**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Import Registration Division, on September 4, 9071, outlines timelines for cargo clearances at CDSCO port offices. This directive follows a decision made by the NCTF working group on PGA Regulations and Procedures, aiming for PGAs to publish clearance timelines on their websites by October 1, 2021. The notice specifies the following timelines for the issuance of No Objection Certificates (NOCs) for imported consignments: 3 hours for NOCs based solely on document checks; 24-48 hours for NOCs following document checks and physical inspection without lab testing; and 48-72 hours for NOCs after document checks, physical inspection, sample collection, and laboratory testing. Consignments requiring sampling may be released based on a Letter of Guarantee from the importer. This notice is addressed to all CDSCO Port Offices, Zonal/Sub-Zonal offices, and the CDSCO website. A copy has also been sent to the Under Secretary (R), Ministry of Health and Family Welfare. The issuing authority is Dr. V. G. Somani, Drugs Controller General. The file number for this notice is ImportMisc.392018DC Pt.12.
Key Entities Referenced
Directorate General of Health Services: A department within the Government of India responsible for health services.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) of India, under Ministry of Health & Family Welfare, responsible for regulation of drugs, cosmetics and medical devices.
New Delhi: City in India. Location of FDA Bhawan and Nirman Bhawan, where relevant offices are situated.
CDSCO: An abbreviation for Central Drugs Standard Control Organization.
NCTF working group on PGA Regulations and procedures: A working group focused on regulations and procedures related to Port Governing Agencies (PGAs).
Port Offices of CDSCO: Offices of the Central Drugs Standard Control Organization located at various ports.
Dr. V. G. Somani: Drugs Controller General, an official within the CDSCO.
Ministry of Health and Family Welfare: A ministry of the Government of India.
File No. Import/Misc./39/2018-DC (Pt.-12)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Import & Registration Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 4 + SEP 9071
NOTICE
Subject: Timelines for activities requiring minor and major procedures for cargo
clearances at port offices of CDSCO -Reg.
The NCTF working group on PGA Regulations and procedures was constituted in
accordance with the decision taken by the Steering Committee in its 5" meeting. The
third meeting of the working group on PGA Regulations and Procedures was held on
27.07.2021, wherein one of the — taken by the working group is as under:
“PGAs should publish timelimes for activities requiring minor and major procedures
for cargo clearances on their websites by 01.10.2021.”
“wt
In this regard, Port Offices of CDSCO shall follow the following timelines for
issuance of NOC in respect of release of imported consignments:
S. No. Activity Timeline
1 NOC to be granted only based on documents checks. 2 —3 hours
2 NOC to be granted after document checks and physical | 24 — 48 hours
inspection without involving lab-testing.
3 NOC to be granted after document checks, physical 48 72 heure
inspection, drawing of samples and testing by a laboratory.
In case of consignments where sampling is done, consignments may be
released based on Latter of Guarantee submitted by the importer.
iu
—_—
(Dr. V. G. Somani),
Drugs Controller General (I)
To,
1. All Port Office of CDSCO.
2. All Zonal/Sub-Zonal office of CDSCO.
3. CDSCO website.
Copy to:
4: The Under Secretary(R), Ministry of Health and Family Welfare, Nirman
Bhawan, New Delhi