November 17, 2018


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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In these IISs, he dons the dual mantle of an investigator and ‘sponsor’ and thus directly becomes responsible for ensuring regulatory compliance. Steps being taken by the MoH toward harmonization of standards and convergence of regulatory practices are laudable.

In such studies, the study drugs are part cdgi the treatment of the patient in the wisdom of the prescriber included in the protocol.

Clinical research regulation in India-history, development, initiatives, challenges and controversies: Such trials need to be conducted under an approved protocol with defined scientific objectives, inclusion and exclusion criteria, safety efficacy assessment criteria, etc.

Still long way to go. If the IEC does not hear from the DCGI within 30 days, it should be presumed that no permission is needed from the licensing authority. Regulatory environment for clinical research: In case a local CT waiver is required for any category other than those above, the matter should be brought before dcbi technical review committee for consideration.

Registration must be done before the first participant is enrolled. GSR E also has a provision for complete fee tuidelines provided the CT is to be conducted by a person of an institution or organization funded or owned, wholly or partially, by the central government or a state government.


Ministry of Health and Family Welfare.

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Of these, research, though long and difficult, is extremely fulfilling. 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 Guiidelines opinion.

It is recommended that all studies are registered at a public portal. Table 2 Key rules of the Drugs and Cosmetics Act and what they mean for the researcher. For institutes that do not have them, this would be a good committee to constitute. 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.

Institutional Ethics Committees function according to standard operating procedures [SOPS] that are usually available on their websites. He has a doctorate in pharmacology and over 20 years of industry experience.

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

Addressing problems facing the anesthesiologist. Feb 08, [Last accessed on Feb 25]. Bhave A, Menon S. Company Name Clinical Leader. Subscribe I agree to the Terms and Privacy Statement.

Get the latest articles from Clinical Leader delivered to your inbox. It has 12 appendices, formats for clinical trial protocols, informed consent forms, ethics committee EC approval templates and a format for serious adverse event SAE reporting.

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

Therefore preparedness of the study site at all times must be ensured. How to improve R and D productivity: This definition is proposed to be broadened per GSR E to include a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority which is the Drug Controller General of India [DCGI] officeliving modified organism, monoclonal antibody, stem cell, and gene therapeutic product or xenografts intended to be used as drug.


Academicians, however, also carry out their own research and these studies are called as ‘Investigator initiated studies’ IISs. Audio-visual Recording of Informed Consent of Process.

The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Recent past and expected future. It has Chapters, Rules and Schedules[ 67 ] and is amended at regular intervals to ensure greater safety, efficacy and drug quality.

The double burden of communicable and non-communicable diseases in developing countries. While there has been opposition to this spike in fees from some quarters, MoH is of the view the fee hike is long overdue considering the growth achieved by the pharmaceutical sector over the years. 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.

The formulae for compensation for both are described below.