**Summary:**
This notice, No. 21013152017DC, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare on February 2, 2017, establishes a streamlined grievance redressal mechanism for applicants dissatisfied with the recommendations of Subject Expert Committees (SECs) regarding clinical trials, new drugs, and new medical devices.
The revised procedure mandates that appeals, including all relevant details, must be submitted to the DCGI within 7 days of the issuance of the SEC meeting minutes. The DCGI will then refer the appeal to a committee chaired by the concerned JDCI, which will provide its recommendations within 7 days.
The committee will consist of:
1. The concerned JDCI (Chairman).
2. The concerned DDCI.
3. One DDC from the Zone: DDC(EZ) or Ahmedabad for Biologics and other products, and DDC(SZ) or Hyderabad or Bangalore for Medical Devices and other products.
4. DDCI (AKP Coordinator).
The notice was approved by the competent authority and issued by Arun Sharma, Director (Admn). Contact information: Tel: 23216376. Relevant officers are to be notified. The notice is to be placed on the CDSCO website and filed.
Key Entities Referenced
Central Drugs Standards Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
Directorate General of Health Services: A government organization under the Ministry of Health and Family Welfare, involved in health administration and policy.
Ministry of Health Family Welfare: The Indian government ministry responsible for public health.
DCGI: Drugs Controller General of India, the head of the Central Drugs Standards Control Organization (CDSCO).
Subject Expert Committees SECs: Committees constituted by the Ministry of Health Family Welfare to evaluate applications for clinical trials, new drugs, and new medical devices.
JDCI: Joint Drugs Controller of India, who chairs the appeal committee.
DDCI: Deputy Drugs Controller of India, members of the appeal committee.
DDCIEZ: Deputy Drugs Controller of India, Eastern Zone.
No.21013/15/2017-DC
Central Drugs Standards Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
(Office of DCGI)
FDA Bhavan, Kotla Road,
New Delhi-110002.
Dated the 2TM February, 2017
NOTICE
For evaluation of various categories of applications of clinical trials, new drugs
and new medical devices, Subject Expert Committees (SECs), have been constituted
by the Ministry of Health & Family Welfare. These SECs meet regularly and submit
their recommendations to DCGI. It is however, observed that in a few cases where the
applicant is not satisfied with the recommendations of the SEC, he/she approaches
various authorities for redressing his grievance. In order to streamline the grievance
redressal mechanism, the following procedure will henceforth be adopted :
The appeal relating to the grievance, together with all details, will be submitted to the
o/o DCG! within 7 days of issue of the minutes of the meeting of the SEC. DCGI shall
refer the appeal to the following Committee under the chairmanship of concerned
JDC(I), which shall give its recommendations within 7 days. Other members of the
Committee will be :
1. DDCI concerned.
2. One DDC! from the Zone —- (DDCI)~EZ or Ahemedabad for Biologics & other
products and DDCI(SZ) or Hyderabad or Bangalore for Medical Revices &
other products).
3. DDCI (AKP) — Coordinator.
This issues with the approval of the competent authority.
( Arun Sharma )
Director(Admn.)
Tel : 23216376
RON> Officers concerned.
O/o DCGI/PPS to JS(R)
Website of CDSCO.
Guard file.