Licenses and Compliance

• Domestic manufacturing license:
• 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: 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 (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 license:
• Form 8 (application as per Rule 24 of Drugs and Cosmetics Rules), Form 10 (license as per Rule 23 and 27 of Drugs and Cosmetics Rules)
• In case of new drug, Form CT-18 (permission to import as per Rule 75 of NDCT Rules) in addition to the applicable import licence requirements.
• Trademark registration: Form TM-A (application as per S. 18 of the Trade Marks Act, 1999)
• Certificate of Analysis (Not a prescribed statutory form; supported by Rule 74(c) read with Schedule U and GMP requirements under Schedule M.)
• Labelling and stickering compliance (as per Rule 96 and 97 of Drugs and Cosmetics Rules)
• Repacking: Form 24-B (application), Form 25-B (license) (as per Rule 69 and 70 of Drugs and Cosmetics Rules)
• Retail License: Form 19 (application as per rule 59(2)), Form 20 (license as per rule 61(1))
• Post-Approval changes compliance
• Pharmacovigilance compliance
• IPDMS registration: (as per Schedule II of the Drug (Prices Control) Order, 2013)
• Form I for application for price fixation/revision of a new drug formulation related to NLEM formulation (paragraphs 2(u),5,7,8,9,15);
• Form II for submission of revised prices for scheduled formulations (paragraph 16);
• Form III for quarterly return of production/import and sale of NLEM drugs (paragraphs 21(1));
• Form IV for discontinuation of production and/or import of scheduled formulations (paragraph 21(2));
• Form V for price list including price to retailer/price to distributor (paragraphs 2(x),24,25,26).
• 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).
• Form of undertaking for marketing a drug under a brand name or trade name: Form 51 (as per rules 71(9), 71A(5), 71B(v), 76(11) and 76A(v))
• GST registration: FORM GST REG-01 (as per Rule 8 of the CGST Rules, 2017)
• Wholesale license: Form 19 (application), Form 20-B (license) (as per Rule 61 Drugs Rules).
• Loan license: Form 24-A (application), Form 25-A (license) (as per Rules 69A and 70A of the Drug Rules).

As per the cosmetic rules, 2020:

• COS-1 (Application for import registration as per Rule 12), COS-2 (Import Registration Certificate as per Rule 13)
• COS-3 (Prior permission for a new cosmetic as per Rule 13(2), 23(3), 32(2) and 32(3))
• COS-4 (Application to import an already-registered cosmetic for new importer as per Rule 17(11))
• COS-5 (Application for manufacturing license as per Rule 23(2)), COS-8 (Manufacturing license as per 25, 26(g), 27(1), 28 and 30(1))
• COS-6 (Application for loan license as per Rule 23(2)), COS-9 (Loan license as per rule 25, 26(g), 27(1), 27(3), 28 and 30(1))
• COS-7 (Self-declaration of GMP compliance as per as per rule 23(4) and 23(7))
• COS-12 (Application for permission to import/manufacture new cosmetic as per rule 32(1))
• 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)
• Marketing Authorisation and Free Sale Certificate: Part I of the Second Schedule (as per rules 12(4), 23(2) and 23(4))
• Undertaking for import of cosmetics: prescribed under the Sixth Schedule
• IEC and GSTIN: Assistance with Import Export Code (IEC) requirements and GST registration (GSTIN)

• Import license, Registration certificate

As per Medical Devices Rules, 2017

• Manufacturing License:
• Class A and B: Form MD-3 (application as per sub-rule (2) of rule 20), Form MD-5 (license sub-rule (4) of rule 20 and sub-rule (6) of rule 20);
• Class C and D: Form MD-7 (application as per sub-rule (1) of rule 21 and sub-rule (2) of rule 21), Form MD-9 (license as per sub-rule (1) of rule 25);
• Loan License:
• 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: 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).
• Import Licence: Form MD-14 (application as per sub-rule (1) of rule 34), Form MD-15 (license as per sub-rule (1) of rule 36)
• 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).
• Labelling compliance as per rule 44, Unique Device Identification as per Rule 46 and shelf-life requirements as per Rule 47
• LMPC Labelling compliance as per section 18 of the Legal Metrology Act, 2009 along with rules 6 of the LMPC Rules
• BIS License and Certification
• IPDMS Registration: Registration with NPPA's Integrated Pharmaceutical Data Management System (IPDMS) for applicable price or data submissions.
• NOC from custom bonded warehouse for imported MD
• Medical Device Price List: Form VI regarding Proforma for Price List of Medical Devices (as per Schedule II of the DPCO, 2013)
• NPPA Price Fixation or Revision: Forms I and II, as applicable (as per DPCO)
• Change in Constitution: Compliance as per Rule 27 for manufacturers and Rule 39 for importers;
• Claim review as per registration certificate
• LMPC Registration Certificate for Manufacturer, Packer, Importers: Registration under Rule 27 of the LMPC Rules, 2011.
• De-bundling of Medical Devices
• Renewal of licence for manufacture of weights and measures (as per Section 23 read with Rule 11)
• 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.

• FSSAI Registration: Form A (as per Schedule 2 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011)
• FSSAI State license: Form B (as per Schedule 2 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011)
• FSSAI Central License: Form B (as per Schedule 2 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011)

As per NDCT Rules, 2019:

• Clinical Trial Permission: Form CT-04 (application as per rule 21), Form CT-06 (permission as per rules 22, 25, 26, 29 and 30)
• BA/BE Study Permission: Form CT-05 (application as per Rule 33), Form CT-07 (permission as per Rules 34, 35, 36, 37 and 38)
• 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)
• 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)
• Import of New Drug for Sale or Distribution: Form CT-18 (as per rule 75)
• Import of Drugs for Test/Analysis: Form 12 (application as per Rule 34 of Drugs Rules), Form 11 (licence as per Rule 33 of Drugs Rules)
• Registration of Ethics Committee: application in Form CT-01 (as per rules 8,10 and 17) and registration in Form CT-02 (as per rules 8,9,10 and 14)
• Approval of Phase -1 CT: application in Form CT-04 (as per rule 21) and permission in Form CT-06 (as per rules 22, 25, 26, 29 and 30)
• Approval of Phase -2 CT: application in Form CT-04 (as per rule 21) and permission in Form CT-06 (as per rules 22, 25, 26, 29 and 30)
• Approval of Phase -3 CT: application in Form CT-04 (as per rule 21) and permission in Form CT-06 (as per rules 22, 25, 26, 29 and 30)

• Clinical establishment registration as per the Clinical Establishments (Registration and Regulation) Act, 2010
• Pharmacy Retail Licence: Form 19 (application as per rule 59(2)), Form 20 (retail licence as per rule 61(1))
• Narcotic Drugs / Psychotropic Substances: Compliance under the NDPS Act, 1985 and applicable NDPS Rules
• Registration for organ transplantation: As per the Transplantation of Human Organs and Tissues Rules:
• Form 12: Application for Registration of Hospital to Carry Out Organ or Tissue Transplantation Other Than Cornea
• Form 13: Application for Registration of Hospital to Carry Out Organ/Tissue Retrieval Other Than Eye/Cornea Retrieval
• Form 14: Application for Registration of Tissue Banks Other Than Eye Banks
• Form 15: Application for Registration of Eye Bank, Corneal Transplantation Centre, Eye Retrieval Centre
• Form 16: Certificate of Registration
• Allied healthcare professionals: Compliance as per National Commission for Allied and Healthcare Professions Act, 2021

• Clinical establishment registration
• PCPNDT registration and compliance
• AERB Registration and license
• NABL accreditation and advisory

• Nomination of Director/Responsible Officer: Rule 29, read with Section 49(2) for nomination of a responsible director/officer for the company/establishment/branch.
• Mandatory Package Declarations
• Country of Origin: Rule 6(1)(aa) applicable to imported packages
• Best Before / Use By: Rule 6(1)(da), where applicable
• Unit Sale Price: Rule 6(11), where applicable
• Manner of Declaration
• PDP and Font Requirements
• E-commerce Display of Declarations
• Registration of Manufacturer/Packer/Importer: Rule 27 registration of applicable manufacturer, packer and importer of pre-packaged commodities
• Wholesale Packages: Rule 24 requirements applicable to wholesale packages
• Stickering / Revised MRP: Rule 6(3) proviso and Rule 18(3) permitted MRP-related sticker/revised-MRP declarations subject to applicable conditions
• Wholesale package: Rule 24 of LMPC Rules prescribes the declarations required on a wholesale package
• Advertisement / E-commerce Compliance: Rule 6(10) applicable mandatory declarations must also be displayed for products offered through e-commerce
• Nutraceutical product compliance
• Penalty / Enforcement

• Compliance with Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021
• Internet Service Provider Guidelines, 2007
• PAN Code for Online Website,
• FDI in Digital Media,
• E-commerce Activities,
• CMRDS Licence,
• ILD Licence,
• OTT platform,
• News Broadcasting Standards Regulations,
• News Broadcaster-Specific Guidelines covering reporting,
• Copyright Act, 1957 and Copyright Rules, 2013 for social media, OTT, films and tv compliance
• artist agreement,
• producer agreement,
• director agreement,
• magician agreement,
• child-artist agreement.