Govt to amend Schedule-V of D&C Rules to revise 'free salicylic acid' content in drugs containing aspirin
The Union health ministry will soon amend Schedule-V of the Drugs and Cosmetics (D&C) Rules, 1945 to revise the limit of 'free salicylic acid' content for medicines containing aspirin based on pharmacopoeial standards applied globally. The matter was taken up for deliberation by the Drugs Technical Advisory Board (DTAB) at its meeting held in New Delhi recently, and it was concluded that the limit of free salicylic acid content shall be not more than 3 per cent in all medicines containing aspirin. The current provision under Schedule-V of the D&C Rules, 1945 states that all patent and proprietary medicines containing aspirin shall be subjected to free salicylic acid test and the limit of such acid shall be 0.75 per cent, except in case of soluble type aspirin in which case the limit of such acid shall be 3 per cent. Aspirin and aspirin containing FDCs are widely used formulations and several such single ingredient, formulations and FDCs are covered u...