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Case Details

Case Code: LAW007
Case Length: 5 Pages 
Period: 2016-2017    
Pub Date: 2016
Teaching Note: Not Available
Price: Rs.200
Organization :-
Industry : Pharmaceutical
Countries : India
Themes:  -
Case Studies  
Business Strategy
Marketing
Finance
Human Resource Management
IT and Systems
Operations
Economics
Law

Ban on Fixed Dose Combination Drugs in India Stokes Controversy

 

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.
 
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Issues

The case is structured to achieve the following teaching 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.
Contents
INTRODUCTION
EXHIBITS

Keywords

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

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