Under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Rules) the sale and distribution of Narcotic drugs or psychotropic substances in India is Regulated by the Central Bureau of Narcotics, Gwalior, Madhya Pradesh India. NKG team has been providing a clear regulatory pathway to companies active in Import or Export or Manufacture of various types of Narcotic Drugs or psychotropic substances.
Means Coca leaf, Cannabis (hemp), Opium poppy straw and including all manufactured drugs;
means
(a) all coca derivatives, medicinal cannabis, opium derivatives and poppy straw concentrate;
(b) any other narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature, or to a decision, if any, under any International Convention, by notification in the Official Gazette declare to be manufactured drug;
(Govt. of India’s Notifiction S.O. 826(E) dated 14/11/1985 and S.O. 40(E) dated 29/01/1993 & S.O. 1431(E) dated 21/06/2011 and S.O. 2373(E) dated 12/07/2016) wherein the Central Government has declared certain narcotic drugs and preparations to be manufactured drugs. According to these notifications preprations, admixtures, extracts or other substances containing any of these drugs also come under the definition of manufactured narcotic drugs.
means any substance, natural or synthetic, or any natural material or any salt or preparation of such substance or materials included in the List of Psychotropic Substances specified in the Schedule to the NDPS Act, 1985.
means all parts (except the seeds of the Opium poppy after harvesting whether in their original form or cut, crushed or powdered and whether or not juice has been extracted therefrom;
means any substance which the Central Government may, having regard to the available information as to its possible use in the production or manufacture of narcotic drugs or psychotropic substance or to the provisions of any International Convention, by notification in the official gazette, declare to be a controlled substance.
No person shall export any controlled substance in Schedule B/ import any controlled substance in Schedule C except in accordance with the conditions of the No Objection Certificate issued by the Narcotics Commissioner under the provisions of NDPS (RCS) Order, 2013 Anyone who intends to export a controlled substance in Schedule B/ import a controlled substance in Schedule C shall apply to the Narcotics Commissioner in Form J for export/ Form K for import respectively for a No Objection Certificate.
As per the Narcotic Drugs and Psychotropic Substances Act, 1985 various provisions relating to import and export of Narcotic Drugs and Psychotropic Substances are clearly laid out. These provisions are as follows:
Rule 55 and Rule 58 of NDPS Rules 1985
As per Rule 55 & Rule 58 , No narcotic drug & psychotropic substance as specified in the NDPS ACT & RULES can be imported into India or Exported out of India without an valid Import Certificate or an Export Authorisation issued by the Narcotics Commissioner, Central Bureau of Narcotics, Gwalior.
As per Rule 55(3) and rule 58(3) of the NDPS rules,1985, Each application for Export or Import of the Narcotics Drugs or Psychotropic substances has to be submitted to Narcotics Commissioner with a Fees INR 1000/-.
Post grant of above permissions, The concerned Importer or Exporter of such Narcotic Drugs & Psychotropic Substances are required to mandatorily submit monthly report of Actual Import or Export during a particular month in the “Return Import” or Return Export” formats issued by CBN respectively.
No person shall manufacture any of the psychotropic substances defined under section 2(xxiii) of NDPS Act, 1985, except in accordance with the conditions of a licence granted under the Drugs and Cosmetics rules,1945 framed under the Drugs and Cosmetics Act,1940 (23 of 1940), by an authority in-charge of Drugs Control in a State appointed by the State Government in this behalf. Besides, every manufacturer of psychotropic substances is also required to register with the Narcotics Commissioner in terms of the Rules 65 of the NDPS Rules.
On Issuance of the Certificate to Manufacture the Said psychotropic substance, The Licensing Authority Shall Intimate the License holder the permitted Quantity which can be manufactured.
As per rule 67A of NDPS Rules,1985 manufacture, possession, transport, import-export, Purchase and consumption of narcotic drugs and psychotropic substances in “Schedule I” is permitted only for medical, scientific and training purposes.
The License holder has to submit Quarterly reports on website of http://www.cbnonline.gov.in/ and submit reports of Substances Manufactured of each substance. The return for a quarter shall be filed before the last day of the month following that quarter. If the return for a quarter is not filed before the due date by an applicant registered, the Narcotics Commissioner may issue notice to the concerned applicant.
Licensing authority Shall revoke the Registration, if the quarterly return for three successive quarters is not filed.
Any one who intends to export a controlled substance in Schedule-B shall apply to the Narcotics Commissioner in Form-J for a No Objection Certificate along with the documents detailed in Form J for export along with additional documents appended in Form J for export in case of first time exporter.
The export of Precursor Chemicals are governed by the System of Pre- Export Notification (PEN). This office uses a system of PEN to verify the genuineness of the transaction and to notify the Competent Authority of the importing and transhipping country of the impending export. The export of a controlled substance are allowed against the NOC issued by the Narcotics Commissioner subject to following conditions:
Any one who intends to export a controlled substance in Schedule-C shall apply to the Narcotics Commissioner in Form K for import for a No Objection Certificate along with the documents detailed in Form-K along with additional documents appended in Form J for export in case of first time exporter.
The import of a controlled substance are allowed against the NOC issued by the Narcotics Commissioner subject to following conditions :-
Any company/applicant desirous of importing poppy seeds shall apply to the Narcotics Commissioner in a prescribed manner along with the documents detailed at (IX)
Download the Checklist of Documents
Central bureau of Narcotics has also mandated that While registering contracts for import of poppy seed, it is ensured that the conditions of the Ministry of Commerce and Industry, Department of Commerce, Notification No.27(RE-2000)/1997-2002 dated 1.8.2000 and subsequent import policy & import policy conditions framed under EXIM-Policy (Please refer import licensing note (3) issued under Chapter-12 of the EXIM-Policy, 2004-09) are complied with.
NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements.
NKG team has a cumulative experience of more than 70 Years in Regulatory affairs and have been Behind Breakthrough Medical Devices Technology approvals helping Various Clients to Device Regulatory Pathwork for Successful Launch.
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
