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.
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) 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.
4) Limitations for Investigator to undertake maximum of 3 trails will ensure more accountability and least chances of negligence in clinical trials.
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.
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.
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.
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.
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.
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.
11) Generics/ Biosimilars for countries like USA that have been marketed there for > 4 yrs & have a satisfactory report would be approved for marketing in India after abbreviated trials. 12) 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.
13) 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.
14) 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.
15) 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.