Drug & Cosmetic License (CDSCO)

Documents Required

Items marked Required are mandatory; others are situational.

Entity and Location Documents

• Certificate of Incorporation, Partnership Deed, or proprietorship declarationRequired
• PAN of the entity and all directors or partnersRequired
• Proof of ownership or registered lease of premisesRequired
• Site plan and layout drawings of premises (dimensioned)Required
• Municipal NOC for use of premises as manufacturing or storage unitRequired
• Pollution Control Board consent to establish and consent to operateRequired

  Required for drug manufacturers; confirm applicability for cosmetics

Technical and Qualified Person Documents

• Degree certificate of Qualified Person (B.Pharm, M.Pharm, MBBS, or equivalent)Required
• Experience certificate of Qualified Person from previous employer(s)Required
• Full-time employment agreement with the Qualified PersonRequired
• List of all drug or cosmetic products proposed to be manufactured or soldRequired

GMP and Infrastructure Compliance (Manufacturers)

• Air handling unit (AHU) and HVAC specifications meeting Schedule M requirementsRequired
• Water purification system (purified water or WFI as applicable) in placeRequired
• Quality control laboratory with required instruments (or third-party QC arrangement)Required
• Standard Operating Procedures (SOPs) drafted for key manufacturing steps

  Inspectors expect SOPs to be in draft or final form at the time of inspection

• Equipment list with make, model, and capacity detailsRequired