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State approvals / Assam / State Drugs Control Administration

Application for grant of a licence to manufacture for sale or for distribution of drugs specified in Schedules-5

License Fees of Rs. 6000 plus inspection fees of Rs. 1500 (Rs 7500)

DepartmentState Drugs Control Administration
TypeNew
StageOperation / Renewal
Fee₹7,500
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 Copy of Partnership Deed/Memorandum and Articles of Association — Required
2 Declaration of Proprietor/Partner/Director etc in affidavit — 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
15 Technical document to be submitted for BULK DRUGS 1. Manufacturing procedure of each product — Required
16 Flow Chart with structural formula of reaction as per Master Formula record and analytical procedure of the each applied product with mode of procurement of official reference standard or working standard — Required
17 Official Monographs copies — Required
18 Details of effluents generated and their treatment followed — Required
19 Specimen labels of all applied products — Required
20 Technical document to be submitted for Formulations 1. Consolidated list of Formulations with packing particulars separately category wise viz. Tablets, Capsules,Injections etc — Required
21 Manufacturing and Analytical procedure of each product — Required
22 Specimen labels — Required
23 Labels of the similar products moving in the market for formulations not included in IP — Required
24 Declaration regarding the Brand Names of the product — Required
25 Copies of monographs of drugs which are not included in IP — Required

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