Abstract

This case discusses the decision of Indian regulators in 2016 to ban 344 fixed dose combination (FDC) drugs and the controversy that followed. On March 10, 2016, the Indian Ministry of Health and Family Welfare notified the ban which would affect about 6,000 brands, citing health risks. Several pharmaceutical companies such as Pfizer, Glenmark, and Workhardt challenged the ban in court, which granted an interim stay on the ban. While the Indian government argued that the ban on FDCs was intended to safeguard public interest, the pharmaceutical companies held that FDCs had been in wide use for a long time and suddenly stopping supplies would cause chaos and result in patients suffering. The issue of the ban on FDCs sharply divided the various stakeholders.

Learning Objectives

The case is structured to achieve the following Learning Objectives:

• Understand the issues, challenges, and health considerations in allowing FDCs to remain in the market.
• Discuss the issues related to drugs regulation in India to safeguard public interests.
• Explore ways in which the government can regulate the FDCs.

Keywords

Business environment, Business ethics, Business law, Pharmaceuticals, Patient adherence, Public health and safety