Regulations & Guidelines specific to Ethics-Schedule Y and Indian GCP

Shanthy GunasekaranDeputy Drugs Controller (I)

CDSCO, Bangalore

1. Drugs and Cosmetics Act and Rules Central Drugs Standard Control Organisation (CDSCO )

2. Legal provisions (in D&C Rules & Schedule-Y) for

• Regulation of Clinical Trials and • Ethics Committee• Amendments in 2013, 2014 & 2015 expected in 2016

3. GCP guidelines for Ethics Committee

4. Measures taken by CDSCO to strengthen CT regulations

Outline

Ensures the Safety, Efficacy and Quality of Drugs , Cosmetics and Medical Devices

through

Regulation ofImport, Manufacture, Distribution and Sale

Drugs , Cosmetics and Medical Devices

Drugs and Cosmetics Act and Rules

Regulating Authorities

State GovernmentsDrug Control Department

Director / Drug Controller (SLA )(Head and LA)

•Manufacture

•Distribution

•Sales

Central GovernmentCentral Drugs Standard

Control Organization (CDSCO)

DCG(I) (Head and LA)

•Import

•New drugs

•Clinical Trials

Permission/ Licence for EXISTING Drugs

Licence to Import Licence to Manufacture

Licence to Distribution

Licence to Sell (Wholesale)

Licence to Sell (Retail)

ExistingDrugs, 

Cosmetics, Medical Devices

CDSCO StateLicensing Authority

Permission/ Licence for NEW Drugs

Permission to Clinical trials Permission to Clinical trials

Permission to import Permission to manufacture

Licence to Import Licence to Manufacture

Licence to Distribution

Licence to Sell (Wholesale)

Licence to Sell (Retail)

ExistingDrugs, 

Cosmetics, Medical Devices

NEWDrugs  & Medical 

Devices 

CDSCO StateLicensing Authority

Central Drugs Standard Control Organization (CDSCO)

Drugs Controller General (I)

HEAD QUARTER SUB ZONALOFFICE (4)

ZONALOFFICE (6)

LABORATORY(7)

PORT OFFICE(13)

New Delhi GhaziabadMumbaiChennaiKolkata

AhmedabadHyderabad

ChandigarhBangalore

Goa Jammu

Functions of CDSCO

• Amendment to D &C Act and Rules• Approval of New Drugs and Clinical Trials• Grant of Import Registration Certificate and Import Licence• Approval of Licensing of Blood Banks, LVPs, Vaccines, r-DNA

products & some Medical Devices• Prohibit / restrict use of drugs and cosmetics – if found risky • Grant of License to import or manufacture drugs for testing• Grant of Licence to import drugs for personal use• Grant of NOCs for Export of drugs, cosmetics and medical devices• Testing of Drugs

Regulations & Guidelines for Clinical Trials

Drugs & Cosmetics Rules (Part X-A, Import or Manufacture of New Drug for

CT/marketing)

Schedule Y Requirements and guidelines for permission to Import and/or

Manufacture of New Drugs for sale or to undertake CT

GCP For Clinical Trials in India

Drugs & Cosmetics Rules (Part X-A) (Import or Manufacture of New Drug for CT /marketing)

Rules Till 30-1-2013:122A - Permission to import New Drug122B - Approval to manufacture New Drug122D - Permission to import /manufacture FDC122DA - Permission to conduct CT for New Drug / IND122DAA – Definition of Clinical trial122DB - Suspension / cancellation of Approval /Permission122DC - Appeal122E - Definition of New Drug

D&C Rules for CT till 30-1-2013• 122DA - Permission to conduct CT for New Drug / IND

No CT without permission from DCG(I), the Licensing Authority.Application (Form 44)+fee + Data (Schedule-Y) = permission (form 45/45A/ 46/ 46A)Fee exempted for Central or State Govt. if, for academic or research purposes

• 122DAA - Definition of Clinical TrialA systematic study of new drug(s) in human subject(s) to generate data for discoveringand/or verifying the clinical, pharmacological (including pharmaco-dynamic andpharmaco-kinetic) and/or adverse effects with the objective of determining safety and /or efficacy of the new drug

• 122E - Definition of New DrugA drug which has not been used in the country, new claim for a drug already approved,FDC (combined for the first time or change in ratio) and all vaccines.

Amendments in 2013 & 2014G.S.R. 53(E) dt. 30-Jan -2013 - Inserted

Rule 122DAB - Compensation in case of injury or death during CT

G.S.R. 63(E) dt. 01-Feb-2013 Inserted

Rule 122DAC- Permission to conduct Clinical Trial subject to certain Conditions , Authority for CT inspections , Actions in case of non-compliance

G.S.R No. 72(E) dt. 08-Feb-13 Inserted

Rule 122DD - Registration of Ethics Committee - Requirements and guidelines for registration of Ethics Committee

G.S.R. 889(E) dt. 12-12-2014 - Amendment

Rule122DAB – clarifications on the criteria for eligibility of Compensation.(implemented from 12-6-2015)

Drugs & Cosmetics Rules (Part X-A) (Import or Manufacture of New Drug for CT /marketing)

Rules at present:122A - Permission to import New Drug122B - Approval to manufacture New Drug122D - Permission to import /manufacture FDC122DA - Permission to conduct CT for New Drug / IND122DA A - Definition of Clinical trial122DAB - Compensation in case of trial related injury or death122DAC- Conditions to conduct Clinical Trials, Authority for CT

inspections , Actions in case of non-compliance 122DB - Suspension / cancellation of Approval /Permission122DC - Appeal122DD - Registration of Ethics Committee122E - Definition of New Drug

Amendments in 2015GSR 611 dt. 31-7-2015

Sch -Y,Informed Consent

• A-V recording of informed consent process is required for vulnerable subjects in NCE/NME trials;

• for anti-HIV & anti-leprosy drug trials, only audio recording.

• Essential elements in ICF– Possibility of failure of investigational product– Placebo will not any therapeutic effect

Amendment coming in 2016

Draft announced in Feb 2015; GSR .No: 69(E) Dt:3-2-2015

Addition Under Rule 122DA - Explanation for -Clinical Trial (CT)- definition (Rule 122DAA )deletedGlobal Clinical Trial (GCT)Investigational New Drug(IND), New Chemical Entity (NCE)

Insertion under SchY -appendix I and Form 44 -For NCE and GCT-

Assessment of Risk vs Benefit to the patientsInnovation Vs existing therapeutic options,Unmet medical need in the country

Applicants required to submit data to comply with the above.

1. If injury to the CT subject, free medical management shall be providedas long as required.

2. If the injury is related to Clinical Trial, the subject is entitled forfinancial compensation, in addition to free medical management

3. Compensation to the nominee, if CT related death of the subject,.

4. The expenses on medical management and financial compensation shall beborne by the Sponsor.

5. Sponsor shall give an undertaking along with the CT application to providecompensation in case of CT related injury or death.

6. If failure to provide medical management and/or compensation -CT can be suspended / cancelledSponsor can be restricted from conducting future CTsAny other action deemed fit.

Compensation in case of injury or death during CTRule 122DAB - Inserted vide G.S.R. 53(E) dt. 30-Jan -2013

R-122DAB(7)

a) Adverse effect of investigational product(s);b) Adverse effects due to concomitant medication excluding

standard care, necessitated as part of approved protocol;c) Failure of investigational product to provide intended

therapeutic effect;d) Use of placebo in a placebo-controlled trial;e) Violation of the approved protocol,

misconduct or negligence by the Sponsor or hisrepresentative or the investigator;

a) For injury to a child in–utero because of the participation ofparent in clinical trial;

b) Any clinical trial procedures involved in the study.

Injury or Death related to Clinical Trial

1. In case of injury to CT Subject subject during CT, free medicalmanagement shall be provided as long as required or till it isestablished that the injury is not related to the CT, whichever isearlier.

2. In case of CT related injury or death, subject is entitled for financial compensation as per order ofDCG(I).

2A. In case of no permanent injury, compensation commensurate withthe nature of non-permanent injury and loss of wages.

3. In case of CT related death, compensation to the nominee.4. The expenses on medical management and financial compensation shall be borne by the Sponsor.5. Sponsor shall give an undertaking along with the CT application to provide compensation in case of CT

related injury or death.6. In case of failure to provide medical management and/or compensation to the subject / nominee,

CT can be suspended / cancelled Sponsor can be restricted from conducting future CTs Any other action deemed fit.

Clarification to Compensation Amendment to G.S.R. 889 (E) dt. 12-12-2014,

implemented from 12-6-2015

7. Injury or Death due to following are considered as related to CTa) Adverse effect of investigational product(s);

b) Violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his representative orthe investigator;

c) Failure of investigational product to provide intended therapeuticeffect where the standard care, though available, was notprovided to the subject as per the clinical trial protocol

d) Use of placebo in a placebo-controlled trial where the standardcare, though available, was not provided to the subject as perthe clinical trial protocol

e) Adverse effects due to concomitant medication excluding standard care, necessitated as part of approvedprotocol;

f) For injury to a child in–utero because of the participation of parent in clinical trial;

g) Any clinical trial procedures involved in the study.

Clarification to Compensation Amended by G.S.R. 889 (E) dt. 12-12-2014,

implemented from 12-6-2015

Conditions with the Permission to conduct CT Rule 122DAC , – Inserted vide G.S.R. 63(E) dt. 01-Feb-2013

a) To comply with approved protocols, SchY, GCP guidelines & other regulations

b) Obtain Approval of the Ethics Committee - before initiation of the study

c) Before enrolling first patient, Register with Clinical Trials Registry of India

d) Should send Annual Status report to DCGI

e) Any SAE, analyse & send report within prescribed time as per Schedule- Y

f) If injury / death during CT, provide medical management and compensation and

send information to LA about the compensation paid, within time.

g) Inspection by CDSCO with State Authorities

h) To allow the inspection; search, seize records, documents, drugs; & answer

queries.

Conditions with the Permission to conduct CT Cont-----

2. The LA may impose additional conditions regardingobjective, design, population, eligibility assessment,conduct, treatment etc.

3. Failure to comply with the conditions , the LA maya. issue warning letter,b. to discontinue/ reject the study,c. suspend or cancel the trial permission,d. Debar the sponsor, investigator from

conducting CT in future4. Sponsor & Investigators may appeal to the Central Govt.

within 90 days of the order.

Rule 122DD - Registration of Ethics Committee Inserted vide G.S.R No. 72(E) dt. 08-Feb-13

1. Without registration with the LA, don’t review /approve any CT.2. Apply for registration as per App-VIII of Sch-Y. If submission

satisfactory, LA grants Registration or rejects application,3. Registration valid for 3 years from date of issue; Re-registration before 3

months of expiry; if any change in constitution or membership inform LA.4. Follow Sch-Y, GCP to Review and accord approval to a CT, carry out

ongoing review at appropriate intervals.5. If any SAE, analyse & forward opinion as per procedure, App-XII, Sch-Y6. Allow CDSCO to inspect the facilities, records, data and documents.7. Failure to comply conditions, LA can suspend / cancel the registration8. If so, may appeal to the Central Govt within 90 days of order

Application for EC Registration

a) Name and Address of ECb) Authority under which EC constituted, Membership requirements, Terms

of reference, Conditions of appointment, Quorum requiredc) Procedures for resignation, replacement / removald) Office address of ECe) Details of Chairman & all members(Name, qualification, organisation,

contact address & number, speciality)f) supporting staff detailsg) Details of protocols reviewedh) All SOPs , incl. for vulnerable populationi) Prevention of conflict of interestj) Training policyk) Audit report, if any

Schedule Y

Requirements and guidelines forpermission

to Import and/or Manufacture of New Drugs for sale or to undertake CT

Schedule Y1. Application for permission to Import or Manufacture of New Drug for CT/marketing2. Clinical trial

1. Approval for Clinical Trial2. Responsibilities of Sponsor3. Responsibilities of Investigators4. Informed Consent5. Responsibilities of EC6. Phase-I Trials7. Phase-II Trials8. Phase-III Trials9. Phase-IV Trials

3. Studies in special population1. Geriatrics2. Paediatrics3. Pregnant or nursing women

4. PMS5. Special Studies – BA/ BE Studies

Annexure to Sch-Y, Appendix I to XII

1. Data – to be submitted with the application2. Clinical Study Reports – structure, content, format3. Animal Toxicology4. Animal Pharmacology5. Informed Consent – structure, content, format6. FDC7. Investigator’s Undertaking8. Ethics Committee 9. Stability testing10. Contents of the Protocol for CT11. Data elements for SAE reporting12. Compensation in case of injury / death during CT – Added

GSR 53(E), 30-1-2013

Amendments in Sch-Y and AnnexureG.S.R. 53(E) dt. 30-1-2013 and G.S.R. 889(E) dt. 12-12-2014

• SAE – Definition• Reporting SAE

– Responsibilities of Sponsor– Responsibilities of Investigator– Responsibilities of Ethics Committee

• Ethics Committee• Informed Consent process, documentation• Procedure for Compensation payment

Serious Adverse Events (Sch-Y, 5A)

Definition inserted vide GSR 53(E) dt. 30-Jan -2013

SAE is an untoward medical occurrence during CT – associated with •death, •hospitalisation (study conducted on out patients), •prolongation of hospitalisation (study conducted on inpatients), •persistent or significant disability / incapacity, •a congenital abnormality or birth defect or is •life threatening

Responsibilities of Sponsor (Sch-Y, 2.2 - amended vide GSR 53 / GSR 889)

To maintain quality in conduct of CT, data generation, documentation and reports.

To comply with GCP and other applicable guidelines.

Status Report to LA at prescribed periodicity.

If study discontinued, submit summary report within 30 days.

SAE (unexpected) communicate within 14 days to LA and other investigators

SAE (death &others) report after analysis, within 10 days to Chairman of the EC, Head of the Institution and the LA. Additionally to the Chairman of the Expert Committee (death only) from 30/1/2013 to 12/6/2015)

SAE ( any) report after analysis, within 14 days to Chairman of the EC, Head of the Institution & the LA. – From 12/6/ 2015

In case of clinical trial related injury or death, sponsor to pay for medical management and financial compensation

Submit details of compensation paid, within 30 days of the order of DCG(I)

Responsibilities of Investigators (Sch-Y, 2.3 amended vide GSR 53 / GSR 889)

To conduct trial according to approved protocol, GCP guidelines

To comply with the undertaking given in App-VII.

To Maintain SOPs, documents.

To ensure adequate care in case of AE to the subjects

Report all Serious & unexpected AEs to Sponsor within 24 hrs and EthicsCommittee within 7 days (till 30-1-2013)

Report all Serious & unexpected AEs to Sponsor, EC and LA within 24 hrs.If SAE (death or others) report after analysis, within 10 days to Chairman ofthe EC, Head of the Institution and the LA. Additionally to the Chairman ofthe Expert Committee if death (from 30/1/2013 to 12/6/2015))

Report all Serious & unexpected AEs to Sponsor, EC and LA within 24 hrs.Failure to report within time, submit reasons with the report. After analysis, toreport within 14 days to Chairman of the EC, the LA, and Head of the Institution– From 12/6/2015

Responsibilities of Investigators (Sch-Y, 2.3) amended vide GSR 53 / GSR 889

The Investigator shall provide information through informedconsent process to the subject about

– Essential elements of the clinical trial as per Appendix - V

– Right to claim compensation in case of trial related injuryor death

– Right of the subject / nominee to contact the Sponsor/representative for the purpose of making claims in thecase of trial related injury or death

Responsibilities of EC (Sch-Y, amended vide GSR 53 / GSR 889)

1. Review and accord approval to a trial protocol to safeguard the rights, safetyand well being of trial subjects.– Exercise particular care to protect the rights, safety and well being of all

vulnerable subjects participating in the study ,– Prepare SOPs– Maintain record of the proceedings

2. To review all on going trials approved, at periodic intervals based on theprogress reports from Investigator, monitoring internal audit reports fromsponsor & by visiting study sites.

3. If approval for a protocol is revoked, record reasons for the same ;immediately inform the investigator and the LA

4. In case of SAE (death or others), report after analysis with opinion oncompensation to LA (death or others) and Chairman of the ExpertCommittee (death only) within 21 days.(from 30/1/2013 to 12/6/2015)

5. In case of SAE (any) report after analysis with opinion on compensationto LA within 30 days – From 12/6/2015

Patient Information Sheet/ ICF ( Sch-Y, App-V)Amended vide G.S.R. 53(E) dt. 30-Jan -2013

In ICF, it is included that

– in the event of injury, free medical management as long as requiredor till it is established that the injury is not related to the CT,whichever is earlier.(Amendment G.S.R. 889(E) dt. 12-12-2014)

– in case of CT related injury or death, sponsor will provide financialcompensation

For the subject, details are added -

– Address– Qualification and Occupation– Annual income of the subject– Name & address of his nominee & relationship with subject

Mandatory for Investigator to hand over a copy of filled ICD to thesubject or his/her attendant

Ethics Committee in

Sch- Y and GCP

EC’s Approval for CT (Sch-Y, 2.1)

1. Initiate trial only after permission from the LA, and the approval from the EC.

2. No deviation from protocol and no protocol amendment, without approval from EC and notification to the LA,

o except to avoid immediate hazard to trial subjects or in case of administration or logistic matters.

3. Exception to be notified immediately to the EC and within 30 days to the LA.

EC composition(App- VIII of Sch- Y and GCP 2.4.2.2)

• Not less than 7 members – Sch-Y / 5-7 members, max 12-15 - GCP• Minimum 5 members for quorum - Sch-Y and GCP• Chairman from outside the institution – Sch-Y and GCP• Member Secretary, may be within the institute – Sch-Y and GCP• Members from medical, non-medical, scientific & non- scientific – R122 DD,

Sch-Y &GCP• 1member shall be non- scientific and 1member independent of the institution

– Sch-Y • Appropriate representation: Gender (SchY), age, gender, community (GCP)• Members from other institutions communities if required – Sch-Y

EC Members (App-VIII of Sch-Y and GCP 2.4.2.2)

• 1,2 Basic medical scientist (preferably 1 pharmacologist) – Sch-Y and GCP• Clinician (1,2 from various institutes) – Sch-Y and GCP• Legal expert/ Legal expert or retired judge – Sch-Y and GCP• Social scientist/ representative of non govt. voluntary agency/ philosopher/

ethicist/ theologian – Sch-Y and GCP• Lay person from the community – Sch-Y and GCP• Subject experts / specific patient groups (based on requirement like HIV,

genetic disorders etc) can be invited to offer their views( Sch-Y and GCP ) But no voting for them (Sch-Y)

• Members should be aware of social, local, cultural norms – GCP• Medical scientist or clinician should have PG qualification and adequate

experience in their field and aware of their role and responsibilities – Sch-Y • No conflict of interest. If any, withdraw citing reason – GCP

Responsibilities of ECRule 122 DD & GCP 2.4.2.1

• To protect the dignity, rights, safety and well being of researchparticipants

• Responsible to review and approve protocol, suitability of investigators,facilities, methods, adequacy of information to be used for obtainingand documenting informed consent of the study subjects and adequacyof confidentially safeguards

• To ensure universal ethical values and international scientific standardsare expressed in terms of local community values and customs

• Assist in the development and education of research communityresponsive to local health care requirements

• To ensure adequacy of confidentially safeguards• To evaluate possible risks and expected benefits to the subjects

Ethics Committee (GCP 2.4.2) • Independent and competence are the hall marks • Sponsor / investigator to seek opinion regarding suitability of

– Protocol, methods and documents to be used in recruitment of subjects and obtaining informed consent including adequacy of information provided to the subjects

• Initial approval for every trial protocol• Regular continuous monitoring till completion – for compliance of

ethics in the approved program• Ensure competent review of all ethical aspects of the project proposal

received• Execute the same, free from any bias and influence that could affect their

objectivity• Specify in writing authority, for committee establishment, membership

requirements, ToR, conditions of appointment, the offices and quorum requirements

Terms of Reference for EC members - GCP 2.4.2.3

Members must be aware of • their role and responsibilities• provisions of CT under Sch Y, GCP and other

regulatory requirements to safeguard rights, safety and well being of the trial subjects

• Change in regulation , national & international developments in this regard

• EC should have its SOP, every member should have a copy

• ToR to include Terms of Appointment, policy for removal/ replacement/ resignation etc

Review procedure GCP 2.4.2.4

• Review only through formal meetings and not through circulation of proposals

• Must review every proposal• Before ethical review, scientific review must be

completed• Evaluate possible risks to subjects with proper

justification, expected benefits .• Adequacy of documentation for ensuring privacy,

confidentiality and justice issues.

Records to be maintained by EC

For – NLT 5 years from the date of completion of triala) Constitution and Composition of ECb) Curriculum of vitae of all membersc) All SOPsd) National and international guidelinese) Copies of protocols, CRF, IB etc submitted for reviewf) All correspondences with members and investigatorsg) Agenda and Minutes of all meetings with chairman's signatureh) Copies of decisions communicated to the applicanti) Records of all notifications issuedj) Final Reports of the study- microfilms, CD, video recordings

Ethics Committee In

Compensation Payment

Procedure for Compensation PaymentAppendix XII, Sch- Y

Inserted vide GSR 53 dt. 30-1-2013 & amended vide GSR 889 dt. 12-12-2014 (implemented from 12-6-2015)

In case of SAE (death / others) -

The EC has an important role in payment of compensation.

EC must get the 1st report within 24 hrs from the Investigator.

EC must get the 2nd report after analysis, from Investigator and sponsor within 10 days / 14 days.

EC to send its report after due analysis, to the LA and Expert committee within 21 days (only if death) / Only to LA within 30 days

The LA to pass order within 3 months days of Expert Committee’s report / 150 days of occurrence of SAE

Sponsor to pay within 30 days of order.

Investigator(All  unexpected SAE)

Sponsor(Any unexpected SAE)

Other Investigators

Ethics Committee

DCG(I) Licensing Authority

2 2

1

1within 24hrs 

within 7 days 

within 14 days 

within 14 days 

Before 2013

Investigator ( All SAE ;  Inform within 24hrs )

Sponsor and  Investigator (separately)(after analysis &  within 10 days )

Head of Institution 

Expert Committee(within 21 days of EC 

report receipt Recommendation + 

quantum of compensation)

Ethics Committee within 21 days 

(Report ‐ analysis opinion about compensation)

DCG(I) (pass orders, within  3 months of occurrence of SAE)

Sponsor / Applicant To pay Compensation within 30 days 

of the  DCG(I) order

If Death, (additional)

If Death (additioal)

2 2

2

2

33

4

5

1

1

1

If Death

Investigator ( All SAE ;  Inform within 24hrs )

Sponsor and  Investigator (separately)(after analysis &  within 10  14 days )

Head of Institution 

Expert Committee(within 30 days of EC report 

105 days of occurrence of event Recommendation + 

quantum of compensation)

Ethics Committee within 21 30 days (Report ‐ analysis opinion about compensation)

DCG(I)(pass orders, within 3 months 150 days of SAE)

Sponsor / Applicant To pay Compensation within 30 days 

of the  DCG(I) order

If Death, (additional)

If Death (additioal)

2 2

2

2

33

5

6

1

1

1

If Death 4

f d h

reports

If death, Send 3 reports

Measures taken by CDSCOto strengthen CT regulations

Measures to strengthen CT regulations

• Inspections of CT sites, Ethics Committees, Sponsors

• After the Supreme Court order, D&C Rule was amended thatA-V recording of Informed Consent Process isrequired for vulnerable subjects in NCE/NME trials. For HIV& Leprosy trials only audio recording. GSR 611 – 31-7-2015

• Global CT – applicants are required to provide undertakingthat they will market the drug in India post successfulcompletion of the study.

• CT proposals are evaluated through 3 tier system - SubjectExpert Committee, Technical Committee and ApexCommittee for NCE,s .

Measures to strengthen CT regulations

• To ensure that design used in a placebo control trial is appropriate,efficient and ethical.

• Not more than 3 clinical trials for an investigator - at a given time

• For Academic clinical research, approval of DCG (I) is necessary if theevaluation is for a new drug or a new use for an existing drug.

• Conduct CTs only at sites which have their own Ethics Committee –approved by DTAB for Amendments in Schedule-Y

• Online processing of CT applications

• Drugs and Cosmetics (Amendment) Bill, 2015 has a chapter on clinical trials containing penal provisions, provisions for payment of compensation, Ethics Committees, etc.

Action on Dr. RRC Committee’s report

• Independent Expert Committees constituted to examine the reports ofdeaths in clinical trials.

• Expert Committees has prepared the formulae for the quantum ofcompensation in case of clinical trial related deaths, injury other than death.

• CT - to be conducted in medical colleges, multispecialty hospitals havingemergency facilities and Institutional EC registered with CDSCO

• Sponsor/his representative to submit with CT application - Details of theircontract with the Investigator/institutions regarding financial support, fees,honorarium, payments etc. to be paid to the Investigator – DCGI order dt. 30Aug 2013

• Accreditation of Clinical Trial sites, Ethics Committees, Investigators –standards and formats have been issued The Quality Control of India, NABH

Thank You