Office of the Drug Control General of India (DCGI) is preparing a basic checklist to verify the deficiencies in the applications submitted for approval of global clinical trials. The checklist and details of annexure for comprehensive data of clinical trials safety and efficacy will be finalized soon and the draft is likely to be published for comments by December, it is learnt.
The draft is likely to classify clinical trial applications into two sections, Category A and Category B for the purpose of granting permission.
Category A will include clinical trials for which the protocols are approved by some of the recognised and developed countries such as USA, UK, Switzerland, Australia, Canada, Germany, South Africa and Japan. Permission for this category will be granted after accepting the approval of protocols by the respective countries. Further, the time frame for clearance of Category A, based on the current load of 20 applications per month, will be two to four weeks.
Applications from the countries which are not covered under category A will fall under category B, for which the time frame is comparatively longer as the adequacy of the protocol have to be verified to protect the subjects. The approximate approval time for this category is expected to be eight to twelve weeks. The application once considered under Category B will not be shifted to Category A even though the applicant produces an approval from the developed countries.
Sources said incomplete applications are currently causing delay in clearance. Once the guidelines and checklist are in place, the authority will reject incomplete and non-complying applications, without seeking a second opinion. The applicant will have to re-apply for consideration of approval in the case of rejected applications.
The applicant would be instructed to file summarise information in the investigator's broachers duly supported by an affidavit to authenticate the filing. Besides, the CROs carrying out the global clinical trials should submit half yearly returns on the status of clinical trials.
The protocol amendments, according to the proposal, would be classified as those which do not require any information or permission, those which require to be informed but need not wait for permission and those which require prior permission before implementation of the amendments. There are also suggestions to simplify the procedure of issuing NOC for test license, clinical trial and export of serum samples in one permission letter as against the current practice of three permission letters.
Destruction of drugs imported for clinical trials has to be carried out by the CROs or sponsorer and a certificate on the status should be furnished along with the half-yearly returns, to be implemented. The authority may also probe on mandating an audit of the investigators and the ethical committees in clinical trials considering the request of the industrial associations.