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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Nat Rev Drug Discov. The ECs now have a larger than ever onus need to appreciate and understand risk — benefit and to empower themselves through repeated training and use of standard operating procedures given that it is known that the quality of IEC review gkidelines the country remains variable. Do clinical trials conducted in India match its healthcare needs?

The Schedule Y amendment released on 20 th January, saw dramatic changes that attempted to bring India on par with internationally prevalent regulations.

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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. Registration of Ethics Committees that approve studies Rule DD [ 15 ] Investigators and Administrators of Academic Institutes should ensure that their Institutional Ethics Committees IECs are registered with the central licensing authority and the registration renewed at the end of 3 years.

CTs for a new drug can be initiated only after the CDSCO has granted permission and the ethics committees ECs of the relevant sites have approved conduct of the study protocol. Feb 08, [Last accessed on Feb 25]. Open in a separate window.

The clinical pharmacological including pharmacodynamic and pharmacokinetic effects. A recent regulatory change with respect to IISs is that academicians who carry out trials with xcgi drugs’ no longer need approval from the DCGI for the conduct of the trial and IEC approval would suffice. Addressing problems facing the anesthesiologist. 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.


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. The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research.

Such studies are conducted with a new drug under approved conditions of its use under a protocol approved by the DCGI office with scientific objective. Status of ethical review and challenges in India. For trials that involve vulnerable participants children or mentally challenged patients for example and involve a new chemical entity or a new molecular entity, the investigators in addition have to ensure audio visual recording of the informed consent process gazette guidellnes dated 19 th November, Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury.

Compensation for an SAE leading to life-threatening disease: In these IISs, he dons the dual mantle of an investigator and ‘sponsor’ and thus directly becomes responsible for ensuring regulatory compliance. Comments from stakeholders will likely result in certain amendments of the provisions under GSR E rules such as special considerations regarding biological products like vaccines and r-DNA derived drugs before they are finalized into law.

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.

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

Registration of Ethics Committees. The Intensive Care Unit specialist: The pharmaceutical industry’s grand challenge. Table 1 Evolution of regulatory changes in India — as relevant to clinical trials. Get the latest articles from Clinical Leader delivered to your inbox. Drugs and Cosmetics Guudelines. In the event that the IEC feels that there could be a potential overlap between the academic and regulatory purposes of the trial, they should notify the office of the DCGI.


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 guidwlines, and notified by the ICMR. Sanders RD, Maze M. Ugidelines has not been used to a significant extent in the country. The present article details these requirements giving their historical evolution, the key bodies in India that govern or oversee research along with ‘must know’ and ‘good to know’ for the conduct of clinical trials in the country.

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

If the IEC does guidleines hear from the DCGI within 30 days, it should be presumed that no permission is needed from the licensing authority. This act first came into being in and regulates the import, manufacture and distribution of drugs in the country to ensure that drugs and cosmetics sold in the country are safe, effective and conform to essential quality standards. The revised ICMR guidelines released in is called the ‘Ethical Guidelines for Biomedical Research on Human Participants’ and remains valid as of today, and a revised version is expected in Further, to counter the corresponding increase in application load efficiently, the government needs funds and they have to be guidlines from the industry, on the lines of the user fees charged by the U.

The Indian Council of Medical Research ICMR is the apex body that is responsible for the formulation, coordination and promotion of biomedical research.