India Pharma Industry Floats Ombudsman As Way To Curb Unfair Marketing Practices
This article was originally published in PharmAsia News
Executive Summary
Indian industry pushes for self-regulation in effort to ward off new regulations.
MUMBAI – Amid mounting criticism of unfair practices to lure doctors and generate prescriptions, the Indian pharmaceutical industry – mostly divided between Indian and global drug makers – may cut their differences and set up an independent ombudsman to act on grievances filed by any individual or agency. If the government approves the idea, the ombudsman would become operational within three months.
Prominent industry representatives drawn from the Indian Pharmaceutical Alliance, the Organization of Pharmaceutical Producers of India and the Indian Drug Manufacturers Association, along with key members from the Medical Council of India, were summoned today by Indian government officials to discuss ways to regulate industry practices. The government side was represented by senior level bureaucrats from the health ministry and the National Pharmaceutical Pricing Authority.
Self-Regulation Or Binding Laws?
An important suggestion by government representatives, and one which formed the basis of discussions, is to make the Uniform Code of Pharmaceutical Marketing Practices (a voluntary set of standards) mandatory for drug firms operating in India (See: Uniform Code).
But the industry could for now avert binding rules and punitive action. As an alternative, IPA advocated setting up an ombudsman – a suggestion that could be seconded by IDMA. However, OPPI, which represents global pharma companies, has asked for more time to share its views on an independent ombudsman and its potential powers.
IPA drew inspiration for an independent ombudsman from a model followed by Indian media, which has a self-regulatory mechanism.
According to an industry source, IPA drew inspiration for an independent ombudsman from a model followed by Indian media, which has a self-regulatory mechanism under the aegis of the Press Council of India.
Notably, last May the government floated a set of draft marketing guidelines with a rider that industry actions will be reviewed after six months. But the draft also said, “If it is found that it has not been implemented effectively by the pharmaceutical associations or companies, the government would consider making it a statutory code.”
The code, still under discussions, is a set of guidelines that restricts companies from doling out expensive gifts or extending advantages or benefits to physicians or even suppliers. For years, Indian regulators have pleaded with industry to adhere to a set of self-regulated standards (Also see "Indian Regulators Warn Companies Against “Unethical Promotion” Of Drugs To Doctors" - Scrip, 19 Jan, 2009.).
Reckless Race
Although it could not be confirmed directly from government sources, it is learned that the health ministry has come under tremendous pressure from the Prime Minister’s Office to implement restrictions to end unfair practices like reckless brand promotions that could lead to higher drug prices.
Brinda Karat and Jyoti Mirdha have been named in local media as the two most vocal parliamentarians pushing for tighter controls against illegal industry practices. Karat is a well-known social activist and a member of India’s Communist Party, while Mirdha, a physician, is a member of the ruling Congress Party and is active on healthcare issues.
PharmAsia News spoke to two senior officials in medium-sized Indian companies who maintained that many companies were indulging in wrong practices to attract prescriptions. One executive, however, informed that over a period of time the practice of gifting has slowed, but many large companies are routinely taking doctors and their families to international holiday locations under the label of international medical conferences or continuous medical education or CME.
Another executive said large companies are under pressure for higher returns on investment, and he questioned if the spiraling spend on doctors could be sustained. While well-known medical experts in India’s metropolitan areas are generally lavished with trips to various international conferences, doctors in India’s rural markets are often lured by gifts or monetary benefits, the executive added.