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State approvals / Telangana / Health, Medical and Public Health Department

Drug License from Drug Control Administration (Retail Drug License/Wholesale Drug License)

This license is required by any individual, partnership, limited liability company, corporation or business firm located In Telangana and who is physically distributing and stocking the drugs & cosmetics in the state.

DepartmentHealth, Medical and Public Health Department
TypeNew
StagePre-Operation
Time limit14 days
FeeNo fee
AppliedApply on NSWS
Apply on TS-iPASS

Documents to submit

#DocumentConditionRequired
1 For Retail Drug License — Required
2 Statutory form – 19 for licenses in forms (20, 21) — Required
3 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 — Required
4 Partnership deed in case of partnership firm/ List of Directors downloaded from MCA website signed by Company Secretary / Managing Director (In case of a company) — Required
5 In the case of a company an Affidavit under Section 34 of the Drugs and Cosmetics Act, 1940 on Rs.20/- stamp paper signed by one of the Directors of the company. In prescribed proforma — Required
6 Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial stamp paper. In prescribed proforma — Required
7 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 Drugs Inspector at the time of inspection for endorsement — Required
8 Plan of the premises indicating the carpet area (specifying length and breadth in meters and area in Sq.m) with the signature of the Building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director, etc,.) in legal size — Required
9 Declaration of the 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 — Required
10 For Wholesale License — Required
11 Statutory form – 19 for licenses in form (20B, 21B) — Required
12 Same as retail drug License — Required
13 Experience certificate of Competent person — Required
14 Application (statutory) in form-24/ 27/ 31/ 27D/ 24Bduly signed by the Proprietor / Managing Partner / Managing Director/ Person declared as responsible under Sec.34 / Person Authorized by the Board of Directors accompanied by Company Board Resolution For Drug Manufacturing License If applicable
15 Declaration of the Proprietor / Partners / Directors etc. in Affidavit (as per format)& List of Directors downloaded from MCA website signed by Company Secretary /Managing Director (In case of a company) For Drug Manufacturing License If applicable
16 Partnership deed In case of Partnership firms If applicable
17 Self-attested Copy of Aadhar card/Passport/Electoral card as proof of residential address of the responsible person as mentioned in the Affidavit at Sl. No. 2 For Drug Manufacturing License If applicable
18 Rent / Lease deed In case of Rental premises If applicable
19 Declaration of the ownership of the premises if premises are owned by the applicant firm or company, with the documentary evidence of ownership like a Registered sale deed and/or proof of allotment of the site along with the latest property tax receipt For Drug Manufacturing License If applicable
20 Plan and layout of the premises showing the installation of Machinery and Equipment, preferably a Blue Print duly signed by the applicant who signed in the statutory form For Drug Manufacturing License If applicable
21 Detailed list of Manufacturing and Analytical Equipment For Drug Manufacturing License If applicable
22 Application for approval of Technical Staff in the prescribed format with enclosures of consent letter, copies of qualification certificates, experience certificates of proposed technical staff along with earlier approvals If any, appointment order of the Technical staff If applicable
23 Permission obtained from the Municipal Authorities/ Panchayat authorities / Certificate in conformity with the Factories Act for construction and starting the Unit & Permission fromT.S. Pollution Control Board clearance of the area for setting up the manufacturing facility For Drug Manufacturing License If applicable
24 Form-46/ Form-46A from Drugs Controller General (India), New Delhi in case of new drugs (Either Bulk drug or Formulation) – New Drugs as defined under Rule 122 E of Drugs and Cosmetics Act and Rules made thereunder For Drug Manufacturing License If applicable

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