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State approvals / Assam / State Drugs Control Administration

Grant of a loan Licence to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X Form 27 A

DepartmentState Drugs Control Administration
TypeNew
StagePre-Operation
Time limit60 days
Fee₹7,500
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 True copy of a letter from the manufacturing concern whose manufacturing capacity is intended to be utilised by applicant — Required
2 True copy of a letter from the manufacturing concern that they agree to land the service of their expert staff, equipment and premise of manufacture of each item required by the applicant & that will analyse every batch of the finished products and repose of the analysis seperately on this behalf — Required
3 Application in Form 27A duly signed by the Proprietor/Managing Partner/Managing Director/Person declared as a responsible under Section 34/Person authorised by the Board of Director accompanied by Company Board Resolution — Required
4 Copy of Partnership Deed/Memorandum and Articles of Association — Required
5 Declaration of Proprietor/Partner/Director etc in affidavit — Required
6 Copy of Ration Card/Passport/Electoral Card/Aadhar Card/Bank Passbook details in support of residential address & ID proof of the responsible person — Required
7 Copies of rent/lease deed In case of Rental premises If applicable
8 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
9 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
10 Design and layout of HVAC systems If applicable If applicable
11 Detail list of manufacturing and analytical equipment with copies of purchase bills — Required
12 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
13 Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit — Required
14 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
15 Clearance from Drugs Controller General (India), New Delhi in case of a New Drugs (either Bulk drug or formulation) — Required
16 Site Master File (refer para 29 of Part 1 of the Schedule M) — Required
17 Technical data in respect of the products of the manufacturer — Required

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