The Union Health Ministry has proposed to soon amend the Schedule-V of the Drugs and Cosmetics (D&C) Rules, 1945, in order to revise the free limit content of the salicylic acid in medicines containing aspirin. This limit is uniform throughout the globe based on pharmacopoeia standards.
The matter was discussed 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.
Key points of the new proposal
Aspirin and Aspirin containing FDCs are widely used formulations, and several such single ingredient, formulations and FDCs are covered under various Pharmacopoeia. The "Free Salicylic Acid" content limit specified in such Pharmacopoeia are as under:
- y IP 2018: Maximum 3 per cent
- y BP 2018: Maximum 3 per cent
- y USP 41: Not more than 3 per cent
- y USP 41: 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.
Note: 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.'
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