Type Of Enclosure
Original / Photocopy
Attestation Required
Documents Recommended
Declaration regarding the Brand Names of the product.
Original
Not Required
Declaration regarding the Brand Names of the product.
Copies of monographs of drugs which are not included in IP.
Original
Not Required
Copies of monographs of drugs which are not included in IP.
Treasury Challan
Original
Not Required
Treasury Challan
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.
Original
Not Required
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.
Design and layout of HVAC systems, if applicable.
Original
Not Required
Design and layout of HVAC systems, if applicable.
Detail list of manufacturing and analytical equipment with copies of purchase bills.
Original
Not Required
Detail list of manufacturing and analytical equipment with copies of purchase bills.
Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit
Original
Not Required
Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit
Clearance from Drugs Controller General (India), New Delhi in case of a New Drugs (either Bulk drug or formulation)
Original
Not Required
Clearance from Drugs Controller General (India), New Delhi in case of a New Drugs (either Bulk drug or formulation)
Site Master File (refer para 29 of Part 1 of the Schedule M)
Original
Not Required
Site Master File (refer para 29 of Part 1 of the Schedule M)
Technical data in respect of the products of the manufacturer.
Original
Not Required
Technical data in respect of the products of the manufacturer.
Manufacturing procedure of each product.
Original
Not Required
Manufacturing procedure of each product.
Official Monographs copies.
Original
Not Required
Official Monographs copies.
Specimen labels of all applied products.
Original
Not Required
Specimen labels of all applied products.
Consolidated list of Formulations with packing particulars separately category wise viz. Tablets, Capsules,Injections etc.
Original
Not Required
Consolidated list of Formulations with packing particulars separately category wise viz. Tablets, Capsules,Injections etc.
Manufacturing and Analytical procedure of each product.
Original
Not Required
Manufacturing and Analytical procedure of each product.
Specimen labels.
Original
Not Required
Specimen labels.
Labels of the similar products moving in the market for formulations not included in IP.
Original
Not Required
Labels of the similar products moving in the market for formulations not included in IP.
UBIN Certificate
Original
Not Required
Copy of UBIN (Unique Business Identification Number) Certificate
Common Application Form (Department of Industries and Commerce)
Original
Not Required
Copy of Common Application Form
1. Copy of Partnership Deed/Memorandum and Articles of Association.(Notarized)
Original
Not Required
1. Copy of Partnership Deed/Memorandum and Articles of Association.(Notarized)
Declaration of Proprietor/Partner/Director etc in affidavit
Original
Not Required
Declaration of Proprietor/Partner/Director etc in affidavit
Copy of Ration Card/Passport/Electoral Card/Aadhar Card/Bank Passbook details in support of residential address & ID proof of the responsible person.
Original
Not Required
Copy of Ration Card/Passport/Electoral Card/Aadhar Card/Bank Passbook details in support of residential address & ID proof of the responsible person.
Copies of rent/lease deed in case of Rental premises.
Original
Not Required
Copies of rent/lease deed in case of Rental premises.
Details of effluents generated and their treatment followed.
Original
Not Required
Details of effluents generated and their treatment followed.
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