The Drug Controller General of India (DCGI) has finalized and notified the requirements to be followed for submission of applications for Global Clinical Trials, with effect from December 1.
As per the requirements for filing applications for global clinical trial (for submission of data to countries other than India also), the applicant has to give details like of the applicant, authorization letter from the sponsor, name of the drug, regulatory status of the drug in other countries including names of countries where the drug is approved along with international package insert or where IND application is filed.
Objective of the study, phase of study, names of the participating countries /investigator sites, total number of patients to be enrolled globally, number of investigator sites to be enrolled in India and number of patients to be included in India and regulatory/ IRB approvals from participating countries. These approvals should be submitted along with their English translation and reason in case the company is submitting an expired IRB/ IEC approval.
Status of the study in other countries furnished should include details like the number of patients enrolled, number of patients completed in the study and number of patients discontinued. The applicant has to report any Suspected or Unexpected Serious Adverse Reaction (SUSAR) from other participating countries, if any reported. Further, it is necessary to give an affidavit from the sponsor that the study has not been discontinued in any country and in case of discontinuation; the reasons have to be further communicated to DCG (I) about future discontinuation.
Data Submitted to the DCGI should include chemical and pharmaceutical data, generic name and chemical name, dosage form, composition, animal pharmacology and toxicity data, animal toxicology data and clinical data, phase- I, II, III and IV etc. Documents submitted should include Form 44 and Treasury chalan, Form 12 and Treasury chalan, details of Biological specimens to be exported, Protocol, Informed Consent Documents (ICD), Case Report form, investigator's brochure, undertakings by the Investigators and Ethics Committee approvals, if already available.
Certain protocol amendments do not require notification or permission of the Licensing Authority. These include administrative and logistic changes and minor protocol amendments and additional safety assessments in case the institutional ethics committee has already approved these changes. In the case of additional investigator sites, change in investigator with the consent to withdraw from the earlier investigator and amended Investigators brochure and amended informed consent, it requires notification to the Licensing Authority but need not wait for permission. Prior permission of the Licensing Authority is required in the case of additional patients to be recruited, major changes in protocol with respect to study design, dose and treatment options and any change in inclusion or exclusion criteria.