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Pre-Operational Approvals

Application for Retail Drugs/Wholesale Drugs

The Proponent shall submit the application for Retail Drug License/Wholesale Drug License to Drug Control Administration, Directorate of Health Services, Port Blair.
Note: Online application for issue of Drug License is under process.

Processing of the Application:

The applications in relevant format with all its enclosures will be scrutinized and verified and if any deficiencies found in the application will be informed to the applicant, who must then respond appropriately for further process.

Site Visit:

On receipt of the complete application form, the DCA official will schedule an inspection of the premises/unit to check the following:
a. Area of the outlet to verify the compliance with the statutory limits (Minimum 100sq.feet).
b. Capabilities to provide good storage conditions of the drugs stocked in the premises such as racks, refrigerator (for cold storage drugs) etc.
c. Premises should be RCC structure and located on ground floor.
The DCA officials will submit the Inspection report to the Drug Controller along with their remarks of fulfillment / Non-fulfillment of the norms. Based on the report, the applicant will be informed to deposit necessary fees in form of DD drawn in favour of Sr. Account Officer, DHS, Port Blair following which the application will be processed further for grant of License by the Licensing Authority.

Checklist of Documents to be submitted with the Application

For Retail /Wholesale Drug License

a. Statutory Form – 19 for licenses in form (20, 21)
b. Declaration by the Proprietor/Partner/Director/Competent Persons/Regd Pharmacist with proof of residential address(Present and Permanent) for proof of residential address – Aadhar Card, Pass Port, Driving License, Voter ID.
c. Partnership deed in case of partnership firm/ List of Directors downloaded from MCA website signed by Company Secretary/Managing Director (in case of company).
d. In case of company an Affidavit under section 34 of Drug and Cosmetics Act, 1940 on Rs.20/- stamp paper signed one of the Directors of the company in prescribed proforma..
e. Declaration of the Registered Pharmacist regarding acceptance of job on Rs..20/- Non- Judicial stamp paper in prescribed proforma.
f. Declaration of the Proprietor regarding full time employment of Pharmacist on Rs..20/- Non- Judicial stamp paper in prescribed proforma.
g. Declaration of the Proprietor regarding non-conviction under Drugs & Cosmetics Act & Rules on Rs..20/- Non- Judicial stamp paper in prescribed proforma.
h. Declaration of building owner regarding no objection for conducting the business of Retail drugs on Rs..20/- Non- Judicial stamp paper in prescribed proforma.

i. Self attested copy of Registered Pharmacist certificate ( renewal up to date) affixed with latest original photograph and signature of the candidate /original to be produced to the Drug Inspector at the time of inspection for endorsement.
j. Self attested copy of qualification certificate of the Registerd Pharmacist.
k. Plan of the premises indicating the carpet area ( specifying length and breadth in meters and area in sq.m) with the signature of Building owner and the applicant(Pro/partner/Authorized signatory/Managing Director, etc) in a legal size.
l. Declaration of building owner(Photograph of the building owner with self attestation) in prescribed proforma. Self-attested photocopy of the document showing the proof of ownership of the building owner for the premises to be licensed (E.C/ any other legal document showing the present ownership.

Timelines for Approvals:

i. For all New Drug License- 30 days(Subject to satisfactory verification premises and documents)
ii. For Renewal - 15 days(Subject to satisfactory verification premises and documents)