New Delhi: A high-level government panel set up to review the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in India has recommended that pharma associations should disclose the money they spend per doctor in conferences. As an addition to the existing UCPMP, it has also suggested that doctors cannot be given brand reminders, where the value exceeds Rs 1,000 per item, ThePrint has learnt.
Brand reminders are free products often offered to doctors by marketing representatives of pharma companies with names of popular medicinal brands.
The guidelines (modified UCPMP, according to the panel’s recommendations), however, should remain voluntary in nature, though its implementation should be strengthened, the panel headed by Dr V.K. Paul, federal think tank Niti Aayog’s member (Health), has said in a detailed report submitted to the government last month. ThePrint has seen the recommendations made in the report.
According to the recommendations made by the five-member panel, amounts received for “permissible research” by doctors from pharma companies should be taxable, while the drugmakers themselves will get tax exemption on the amount spent on research activities.
The UCPMP, first notified in 2015, draws lines of “ethical relationships” between medical professionals and drugmakers. These codes are voluntary in nature, with the implementation being watched by the Ethics Committee for Pharma Marketing Practices (ECPMP) — a panel constituted by the pharma associations. The penalty, in case of a company found violating the prescribed ethical guidelines, is suspension from the association.
In addition, The Indian Medical Council Act, 1956 (Professional conduct & ethics) regulations, 2002, applicable to doctors, also define the terms of engagement between doctors and pharma companies
The Centre had in 2022 constituted the five-member committee under Paul to review the code following a notice from the Supreme Court last year. The other members of the committee included the secretaries of health and pharma departments and officials from the Central Board of Direct Taxes and Department of Personnel.
The Supreme Court notice came in a case filed by the Federation of Medical & Sales Representatives Association of India (FMRAI) in 2021.
Through the case the Federation had petitioned that there should be statutory code to guide marketing practices by drugmakers, as owing to voluntary nature of the existing code, there are “ever-increasing instances of unethical marketing practices by pharmaceutical companies in their dealings with healthcare professionals is resulting in prescription of excessive and/or irrational drugs and a push for high-cost and/or over-priced brands..”.
The petition, a copy of which is with ThePrint, had also argued that there are abundant examples that show how corruption in the pharmaceutical sector endangers positive health outcomes.
“Whether it is a pharmaceutical company directly bribing a doctor for prescribing its medicines irrationally and/or irrespective of a health need or providing an indirect advantage to a healthcare professional for the same reason(s), it is the patient’s health that is put at risk,” it said.
The petition added: “As violations of this kind have become a recurring phenomenon and are progressively becoming more pervasive, the petitioners pray that a statutory code of ethical marketing for the pharmaceutical industry with penal consequences be established to curb such practices for the enforcement of the fundamental Right to Health of the people of India.”
Talking about the recommendations of the five-member panel, Paul told ThePrint that the panel had submitted the report to the government and now it was for the government to consider it. He, however, refused to elaborate on the observations and suggestions in the report.
When contacted, Arunish Chawla, secretary, department of pharmaceuticals (DoP), said that the department was reviewing the report and the first step involved analysing what came under its purview and what needs to be done through the National Medical Commission (NMC) — a regulator for doctors in India.
“We will then take the next step,” he said.
ThePrint has also reached NMC spokesperson Dr Yogender Malik over text message for his response to the recommendations, the report will be updated when a response is received.
While pharma associations have welcomed the effort to review the existing guidelines, the recommendations made by the Paul-led panel have drawn criticism from both representatives of rights organisations and medical practitioners, albeit for different reasons.
ThePrint looks at some of the key recommendations made, and the reactions to them.
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Complaint redressal audit, transparency in medical conferences
While maintaining that gifts of any nature to medical professionals by pharmaceutical and medical device companies should not be allowed, the panel has permitted pharma companies to give brand reminders and free samples to doctors.
Value of brand reminders, however, should not be more than Rs 1,000 per item and it should be transparently disclosed through labeling, added the report. Also, brand reminders to medical practitioners should be treated as income for medical practitioners, the panel has recommended.
Tax deducted at source (TDS) would be deducted by the pharma company giving these brand reminders, when the value exceeds Rs 20,000 cumulatively in a year, recommended the panel. There is no mention of brand reminders in the existing UCPMP even though companies are allowed to offer free samples to doctors.
On continuing medical education (CME) by pharma companies, the committee has suggested that conduct of such programmes in foreign locations should be prohibited and engagement of pharma industry with doctors may be allowed both directly and indirectly through a well-defined, transparent, verifiable set of guidelines.
According to the panel’s suggestions, trusts or associations of pharmaceutical companies, including those in association with professional bodies and educational or research institutes may organise such conferences, but the organiser will explicitly spell out the procedure followed in the selection of speakers and participants.
“UCPMP should make enabling provisions for random/ independent audits of CME/CPD [continuous professional development] and may also work out guidance on expenditure by pharma companies permissible per doctor,” the panel has said.
It has added that pharmaceutical companies will need to share the relevant details including the expenditure incurred on their website or on a common website set up by industry associations or government for this purpose
On research, it has said that expenditure on research by the pharmaceutical companies is allowable expenditure subject to the provisions of the Income Tax Act, 1961. But amounts received in the course of permissible research activity from pharma companies will be treated as income in the hands of the doctor and taxable under relevant provisions of the income tax act.
The panel has further suggested that the DoP put in place a common portal for reporting and disclosure by industry associations in respect of implementation of UCPMP in order to facilitate monitoring of effective implementation.
It has also said that ECPMP should be encouraged to engage the services of professional auditors to facilitate better and independent examination of complaints “for arriving at a more informed decision”.
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‘Self-regulation not enough’
Representatives of some patient rights groups meanwhile expressed disappointment that the Paul-LED committee had not acknowledged that the premise of self-regulation, with UCPMP being administered by pharma associations, is fundamentally flawed.
The reaction followed ThePrint sharing the panel’s recommendations with these organisations.
“The code, because it was framed by the industry, is set up in a way to make it unworkable, for instance, action against any company is meaningless and has never been a deterrent,” said Malini Aisola, co-convener of the All India Drug Action Network, an independent network that works to increase access and improve the rational use of essential medicines.
She added: “The most contentious issue of sponsorship of continuing medical education was the reason for putting the NMC conduct norms for doctors [released in August this year] in abeyance.”
The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, first released on 2 August and put on hold within days following protests by the Indian Medical Association (IMA), had said that every registered medical practitioner (RMP) should attend CPD programs regularly each year, totaling at least 30 credit hours every five years.
“Only recognised medical colleges and health institutions or medical societies accredited or authorized by the Ethics & Medical Registration Board under NMC/State Medical Councils can offer training and credit hours for this purpose,” the NMC notification said.
It added that RMPs should not be involved in any third-party educational activity — including CPD, seminars, workshops, symposia and conferences — that involves direct or indirect sponsorship from pharmaceutical companies or the allied health sector.
“But now the latest committee report seems to be legitimising activities the NMC sought to regulate — I feel that the DoP is complicit in perpetuating the nexus between the medical fraternity and companies,” Aisola alleged.
Saying that the new recommendation on disclosure (on cost in organizing CMEs) is a positive step, but it was misplaced in a voluntary code and cannot be enforced, Aisola also stressed that the DoP has the powers to require sufficiently detailed regular disclosures, which should be publicly available, for pharma/medical device firm expenditures.
The idea of a common portal to track the implementation of UCPMP was an eyewash because the code is not functional, she alleged.
On their part, some doctors meanwhile protested the move suggested by the committee to tax them on receiving research grants from pharma companies.
“Why should the government receive tax on research grants? This would be detrimental to the cause of promoting medical research in the country,” said Dr Sharad Kumar Agarwal, IMA president, when ThePrint shared the Paul-led panel’s recommendations with him.
He also said that the government should stay away from micromanaging the terms of engagement between medical professionals and pharma companies, adding that there were enough safeguards in place already to deter any malpractices and many suggestions given by the Paul panel may be “impractical”.
‘Norms for doctors, drugmakers should be in sync’
The Indian Drug Manufacturers’ Association (IDMA) — a group of generic drugmakers in the country — said that they welcomed the government’s efforts to review the existing UCPMP, when ThePrint approached them with the panel’s recommendations.
“IDMA was probably the first association to implement UCPMP at the association level. We have an Ethics committee and an apex committee under UCPMP. We also have the requisite reporting mechanisms,” IDMA president Viranchi Shah told ThePrint.
He however said that while it is good that brand reminders up to Rs 1,000 would be allowed, additional requirements of it being of informative or educational value may bring subjectivity.
“Therefore, this additional requirement may be avoided,” he said.
The Organisation of Pharmaceutical Producers of India (OPPI), a network of multinational drugmakers, meanwhile said that its members are committed to following highest ethical standards in their interaction with healthcare professionals, medical institutions and patient organisations and follow the stringent OPPI Code of Pharmaceutical Practices 2019 that is well aligned to applicable ethical norms in India.
“OPPI has, in the past, worked closely with the government in developing the voluntary UCPMP and is appreciative of the consultative process adopted by the high-level committee under Dr Paul,” says its director general Anil Matai.
He added that the association had provided its detailed comments to the committee and looked forward to working with the government in evolving a mechanism that was mutually beneficial for all — patients, industry, doctors and most importantly, science.
“OPPI hopes that the committee recommendations would enable establishing a regime that is transparent and permits ethical collaboration between the industry and doctors for the purposes of clinical or medical research, continued medical education, faculties or trainers for dissemination of information particularly, in respect of niche therapies remain key to advancement of newer therapies that benefit patients and help in achieving better clinical outcomes and address unmet medical needs,” Matai also said.
He added that the group believed that for better implementation of any ethical code and to enable ease of doing business in India, it was critical that the provisions are clear, unambiguous and most importantly, all ethical codes for the industry are aligned with the code framed for doctors.
The Indian Pharmaceutical Alliance, a body of research-based drugmakers from India, however, refused to comment on the suggestions put forth by the committee.
(Edited by Poulomi Banerjee)
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