Shares of several pharmaceutical companies are likely to remain in focus after the Ministry of Health and Family Welfare (MoHFW) banned the manufacture, sale and distribution of oral Nimesulide formulations above 100 mg in immediate-release dosage form, citing potential risks to human health. The decision, notified on December 29, has come into effect immediately.
Nimesulide is a widely prescribed non-steroidal anti-inflammatory drug (NSAID) used for pain, inflammation and fever in adults. It is sold under popular brand names such as Nise, Nimulid and Nicip, along with several fixed-dose combinations.
What has been banned?
As per the government notification, the restriction applies to:
- All oral Nimesulide formulations above 100 mg
- Immediate-release dosage forms only
- Human use
Lower-dose formulations of 100 mg or less and other permitted forms are not covered under this ban.
Why did the government act?
The MoHFW stated that high-dose immediate-release Nimesulide formulations are “likely to involve risk to human beings”, adding that safer alternatives are available. The move follows recommendations from the Drugs Technical Advisory Board (DTAB) and has been issued under Section 26A of the Drugs and Cosmetics Act, 1940.
Health authorities have long raised concerns over hepatotoxicity (liver toxicity) associated with Nimesulide, particularly at higher doses.
Previous curbs on Nimesulide
- Use of Nimesulide in children below 12 years was banned earlier.
- In February this year, the government also prohibited Nimesulide for animal use.
- The latest step extends regulatory scrutiny to high-dose adult formulations.
Pharma stocks to watch
Several listed drugmakers manufacture or market Nimesulide either as standalone products or in combinations. Stocks likely to be tracked by investors include:
- Dr Reddy’s Laboratories
- Cipla
- Sun Pharmaceutical Industries
- Abbott India
- Alkem Laboratories
- Torrent Pharmaceuticals
- Lupin
The ban may lead to withdrawal or reformulation of high-dose products, while companies may continue to sell lower-dose versions where permitted.
What does this mean for patients?
Authorities have advised patients not to stop medication abruptly and to consult doctors for alternative pain-relief options. Physicians are expected to shift prescriptions toward safer substitutes where required.
With the regulatory action now in force, pharmaceutical stocks linked to Nimesulide formulations are expected to see heightened investor attention as markets assess the business and compliance impact.
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