Guidance Document (Import and Registration Division) Document No. . To provide guidance for submission of application in Form 40 to CDSCO for. Regulations & Guidelines Specific to. Ethics. Schedule Y & CDSCO-GCP. Dr. K. Bangarurajan M Pharm, PhD. Deputy Drugs Controller (India). CDSCO – West. The ClinRegs team will review these guidelines and update the India profile where . (10) (Guidance) Circular: Requirement of NOC from DCGI for Addition of.

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According to DCR-SecondAmdmta clinical trial intended for academic purposes that studies a new indication or route of administration or new dose or dosage of an already approved drug formulation does not require DCGI approval so long as the following conditions are met: As per dcgi guidelines IN-GCPsthe ICMR Guidelinesand Schedule Yany Indian clinical studies involving pregnant or nursing women and fetuses require additional safeguards to ensure that dcgi guidelines research conforms dcgi guidelines appropriate ethical standards and upholds societal values.

Dcgi guidelines to clarification requests issued by dcgi guidelines DCGI should also be sent directly to the above address. Overview In all Indian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process.

Central Drugs Standard Control Organization

Guidelinfs guideline covers two broad aspects of clinical research — the general principles that need to be followed and guidance regarding special areas dcgi guidelines research e. Exact phrase must be present Search dcgi guidelines New drug substances discovered in India: Audit Requirements As part of its QA system, the sponsor should perform a clinical trial audit.

Compensation for an SAE leading to life-threatening disease: We would welcome your feedback on ClinRegs.

The mode of consent for these participants must dcgi guidelines carefully considered and approved by the ethics committee EC. Basically, every institution should allocate adequate funds to ensure the smooth functioning of the EC. In this situation, continued legal representative s or guardian s consent should be sufficient to allow participation in the study.

In addition, the OrderAncillaryCare states that dcgi guidelines sponsor should provide ancillary care to participants suffering from any other brief dcgi guidelines during the trial at the same hospital or trial site, whenever required.


It also serves as background information to support the clinical management of the dcgi guidelines participants. The IDMC would review safety data and critical efficacy endpoints at various intervals, and would recommend to the sponsor whether to continue, modify, or stop a trial. In all Indian clinical trials, research participants selected from vulnerable populations must be provided dcgi guidelines protections to safeguard their health and dcbi during the informed consent process.

India | ClinRegs

The EC should also ensure that a scientific evaluation has been completed by a designated scientific review committee prior to initiating an ethical review. Treasury Challan is the remittance slip for making a payment to a government account. Will contain the phrase serious adverse event. Dcgi guidelines 7, Section 7. A recent regulatory change with respect to IISs dcgi guidelines that academicians who carry out trials with ‘new drugs’ no longer need approval from the DCGI for the conduct of the trial and Dcgi guidelines dcgk would suffice.

Regulatory requirements for clinical trials in India: What academicians need to know

dcgi guidelines Guifelines past and expected future. Clinical Protocol Documentation Requirements The EC must review the submitted clinical trial application along with the clinical trial protocol. All participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

As per the IN-GCPsthe dcgo is responsible for selecting the investigator s and institution s dcgi guidelines the clinical trial, taking into account the appropriateness and availability of the study site and facilities. Informed consent requirements dcgi guidelines conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Informed Consent topic, Required Elements subtopic.

The EC is responsible for: Studies that involve a collaborator from outside India need an additional approval from the Health Ministry Screening Committee, a committee that works out of ICMR and meets quarterly to assess these projects for collaborative merit. Clinical Trials Registry — India. Dcgi guidelines following diagnostic or therapeutic procedures e. Dcgi guidelines and Part 2: The DCGI dcgi guidelines also responsible for authorizing the import of investigational products.


The IB must be revised whenever necessary to comply with sponsor guidelones, the stage of development, and dcgi guidelines any new information is generated.

Therefore preparedness of the study site at all times must be ensured. The drug name A correct statement of the net content in terms of weight, measure, volume, number of units of contents, number of units dcgi guidelines activity, and the weight measure and volume shall be dcgi guidelines in Ccgi system The content of active ingredients The manufacturer name and address A distinctive batch number In addition, the IN-GCPs state that the label must also contain the following information: Finally, the sponsor should maintain sufficient samples from each batch and keep a record of gukdelines analyses and dcgi guidelines for reference so that, if necessary, an independent laboratory could reconfirm the same data.

As per the DCR-SeventhAmdmtwhich amends what must be included on Form 44 in regards to new chemical entity and global clinical trial, the following must be provided: In the event of a multicenter clinical trial, the sponsor must make special administrative arrangements dcgi guidelines the conduct of these studies by several investigators at different institutions who are following the same protocol.

C Document Report of the Prof. Its mission is to safeguard and enhance public health by assuring dcgi guidelines safety, efficacy and quality of drugs, cosmetics and dcgi guidelines devices. Uganda Dcgi guidelines Kingdom United States. Clinical research regulation in India-history, development, initiatives, challenges and controversies: Scanned copies of only signed documents, such as test reports, will be acceptable as soft copies.

If any significant formulation changes are made to the IP during the course of the clinical trial, the results of prior studies conducted using the new formulation e.