The Drugs & Food Control Organization Jammu & Kashmir (DFCO, J&K), on August 27, 2024, issued a notification regarding the Prohibition of manufacture for sale, distribution for Human Use of drugs of 156 Fixed Dose Combinations.
The Drugs Technical Advisory Board (DTAB) has recommended that the FDCs of such 156 drugs may involve risk to human beings, and hence, in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of such FDCs. The list is attached to the document.
•All the manufacturers existing within the Union Territory of Jammu & Kashmir holding License(s) / Product Approvals to manufacture for sale, sale and distribution of various drug formulations are hereby ordered to stop the manufacture sale, sale and distribution of prohibited FDCs if any with immediate effect & the prohibited FDCs if held by any manufacturing unit(s) is/are deemed to be withdrawn;
•All the manufacturers existing within the Union Territory of Jammu & Kashmir holding License(s) / Product Approvals of prohibited FDCs if any to submit the original copies of such product approvals for cancellation from office records;
•All the manufacturers existing within the Union Territory of Jammu & Kashmir holding License(s) / Product Approvals of prohibited FDCs if any to initiate the procedure of product recall on an immediate basis & submit a detailed report on this behalf w.r.t action taken within one month positively without fail.
•All the manufacturers existing within the Union Territory of Jammu & Kashmir holding License(s) /Product Approvals of prohibited FDCs if any to dispose off the recalled product(s) of batch(es) as per SOP in vogue;
•The Dy. Drugs Controller Jammu / Kashmir and all Assistant Controller Drugs (concerned) shall instruct the enforcement officers working in their respective jurisdictions to ensure that the prohibited FDCs are returned by the stakeholders in the supply chain to their principal sources and that no such FDC is/are available in the market for sale and distribution with Immediate effect.
[Notification No. DFO/D-1015/2055-235]
