27 Mar Guidelines (ICH-GCP) for clinical trials and follow the recently amended Schedule Y . Currently, the Drug Controller General of India (DCGI). The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final The revised ICMR guidelines released in is called the ‘Ethical. 1 Aug PDF | Organization (CDSCO), headed by the Drug Controller General of India Guidelines (ICH-GCP) for clinical trials and follow the recently.

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The past three decades have also seen remarkable advances in the field of anaesthesia, some of which include pulse oximetry, end-tidal gas monitoring, introduction of propofol and the laryngeal mask airway. Nov 19, [Last accessed on Feb 26].

Evolution of regulatory changes in India — as relevant to clinical trials. Do clinical trials conducted in India match its healthcare needs? How to improve R and D productivity: In case of SAEs other than deaths and permanent disability, the sponsor or its representative shall have to pay the compensation for a CT-related injury within 30 days of receipt of the EC opinion.

Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury. A fixed-dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio. Projects submitted essentially undergo two broad types of review- Full board or full committee review [for all projects that present more than minimal risk] or expedited review [for projects that pose no more than minimal risk; e.


It has Chapters, Rules and Schedules[ 67 ] and is amended at regular intervals to ensure greater safety, efficacy and drug quality. However, the sponsor shall have no liability for post-trial use of an investigational new drug or new drug.

Table 1 Evolution of regulatory changes in India — as relevant to clinical trials. FDA or by EU agencies. Clinical Trials Registry — India. The present article details these requirements giving their historical evolution, the key bodies in India that govern or oversee guideoines along with ‘must know’ and ‘good to know’ for the conduct of clinical trials in the country.

The interim compensation paid would not be recoverable irrespective of the causality relationship to the study.

For institutes that do not have them, this would be a good committee to constitute. The applicants are now mandated to have a pharmacovigilance system in place for reporting to the licensing authority. In such trials, the ethical aspects for protection of rights, safety, and well-being of the trial subjects shall be followed per the regulatory provisions, including that for compensation in case of CT-related injury or death and GCP guidelines.

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

His ambit, in addition, also extends to inspections of trial sites, inspections of sponsors of clinical research and manufacturing facilities in the country, oversight of the Central Drugs Testing Laboratory Mumbai and the Regional Drugs Testing Laboratory as also heading the Indian Pharmacopeia Commission among guidwlines other roles, responsibilities and functions.

Clinical research regulation in India-history, development, initiatives, challenges and controversies: Key updates or changes proposed in GSR E are discussed in this article.


A recent regulatory change with respect to IISs is that academicians who carry out trials with ‘new drugs’ no longer need approval from the DCGI for the conduct of the trial and IEC approval would suffice. In case a local CT waiver is required for any category other than those above, the matter should be brought before the technical review committee for consideration.

This is provided that these studies are not intended for generating data to make a regulatory submission. The control of the study including its conception, conduct and analysis remains exclusively with the investigator in these studies and would need a clear memorandum of understanding with the industry funder.

This guideline covers two broad aspects of clinical research — the general principles that need to be followed and guidance regarding special areas of research e.

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Registration is important from a publication standpoint point as editors of many Biomedical Journals will not accept papers that have interventional studies not registered with a Clinical Trials Registry. The pharmaceutical industry’s grand challenge.

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. Compensation for birth defect or congenital anomaly: Several governmental and non-governmental organisations within the country fund academic research and the academician needs to make an application to them with application formats and timelines being available on their home pages.

Further, the financial compensation has to be paid only upon receipt of a CDSCO letter, which follows the receipt of opinion from an independent expert committee constituted by the MoH.


Compensation for an SAE leading to life-threatening disease: However, this option has rarely been exercised for orphan drugs approved in the U. Academic CTs shall be conducted in accordance with the approved CT protocol by the EC, ethical principles specified in guidelines for biomedical research on human participant, and notified by the ICMR.

Anaesthesiologists are uniquely positioned to carry out translational research given the data-rich environment in which they practice[ 2 ] and this research can be used successfully to guide evidence-based practice of the discipline as gudielines public health policy. Academicians often carry out research that is based on observations in practice or in response to their patient’s needs.

Institutional Ethics Committees function according to standard operating procedures [SOPS] that are usually available on their websites. An example of this would be the intrathecal or epidural route of use of dexmedetomidine. Open in a separate window.

Registration must be done before the first participant is enrolled. Registration is free of charge, and once a CT is registered, it must be updated by the applicant.

Guest Column May 10, The double burden of communicable and non-communicable diseases in developing countries. Registration of Ethics Committees.