Amendment in export Policy of Human Biological Samples under Chapter-30 of ITC HS schedule-2 of export policy.

[To be Published in the Gazette of India Extraordinary Part-II, Section - 3, Sub-Section (i1)] Ministry of Commerce & Industry

Department of Commerce Directorate General of Foreign Trade Vanijya Bhawan, New Delhi Notification No. “¢2/2023 New Delhi, Dated: !{*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:

|HSCode|[tem Description|Revised|||Revised|Policy Condition|
|---|---|---|---|---|---|
|||Export||||
|||Polic||||
|30021020||Antisera<br>and<br>other<br>blood <br>fractions<br>and<br>immunological<br>products,<br>whether<br>or<br>not <br>modified or obtained by means<br>of biotechnological processes||Free<br>|subject<br> NOC|to|1.|Any<br>human<br>biological<br>materials/samples/products which<br>are related to activities covered<br>under the provision of Drugs &<br>Cosmetics<br>Act<br>1940 &<br>Rules|
|0021091||Antisera<br>and<br>other<br>blood<br>fractions<br>and<br>immunological<br>products,<br>whether<br>or<br>not||||thereunder are<br>free for export<br>subject<br>to No<br>objection<br>from<br>CDSCO.|
|30021210 <br>30021220<br>=|modified or obtained by means<br>ofbiotechnological processes<br> [Fordiphtheria<br>i<br>:<br>:|||2.|oo,<br>Any<br>human<br>biological<br>materials/samples/products NOT<br>covered under (1) above are free<br>for export subject toNo objection|
||||||ae<br>:|
|30021240||||||
|50021290||||||
|30029010||||||

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). LANA

LANA B ee ne (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-35188)