**Policy Summary: Risk-Based Sampling for Import Consignments**
This order, issued by the Ministry of Health and Family Welfare, Government of India on December 29, 2015, announces the implementation of risk-based sampling for imported consignments covered under the Food Safety and Standards Act, 2006, and the Drugs and Cosmetics Act, 1940, and associated regulations. The policy aims to expedite trade across borders by reducing the time taken for clearance of import and export consignments. Instead of drawing samples from every consignment, a risk-based approach will be adopted, wherein only consignments identified based on predefined risk parameters will be subject to sampling at ports, airports, and other points of entry. The Department of Revenue, in consultation with other relevant departments, is developing a software to facilitate this process. The operationalization of the new risk-based sampling procedure is scheduled to begin on March 1, 2016, subject to the completion of the software development.
**Key Points:**
* **Objective:** To facilitate speedier trade across borders by reducing clearance times for imported consignments.
* **Scope:** Import consignments covered under the Food Safety and Standards Act, 2006, and the Drugs and Cosmetics Act, 1940, and regulations thereunder.
* **Methodology:** Shift from universal sampling to risk-based sampling based on predefined risk parameters.
* **Implementation:** A software is under development by the Department of Revenue.
* **Effective Date:** March 1, 2016 (subject to software completion).
**Contact:**
K.L. Sharma
Joint Secretary to the Government of India
**Distribution:**
1. Chief Executive Officer, FSSAI, FDA Bhavan, New Delhi
2. DCGI, CDSCO, FDA Bhavan, New Delhi
3. Secretary, Department of Revenue, Cabinet Secretariat (Attn: Shri T.K. Pandey, Joint Secretary)
4. Websites of MOHFW/FSSAI/CDSCO
Key Entities Referenced
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
New Delhi: The location of Ministry of Health and Family Welfare, India
Food Safety and Standards Act, 2006: An act of the Parliament of India to consolidate the laws relating to food safety and standards.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Department of Revenue: The department responsible for tax collection in India.
FSSAI: Food Safety and Standards Authority of India, an organization responsible for food safety regulations.
CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for Indian pharmaceuticals and medical devices.
K.L. Sharma: Joint Secretary to the Government of India
4
F.No. P-15025/44/2014-FQC
Government of India
Ministry of Health and Family Welfare
Nirman Bhavan, New Delhi - 110008
Dated: 29.12.2015
Order
Whereas the matter relating to faster clearance of import and export
consignments at the ports/airports/other points of entry has been under
consideration of the Government; and).
Whereas after detailed corisultations, it has been decided that amongst others,
it is possible to reduce the time taken for clearance of imported consignments by
adopting a risk based criteria for clearance of such consignments in place of
samples being drawn from each consignment.
Now, therefore, the Government of India has, with a view to facilitate speedier
trade across borders, decided to introduce risk based sampling of import
consignments covered under the Food Safety and Standards Act, 2006 and
. reguiations _ thereunder and, the Drugs and Cosmetics Act, 1940 and Rules
thereunder. For this purpose, a software is being developed by ihe Sepsitment of
Revenue in consultation with other Departments concerned, Subject to development
of software, the new procedure of risk based sampling for clearance of imported
consignments would be operationalized with effect from 01.03.2016, Accordingly,
samples from only such consignments of food and drugs as identified on the basis of
pre-defined risk parameters will be subjected to sampling at the ports/airports other
points of entry.
—_—
(K.L. Shérma)
Joint Secretary to the Government of India
To pane
1. Chief Executive Officer, FSSAI,FDA Bhavan, New Delhi
2, DCGI, CDSCO, FDA Bhavan, New Delhi
Copy to:
1 Secretary, Department of Revenue
> Cabinet Secretariat ( Attn: Shri T.K. Pandey, Joint Secretary)
3. Websites of MOHFW/FSSAI/CDSCO
WSC Preys) / Oreys Sela, a
(K. L. Sharma)