CLINICAL RESEARCH POSITIVE NEWS - VRY IMPORTANT - NEW DCGI RULES- CLICK HERE - CLINI INDIA CANDIDATES MUST LEARN - "D2"

Recent Updates by DCGI which will ultimately attract new trials in India:

1) Confirming the turnaround time for approvals and making the deadline as 180 days for all 

Global Clinical Trials. Confirmed on 30 May 2014.

2) Drafting a revision over the last update done as 122 DAB over the compensation for the trail 

related injuries. Also order released confirming that compensation for death or trial related 

injuries should be paid to the trial subject or nominee if any drug related anomaly is been 

identified and accepted. 3 July 2014

3) Now instead of just one NDAC, now load of new drug clinical trial approval will go in two 

layers primarily first review by SEC (Subject Expert Committee) and their recommendations 

will be reviewed by TRC (Technical Review Committee) and finally CDSCO will grant approval 

from TRC recommendations. This will now decrease the turnaround time of clinical trial 

approval. 03 July 2014

4) Limitations for Investigator to undertake maximum of 3 trails will ensure more accountability 

and least chances of negligence in clinical trials. 3 July 2014

5) Though Phase I clinical trial is exempted for medical devices but procedure for clinical trial 

approval, accreditations of investigators, sites, ethics committee and such other conditions 

will remain same. 03 July 2014

6) All trail subjects will be provided with primary care for any illness during their trial 

participation this may be within the site or hospital. 3 July 2014

7) Academic studies will be conducted upon approval by IEC but if there is any new drug or new 

use of an existing drug involved then it requires DCGI approval. 3 July 2014

8) Clinical trial for new drugs which are already approved in other countries outside India can 

be waived if it’s for national emergency, extreme urgency and conditions / diseases for which 

there is no therapy. 3 July 2014

9) There were factors which will be now reviewed by SEC which will decide if there are ethnically 

sensitive or insensitive before giving approval to any clinical trial. 3 July 2014

10) It has been decided if Indian patients have been participated in phase III global clinical trials; 

the number of participants would have adequate considering the approval of drug in India. 3 

July 2014

11) Considering the placebo control to be very uncommon CDSCO considered there should be an 

existing therapy to compare the test drug. It should be appropriate, efficient and ethical. 3 

July 2014

12) If Indian population is participating in global clinical trials and for indication which is 

prevalent in India so in that sponsor/ innovator should market this NCE in an expedited way 

by manufacturing. This needs to be confirmed in the form of undertaking while submitting 

the application. 3 July 2014

13) If two or more countries have removed drug from the market in grounds of safety and 

efficacy then the continued marketing of the drug will be subjected to examination and 

action. 3 July 2014

14) CDSCO require post marketing surveillance of drugs, rational use of drugs, drug utilization 

studies and adverse drug reactions monitoring so for the same there was a cell constituted 

within CDSCO which will be working with ICMR for the sponsoring various studies. 3 July 2014

BY..,

VIRENDRA SHUKLA

Consultant Clinical Operations, WCT & Clini India

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