D&C Act 1940 & Current Regulatory
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D&C Act 1940 & Current Regulatory
Search in ordinary words. The system connects related terms to indexed provisions, amendment records and official CDSCO sources.
Chapter I — Introductory
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Chapter II — Technical Advisory Board, Central Drugs Laboratory and Consultative Committee
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Chapter III — Import of Drugs and Cosmetics
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Chapter IV — Manufacture, Sale and Distribution of Drugs and Cosmetics
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Chapter IV-A — Ayurvedic, Siddha and Unani Drugs
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Chapter V — Miscellaneous
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →The Drugs Rules, 1945
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →The Cosmetics Rules, 2020
Official CDSCO source linked. Read the current PDF and later Gazette amendments for exact wording.
Open original official document →Part I — Preliminary
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part II — Central Drugs Laboratory
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part III — Omitted provisions
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part IV — Import and Registration
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part V — Government Analysts
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part VI — Inspectors
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part VII — Sale of Drugs other than Homoeopathic Medicines
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part VIII — Manufacture for Sale or Distribution of Drugs other than Homoeopathic Medicines
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part IX — Labelling and Packing of Drugs other than Homoeopathic Medicines
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part X — Special Products and Biological Products
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XI — Testing of Drugs by Purchasers
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XII — Omitted / transitional provisions
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XIIA — Blood Banks and Blood Components
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XIIB — Blood Products
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XIIC — Large Volume Parenterals
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XIII — Homoeopathic Medicines
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XIV — Cosmetics legacy provisions
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XV — Ayurvedic, Siddha and Unani Drugs
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XVA — Approved Institutions for Drug Testing
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XVI — Standards and related requirements
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Part XVII — Miscellaneous
Structure indexed from an official consolidated source; wording and later amendments require provision-level reconciliation.
Open original official document →Amendments and changes
2026.07.08 G.S.R. 607(E)_Notification regarding restriction of sale of drug products containing alcohol content under Drugs Rules 1945
Pending CommencementInsertCommencement: They shall come into force after the 6 months of publication of these rules in the Official Gazette.
Open original Gazette / official source →2026.06.01 G.S.R. 444(E)_Notification for amendment in Schedule V w.r.t. unit of measurement of Folic Acid under the Drugs Rules, 1945
Pending CommencementSubstituteCommencement: They shall come into force after six months from the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.05.22 G.S.R. 407(E)_Notification for Revision of testing fees under Schedule B and B1 of Drugs and Cosmetics Act
In ForceSubstitute · RestrictCommencement: They shall come into force after three months from the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.08.19 G.S.R 745(E)_Draft notification for inclusion of additional four drugs in Schedule H1
Commencement Requires ReviewOpen original Gazette / official source →2026.08.18 S.O. 4595(E)_Prohibition of all formulations of FDC containing Chlorpheniramine Maleate and Phenylephrine HCl in children below four years of age
In ForceRestrictCommencement: This notification shall come into force on the date of its publication in the Official Gazette.
Open original Gazette / official source →2026.08.06 G.S.R. 713(E)_Notification for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F
Commencement Requires ReviewSubstituteCommencement: They shall come into force from the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.06.11 S.O. 3068(E) to S.O. 3083(E)_ Prohibition of 16 FDCs
Commencement Requires ReviewRestrictOpen original Gazette / official source →2026.07.02 G.S.R. 561(E)_Notification for consideration of Navi Mumbai International Airport (NMIA) as authorized Airport for Drug Import, under the provision of Rule 43A of Drugs Rules 1945
Commencement Requires ReviewSubstituteCommencement: They shall come into force on the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.06.29 G.S.R. 530(E)_Notification regarding Inclusion of additional items under CLAA in Drugs Rules 1945
Commencement Requires ReviewSubstitute · InsertCommencement: These rules shall come into force on the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.06.23 G.S.R. 509(E)_ Draft notification regarding simplification of the process for obtaining test licences for import of drugs under Form 11 of the Drugs Rules, 1945
Commencement Requires ReviewOpen original Gazette / official source →2026.06.22 G.S.R. 506(E)_Notification regarding amendment under Drugs Rules to include more categories under Schedule H2
Commencement Requires ReviewInsertCommencement: These rules shall come into force on the 1 st day of July, 2027, except serial number 2 in Table 2 of clause (b) of rule 2, which shall come into force on the 1 st day of July, 2028.
Open original Gazette / official source →2026.06.22 G.S.R. 505(E)_Draft notification regarding rationalization of shelf life under Rule 31 of Drugs Rules, 1945
Commencement Requires ReviewOpen original Gazette / official source →2026.06.18 G.S.R. 496(E)_Notification of Chaudhary Charan Singh National Institute of Animal Health, Baghpat, UP, as a CDL for testing viral and bacterial veterinary vaccines under the D and C Act
Commencement Requires ReviewSubstituteCommencement: They shall come into force on the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.06.11 S.O. 3068(E) to S.O. 3083(E)_ Prohibition of 16 FDC's
Commencement Requires ReviewRestrictOpen original Gazette / official source →2026.06.09 G.S.R. 477(E)_Notification for Removal of Syrup exemption under schedule K in the Drugs Rules,1945
Commencement Requires ReviewOmitCommencement: They shall come into force on the date of their publication in the Official Gazette.
Open original Gazette / official source →2026.05.13 G.S.R. 377(E)_Notification for amendment in Schedule H1 for inclusion of Pregabalin and its drug formulations
In ForceInsertCommencement: They shall come into force after one eighty days from the date of publication of these rules in the Official Gazette.
Open original Gazette / official source →2026.04.21 G.S.R. 299(E)_ Draft Notification for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F
Commencement Requires ReviewOpen original Gazette / official source →2026.03.09 G.S.R. 173(E)_Draft Notification reg PAC for amendment in Drugs Rules, 1945
Commencement Requires ReviewOpen original Gazette / official source →2026.03.09 G.S.R. 164(E)_Draft Notification regarding Blood product testing under Drugs Rules,1945
Commencement Requires ReviewOpen original Gazette / official source →2026.02.16 G.S.R. 135(E)_Notification for amendment in certain Drugs Rules (Related to Rule 121 – Test for Pyrogen, Footnote of Schedule H, condition of license under Form 20B, 20BB, 21B, 21BB, inclusion of name of competent person in Form 20G)
Commencement Requires ReviewSubstitute · InsertCommencement: These rules shall come into force on the date of their publication in the Official Gazette.
Open original Gazette / official source →Drug Manufacturing
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Broad subject → requirement → legal source1 document
Manufacturing requirements must be read with the applicable licence conditions, GMP schedule and manufacturing/analytical record requirements.
Open original official document →Drug Testing
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Broad subject → requirement → legal source3 documents
Testing obligations depend on the product, laboratory role, applicable standard, sampling route and official test method.
Open original official document →Testing obligations depend on the product, laboratory role, applicable standard, sampling route and official test method.
Open original official document →Testing obligations depend on the product, laboratory role, applicable standard, sampling route and official test method.
Open original official document →New Drug Approval
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Broad subject → requirement → legal source1 document
New-drug and clinical-trial approvals require cross-reference to the New Drugs and Clinical Trials Rules, 2019; this Drugs Rules link is retained as historical/legal context.
Open original official document →Traditional Medicine
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Broad subject → requirement → legal source1 document
Ayurvedic, Siddha and Unani manufacture and related requirements are organised under the applicable Part and Schedule T, subject to current AYUSH-administered provisions.
Open original official document →Approval Types
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Broad subject → requirement → legal source3 documents
Approval type depends on the regulated activity, product class and prescribed application/licence form.
Open original official document →Approval type depends on the regulated activity, product class and prescribed application/licence form.
Open original official document →Approval type depends on the regulated activity, product class and prescribed application/licence form.
Open original official document →Licensing
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Broad subject → requirement → legal source3 documents
Licensing is activity-specific; verify the applicable form, authority, conditions, premises and product category.
Open original official document →Licensing is activity-specific; verify the applicable form, authority, conditions, premises and product category.
Open original official document →Licensing is activity-specific; verify the applicable form, authority, conditions, premises and product category.
Open original official document →Labelling
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Broad subject → requirement → legal source1 document
Labelling requirements combine general rules with product- and schedule-specific warnings and sale controls.
Open original official document →Packaging
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Broad subject → requirement → legal source1 document
Packaging and pack-size requirements depend on dosage form, product stability and applicable schedule.
Open original official document →Cosmetics
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Broad subject → requirement → legal source1 document
Legacy Drugs Rules references must be checked against the Cosmetics Rules, 2020 before being treated as current.
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