New Delhi: After new guidelines of the National Medical Commission (NMC) came into force through a gazetted notification dated August 2, 2023, various medical associations across India are trying to find ways to organise their conferences to overcome the limitations imposed by the new rules.
The new NMC guidelines prohibit doctors from attending medical conferences, also known as CPDs (Continuing Professional Development programmes), which are sponsored by pharmaceutical companies. However, this prohibition was meant for individual doctors only, and not their associations.
The NMC guidelines said: “Registered medical practitioners (RMPs) should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. RMP should be aware of the conflict-of-interest situations that may arise.”
The Association of Physicians of India (API) held a meeting at 5 pm on August 21. The Wire possesses a copy of ‘conclusive pointers’ which were circulated after the meeting. The API, which according to the website is an association of 20,000 doctors, suggested its members take a different route for organising such conferences.
It said: “[The] Societies/Associations can officially receive money from Pharmas to organise a conference/CPD, but pharma cannot sponsor an individual doctor (any kind of individual sponsorship such as registration, travel, stay for a conference is not allowed).”
A delegation of the Indian Medical Association (IMA) also met Union health minister Mansukh Mandaviya on August 21 evening with a request that this norm be done away with.
Talking to The Wire, IMA president Dr Sharad Kumar Agarwal, said, “How can the doctors keep themselves informed with new knowledge if such conferences are not organised — and for that purpose we need money. Otherwise from where would the money come?”
When asked that there have been documented instances of conflict of interest and corruption linked with pharma-backed conferences, he said, “This is a prejudice and we don’t believe in it…Such words should be avoided.”
Dr Agarwal said the IMA believes that all future medical conferences should be organised by various doctors’ associations – something that the API also mentioned in the pointers, as mentioned above.
Former Punjab Medical Council president and someone who has for a long time tried to highlight the illicit practices of his profession, Dr G.S. Grewal, said that it was wrong to say that if pharma companies stopped sponsorships, the conferences would cease to happen. “We pay for them…each and every delegate is supposed to pay what is known as registration fee.”
Dr Grewal said it was possible that such medical conferences be organised without logistical and monetary support of pharmaceutical companies but sans what he called “lavish lunches in big, five-star hotels”.
“I know of many instances where pharmaceutical companies went on to book air tickets and reserve hotel rooms – let alone paying the registration fee,” Grewal claimed.
The NMC guidelines also said, “[An] RMP himself or as part of any society, organisation, association, trust, etc. make regarding the relationship with the pharmaceutical and allied health sector industry clear and transparent open to scrutiny.”
The API told its members on August 21 that no tax rebates should be sought to avoid scrutiny.
“[The] best way for a Society/Association to avoid any scrutiny is to pay the full tax (as applicable) after its conference/CPD [Continuing Professional Development programme] is done with; do not try to save on tax returns even though the association is registered with the charity Commissioner, as the Income Tax office clearly looks upon the conference/CPD as a commercial activity done in a commercial premises (such as a five star hotel).”
As per the current form of the NMC regulations, if a registered doctor is found violating this norm, s/he is liable to punished as per level 3 of the punishments of the NMC guidelines, which stipulate suspension of licence to practise for a period of maximum of three months after a registration of complaints and inquiry at multiple levels.
Also read: Union Govt Flips Stance, Tells SC ‘Don’t Push for Mandatory Rules to Curb Pharma-Doctor Nexus’
The Union health minister, according to the IMA president, had told the delegation that he would look into the demand, but did not specifically say anything else.
Meanwhile, a couple of medical conferences, whose dates for organisation had been declared, now stand cancelled or postponed due to the NMC gazetted notification. Dr Anirduddha Malpani, a renowned IVF specialist based in Mumbai, shared two such instances on Twitter.
The Bihar chapter of the Cardiological Society of India has postponed the CARDICON-2023, slated to be held in September at Patna’s Hotel Maurya. In a note to its members it said: “…the executive committee has decided that due to the unprecedented development [that has] taken place because of above notification [NMC gazetted notification issued on August 2] Cardicon-2023 is going to be postponed till actual clarification [is] received from National Medical Commission or Cardiological Society of India.”
Similarly, GSICON-2023, which was slated to be held in the last week of August for specialists in geriatric medicine, has been cancelled due to “difficulties to organise it in view of recent guidelines issued by the NMC”, according to its organisers.
Generic drugs
The other issue against which the doctors are up in arms pertains to the prescription guidelines made by the NMC. The guidelines state that doctors should only prescribe generic medicines except in certain circumstances that it has defined.
The NMC guidelines say, “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.” The NMC says doctors should prescribe “generic”, “non-proprietary”, “pharmacological” names only and they should ‘avoid’ prescribing “branded generic drugs”.
Not following the directive would first lead to an advisory being issued to a doctor and/or suspension of licence for a maximum of one month.
A pure generic drug is one which is a copy of an innovator drug – it has no company/brand name mentioned and has only the pharmaceutical ingredients on the label. Branded generic drugs are the ones which are also copies of the innovator drug but have a brand name and are produced when the former has come off patent. They are usually cheaper than the original ones and are supposed to be manufactured without compromising safety and efficacy as comparable to the original drug.
A large number of medical doctors, on various social media platforms, have shown a great deal of reluctance towards the NMC prescription guidelines, saying that due to the lack of enough regulation for ensuring quality in drugs, especially in many branded generic medicines, they tend to ‘trust’ certain brands owing to feedback from their own patients. They cited empirical examples to support this. And the regulation will take away their right to choose the prescription, they say.
However, another section of voices says that while there are scientific studies to say that an innovator brand was more effective than the generics, not every doctor’s feedback is based on such studies because their number is far and few. They bring into the fore the importance of ‘access to medicines’ as generics or branded generics are cheaper than the original drugs.
Nonetheless, the IMA has said that the new notification only puts the ball in the court of the chemist as s/he would decide which drug for the formulation prescribed by the doctor has to be dispensed to the patient — rather than the doctor taking this call – and this wouldn’t necessarily ensure the best interest of the patient.
Dr Grewal called the NMC move on this front ‘dishonest’ if the government’s move was aimed at reigning in exorbitant trade margins against the medicines.
Referring to a report which was submitted by a government-constituted committee in March 2016 on the issue of trade margin rationalisation of drugs, Grewal said the report clearly pointed out that the trade margins could be capped and through which process. “Instead of using measures such as those suggested by the committee and without bringing in necessary drug regulatory overhaul, this step would not be the best thing for patients to happen,” he told The Wire.
The NMC rules can be done away with drugs which are biosimilars, drugs with narrow therapeutic index (NTI) and “and similar other exceptional cases”, according to the guidelines. Biosimilars are those products which are similar to other biologics – medicines made of living entities – unlike other medicines which are chemically similar synthesised and their generic or copied versions can be relatively easily made.
NTI drugs are the ones in which a very small difference in dosage can lead to the drug being rendered ineffective (if present in small amounts as compared to what is said in the label) or becoming toxic (if present in a greater amount). In other words, if doctors are prescribing biosimilars or drugs with NTI, they can prescribe brand names too.
What next?
IMA president Dr Agarwal told The Wire he was “satisfied” with the meeting with Mandaviya because the delegation was “heard patiently” as far as the two demands are concerned, and was told that “the minister would get back after discussing with his team”. The minister didn’t specify any timeline for the purpose, he said.
However, the NMC guidelines were published in the form of a gazetted notification on August 2. On being asked if the minister had agreed to put them in abeyance till his final decision, the IMA president replied in negative. Asked how doctors would need to go ahead in that case, he didn’t specify except for saying, “There was no change in the status [of existence of guidelines] before or after the meeting.”
He said he didn’t wish to speculate on the next course of action by the powerful doctors’ organisation should the minister refuse to pay heed to its demands.
