Hyderabad, Dec 31 Telangana's Drugs Control Administrationon Wednesday strongly advised people to stop using all oral formulations containing Nimesulide above 100 milligrams in immediate release dosage form, with immediate effect.
The public advisory was issued after the Union Ministry of Health and Family Welfare issued a notification prohibiting the manufacture, sale and distribution of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form for human use, with immediate effect.
Nimesulide, a non-steroidal anti-inflammatory drug, has been under global scrutiny for potential liver toxicity and other adverse effects.
Patients currently using such medicines should discontinue their use and consult a qualified Registered Medical Practitioner for safer and appropriate alternative treatment, Drugs Control Administration's Director General Shahnawaz Qasim said.
He advised people not to purchase, use, or store the prohibited formulations under any circumstances.
This prohibition has been imposed as such formulations are likely to pose a risk to human health, and safer alternative medicines are available.
The Drugs Control Administration is taking necessary steps to ensure that the prohibited products are withdrawn from the market and supply chain across the state. The cooperation of the public is solicited in the interest of public health and safety. In case any prohibited formulation is found being sold or distributed, the public may bring the same to the notice of the nearest Drugs Inspector/Drugs Control Administration office.
The drug was prohibited under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board. The move aligns with efforts to tighten safety standards and phase out high-risk medicines.
Pharmaceutical companies marketing Nimesulide brands have to halt production and recall impacted batches.
The ban is only applicable to high-dose products for human use while allowing lower dose formulations and other therapeutic alternatives to remain available.
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