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. Guidelines (ICH-GCP) for clinical trials and follow the recently amended Schedule Y . Currently, the Drug Controller General of India (DCGI). o Office of Drugs Control General (“DCGI”) (India’s licensing authority) o Indian Council of Medical Research (“ICMR”) guidelines; Indian.

Author: Tat Zolot
Country: Canada
Language: English (Spanish)
Genre: Automotive
Published (Last): 9 November 2016
Pages: 67
PDF File Size: 3.20 Mb
ePub File Size: 13.52 Mb
ISBN: 631-1-18844-251-6
Downloads: 18625
Price: Free* [*Free Regsitration Required]
Uploader: Kazikazahn

Institutional Ethics Committees function according to standard guidelihes procedures [SOPS] that are usually available on their websites. A ‘new’ drug[ 12 ] is one:. In addition, send to Chairman of IEC and the Head of the institution where the trial has been conducted within 14 calendar days of occurrence of the event.

Here, the academician raises funds for the study through his efforts from various sources including possibly the pharmaceutical industry. The Indian Council of Medical Research ICMR is the apex body that is responsible for the formulation, coordination and promotion of biomedical research. The double burden of communicable and non-communicable diseases in developing countries.

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

Global Focus: Clinical Trials in India – Food and Drug Law Institute (FDLI)

GSR guideilnes E dated January 31, This is provided that these studies are not intended for generating data to make a guideljnes submission. Drugs and Cosmetics Act. 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.

Audio-visual Recording of Informed Consent of Process. Addressing problems facing the anesthesiologist.

The draft CT Rules seek to address the healthcare landscape in India by providing accelerated approval for new drugs intended to treat serious or life-threatening conditions or diseases of special relevance to the country, address unmet medical needs, and include postmarketing trials to validate the anticipated clinical benefit. Drug development research, in particular, is long and arduous and bringing a single new drug costs on an average USD 1.


Sanders RD, Maze M. For example, a requirement to obtain video-recorded consent from all human subjects was modified to apply only to vulnerable populations, 3 the rule limiting investigators to only three trials was revoked, and the requirement for institutional ethics committee IEC permission for the addition of new trial sites or investigators was also eliminated.

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

The amended Schedule Y provides a checklist of essential elements to be included in the informed consent form as well as the contents of protocols for conducting CTs. Abstract The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research.

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. In addition, several pharmaceutical companies in the country also fund investigator initiated research. Registration of the clinical trial with the Clinical Trials Registry of India The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered.

Site preparedness rule DAC Understand that the regulator can inspect the site at any time and that he can cancel the trial permission and discontinue the study. Still long way to go.

Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements. These studies called clinical trials or regulatory studies are conducted with the academician as the principal investigator largely in academic centres.

An already approved drug that is now proposed to be used in a different dosage, different dosage form, a new route or a new indication. For institutes that do not have them, this would be a good committee to constitute.


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 notification dated 19 th November, An example of this would be the intrathecal or epidural route of use of dexmedetomidine.

The academic investigator needs to be up to speed in reading, understanding and applying regulations and work in tandem with the pharmaceutical industry for greater patient benefit. The pharmaceutical industry’s grand challenge. How to improve R and D productivity: Its mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Obtain informed consent from participants Investigators must ensure that written, informed consent is obtained from all participants in a clinical trial.

Is it the Answer for Terminally Ill Patients? 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

Regulatory environment for clinical research: What is a ‘new drug’ A ‘new’ drug[ 12 ] is one: Therefore preparedness of the study site at all times must be ensured. It is recommended that all studies are registered at a public portal.

Clinical research regulation in India-history, development, initiatives, challenges and controversies: 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 also public health policy.