New Delhi: The health ministry has stated that a committee has been formed to work on the regulatory framework around marketing practices of pharma but, along with the pharmaceuticals department in the chemicals and fertilisers ministry, it has submitted in the Supreme Court that “a robust and effective legislative scheme exists” to regulate unethical practices of pharmaceutical companies.
The government submission in the apex court was in response to a petition filed by the Federation of Medical and Sales Representatives Associations of India (FMRAI). The petition sought regulation of marketing practices by pharmaceutical companies in their dealings with healthcare professionals “resulting in the prescription of excessive and/or irrational drugs and a push for high cost and/or overpriced brands”, which were directly affecting citizens’ health.
The government’s flip flop on regulation in this area has been on since December 2014 when it issued a notification that the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) prepared by the pharmaceuticals department would be complied with by the industry voluntarily for six months starting January 1, 2015, after which it would be made mandatory. In 2016, Parliament was told that the voluntary code “was not working well” and that making it statutory would help control unethical practices. Yet, it was given an indefinite extension and remains voluntary to date.
After widespread consultations with all stakeholders including the pharmaceutical industry, the government brought out draft legislation in 2017 stating that legislation with penal provisions would be more effective than merely converting “a toothless voluntary code” into a mandatory code.
After much toing and froing between the law ministry and the pharmaceutical department on the legislation, in a volte-face, in 2019 the minister of state for health and family welfare stated in the Rajya Sabha that with the voluntary adoption of UCPMP, it was expected that drug promotion was done within ethical boundaries and added that “no instance of an unsuccessful implementation of UCPMP by pharma associations/companies have been noticed by Department of Pharmaceuticals”. In September 2020, the government said in the Rajya Sabha that it had not decided to make UCPMP mandatory.
Six years after flagging the need for legislation as the voluntary code was not working, the health ministry has announced the formation of a “high-level committee” under Niti Aayog’s Dr VK Paul to review the regulatory framework around the pharmaceutical industry’s marketing practices. This comes in the wake of the FMRAI petition in the Supreme Court.
In its response, the government stated that the “existing legal regime consists of multifarious legislations” to cover and curtail such unethical practices. As part of the existing legal regime, it then went on to list the UCPMP, which it had earlier termed as “not working well” and the Ethics Code for doctors, which includes penal provisions for doctors for taking bribes in any form from pharmaceutical companies. However, the ethics code penalises only the bribe taker, the doctor, and not the bribe giver, the pharmaceutical company. The list also included the Central Board of Direct Taxes circular of 2012 that prohibited companies from claiming money spent on incentives and freebies to doctors as a business expense, which was upheld by the Supreme Court.