New Delhi: Relaxed rules for the distribution of free samples and permission for doctors to work at pharmaceutical companies — these are two of multiple tweaks sought by the pharmaceutical industry in the voluntary code of ethics that currently governs marketing and promotions, ThePrint has learnt.
The list of recommendations, accessed by ThePrint, was prepared after the Department of Pharmaceuticals, under the Ministry of Chemicals & Fertilizers, reportedly warned the industry about malpractices and sought suggestions for a revised code that is likely to be mandatory.
The proposal has been prepared by drug firms through the Indian Pharmaceutical Alliance (IPA), a body that represents companies such as Sun Pharma, Lupin, Wockhardt, Dr Reddy’s and Cipla.
The IPA proposal has been floated among pharmaceutical companies for comments. Once approved by all member companies, it will be sent to Department of Pharmaceuticals secretary P.D. Vaghela.
At a review meeting in December, the department had warned companies that continued violations would force them to make the code a statutory provision under law.
The meeting was attended by all drugmakers’ associations, including the IPA, the Indian Drug Manufacturers’ Association (IDMA), and the Organisation of Pharmaceutical Producers of India (OPPI).
The warning followed an NGO’s report that claimed medical representatives, who promote products on behalf of pharma firms, bribe doctors with foreign trips, expensive smartphones and “even female companionship”.
The study by NGO Support for Advocacy and Training to Health (SATHI) also reportedly led PM Narendra Modi to warn pharma companies, at a meeting this month, against offering bribes to doctors while marketing drugs and medical devices.
Patient-rights activists have criticised the IPA’s suggestions as a bid to dilute the code. Approached for comment by email, IPA secretary general Sudarshan Jain said pharmaceutical companies “are committed to the implementation of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP, the voluntary ethics code) and the same is being reinforced in all our discussions with member companies”.
“We are in discussion with member companies regarding our suggestions on UCPMP, as requested by the Department of Pharmaceuticals. We are yet to finalise our recommendations,” he added.
ThePrint has also emailed some of its member associations for comment but was yet to receive any by the time of publishing.
Also Read: Leave phones outside doctor’s chamber: IMA branch after PM’s bribe warning to pharma firms
The existing code
Marketing practices for pharmaceutical companies and the medical devices industry are governed by the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), which was released in 2014.
A voluntary set of guidelines, it seeks to curb gifting and circulation of product samples among healthcare professionals. The code states that each sample pack given to a doctor should be limited to the prescribed dosage for three patients.
The UCPMP adds that “no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers etc”.
‘No signatures for samples’
Suggestions listed in the draft include not requiring recipients to furnish “signatures” for samples.
As it stands, the code asks pharma companies to “supply samples in response to a signed and dated request from the recipient”.
In its proposal for a new code, the IPA says the “existing provisions are impractical and further complicate the subject”.
“Asking for a signed request would be futile, making the whole process highly bureaucratic without adding any value from the patient’s point,” it adds.
Another suggestion is to replace the word “gifts” with “giveaways”, with the companies asking the government to provide “greater clarification” on this matter.
Exempt ‘medical education programmes’
The pharma companies also want the code to exempt “continuing medical education (CME)” programmes in the interest of “patient safety”.
According to the firms, the programmes allow pharma companies to collaborate with doctors and help them update their knowledge, skills and practices through seminars and workshops at domestic or international locations.
“These medical practitioners are busy with their practice and may not get enough time to devote to reading, digesting and clarifying their doubts about advances in medical science,” the proposal writes.
Citing the importance of these programmes for ‘patient safety’, the draft said, “they should be exempt from the purview of the code”.
‘Shift onus of compliance from honchos’
The companies also want the onus of compliance away from their brass.
Under the current code, the managing director or chief executive officer (CEO) of every pharma company is ultimately responsible for ensuring its adherence to the code.
They also have to submit a self-declaration in this regard to the association they are affiliated to, for example, IPA, IDMA, and OPPI. The declaration is then uploaded on the association’s website.
According to the draft, “the self-declaration should be signed by the sales or marketing head of the domestic operations or a member of the executive committee to seek collective responsibility, make more people accountable and ensure effective implementation”.
“The MDs and CEOs of large companies,” it adds, “are not involved in day-to-day operations and hence it is important to keep the responsibility for implementation at an operational level.”
‘Allow doctors to work for pharma companies’
Under a subhead titled “additional recommendations”, the lobby has asked the government to consider allowing medical practitioners to work for pharma companies.
“As per the clause of Medical Council of India (MCI), a medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity,” it says.
“The current UCPMP is silent on this. This needs to be considered,” it adds.
While doctors do work for pharma companies, mostly in research and medical affairs sections, it is seen as conflict of interest if they continue their own practice as well.
Another recommendation is to allow pharma companies to engage with healthcare practitioners for preventive healthcare camps.
Also Read: Pharma group denies PM Modi had warned companies against unethical marketing
‘NPPA should not be involved’
The companies have also suggested that, if the code is made “mandatory”, its implementation and enforcement should come under the department of pharmaceuticals. “Other authorities such as NPPA may not be involved,” it adds.
The National Pharmaceuticals Pricing Authority or the NPPA is the government’s drug price watchdog and functions as an attached office of the pharmaceuticals department.
It functions as an independent regulator for drug pricing. But under the UCPMP, the pharma associations are required to send quarterly compliance updates to the NPPA.
‘Attempt to whittle down code’
The proposal is yet to be submitted to the government, but patient-health activists have decried the provisions suggested.
“The proposal floated by the IPA for comments is nothing but an attempt to further whittle down the already weak clauses of the UCPMP,” said Malini Aisola, co-convenor of the All India Drug Action Network, a group of NGOs involved in ensuring healthcare access to all.
“Most striking is the demand for exemption from regulatory oversight for CME activities, screening camps and doctor’s consultancies with pharma companies — all of which are well known avenues for providing inducements,” she added.
“It also tries to create a fictional separation between any wrongdoing of the company and that of its MR [medical representatives] staff, as if their actions could be without the explicit and implicit approval of his employer,” she said.
Also Read: PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets
This report has been updated with the IPA’s comment