This notification amends the export policy for human biological samples under Chapter 30 of the ITC HS schedule-2.
The export of items containing human biological materials/samples/products under Chapter 30 is now free, subject to 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).
Key Changes
The export policy for specific HS codes under Chapter 30 has been revised.
HS Code 30021020 (Antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes) is now free for export subject to NOC from CDSCO if related to activities covered under the Drugs & Cosmetics Act 1940 & Rules.
HS Code 30021091 (Antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes) NOT covered under the Drugs & Cosmetics Act 1940 & Rules is now free for export subject to NOC from ICMR/DHR.
HS Codes 30021210 (For diphtheria), 30021220 (For tetanus), 30021230 (For rabies), 30021240 (For snake venom), 30021290 (Other), and 30029010 (Human Blood) are now free for export subject to NOC from ICMR/DHR.
Impact Analysis
Exporters of Human Biological Samples
Action Item: Exporters should carefully classify their products under the correct HS codes to determine the relevant authority for obtaining the NOC.
Central Drugs Standard Control Organization (CDSCO)
Action Item: CDSCO may need to streamline its NOC issuance process to handle potential increase in applications.
Indian Council of Medical Research (ICMR) / Department of Health Research (DHR)
Action Item: ICMR/DHR may need to streamline its NOC issuance process to handle potential increase in applications.
Research Institutions and Pharmaceutical Companies
Action Item: Understand the revised export policy to leverage the streamlined process for obtaining necessary samples.
Key Entities Referenced
Foreign Trade (Development & Regulation) Act, 1992: The Act that grants the Central Government the power to amend export policies.
Foreign Trade Policy, 2023: The prevailing foreign trade policy under which this amendment is made.
ITC HS schedule-2: The Indian Trade Classification (Harmonized System) of Coding, which categorizes goods for import and export purposes.
Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India.
Indian Council of Medical Research (ICMR): The apex body in India for the formulation, coordination and promotion of biomedical research.
Department of Health Research (DHR): Department under the Ministry of Health and Family Welfare, Government of India, responsible for health research.
Drugs & Cosmetics Act, 1940: An act of the Parliament of India which regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Chapter 30 of ITC HS schedule-2: Chapter specifically related to pharmaceutical products, including human blood and related items.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-14032024-252980
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 1187] नई दिल्ली, सोमवार, मार् च11, 2024/फाल्ग नु 21, 1945
No. 1187] NEW DELHI, MONDAY, MARCH 11, 2024/PHALGUNA 21, 1945
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30021220 VVs ul ds fy,
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MINISTRY OF COMMERCE AND INDUSTRY
(Department of Commerce)
(DIRECTORATE GENERAL OF FOREIGN TRADE)
NOTIFICATION
New Delhi, the 11th March, 2024
No. 72/2023
Subject: Amendment in export Policy of Human Biological Samples under Chapter-30 of ITC HS schedule-2 of
export policy.
S.O. 1249(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:
HS Code Item Description Revised Export Policy Revised Policy Condition
30021020 Antisera and other blood fractions Free subject to NOC (1) Any human biological
and immunological products, materials/samples/products
whether or not modified or which are related to activities
obtained by means of covered under the provision
biotechnological processes of Drugs & Cosmetics Act
1940 & Rules there under are
30021091 Antisera and other blood fractions
free for export subject to No
and immunological products,
objection from CDSCO.
whether or not modified or
obtained by means of (2) Any human biological
biotechnological processes materials/samples/products
NOT covered under (1)
30021210 For diphtheria
above are free for export
30021220 For tetanus subject to No objection from[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
30021230 For rabies ICMR/DHR.
30021240 For snake venom
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/productsunder 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).
[F. No. 01/91/191/48/AM23/EC/e-35188]
SANTOSH KUMAR SARANGI, Director General of Foreign Trade Ex-Officio Addl. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.