
While not mentioning the generic name can lead to an L1 or L2 punishment, the document doesn't mention any level of punishment for also prescribing branded drugs as well.
Speaking to FIT, Dr Aishwarya Yadav, General Secretary, IMA-JDN, Maharashtra, says the reason the IMA has taken out an official statement against the guidelines is so it doesn't create fear and imbalance in the medical community.
"We feel its better to raise voice now before it becomes a mandate," she says.
Generic Vs Branded Drugs: Why Does it Matter?
While generic drugs are less expensive, and eliminate the possibility of the RMP being influenced by a pharma company, several valid questions have been raised regarding the push for the prescription of generic drugs over branded ones (even if it's not a punishable offence).
IMA in its statement, for instance, asks:
"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 prescription of doctors of this system."
There is also the question of if not the RMP, does the chemist get to decide which brand of the drug the patient gets?
"This measure is just shifting the choice from a medical practitioner who is primarily concerned, trained and responsible for the patients’ health...This naturally wouldn't be in the best interest of the patient."Indian Medical Association
"A pharmacist may choose to sell them a more expensive brand. The patient often doesn't know about the alternative brands available and ends up just buying what they're given," says Dr Aishwarya Yadav.
"If it was a public health system, where patient doesn't have to pay, and if it is acquired by the Public Health Services (PHS) and given to the patient, it absolutely makes sense," Dr Ray adds. However, that is not how it goes often.
The Root of The Problem
A looming issue that many doctors have raised is that not all brands and generic drugs work well, and they are not all of the same quality.
"The biggest impediment to generic drugs is the uncertainty about their 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," the statement from IMA says.
"Less than 0.1 percent of the drugs manufactured in India are tested for quality. This step should be deferred till the Government can assure the quality of all the drugs released into the market."Indian Medical Association, in a statement
Dr Setya agrees, adding, "If all drug manufacturers are following the Good Manufacturing Practices (GMPs) and they are all coming under the checks of the Drugs Controller General of India (DCGI), then you know you're getting uniformly quality medicine. But in the absence of that doctors are left to prescribe on the basis of their own trust in brands through experience."
However, this isn't ideal because "It is based on your qualitative judgment. There is no evidence," says Dr Ray.
So essentially, it all boils down to India's long-standing issue of substandard drug manufacturing practices and a lack of strict regulations governing them.
"There needs to be checks and balances but an individual doctor will find it very difficult to assess which brands are good."Dr Sumit Ray, Critical Care Specialist, Holy Family Hospital, Delhi
Dr Ray also raises the question that in such a situation where it's left to the discretion of the RMP, how can one be sure of the motivation behind prescribing a certain brand?
"Is this prescribing practice a bias due to the fact that they fund my trips? or do I have evidence to say that they work? An effective, accountable mechanism is the only one that can check this," he adds.
(At The Quint, we question everything. Play an active role in shaping our journalism by becoming a member today.)