Introduction:
The Central Government has banned the manufacture, sale, and distribution of all oral Nimesulide formulations above 100mg given on an immediate-release basis, effective today. This is under the Drugs and Cosmetics Act, 1940, based on expert advice by the Drugs Technical Advisory Board (DTAB).
What is Nimesulide?
Nimesulide refers to a non-steroidal anti-inflammatory drug and was commonly applied in the treatment and management of conditions such as:
• Acute
• Osteoarthritis
• Dysmenorrhea
• Aching in
The medication prevents the activity of cyclooxygenase-2 (COX-2) enzymes that cause inflammation and pain in the body.
Why the Ban?
The Central Government has expressed concerns over the safety of high-dose Nimesulide, particularly in immediate-release oral formulations above 100 mg. Key reasons for the ban include:
- Risk to Human Health: Multiple studies have indicated that higher doses of Nimesulide are associated with hepatotoxicity (liver damage), gastrointestinal bleeding, and other serious adverse effects.
- Availability of Safer Alternatives: There are several other NSAIDs and pain management options available that offer similar efficacy with a lower risk profile.
- Public Interest and Safety: Given the potential for misuse and overdose, the government has acted in the larger interest of public health.
What Patients Should Do:-
- Do not stop medication suddenly without consulting your doctor.
- Ask your healthcare provider about safe alternatives like paracetamol, ibuprofen, or lower-dose Nimesulide.
What This Means:-
- Patients: Switch to safer pain management options.
- Manufacturers & Sellers: Must immediately stop production and sale of affected Nimesulide pills.
Conclusion:-
This regulatory action highlights the government’s proactive approach to drug safety and public health. While Nimesulide remains an effective pain-relief option at safer doses, high-dose immediate-release formulations are now off-limits in India. Patients are encouraged to stay informed and consult healthcare providers for guidance.
Disclaimer: This is an effort by Lexcomply.com, to contribute towards improving compliance management regime. User is advised not to construe this service as legal opinion and is advisable to take a view of subject experts.