Close to a fortnight ago, an evening communication from the Government gave details of a search and seizure operation at a Bengaluru-based pharmaceutical company. An exercise that revealed “substantial ïncriminating evidence”, including unethical practices and freebies to medical professionals, the note alleged. The quantum of such freebies was estimated at ₹1,000 crore.
The pharmaceutical company Micro Labs is maker of the popular brand Dolo that had virtually become the paracetamol of choice for doctors and people during the multiple waves of Covid-19.
“The initial gleaning of the evidence has revealed that the group has been debiting in its books of account unallowable expenses on account of distribution of freebies to the medical professionals under the head “Sales and Promotion”. These freebies included travel expenses, perquisites and gifts etc. to doctors and medical professionals for promoting the group’s products under the heads “Promotion and Propaganda”, “Seminars and Symposiums”, “Medical Advisories” etc. The evidence indicates that the group has adopted unethical practices to promote its products/ brands,” said the Finance Ministry note on the Income Tax Department’s action.
Need for ethical marketing code
While the investigation continues, the strongly-worded Government communique spotlights the much-needed ethical marketing code to define boundaries for drugmakers, to prevent freebies from being masqueraded as product-related or educative material, for instance.
In fact, the Department of Pharmaceuticals has a ‘Uniform Code of Pharmaceuticals Marketing Practices’ (UCPMP) introduced on January 1–2015 as a voluntary practice, which was to be reviewed after six months. Seven years on, as corruption cases continue to get reported, several health experts say, this code needs to be made mandatory. Earlier this year, the Supreme Court too weighed in on the issue, following a petition at the Court.
The discomforting truth is that the latest incident comes barely a month after another corruption-related case hit the headlines, allegedly involving senior representatives in the drug regulatory authority and top industry officials, in a clinical trial-linked waiver. In late-June, the Central Bureau of Investigation had arrested the Joint Drug Controller and top representatives with companies—Bioinnovat Research, Synergy Network and Biocon Biologics—in this case.
It’s not the first time an alleged nexus between pharmaceutical companies, regulators or medical professionals, has come to the fore. But industry-watchers urge representative associations to push for an ethical marketing code to stem the rot from eroding the image of the industry and medical practitioners.
Responding to why the Indian Medical Association (IMA) has been silent on the recent case allegedly linking the paracetamol-maker to some medical professionals, its national president Dr Sahajanand Prasad Singh said, they have called for an internal enquiry. Action would be taken once these reports are in, he said, adding however, that Dolo, in fact was an effective drug, priced on par with top competitors.
Ravi Wankhedkar, treasurer with the World Medical Association and former IMA President pointed out that a stringent ethical marketing code needed to be brought in for the pharmaceutical industry. And, it needs to be mandatory, he says, pointing to developed countries that have such standards covering both industry and medical practitioners.
The recent incidents reflect several concerns on the promotion of products (medicines in this case) to pharmacists, doctors and consumers, and the levels to which this practice goes to ensure more prescriptions and profitability, says an industry-insider and regulatory expert who did not want to be named.
At the core of both cases, there are corporate governance and statutory concerns that need to be addressed, he added. While corporates have governance rules, whistle-blower policies etc, more needs to be done to codefy practices, so that the voluntary code gets “hardwired” into the system to ensure transparent functioning, he points out.
Funding of continuous medical education, for instance, is done through the associations, says one doctor. And the practice of corporate gifting to the distribution channel and medical professionals is less rampant, adds an industry insider.
However, it finally comes down to individual behaviour and implementation of rules. And that’s where a mandatory ethical code will make it that much more difficult to indulge in such practices, they said, batting for a mandatory framework.