There is also a planned ban on immediate production, sale and distribution of all the oral preparations of pain and fever drugs containing the Nimesulide above 100 milligrams in immediate release dosage forms. It was decided under Section 26A of the Drugs and Cosmetics Act, 1940 under the recommendation of the Drugs Technical Advisory Board, citing safety considerations to the health of human beings.
As reported by the Health Ministry, using all oral formulations of more than 100 mg of Nimesulide in an immediate-release dosage form is likely to entail a risk to human beings and safer substitute formulation is available. Nimesulide is also a non-steroidal anti-inflammatory drug (NSAID) that has been questioned by the world regarding its liver toxicity and other side effects. The prohibition is in line with the current initiatives by Indian governments to improve safety standards of drugs and retire high-risk drugs in the market.
This limit is limited to high dose doses of Nimesulide preparations that are to be used as human drugs. Alternatives to therapies in low dose forms and other therapeutic options will still remain accessible to patients and such treatment choices will not be seriously affected. Nimesulide-based products Pharmaceutical firms making Nimesulide-based products must discontinue manufacturing of affected batches immediately and begin recalling prior stock distributed.
Market analysts have opined that the effect on the financial performance of the principal drugmakers will not be significant because Nimesulide represents a minor fraction of total NSAID drug sales. Minor companies that depend heavily on high-dose Nimesulide products can however experience pressure on revenues because of the ban.
Section 26A has been used by India in the past to ban various high-risk drugs and fixed doses combination as a measure to safeguard the health of the masses. It has also enhanced domestic pharmaceutical production in the country. The scheme has been named as Promotion of Bulk Drug Parks whereby, over the last three and a half years up to September 2025, 4,763.34 crore has been invested.
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