Amedment in Schedule-V of D&C Rules: Revise ‘free salicylic acid’ content in drugs containing aspirin [CDSCO]

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 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 under various pharmacopoeia and the free salicylic acid content limit specified in such pharmacopoeia like in Indian Pharmacopoeia (IP) 2018, the limit is maximum 3 per cent, in British Pharmacopoeia (BP) 2018, the limit is maximum 3 per cent, in US Pharmacopoeia (USP) 41, the limit is not more than 3 per cent and not more than 8 per cent for aspirin effervescent tablets for oral solution.

DTAB deliberated the proposal and agreed to amend Schedule-V of the D&C Rules, 1945 to revise the limit of free salicylic acid content in medicines. 

Therefore, it is proposed to revise the free salicylic acid limits under Schedule-V of the D&C Rules, 1945 as: ‘All medicines containing aspirin shall be subjected to “Free Salicylic Acid Test,” and the limit of “Free Salicylic Acid” content shall be not more than 3.0 per cent,’ DTAB stated.

*DTAB: Drugs Technical Advisory Board