Delhi based civil society group All India Drug Action Network (AIDAN) has sought intervention of the Chemicals and Fertilizers minister D V Sadandanda Gowda to curb alleged unethical inducements given by pharmaceutical companies to doctors. The group attached a complaint made by a 'whistle blower' from Vishakhapatnam where he accuses the Indian subsidiary of a multinational company of providing direct payments and inducements to doctors in open violation of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) notified by the Department of Pharmaceuticals for voluntary adoption by the industry.
Terming UCPMP as a failure, AIDAN wanted the government to frame a statutory marketing and ethical promotion code for pharmaceuticals and medical device industry.
The move could trigger a fresh round of debate over the need for government intervention in regulating marketing and promotional practices of pharmaceutical and medical device companies in India.
AIDAN's submission on December 7 cited the whistle blower's letter and documents of proof to allege that the MNC had provided inducements to doctors in the form of honorariums for participation in conferences, travel assistance, accommodation, food expenses, and registration fees - all of which are strictly prohibited under the UCPMP as well as the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 for registered medical practitioners.
According to AIDAN, the agreements the company has drawn up with doctors in the guise of consultancy are not only illegitimate and unethical, but also undermine the medical practitioner's autonomy and professional integrity. The agreement called for some rights for the company to suggest and incorporate reasonable tweaks in the presentations, papers or materials the doctor would be presenting at such sponsored events.
The whisle blower A Manmadha Rao stated that the problem was not confined to one company, but was a routine practice continued by the pharmaceutical companies by giving huge money towards pay for prescription under the guise of CME's strategy. He has also listed the names of some medical practitioners who are allegedly hand in glove with the pharmaceutical firms.
"The implementation of the UCPMP has not resulted in reduction of corrupt and unethical practices. Innovative and more sophisticated mechanisms have been evolved for concealing and misrepresenting illegitimate activities, in order to promote their business interests," AIDAN complains.
The civil society group points out that the Government carries out no scrutiny of professional engagements of pharma or medical device companies with medical practitioners or with health institutions to identify corruption or violation of ethical standards. "Similarly, there is currently neither an oversight nor enforcement mechanism with regards wrongful promotional activities involving actors in the supply chain of pharmaceuticals and medical devices such as distributors and agents, retailers, healthcare institutions etc. Moreover, doctors' associations and medical associations remain outside the purview of the UCPMP. This provides a convenient and widely exploited loophole for corruption and unethical practices, aided by the associations," AIDAN's Malini Aisola said in the submission.
The group wanted the voluntary UCPMP to be replaced with a statutory instrument to regulate pharmaceutical and medical device marketing and promotion. It suggested that the regulation should cover all relevant actors (pharma and medical device companies, their agents, medical professions, medical associations and health institutions), and have strong penal and enforcement provisions.
The group also called for an in-depth, thorough investigation into the allegations made by the whistle blower and wanted all pharma and medical device companies to be made to submit records and furnish details of all professional engagements including agreements for professional services since the implementation of the UCPMP (i.e., 2015 onwards) along with details of services rendered and quantum of payments. It called for investigations into the practice of retaining "scientific advisors" by companies, particularly medical devices companies, and wanted the government to ask for detailed records of services rendered and payments.