Regulatory Updates

Please click on the link below for the latest regulatory updates.

2022

21

Oct

Notice_regarding_implementation_of_gazette_notification_vide_GSR_754_E__dated_30.09.2022

14

Oct

G.S.R_778Edated_14_Oct_2022_regarding_the_New_Drugs_and_Clinical_Trials__Third_Amendment__Rules

11

Jul

Notice_dated_July_11_2022

8

Jul

Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022

7

Jul

Clarification regarding import of non-drug / lab kits shipments related to clinical trial / clinical research purposes

21

Jan

Draft_GSR 32(E)_Insertion of Provisions for deemed approvals in various rules under NDCTR 2019

18

Jan

Final GSR 21(E)_Amendment in Eighth Schedule, Form CT-03

13

Jan

2022.01.13_Final GSR 14(E)_To amend rule 2 to substitute cell or stem cell derived product under NDCTR 2019

2021

1

Oct

Module for online processing of applications for registration of BA BE study centres (CT-08)

29

Sep

Submission of Post Approval Changes Applications through SUGAM Portal

23

Jul

Clarification if change in a) Polymorphs/crystalline/amorphous/solvates/hydrate etc (b) salt and (c) Derivative/analogue/ester etc of already approved active substance to be considered as new drug if main active moiety (Active Pharmaceutical Ingredient-API) is same?

3

Jul

CDSCO office order 7

25

Feb

User Manual For SAE reporting (Serious Adverse Event) On SUGAM portal

25

Feb

Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of SAE’s

2020

21

Sep

Notice for Vaccine Guidelines

21

Sep

Draft Regulatory guidelines for development of vaccines with special consideration for Covid-19 vaccine

21

Sep

Regulatory guidelines for development of Vaccine

28

Aug

Notice regarding approved panel of experts for the Subject Expert Committees

9

Jun

Notice regarding conduct of BA/BE studies for export purpose during Covid-19 outbreak

30

Apr

Circular regarding extension of validity of BA/BE study centres

30

Mar

Notice regarding conduct of clinical trials during Covid-19 outbreak

23

Mar

Notice regarding Covid-19 outbreak

19

Mar

Notice regarding regulatory pathway for R&D of drug or vaccine (including clinical trials) for Covid-19

11

Mar

Notice regarding clarification for inadvertent payment of fees for various applications

21

Feb

Notice regarding simultaneous processing of BA/BE and CT applications under NDCT Rules 2019

20

Feb

Notice regarding timelines for processing of applications for manufacturing/import of new drugs for test and analysis, CT or BA/BE study

18

Feb

Notice regarding additional FAQs on New Drugs & Clinical Trials Rules 2019

1

Feb

Procession of PAC of BA BE for export issued in CT-07 and import license in CT-17

1

Feb

Permission in CT-11, CT-14, CT-17 for Test and analysis, BA/BE study

1

Feb

FAQ on NDCT – update on question 1, 47 & 65 along with addition of question 123

1

Jan

List of reference products for conduct of Be study

2019

1

Oct

Registration of Ethics Committee involved in review and according approval of Clinical Trials and BA BE study protocols

1

Aug

Additional FAQ on New Drugs and Clinical Trial Rules

11

Jul

Extract_of_the_New_Drugs_and_Clinical_Trials_Rules_2019_relevant_to_Ethics_Committee_for_Clinical

1

May

New Drugs and Clinical Trial Rules, 2019 (Slideset)

1

May

New Drugs and Clinical Trial Rules, 2019 (Summary)

19

Mar

MoH Gazette notification regarding New Drugs & Clinical Trial Rules 2019. Schedule Y and Rules related to New Drugs & Clinical Trial approvals have been revised.

15

Feb

Extension granted for making payments in SUGAM via Bharatkosh till 28 Feb 2019

11

Feb

DCGI notice to call meeting of stakeholders to discuss issues regarding payments through Bharatkosh

9

Jan

DCGI circular – Stakeholder Meeting Inviation to discuss issues regarding SAE reporting and compensation procedures

9

Jan

DCGI office issued office memo to all stakeholders that fees payments in SUGAM portal should be done through Bharatkosh only

2018

17

Dec

DCGI office memo to state drug controller offices regarding Implementation of increase in application fees for grant of various import licences, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations under the provisions of Drugs & Cosmetics Rules, 1945

12

Dec

MoH Gazette notification regarding revision in fees of applications for various categories of licenses. For Clinical Trial perspective, Test license [Form 11, Form 11A] fees has been increased

5

Dec

DCGI letter inviting feedback from stakeholders on SUGAM portal

14

Nov

CDSCO Notice – Invite for meeting to discuss CT Draft Rules

29

Oct

Cancellation of previous order dated 25 Oct 2018 regarding SAE reporting process

25

Oct

DCGI office order to stakeholders informing that only SAE reports of clinical trials will be accepted at Sadiq Nagar office of CDSCO. Other SAE reports should be submitted to CDSCO office, FDA Bhawan only

27

Sep

DCGI office Notice on Draft Pharmacovigilance System Inspection Guideline

20

Aug

DCGI office order informing stakeholders about change in SAE submission process

16

Aug

Work distribution of DDC level officials in CDSCO HQ – duties and responsibilities

6

Aug

Meeting Notice – calling all stakeholders for meeting to discuss regulatory requirements for BA BE for Export purpose

1

Aug

Mandatory Sugam Online Application Ethics committees registration w.e.f. 01 Sep 2018

20

Jul

Public notice regarding video-conferencing (Vc) facility for promotion of innovation & start up business in India in Pharmaceutical sector

12

Jun

DCGI Office Memo regarding new CDSCO website cdsco.gov.in

11

Jun

SUGAM online applications for NDA, SND, FDC applications made mandatory from 22 Jun 2018

24

May

Procedures of disposal of matters referred by Public Relation Office, CDSCO(HQ)

23

Apr

DCGI office order regarding creation of email ID for PRO

7

Mar

DCGI Notice regarding creation of Public Relation Office at CDSCO HQ

17

Jan

DCGI Office memo listing details of trials with rDNA to be inspected in year 2018

15

Jan

DCGI notice making submission of applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs mandatory through SUGAM portal w.e.f. 01 Feb 2018

1

Jan

List of Clinical Trials (Vaccines) to be inspected in the year 2018

2017

26

Dec

DCGI Notice on SUGAM Portal for Vaccines

11

Dec

DCGI office order – SUGAM activity coordination

21

Nov

DCGI Notice – Invitation for applications for SEC experts

12

Jul

DCGI Notice on stakeholders meeting regarding SUGAM

27

Jun

DCGI Notice regarding streamlining the regulatory procedures

22

Jun

DCGI Office Order regarding grievance redressal

6

Jun

ACHIEVEMENTS OF CDSCO DURING YEAR 2015-2017

3

Apr

MoH final gazette notification removing entry #8 of Form 44 – Patent status

6

Feb

Notice regarding SUGAM for Vaccines applications

2

Feb

MoH Final gazette notification GSR 103 – Change in Test license validity, Rule 36, 45, 91

2

Feb

Notice – Process of appeal against SEC recommendations

17

Jan

Apex Committee Decision on CT waivers applications

2016

21

Dec

DCGI Notice on Sub-Login ID in SUGAM portal

21

Dec

DCGI office memo – Risk based Inspection of sites facility – biological products

20

Dec

DCGI Office Memo regarding Clinical trial approvals clearance from RCGM

1

Dec

DCGI Notice on SUGAM for Clinical Trial applications

29

Nov

MoH letter to DCGI regarding EC accreditation

22

Nov

DCGI Office Memorandum (Evaluation of PSURs data)

21

Nov

DCGI Office Memo regarding payments in SUGAM

4

Nov

MoH Final GSR 1041 – Amendments to Schedule Y – Animal Toxicity

5

Oct

DCGI Notice regarding SUGAM for GCT applications

21

Sep

DCGI Notice on stakeholders meeting regarding SUGAM for BA BE studies for Export purpose

5

Sep

DCGI Notice – Extension of validity of BA BE study centers from 1 to 3 years

23

Aug

DCGI Notice – regarding follow up on pending applications through consultants

22

Aug

Notice regarding SUGAM for BA BE for export

18

Aug

DCGI Notice regarding workshop on SUGAM for CT applications

8

Aug

DCGI invitation letter calling stakeholders’ meeting for CT NOC application submission in SUGAM portal

4

Aug

NOTICE regarding ease of doing business – clinical trials

3

Aug

DCGI circular on RCGM review process for clinical trials with rDNA products

3

Aug

DCGI circular on DCGI NOC for additional sites and investigators for clinical trials

2

Aug

DCGI circular for removing restriction of three trials per investigator

2

Aug

DCGI Circular for relaxation in requirement of 50 bedded hospitals

13

Jul

DCGI NOTICE on timely submission of query response

5

Jul

DCGI Notice for Meeting dated 12 July 16 on SUGAM for BA BE for Export studies

15

Jun

DCGI advisory to stakeholders to inform DCGI office if applicant firms are unable to attend SEC meetings

7

Jun

DCGI NOTICE related to submission of applications for registration of Ethics Committee on SUGAM

6

Jun

DCGI Notice – revisiting D&C Act and Rules

1

Jun

DCGI Notice on DRAIZE test – inviting comments from stakeholders

30

May

PUBLIC NOTICE – Online portal SUGAM availability for various applications

30

May

DCGI NOTICE – SUGAM portal for Ethics Committee registration applications

30

May

DCGI instruction on Conflict of Interest declaration by SEC experts

27

May

DCGI NOTICE regarding SUGAM for Test License applications

26

May

DCGI Office Order regarding Duty Delegation for various applications

20

May

DCGI Note on ISCR meeting at FDA Bhawan

10

May

Invitation for inclusion of professionals in the expert panels / subject expert committees under CDSCO

6

May

DCGI Notice inviting comments, Suggestions for ease of Drug Regulation

8

Apr

DCGI notice regarding status of pending approvals uploaded on CDSCO website

30

Mar

Minutes of the meeting with stakeholders dated 30 Mar 2016 at FDA Bhawan

29

Mar

DCGI office order on processing of GCT applications in DCGI office for ensuring zero pendency

21

Mar

DCGI Invitation letter calling for meeting with stakeholders to understand their grievances

16

Mar

MoH Final GSR 313 (E) Schedule Y amendment – Academic clinical trial & Animal toxicity

8

Mar

MoH Final GSR 287(E) – Related to Sch Y – Post marketing studies & systemic toxicity data requirement

2015

1

Dec

DCGI Office Memo – Shelf life of drugs less than 60% relevance for clinical trials

30

Nov

Final GSR 918 E – Phytopharmaceutical drugs

19

Nov

Office Order – General admin order on application processing delays

18

Nov

DCGI Office Circular regarding online portal SUGAM

10

Nov

DCGI Circular on removing the practice of repetition of toxicity studies

10

Nov

DCGI Circular on RCGM review of clinical trials with rDNA drugs

10

Nov

DCGI Circular on additional sites for clinical trials

10

Nov

DCGI circular on academic trials

30

Oct

MoH Final GSR 826 – Inclusion of Rule 122DA, Amendment to Form 44

11

Aug

Database of CROs for BA BE studies

31

Jul

MoH Final GSR 611 – AV recording of ICF

22

Jul

Notice on clinical trial initiation

3

Jul

DCGI office order – delegation of duties to CDSCO zonal offices

10

Apr

DCGI notice on public grievance

1

Apr

ISCR Comments_DRAFT STANDARDS AND APPLICATION FORMAT FOR ACCREDITATION OF ETHICS COMMITTEE, INVESTIGATOR AND CLINICAL TRIAL SITE

30

Mar

MoH S.O. 873(E) – Notified Branches of Bank of Baroda for payment for Regulatory fees

10

Feb

ISCR Comments on Notice on Pre-submission meetings

9

Feb

ISCR Comments on Amendments to the Drugs & Cosmetic Rules, 2015

28

Jan

Pre-Submission Meetings Proposed To Be Initiated By CDSCO

16

Jan

ISCR Comments on Draft Drugs & Cosmetic amendment bill, 2015

6

Jan

Duty delegation to zonal offices – clarification

5

Jan

DCGI office order regarding Subject Expert Committee functioning

2014

31

Dec

Draft Drugs and Cosmetics (Amendment) Bill, 2015

20

Dec

CDSCO Notice_ COMPENSATION FORMULAE

12

Dec

Amended Compensation Rules – GSR 889 (E) Released

12

Dec

Gazette Notification dated 12-Dec-14 regarding Clinical Trial Compensation

10

Dec

CDSCO_Strengthening of Drug Regulatory System in India

5

Sep

Office Order

4

Aug

CDSCO -List of subject experts in various therapeutic areas

28

Jul

Proposal For Creation Of It Enabled System1

25

Jul

ISCR Representation_CDSCO office orders

17

Jul

Minutes of meeting of Stakeholders held on 17.07.2014 at Nirmal Bhavan, New Delhi for deliberation on the draft Rules published vide notification GSR 364 (E) dated: 07.06.2013 and draft guidelines on audio-visual recording of Informed Consent Process in Clinical Trial issued by CDSCO

3

Jul

CDSCO office order 13

3

Jul

CDSCO office order 12

3

Jul

CDSCO office order 11

3

Jul

CDSCO office order 10

3

Jul

CDSCO office order 9

3

Jul

CDSCO office order 8

3

Jul

CDSCO office order 6

3

Jul

CDSCO office order 3

3

Jul

CDSCO office order 5

3

Jul

CDSCO office order 4

3

Jul

CDSCO office order 2

3

Jul

CDSCO office order 1

3

Jul

Formula To Determine The Quantum Of Compensation In Case Of Clinical Trial Related Injury (Other Than Death). The stakeholders are therefore requested to forward their comments and suggestions on the above formula within 15 days(i.e. by 16 th May, 2014)

24

Apr

Extraordinary Gazette notification GSR 292 E – Amendment to Rule 122DAB

28

Feb

MoM of Apex committee meeting dated 07-Mar-14 and Technical committee meeting

13

Jan

GCT check list version 13 Jan 2014 with revised annexures.

13

Jan

Global Clinical Trial

9

Jan

Draft guide lines on Audio-Visual Recording of ICF in clinical trial

2013

19

Nov

DCGI office order on AV recording of ICF

21

Oct

Supreme court order on Clinical Trials.

30

Aug

Office order dated 30 Aug 2013 for furnishing of information in respect of financial support, fees, honorarium, payments to be paid to the investigator.

30

Jul

Notice dated 30 Jul 2013 on independent ethics committees in respect of periodic review of the ongoing clinical trials.

7

Jun

G.S.R.364 (E) notification( Drugs and cosmetics second amendment rules, 2013)

3

Jan

Minutes of 16th meeting of the technical committee held on 10.07.2014. Under the chairmanship of DGHS for supervising clinical trials on new. Chemical entities in the light of directions of the hon’ble Supreme. Court of India.

3

Jan

Minutes of the 15th meeting of the apex committee held on 15-07-2014 Under the chairmanship of secretary, health and family welfare For supervising clinical trials on new chemical entities in the Light of directions of the hon’ble Supreme Court of India.

Indian Society for Clinical Research

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