A regulatory framework to address unethical drug marketing

Highlights

• As far as the state government’s statutory and regulatory framework is concerned, we have a State Drugs Control which is vested with the responsibility to ensure the quality of drugs. And we have Karnataka Private Medical Establishment Act to regulate unethical practices of private medical establishments. The regulation of marketing and promotion of drugs doesn’t come under the purview of the state drugs control department.

• However, allegations of unethical marketing practices in the pharma industry is a matter of serious concern and the Government of India is looking into it. India has a Uniform Code for Pharmaceutical Marketing Practices, formulated to prevent unethical practices by pharmaceutical companies. The code outlines the contours of the relationship between healthcare professionals and pharma companies. However, this code introduced in 2015 is a voluntary code. There have been demands from various organisations, including the Federation of Medical and Sales Representatives’ Associations of India (FMRAI), that it be made statutory.

• “I am confident that the Government of India will soon formulate a requisite regulatory framework to fix the problem of unethical marketing practices including a uniform code on pharma marketing practices in order to curb unethical practices and ensure effective monitoring, transparency, accountability and consequences for violations,” K Sudhakar, state health minister, said.