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03 Requirement details
Pharmaceuticals
Domestic manufacturing licence
Domestic manufacturing license:
New drug
New drug: Form CT-21 (application as per Rule 80 of NDCT Rules) and Form CT-22 (API as per Rule 81, 82, 83 and 84 of NDCT Rules) or CT-23 (formulation as per Rule 81, 82, 83 and 84 of NDCT Rules)
Fixed Dose Combinations
Fixed Dose Combinations: Form 44 (application as per rules 122A, 122B, 122D and 122DA), Form 45 (permission to import as per rule 122A, 122D, 122DA), Form 46 (permission to manufacture as per rule 122B, 122D, 122DA)
Old / existing drug
Old/Existing drug (state)- Form 24 (application as per Rule 69 of Drugs and Cosmetics Rules), Form- 25 (license as per Rule 71 of Drugs and Cosmetics Rules)
Import Export Code (IEC): ANF-2A format (application as per Para 2.08 of the DGFT Handbook of Procedures, 2023 and S. 7 of Foreign Trade (Development and Regulation) Act, 1992).
COS-22 (Application for testing laboratory approval as per rule 55(1)), COS-23 (Approval of testing laboratory as per rule 56(1), 56(2), 58(1), 59, 60(1) and 62)
Class A and B: Form MD-4 (application as per sub-rule (2) of rule 20), Form MD-6 (license as per sub-rule (4) of rule 20 and sub-rule (6) of rule 20).
Class C and D — MD-8 / MD-10
Class C and D: Form MD-8 (application as per sub-rule (1) of rule 21 and sub-rule (2) of rule 21), Form MD-10 (license as per sub-rule (1) of rule 25).
Sale, stock or Distribution Registration: Form MD-41 (application as per sub-rule (2) of rule 87A), Form MD-42 (registration certificate as per sub-rule(4) of rule 87A and sub-rule (1) of rule 87C).
Stickering on Medical Device Labels: Compliance with Rule 44(n) of the MDR, 2017 and Rule 6 of the LMPC rules for permitted MRP-related stickers and revisions.
Manufacture of New Drug/IND for CT, BA/BE or Test/Analysis: Form CT-10 (application as per Rule 52), Form CT-11 (permission as per rules 53, 54, 55, 56, 57 and 58)
Unapproved API / formulation manufacture — CT-12 to CT-15
Manufacture of Unapproved API/Formulation for CT, BA/BE or Test/Analysis: Forms CT-12/CT-13 (applications as per rule 59 and 60), Forms CT-14/CT-15 (permissions as per rules 60, 61, 62, 63 and 64)
Import of New Drug/IND for CT, BA/BE or Test/Analysis: Form CT-16 (application as per rule 67), Form CT-17 (licence as per rules 68, 69, 70, 71 and 72)
Nomination of Director/Responsible Officer: Rule 29, read with Section 49(2) for nomination of a responsible director/officer for the company/establishment/branch.
Regulatory advice and commercial agreements for broadcasters, digital media platforms, OTT services, production houses, artists and content businesses.
Digital Media Ethics Code compliance
Compliance with Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021
The information on this page is for general reference. Requirements depend on the product, activity and applicable regulatory framework. Contact us for advice on your specific matter.
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