DCGI has revised the list of documents that needs to be submitted for grant of DCGI BA / BE NOC. This will be effective from 01st February 2014. This article provides the micro details of the updated list of documents required by DCGI for grant of BA / BE NOC
In an effort to streamline the review and approval process for providing permission to conduct BA / BE studies [BA / BE NOC]in India for export purposes, with healthy human subjects or patients, the DCGI has issued a revised checklist for documents. The revised list of documents to be submitted to DCGI for grant of BA / BE NOC will become effective from 01st February 2014. If you want to have a look at the salient features of the new revised list required for DCGI BA / BE NOC application check our post on "Revised list of documents to be submitted to DCGI for grant of BA / BE NOC - Updated JAN-2014". As promised we are posting this detailed article to provide the micro details on the updated list of documents required by DCGI for grant of BA / BE NOC.
The documents required for grant of DCGI BA / BE NOC to conduct a clinical BA / BE study with a drug, varies based on the approval status of the study drug under consideration in India. To find in detail how drugs are classified in India based on their approval status check this post on "Classification of drugs in India based on their approval status."
A: Approved in India for more than 4 years except for modified release dosage form [old drugs]
The below specified documents should be provided for DCGI BA / BE NOC application for drugs approved in India for more than 4 years. However this does not applies to modified release dosage form (i.e) all modified release formulations will be considered as new drugs inspite of thier approval status. It should be noted as per previous gulation you need not get DCGI BA / BE noc for a drug available in India for more than four years.
- Form-12 application along with treasury challan for Rs. 15000/.
- Application for BA / BE NOC in Form-44 duly signed, by the authorized signatory of the company applying for BENOC with details of name and designation.
- Duly executed Sponsor’s authorization letter in company letterhead signed by the authorized signatory of the company whose investigational medicinal products are being tested.
- Undertaking letter from the sponsor that the sponsor will provide complete medical care as well as compensation for the injury or death and the detail of compensation provided in such cases would be intimated to The Office of Drugs Controller General (India) as per Rule 122 DAB of D&C Act 1940 & Rules there under
- Duly signed undertaking by the Principal Investigator (PI) on a company letterhead as per appendix VII of Schedule "Y" of Drugs and Cosmetic Rules. The undertaking should be signed by the principal investigator in original. No one including the co-investigator should sign on the principal investigator's behalf with a "For" tag.
- The approval copy issued by DCGI for the BA / BE Centre along with details of number of beds for which approval was provided. Details of the number of beds at the intensive care unit [ICU] of the BA / BE Centre for effective handling of SAEs in emergency situations should also be provided. This can be provided in the form of a declaration in the BA / BE Centres letter head
- The Office of Drugs Controller General (India) issued registration certificate [under Rule-122DD] for the Independent/Institutional Ethics Committee (IEC), which approved the protocol, should be included in the submission
- Address details of the sponsor, IEC location and study site location. This will be provided in the protocol. However it should be noted that DCGI is in particular stern about the location of the IEC and study centre. The IEC and study site location should be in close vicinity so as to enable the IEC to monitor the study.
- The study protocols, protocol IEC approval letter [if available], Informed Consent Form [ICF] or Patient Information Sheet [PIS] along with SOP or system for audio-visual recording to be implemented in the study under consideration as per Schedule Y guidelines should be submitted
- A statement to that the sponsor will provide complete medical care as well as compensation for the injury or death should be incorporated in the Informed Consent Form.
- A short brief summary of the study briefing the process and procedures to be followed in the study should be part of the submission. The synopsis section of the protocol will serve the purpose in most cases.
- Details of dosage form & strength of the investigational medicinal products to be tested [study drug] in the proposed study and their current regulatory status in India should be provided
- Report of any study related deaths that occurred in the study site during last 3 years while using the drug for which DCGI BA / BE NOC is being applied should be reported
- The pharmaceutical data of the Test formulation including stability data for three months should be shared. If data for three months is not available, current available data [at least one month] can be shared at the time of application. However an update should be filed when the three months data is available.
- Certificate of Analysis (COA) of representative batches of Test & Reference formulations to be used in the BE study should be submitted. If BA / BE NOC is applied for Oral solid dosage forms, dissolution profile of Test & Reference formulations intended to be used in the study should also be submitted.
- For Multiple dose BE study adequate supporting safety data & PK/PD data should be submitted covering the duration of period for which the study has to be conducted. If Regulatory Guidance is available and recommends the need for multiple dosing provide a copy of the guidance.
- If BA / BE NOC involves injectable formulations, the sub-acute toxicity of the test formulation studied in at least two species of animals for a minimum of 14 days should be submitted
- For BE studies involving patients, treated with cytotoxic, hormonal, narcotic or psychotropic drugs/preparations/substances a scientific justification and proper risk mitigation strategy with special emphasis on safety should be submitted
- Depending on the nature of the drug, disease and studies further specific information may also have to be furnished by the sponsor to secure BA / BE NOC
- All BA / BE NOC applications should be accompanied with the above mentioned documents consisting of proper index with page numbers in legible form.
B: New Drugs approved in India for a period of more than 1 year but less than 4 years
For New Drugs approved in India for a period of more than 1 year but less than 4 years, the below specified documents in addition to that specified in Section A, should be provided for DCGI BA / BE NOC application
- Chemical data of the study drug
C: Drug products in modified release form irrespective of their approval statusFor Drug products in modified release form irrespective of their approval status , the below specified documents in addition to that specified in Section B, should be provided for DCGI BA / BE NOC application
- Form-12 application along with treasury challan for
- Rs. 15000/- In case if the study drugs approved in India
- Rs. 25000/- In case if the study drugs is not approved in India
D: New drugs approved in India within a period of one year
For New New drugs approved in India within a period of one year , the below specified documents in addition to that specified in Section C, should be provided for DCGI BA / BE NOC application
- Form-12 application along with treasury challan for Rs. 25000/.
- Published articles, reports or regulatory dossiers with Pharmacokinetic and Pharmacodynamics data of the study drug from studies carried out in healthy subjects/ patients demonstrating safety and tolerability of the study drug
- The patient package insert and or the prescribing information leaflet of the study drug
E: New molecule not approved in India but approved in other countries
For New New drugs approved in India within a period of one year , the below specified documents in addition to that specified in Section D, should be provided for DCGI BA / BE NOC application
- Names of the countries where the study drug is currently being marketed to be mentioned in the covering letter of the application
- The regulatory approval status of the study drug in other countries should be presented along with details of approved strength and dosage form
- The Non-clinical data and clinical data of the study drug should be provided as per Appendix I of Schedule Y
It should be noted that one cannot perform bio studies in India on Indian population for a drug not marketed/approved anywhere in the world. If you have any doubts or require clarification regarding the content please feel free to post in the comment section, we will try to answer your queries at the earliest to the best of our knowledge
Tags: BENOC, CDSCO, DCGI, Regulatory