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State approvals / Assam / State Drugs Control Administration

Grant of a Licence to manufacture for sale or for distribution of Large Volume Parenteral/Sera and Vaccines excluding those specified in Schedule X Form 27 D

DepartmentState Drugs Control Administration
TypeNew
StagePre-Operation
Time limit120 days
FeeVaries with the application
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 Copy of Partnership Deed/Memorandum and Articles of Association.(Notarized) — Required
2 Declaration of Proprietor/Partner/Director etc in affidavit. (Notarized) — Required
3 Copy of Ration Card/Passport/Electoral Card/Aadhar Card/Bank Passbook details in support of residential address & ID proof of the responsible person — Required
4 Copies of rent/lease deed In case of Rental premises If applicable
5 Declaration of owner of the premises owned by the applicant firm or company with the documentary evidence of the ownership like registered sale deed etc and or proof of allotment of the site and or building along with latest property tax receipt — Required
6 Plan and layout of the premises showing the installation of Machinery and Equipment preferably a blue print approved by licensed engineer and sign by the applicant who sign in the statutory form — Required
7 Design and layout of HVAC systems If applicable If applicable
8 Detail list of manufacturing and analytical equipment with copies of purchase bills — Required
9 approval of technical staff in the prescribed format with enclosed with the consent letters, copies of qualification certificate, experience certificate, proposed technical staff along with earlier approvals If any, appointment letter of the technical staff If applicable
10 Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit — Required
11 Permission from the Health Authorities/Pollution Control Board/Clearance of the area for setting up the manufacturing facility in case of license for manufacture of API the Assam Pollution Control Board clearance of API is sought — Required
12 Clearance from Drugs Controller General (India), New Delhi in case of a New Drugs (either Bulk drug or formulation) — Required
13 Site Master File (refer para 29 of Part 1 of the Schedule M) — Required
14 Technical data in respect of the products of the manufacturer — Required

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