Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-10122025-268398
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 803]
NEW DELHI, WEDNESDAY, DECEMBER 10, 2025/AGRAHAYANA 19, 1947
MINISTRY OF FINANCE
(Department of Revenue)
NOTIFICATION
New Delhi, the 10th December, 2025
G.S.R. 889(E). — In exercise of the powers conferred by section 9, read with sections 4 and 76 of the Narcotic
Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government hereby makes the following rules
further to amend the Narcotic Drugs and Psychotropic Substances Rules, 1985, namely:-
(1) These rules may be called the Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2025.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Narcotic Drugs and Psychotropic Substances Rules, 1985,
(a) for Form No. 4A of the said rules, the following form shall be substituted namely:-
"[FORM NO. 4A]
[see rules 54 and 55]
(Official seal of the Issuing Authority)
Official Seal of the Issuing Authority
S. No.
F. No.
MINISTRY OF FINANCE
(GOVERNMENT OF INDIA)
(Department of Revenue)
CERTIFICATE OF OFFICIAL APPROVAL OF IMPORT UNDER THE PROVISO TO RULE 54 of the Narcotic
Drugs and Psychotropic Substances Rules, 1985
.................................................................... (The Issuing Authority) being empowered to issue Import
Certificate under the Narcotic Drugs and Psychotropic Substances Rules 1985, hereby, approves the importation into
India of the following consignments of narcotic drugs:
+---------+---------------------------+-----------+---------+-----------+
| Item No. | Name and description of | HSN Code | CAS No. | GSTIN of |
| | drug | | | Importer |
+---------+---------------------------+-----------+---------+-----------+
| (1) | (2) | (3) | (4) | (5) |
+---------+---------------------------+-----------+---------+-----------+
By M/s......................................................From M/s......................................... to manufacture
formulations for export/for analytical purposes (strike out whichever is not applicable) subject to the following
conditions:
(2) Conditions of import certificate
(i) The consignment containing the drugs shall be imported before....... by....................................
(date in format dd/mm/yyyy) (to be calculated as 180 days from the date of issue of import certificate)
to (airport/seaport) in India.
(ii) If the import is for manufacture of formulations for export, the manufacturer shall,-
(a) ensure that no part of the drug imported under this certificate shall be sold or used to
manufacture formulations for domestic sale;
(b) ensure that the formulations manufactured out of the drug imported against this certificate shall
not be diverted for domestic sale;
(c) furnish to the Narcotics Commissioner and the Drugs Controller General of India details of
export of drugs on completion of export along with documentary evidence such as shipping
bills, bills of lading and invoices;
(d) obtain transport permit from their State Excise authority or State Food and Drugs
Administration permitting transport of their consignment from port of entry to the factory
premises;
(e) maintain separate accounts of actual quantity of narcotic drug imported, formulations produced,
consignments dispatched and the quantity lying in balance;
(f) submit a monthly return of receipt or import, consumption and export of the narcotic drug to
the Narcotics Commissioner;
(g) follow the procedures prescribed in Rules 42, 45, 46 and 47 for security arrangements,
maintenance of accounts and submission of returns, possession, sale and distribution of
formulations manufactured from the drugs imported under this certificate;
(h) comply with such other conditions as may be specified in the notification issued from time to
time under rule 54.
(iii) If the import is for analytical purposes, the importer shall, -
(a) ensure that no part of the drug imported under this certificate shall be used for any purpose other
than for analytical purpose;
(b) inform the Narcotics Commissioner about the complete utilisation of the Narcotic Drug
imported; and
(c) follow the procedures specified in rules 42, 45, 46 and 47.
(3) Any quantity of morphine, codeine, thebaine and their salts or finished formulations for export that remain
unutilised shall be surrendered to the Government Opium and Alkaloids Works and accounting for this purpose shall
be submitted to the Narcotics Commissioner at the end of the period made available to the licensee for import under this
Certificate and subsequent export of the formulation and alkaloids.
(4) This document is for .................................................... (The authority to whom and the purpose for which it is being
sent to be indicated).
(5) The certificate is not valid unless it bears the Official Seal of the Issuing Authority on the top right-hand
corner."
(b) in Form No. 5, after the words “Narcotic Drugs or Psychotropic Substances to be exported:", for the table, the
following table shall be substituted, namely :-
+----------+-------------------+----------------------------+-----------------------+-----------+---------+-----------+
| Item No. | Number of | Name of the Drugs | Basic drug | HSN Code | CAS | GSTIN |
| | packages | Substance/preparations | Substance | | No. | Of |
| | | | content | | | Exporter |
+----------+-------------------+----------------------------+-----------------------+-----------+---------+-----------+
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
+----------+-------------------+----------------------------+-----------------------+-----------+---------+-----------+
[F. No. N.11012/1/2013-SO(NC-II)-2]
VINOD KUMAR, Director (Narcotics Control)
Note.- The principal notification was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section 1
vide number G.S.R. 837(E), dated the 14th November, 1985 and subsequently amended vide notifications numbers
S.O. 786(E), dated the 26th October, 1992, S.O. 599(E), dated the 10th August, 1993,G.S.R. 74E(E), dated The
14th December, 1993, G.S.R 543, dated the 24th October, 1994, G.S.R. 82, dated the 14thFebruary, 1995, G.S.R 556(E),
dated the 14th July, 1995, G.S.R 25(E), dated the 12th January, 1996, G.S.R 509(E) dated the 4th November, 1996,
G.S.R 350(E), dated the 25th June, 1997, G.S.R. 214(E), dated the 19th March, 2002, G.S.R 753(E),
dated 14th November, 2002, G.S.R. 115(E), dated the 21st February, 2003' G.S.R 129(E)' dated the 26th February, 2003,
G.S.R 217(E), dated the 17th March, 2003, G.S.R. 95(E), dated the 4th February, 2004, G.S.R. 104(E), dated the
25th February, 2005, G.S.R. 736(E), dated the 22nd December,2005, G.S.R. 639 (E), dated the 13th October,2006,
G.S.R. 2 (E), dated the 1st January, 2008, S.O. 1661(E), dated the 13th July,2010, S.O. 739 (E), dated the 11th April,
2011, G.S.R. 470(E), dated 21st June, 2011, G.S.R. 426 (E), dated 1st July, 2014, G.S.R. 224(E), dated 25th March, 2015,
G.S.R. 359(E), dated 5th May, 2015 and G.S.R. 500(E), dated 17th June 2015.
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