The regularization of 31 FDCs has been deemed rational, and drug makers have been given six months submit applications.

27th August, 2021
The regularization of 31 FDCs has been deemed rational, and drug makers have been given six months submit applications.
Regulatory BodyCDSCO Product CategoryMedical Device for Importer & Manufacturer
The Central Drugs Standard Control Organization (CDSCO) has issued a letter directing all drug manufacturers holding licenses issued by State Licensing Authorities for specified 31 Fixed Dose Combinations (FDCs) but have not received NOC (No Objection Certificate) from DCGI are to submit an application within six months to regularize FDCs.
Notable Products:Domperidone plus Paracetamol
Applicable For:Importer & Manufacturer
Reference Number:04-146/2007-DC(Part-I)
This letter was in response to the Directorate letter of even number dated 27.02.2019 and 08.09.2020, in which a detailed pathway for gaining authorization from this Directorate in respect of 83 FDCs was published, with three FDCs pronounced rational as a result.
  • Regularization of 31 FDCs have been deemed rational within the 294 FDCs category.
  • Amoxycillin plus Lactic acid Bacillus, Lincomycin plus Lactobacillus, Dicyclomine plus Ranitidine, Ondansetron plus Ranitidine, Cefadroxvl plus Lactic acid Bacillus, Ampicillin plus Flucloxacillin Sodium Salt, Aloe plus Tocopherol, Domperidone plus Paracetamol, and others are among the 31 new FDCs.
  • The DCGI has urged all manufacturers who already have licenses from State Licensing Authorities for such FDCs but have not yet received a NOC from DCGI to submit their applications to this Directorate as soon as possible within the next six months.
  • All State/UT Drugs Controllers should direct all interested stakeholders to file applications on Form CT-21 as per the specified pathway for case clearance, according to the DCGI. Furthermore, it was also requested that all State/UT Drugs Controllers ensure product licenses for these 31 FDCs are issued only after the approval of DCGI.