New Delhi: Government is soon going to revise the limit of free salicylic acid content in medicines containing Aspirin, as the Drugs and Techincal Advisory Board (DTAB) has shown a green flag to amend Schedule-V of the Drugs and Cosmetics Rules, 1945 for the same.

The matter came to light during the DTAB meeting held in New Delhi earlier this month. The board reached a conclusion wherein the limit of free salicylic acid content shall be not more than 3 per cent in all medicines containing aspirin.

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.

The current provision under Schedule-V of the Drugs and Cosmetics Rules, 1945 reads;

‘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 Fixed Dose Combinations (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 as in Indian Pharmacopoeia (IP) 2018, the maximum limit is 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 Drugs and Cosmetics 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 Drugs and Cosmetics 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.’