As the government works on finalising a policy to cap margins taken on medicines and medical devices across the supply chain, a group of civil society bodies have said that the move alone will not help make these products affordable.
The bodies have written to Minister of Chemicals and Fertilizers DV Sadananda Gowda, calling for a statutory code to prevent corruption and unethical marketing practices in these industries.
“We … submit that TMR (trade margin rationalisation) regulation will not be successful as an isolated policy. The government must bring a statutory instrument for legal oversight of marketing and promotion of pharmaceuticals and medical devices,” stated the group consisting of the All India Drug Action Network (AIDAN), Third World Network (TWN), Partners in Change, Praxis: Institute for Participatory Practices and Prayas, Rajasthan.
The group, in its letter dated December 7, claimed that “numerous” instances of “corrupt” promotional activities and “failure” of the industry to self-regulate using the Department of Pharmaceuticals’ (DoP) Uniform Code of Pharmaceutical Marketing Practices (UCPMP) have been brought to the government’s attention.
The UCPMP is a code of marketing practices for the Indian pharma industry which was to be voluntarily adopted and implemented from January 1, 2015.
The code was to be reviewed after a period of six months and, if it was found not to be implemented effectively, the code stated that the government “may” consider making it a statutory code.
“We are dismayed that, in spite of repeated requests, the government has not brought out a statutory code, which we can only presume is due to pressure against such an initiative from the pharma industry lobby,” stated the group in its letter to the Minister.
The patient groups asked DoP to “immediately” replace the voluntary UCPMP with a statutory instrument to regulate pharmaceutical and medical device marketing and promotion.
This regulation should have “strong” penal and enforcement provisions and cover “all relevant actors”, including pharma and medical device companies, their agents, medical professions, medical associations and health institutions, demanded the group in its letter.
“Care must be taken specifically to ensure escape routes are closed for companies to organise the same unethical practices in a ‘legitimate’ way,” it stated.
The activist bodies have further alleged that TMR as the primary form of regulation is “inadequate” to meet the government’s objective of affordability for critical medical devices and is also “poorly adapted to addressing secondary objectives of curbing profiteering and corruption.”
The letter to the minister follows a recent study on promotional practices of India’s pharma industry by Arun Gadre and Archana Giwate of Pune-based public health group SATHI.
The study, which focussed on interviewing medical representatives, stated that trends in promotional strategies have changed from providing scientific information to doctors to “only focussing on generating business by any means”. Its findings also highlight unethical practices such as bribes and, in certain instances, pharma companies catering to demands by doctors for “women for entertainment”.
This study has been opposed by the Indian Medical Association (IMA), which has reportedly asked the Maharashtra Medical Council to take action against the researchers.
“The report contains no generalising or sweeping statements and has quotations from MRs (medical representatives) whom it has interviewed. The report also states that a section of doctors is very ethical,” stated SATHI Monday in response to IMA’s move.