D&C Act 1940 & Current Regulatory
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Currently viewing: New Drugs and Clinical Trials Rules, 2019
New Drugs and Clinical Trials Rules, 2019 & Current Position
Source-first regulatory database with permanent Gazette history.
Informational use only. Verify every automatic mapping against the signed Gazette before regulatory reliance.
Ethics Committees
6 provisions
Rule 6 — Requirement of the Ethics CommitteeOfficial rule source →
Rule 7 — Constitution of Ethics Committee for clinical trialOfficial rule source →
Rule 8 — Registration of Ethics Committee relating to clinical trial, bioavailabilityOfficial rule source →
Gazette change chain · 2
Rule 11 — Functions of Ethics CommitteeOfficial rule source →
Rule 15 — Ethics Committee for biomedical and health researchOfficial rule source →
Rule 17 — 17. Registration of Ethics Committee related to biomedical and healthOfficial rule source →
Gazette change chain · 1
Clinical Trials and Academic Trials
6 provisions
Rule 19 — Clinical trial of new drug or investigational new drugOfficial rule source →
Rule 21 — Application for permission to conduct clinical trial of a new drug orOfficial rule source →
Rule 22 — Grant of permission to conduct clinical trialOfficial rule source →
Gazette change chain · 1
Rule 25 — Conditions of permission for conduct of clinical trialOfficial rule source →
Rule 28 — Academic clinical trialOfficial rule source →
Rule 29 — Inspection of premises relating to clinical trialOfficial rule source →
BA/BE Studies and Centres
7 provisions
Rule 31 — Bioavailability or bioequivalence study of new drug or investigationalOfficial rule source →
Gazette change chain · 3
Rule 33 — Application for permission to conduct bioavailability or bioequivalenceOfficial rule source →
Gazette change chain · 3
Rule 34 — Grant of permission to conduct bioavailability or bioequivalenceOfficial rule source →
Gazette change chain · 3
Rule 35 — Conditions of permission for conduct of bioavailability orOfficial rule source →
Gazette change chain · 2
Rule 44 — Registration of bioavailability and bioequivalence study centreOfficial rule source →
Gazette change chain · 3
Rule 45 — Application for registration of bioavailability and bioequivalenceOfficial rule source →
Gazette change chain · 3
Rule 49 — Conditions of registrationOfficial rule source →
Gazette change chain · 2
Safety, Medical Management and Compensation
5 provisions
Rule 39 — Compensation in case of injury or death in clinical trial orOfficial rule source →
Rule 40 — Medical Management in clinical trial or bioavailability andOfficial rule source →
Rule 41 — Consideration of injury or death or permanent disability to be relatedOfficial rule source →
Rule 42 — Procedure for compensation in case of injury or death during clinicalOfficial rule source →
Rule 43 — Medical management and compensation for injury or death relatingOfficial rule source →
Manufacture for Trial and New Drug Approval
6 provisions
Rule 52 — Application for permission to manufacture of new drug orOfficial rule source →
Gazette change chain · 2
Rule 53 — Grant of permission to manufacture new drugs or investigational newOfficial rule source →
Gazette change chain · 1
Rule 55 — Condition of permissionOfficial rule source →
Rule 59 — Application for permission to manufacture unapproved activeOfficial rule source →
Gazette change chain · 2
Rule 60 — Grant of permission to manufacture unapproved activeOfficial rule source →
Gazette change chain · 1
Rule 63 — Conditions of permissionOfficial rule source →
Import for Trial and Marketing
6 provisions
Rule 67 — Application for import of new drug or investigational new drug forOfficial rule source →
Gazette change chain · 2
Rule 68 — Grant of licence for import of new drug or investigational new drug forOfficial rule source →
Gazette change chain · 1
Rule 70 — Condition of licenceOfficial rule source →
Rule 75 — Application for permission to import new drug for sale or distributionOfficial rule source →
Rule 76 — Grant of permission for import of new drugs for sale or distributionOfficial rule source →
Gazette change chain · 1
Rule 77 — Condition of permission for import of new drugs for sale orOfficial rule source →
Gazette change chain · 2
Marketing Authorisation and Post-Approval
5 provisions
Rule 74 — Regulation of new drugOfficial rule source →
Rule 80 — Application for permission to manufacture new drug for sale orOfficial rule source →
Rule 81 — Grant of permission for manufacture of new drug for sale orOfficial rule source →
Gazette change chain · 1
Rule 82 — Condition of permission for manufacture of new drugs for sale orOfficial rule source →
Gazette change chain · 2
Rule 85 — Responsibility of importers or manufacturers in marketing of newOfficial rule source →
Gazette change chain · 2
Government/Hospital Compassionate Use
4 provisions
Rule 86 — Application for import of unapproved new drug by GovernmentOfficial rule source →
Rule 87 — Grant of licence for import of unapproved new drug by GovernmentOfficial rule source →
Rule 91 — Application for permission to manufacture unapproved new drug butOfficial rule source →
Rule 92 — Grant of permission to manufacture unapproved new drug but underOfficial rule source →
Clinical Research Organisations
4 provisions
Rule 44 — Registration of bioavailability and bioequivalence study centreOfficial rule source →
Gazette change chain · 3
Rule 45 — Application for registration of bioavailability and bioequivalenceOfficial rule source →
Gazette change chain · 3
Rule 47 — Grant of registration to bioavailability and bioequivalence studyOfficial rule source →
Gazette change chain · 3
Rule 49 — Conditions of registrationOfficial rule source →
Gazette change chain · 2
Meetings, Debarment and Digital Forms
4 provisions
Rule 98 — Pre-submission meetingOfficial rule source →
Rule 99 — Post-submission meetingOfficial rule source →
Rule 103 — Debarment of applicantOfficial rule source →
Rule 105 — Digitalisation of FormsOfficial rule source →