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