PHARMA LITERATI

Following its proposal to the state government to mandate issuance of sale licence for ayurvedic drugs, the Maharashtra Food and Drug Administration (FDA) has urged the state government for inclusion of the provision of “Licence for the sale of Ayurvedic drugs”, in the Drugs and Cosmetics (D&C) (Maharashtra Amendment) Act to effectively control spurious drugs sale.     Currently, the state FDA has no control on ayurvedic drugs beyond registering manufacturers. Under the existing norms, FDA has the power to seize spurious cosmetic or Ayurveda products but has no authority for prosecuting retailers found selling them. The state regulator in its ongoing crackdown for non-compliance to Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act) 1954 revealed that ayurvedic drugs were mixed with allopathic medicines in contravention to the provisions of the DMR Act, 1954. Maharashtra also submitted reports of action taken for non-compliance to the state g...

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...