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State approvals / Assam / State Drugs Control Administration

Grant of a Licence to manufacture for sale or for distribution of drugs other than those specified in Schedule C, C (1) and X Form 24

DepartmentState Drugs Control Administration
TypeNew
StagePre-Operation
Time limit60 days
FeeNo fee
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 own 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 — Required
16 Manufacturing procedure of each product — Required
17 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
18 Official Monographs copies — Required
19 Details of effluents generated and their treatment followed — Required
20 Specimen labels of all applied products — Required
21 Technical document to be submitted for Formulations — Required
22 Consolidated list of Formulations with packing particulars separately category wise viz. Tablets, Capsules,Injections etc — Required
23 Manufacturing and Analytical procedure of each product — Required
24 Specimen labels — Required
25 Labels of the similar products moving in the market for formulations not included in IP — Required
26 Declaration regarding the Brand Names of the product — Required
27 Copies of monographs of drugs which are not included in IP." — Required

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