Issue of Installation / Registration / Production Certificate - Drug Control Department

  • Production certificates are issued after the FAA examines a manufacturer's production quality control system to verify that the manufacturer has the ability to produce products that conform to the approved type design and are in a condition for safe operation.
  • Documents to be submitted with application:
    • 1.Copy of the power of attorney/authorization letter in respect of person who has signed the documents
    • 2.Copy of the valid manufacturing licence / renewal certificates/validity certificate
    • 3.Copies for the product permissions for which certificates is required
    • 4.Copy of the notification of tendering authority/ notification of the concern authority demanding the certificate
    • 5.List of equipments installed for the manufacture of the each dosage forms indicating the capacity (in terms of units/ shift or annual output duly certified by the Chartered Accountant)
  • Application Fee : Rs. 1250
  • Service Charge (Grama one| B1| K1) : Rs. 100
  • Service Time (Days) : 7
  • Drug Manufacturers who have registered with the Drugs Control Department and having a valid licence and user credentials provided by the Department.
  • To apply online click here