What are the guidelines used in India for conducting clinical trials?

What are the guidelines used in India for conducting clinical trials?

India follows ICH-GCP guidelines to conduct clinical trials which describes responsibilities of ethics committee, sponsor and investigator and the requirements of a protocol, the investigator’s brochure (IB) and documents to pass audits and inspection.

What is Dcgi approval?

Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.

Who sets the rules for clinical trials?

As set forth in the 2019-CTRules and the Hdbk-ClinTrial, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in India.

What is the difference between Dcgi and Cdsco?

The Drug Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO). CDSCO is the central drug authority in India. CDSCO is a national level regulatory body under the Ministry of Health and Family Welfare.

What is CT 15 form?

The Central Licencing Authority hereby grant permission to (Name and full address of the active ingredient manufacturer) to manufacture the unapproved active pharmaceutical ingredient specified below to manufacture its formulation for test or analysis or for conduct of clinical trials or bioavailability or …

How do I get DCGI approval?

. Submit complete report of clinical trials as per the approved protocol from the individual investigator duly signed by him along with his observations/remarks on the drug. 2. Indicating the date of commencement and conclusion of the clinical trial at each center (in case the study is multi-centric).

What is ICH GCP guidelines clinical trials?

ICH-GCP represents quality standards that improve data quality, minimise unwanted exposure of humans to investigational products, enhance marketing prospects of new drugs and makes trials cost-effective for sponsors.

What are the rules of the clinical trial?

Clinical trials involving human subjects must be safe and the welfare of the subjects must be protected. The results from clinical research must also be reliable.

How do I get Dcgi approval?

Is Dcgi statutory?

The Central Drugs Standard Control Organization is headed by the Drug Controller General of India (DCGI) (CDSCO). CDSCO Is India’s Central Drug Regulator. CDSCO Is A Statutory Agency At The State Level, Reporting To The Ministry Of Health And Family Welfare.

What is ICH and ICH guidelines?

ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.

What is the schedule Y?

Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945. The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document.

How are clinical trials regulated?

The MHRA (Medicines and Healthcare Products Regulatory Agency), is a government agency in the UK that protects participants during a clinical trial by ensuring the trial is conducted safely. The governing body which regulates clinical trials in the US is called the FDA, Food and Drug Administration.

What is CFR in clinical trials?

The Code of Federal Regulations is a compendium of the general and permanent rules and regulations published in the Federal Register by the federal executive departments and agencies. The CFR is divided into 50 titles that represent broad areas subject to Federal regulations.