**Summary:**
This notification, issued by the Directorate General of Foreign Trade, Ministry of Commerce and Industry, Government of India, effective March 1, 2024, amends the export policy for Human Biological Samples under Chapter 30 of the ITC (HS) schedule 2 of export policy. Specifically, Notification No. 22023 revises the export policy for items falling under HS codes 30021020, 30021091, 30021210, 30021220, 30021230, 30021240, 30021290 and 30029010.
The amended policy now permits the free export of human biological materials/samples/products under Chapter 30, subject to obtaining a No Objection Certificate (NOC) from either the Central Drugs Standard Control Organization (CDSCO) or the Indian Council of Medical Research (ICMR), Department of Health Research (DHR). For items under the aforementioned HS codes related to activities covered under the provision of Drugs and Cosmetics Act 1940 Rules thereunder, export is free subject to NOC from CDSCO. Items NOT covered are free for export subject to NOC from IEMRDHR. This change is enacted under the authority of Section 3 and 5 of the Foreign Trade (Development and Regulation) Act, 1992, and paragraphs 1.02 and 2.01 of the Foreign Trade Policy, 2023.
For further information, contact the Director General of Foreign Trade at dgft@nic.in, referencing file number F. No. 01/91/180/148/AM23/EC/e-35188.
Key Entities Referenced
Directorate General of Foreign Trade: The issuing authority of the notification, responsible for foreign trade regulation.
Foreign Trade Development Regulation Act, 1992: The primary legislation authorizing the government to regulate foreign trade.
Foreign Trade Policy, 2023: The prevailing foreign trade policy document that guides export/import regulations.
Human Biological Samples: The subject of the export policy amendment, specifically related to Chapter 30 of the ITC HS schedule 2.
ITC HS schedule2: Indian Trade Classification based on Harmonized System of Coding. This schedule defines the export policy.
Central Drugs Standard Control Organization: An organization from which a No Objection Certificate (NOC) is required for the export of certain human biological samples.
Indian Council of Medical Research: An organization, operating under Department of Health Research, from which a No Objection Certificate (NOC) is required for the export of certain human biological samples.
Drugs Cosmetics Act 1940: The legislation governing drugs and cosmetics, relevant to the export of human biological samples related to activities covered under its provisions.
[To be Published in the Gazette of India Extraordinary Part-II, Section - 3, Sub-Section (ii)]
Ministry of Commerce & Industry
Department of Commerce
Directorate General of Foreign Trade
Vanijya Bhawan, New Delhi
Notification No. {2/2023
New Delhi, Dated: 1(**March, 2024
Subject: Amendment in export Policy of Human Biological Samples under Chapter-30
of ITC HS schedule-2 of export policy.
S.0. (E). — In exercise of powers conferred by Section 3 read with section 5 of the Foreign
Trade (Development & Regulation) Act, 1992 (No. 22 of 1992), as amended, read with Para
1.02 and 2.01 of the Foreign Trade Policy, 2023, the Central Government hereby amends
Export Policy under chapter 30 related to Human Biological Samples, as under:
IHS Code [Item Description Revised |Revised Policy Condition
|Export
30021020 | Antisera and other blood |P Fo rl ei ec y 1. Any human biological
fractions and immunological |subject to materials/samples/products which
products, whether or not [NOC are related to activities covered
modified or obtained by means under the provision of Drugs &
of biotechnological processes Cosmetics Act 1940 & Rules
30021091 | Antisera and other blood thereunder are free for export
fractions and immunological subject to No objection from
products, whether or not CDSCO.
m ofo d bi if oi te ed ch nor o lo ob gt ica ai ln e pd r ob cy e sm se ea s ns 2. Any human biological
30021210 | For diphtheria
materials/samples/products NOT
50021220 | For tetanus covered under (1) above are free
0021230 | For rabies for export subject to No objection
50021240 _| For snake venom from IEMRDHR:
30021290 _| Other
30029010 | Human Blood
2. Effect of the Notification:
Export Policy of Human Biological Samples under Chapter 30 of ITC HS schedule-2 of export
policy is amended to the extent that export of item that contains Human biological
materials/samples/products under chapter 30 is free subject to the NOC from Central Drugs
Standard Control Organization (CDSCO) or Indian Council of Medical Research (ICMR),
Department of Health Research (DHR).
a
. aA
(Santosh ‘Kumar Sarangi)
Director General of Foreign Trade
Ex-Officio Additional Secretary, Government of India
E-mail: dgft@nic.in
(Issued from F. No. 01/91/191/48/AM23/EC/e-35 188)