**Policy Summary: Renaming of New Drugs Advisory Committees and Review Procedure for Clinical Trials and New Drugs**
This order, issued by the Central Drugs Standard Control Organization (CDSCO) on July 3, 2014, outlines a revised procedure for the review of clinical trial and new drug applications. The policy stems from recommendations made by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, which was tasked with formulating policies and guidelines for new drug approvals, clinical trials, and drug bans.
Key changes include:
1. **Renaming of Committees:** New Drug Advisory Committees (NDACs) are renamed as Subject Expert Committees (SECs). Twelve SECs are established, each focusing on a specific therapeutic area, including Oncology/Hematology, Cardiovascular/Renal, Metabolism/Endocrinology, Antimicrobial/Antiparasitic/Antifungal/Antiviral, Reproductive/Urology, Gastroenterology/Hepatology, Dermatology/Allergy/Immunology, Pulmonary, Neurology/Psychiatry, Analgesic/Anesthetics/Rheumatology, Ophthalmology and Vaccines. The terms of reference and other conditions for these committees remain the same.
2. **Evaluation Process:** Clinical trial and new drug applications will be initially evaluated by the SECs.
3. **Technical Review Committee (TRC):** Recommendations from the SECs will be reviewed by a newly formed Technical Review Committee (TRC). The TRC will be constituted under the Directorate General of Health Services (DGHS) and will comprise experts in areas such as clinical pharmacology, regulatory clinical toxicology, pathology, medicinal/pharmaceutical chemistry, pharmacy, immunology, clinicians, basic scientists involved in drug development and subject specialists drug indication wise.
4. **Approval Authority:** The CDSCO will grant approvals for clinical trials and new drugs based on the recommendations of the TRC.
The order mandates the use of the term "Subject Expert Committee (SEC)" in all future correspondence related to the evaluation of clinical trial and new drug applications.
The order was issued by Dr. G.N. Singh, Drugs Controller General of India.
Key Entities Referenced
Dr. G.N. Singh: Drugs Controller General of India
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Ministry of Health Family Welfare: The government ministry responsible for health policy in India.
New Drugs Advisory Committees: Formerly known committees responsible for reviewing new drug applications, being renamed Subject Expert Committees.
Prof. Ranjit Roy Chaudhury: Chair of the Expert Committee formed to formulate policy and guidelines for approval/banning of drugs and clinical trials.
Technical Review Committee: Committee proposed to review recommendations from Subject Expert Committees, under DGHS.
DGHS: Directorate General of Health Services
Subject Expert Committees: Renamed New Drug Advisory Committees, responsible for initial evaluation of clinical trials and new drugs applications.
File No. 12-01/14-DC Pt.47
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
FDA Bhawan, Kotla Road, New Delhi-110002
Dated: 03.07.2014
ORDER
SUBJECT: Procedure for review of applications of clinical trials and new drugs- renaming
of New Drugs Advisory Committees (NDACs) - regarding :
The Ministry of Health & Family Welfare had constituted an Expert Committee under the
Chairmanship of Prof. Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new
drugs, clinical trials and banning of drugs. The Expert Committee submitted its report to the Ministry
of Heaith & Family Welfare. The actions proposed to be taken on the recommendations of the
Expert Committee were finalised by the Ministry of Health & Family Welfare.
As per the action, New Drug Advisory Committees (NDACs) will be renamed as Subject
Expert Committees. The members for their meetings will be drawn randomly from a large pool of
experts. Applications of clinical trials and new drugs will initially be evaluated by the Subject Expert
Committees and their recommendations will be reviewed by the Technical Review Committee
(TRC). The TRC is proposed to be constituted under DGHS consisting of experts from each areas
i.e. clinical pharmacology, regulatory clinical toxicology / pathology, medicinal / pharmaceutical
chemistry, pharmacy and immunology including clinicians, basic scientists involved in drug
development and subjects specialists (drug indication wise). CDSCO will grant approval of Clinical
Trial and New Drugs based on the recommendations of TRC.
In pursuance to above, the twelve NDAC committees constituted vide order number
X.19029/5/2011- DFQC dated 31.03.2011 are renamed as Subject Expert Committees (SEC) as
under:
PO SEC- Oncology & hematology
SEC- Cardiovascular and renal
SEC-Metabolism & endocrinology
SEC- Antimicrobial, Antiparasitic & Antifungal, Antiviral
SEC- Reproductive & Urology
SEC-Gastroenterology & Hepatology
SEC-Dermatology & Allergy, immunology
SEC- Pulmonary
. . SEC- Neurology & Psychiatry
10. SEC- Analgesic, Anesthetics & Rheumatology
11. SEC- Ophthalmology
12.. SEC- Vaccines
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The terms of reference and other conditions will remain same.
Henceforth, in all correspondence related to evaluation of application of clinical trials, new
drugs etc., the term Subject Expert Committee (SEC) as above should be used in place of NDAC.
(Dr. GFN. Singh)
Drugs Controller General (India)
To
1. NDAC members
2. IDMA /IPA/ OPPI/ISCR / ACRO / FOPE / CIPi
3. All officers of CDSCO
Copy to : US (D), MOH&FW, New Delhi.