Drug Manufacturer License

REQUIRED DOCUMENTS FOR GRANT OF DRUGS MANUFACTURING LICENSE

Step 1 (List of Initial Documents for Consent)

•  Key Plan.
•  Site Plan.
•  Proof of ownership of the premises, if rented (NOC of House Owner)
•  Firm Registration by DC/SDM (Certified Copy).
•  Certificate of non-conviction of Proprietor/Partners/Directors under Drugs and Cosmetics Act, 1940.
•  Certified Copy of Registration Certificate of the Pharmacist (Sikkim Pharmacy Council).
•  Affidavit of Registered Pharmacist/Competent Person regarding fulltime working with the
•  Trade License (Certified Copy)
•  CCTV Camera to be installed (Compulsory)

Step 2 (List of Initial Documents for Consent)

•  Application Forms (Form -19 as per Drugs & Cosmetics Act/Rules)
•  Key Plan.
•  Site Plan.
•  Proof of ownership of the premises, if rented (NOC of House Owner)
•  Firm Registration by DC/SDM (Certified Copy).
•  Certificate of non-conviction of Proprietor/Partners/Directors under Drugs and Cosmetics Act, 1940.
•  Certified Copy of Registration Certificate of the Pharmacist (Sikkim Pharmacy Council).
•  Affidavit of Registered Pharmacist/Competent Person regarding fulltime working
•  Trade License (Certified Copy)

  Download Forms

Step 3 LICENSE FEES

•  Drug Manufacturing License - 7,500/-

Step 4 - TIMELINE FOR THE APPROVAL OF APPROVAL

•  Duration - 1 Month
  (Only applicable for the applicants who register and uploads all the necessary documents)