Drugs and Cosmetics rules, 2013 India

Transcription

1 Drugs and Cosmetics rules, 2013 India Dr.Pankaj Shah Professor, Dept of Community Medicine, SRMC & RI, & Member Secretary, IEC II, SRU, Chennai

2 Three important amendments 30 th Jan St Feb th Feb 2013 Please Verify all details from the amendments from. The ppts are only an attempt to simply.

3 Important issues Compensation for clinical trial related injury and death Reporting system Informed consent IEC functioning Inspection by Authorities etc.

4 Compensation for clinical trial related injury and death Free Medical management as long as required for the injury to clinical trial subjects In addition, financial compensation to be provided for injury and death to nominee (s) including in-utero injury To be borne by sponsor, its representative or investigator as sponsors whoever obtained permission from the Licensing authority

5 When to provide financial compensation Adverse effect of investigational product (s). Any clinical trial procedures involved in the study. Violations from approved protocols Failure of inv. Pro. To provide intended therapeutic effect Use of placebo in placebo controlled trials

6 When to provide financial compensation Adverse effects due to concomitant medication excluding standard care necessitated part of approved protocol. Injury to child in-utero

7 Adverse events Serious: untoward medical occurrence associated with death, hospitalization (OP study), Prolongation of hospitalization (IP study), persistence or significant disability or incapacity, congenital anomaly or birth defect or life threatening Non-serious:

8 Serious and unexpected adverse events Investigator will report all serious and unexpected adverse events to Licensing authority, sponsor or his representative and IEC within 24 hrs of the occurrence of event as per appendix XI

9 Serious adverse events Other than death: a) Sponsor: 1. Report after due analysis to Chairman IEC, Licensing authority and head of the institution of the trial site within ten calendar days of the event. Death a) Sponsor: 1. Report to Head of institution of the trial site(at the earliest). 2. Report after due analysis to Chairman IEC, Chairman, Expert Committee with copy of report to Licensing authority and head of institution within ten calendar days of the event.

10 Serious adverse events Other than death: b) Chairman IEC: 1. Report after due analysis along with opinion on financial compensation if any to Licensing authority within 21 calendar days of the event. Death b) Chairman IEC: 1. Report after due analysis along with opinion on financial compensation to Expert Committee with copy of report to Licensing authority within 21 calendar days of the event.

11 Serious adverse events Other than death: c) Independent expert committee: 1. It may be formed if required for finding out cause of the event and quantum of compensation. 2. No direct reporting of IEC to Independent expert committee Death c) Expert Committee: 1. finding out cause of the event and quantum of compensation. 2. Report to Licensing authority within 30 calendar days of the receiving report of IEC. (IEC should send report earlier for participants welfare)

12 Serious adverse events Other than death: c) Licensing authority: 1. finding out cause of the event and quantum of compensation (may be from Independent expert committee). 2. Pass the order within three months of receiving report of the event. Death c) Licensing authority: 1. finding out cause of the event and quantum of compensation from Independent expert committee). 2. Pass the order within three months of receiving report of the event.

13 Serious adverse events For all serious adverse events- sponsor its representative or investigator as sponsor has to act on the orders within 30 days of the receipt of the order.

14 Reporting system In addition to earlier reporting system: Sponsor undertaking to provide compensation while applying to Licensing authority for clinical trial permission. Failure to comply with compensation guidelines: Warning letters, trial rejection, trial discontinuation and debar all inovlved for future trials. Reporting the SAEs to other sites (? Holds true)

15 Periodic Safety Update Reports (PSURs) All relevant clinical and non-clinical safety data should cover only the period of the report (interval data). The PSURs shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years the PSURs need to be submitted annually. Licensing authority may extend the total duration of submission of PSURs if it is considered necessary in the interest of public health. PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period. However, all cases involving serious unexpected adverse reactions must be reported to the licensing authority within 15 days of initial receipt of the information by the applicant. (reporting changes)

16 Informed consent NFORMED CONSENT 1. Checklist for study Subject s informed consent documents 1.1 Essential Elements: 1.Statement that the study involves research and explanation of the purpose of the research 2.Expected duration of the Subject's participation 3.Description of the procedures to be followed, including all invasive procedures and 4.Description of any reasonably foreseeable risks or discomforts to the Subject 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected Subject should be made aware of this. 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject. 7.Statement describing the extent to which confidentiality of records identifying the Subject will be maintained and who will have access to Subject s medical records 8. Trial treatment schedule(s) and the probability for random assignment to each treatment (for randomized trials) 9. Compensation and/or treatment(s) available to the Subject in the event of a trial-related injury (to be modified) 10An explanation about whom to contact for trial related queries, rights of Subjects and in the event of any injury 11The anticipated prorated payment, if any, to the Subject for participating in the trial 12 Subject's responsibilities on participation in the trial 13 Statement that participation is voluntary, that the subject can withdraw from the study at any time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise entitled 14 Any other pertinent information

17 Modification of point 9 of Serial Statement describing the financial compensation and medical management as under: a) In the event of an injury occurring to the clinical trial subject, such subject shall be provided free medical management as long as required. b) In the event of a trial related injury and death, the sponsor or his representative, whosoever has obtained permission from the Licensing Authority for the conduct of the clinical trial, shall provide financial compensation for the injury or death.

18 Serial number 2 2. Format of informed consent form for Subjects participating in a clinical trial Informed Consent form to participate in a clinical trial Study Title: Study Number: Subject s Initials: Subject s Name: Date of Birth / Age: (lot of additions here) i)i confirm that I have read and understood the information sheet dated for the above study and have had the opportunity to ask questions. [ ] iii) To iv) points

19 Additions Address of the subject: ] Qualification: Occupation: Student/selfemployed/Service/House wife/ others (please tick as appropriate) Annual income of the subject: Name of the address of the nominee (s) and his relation to the subject (for the purpose of the compensation in case of the trial related deaths)

20 Signature (or Thumb impression) of the Subject/Legally Acceptable Representative: Date: / / Signatory s Name: Signature of the Investigator: Date: / / Study Investigator s Name: Signature of the Witness Date: / / Name of the Witness: Additions here: (copy of the patient information sheet and duly filled informed consent form shall be handed over tot the subject or his/her attendant).

21 IEC and its functioning Start approving clinical trial only after IEC registration Deadline for existing committee is over. Registration for 3 years from the date of issue. a) If application for renewal given three month before expiry, registration continues to be inforce until the orders are passed by the authority. b) change in membership or constitution are informed to licensing authority in writing.

22 IEC and its functioning Review and accord approval of clinical trial Ongoing review of the trial at regular intervals Opinion for Serious adverse events. Allow inspectors for inspection Scope, composition, Quorum requirement maintenance of records etc. Conflict of interest of members in writing and recorded in minutes of the meeting.

23 IEC and its functioning Importance of SOPs In general For vulnerable population Importance of training for new and exising committee members. Policy to monitor Policy for conflict of interest Minutes to be signed by Chairman.

24 Inspections

25 Thank you