narcotic ppt

WELCOME

ACCREDITED CONSULTANTS PVT. LTD.

D-29, First Floor, Acharyaniketan, Mayur Vihar, Phase-1, Delhi-91, India.

What is In-Vitro Diagnostic Products (IVDs)

Narcotic, Psychotropic & purcussors are Imported,

Exported or Manufactured only with the permission

from Central Bureau of Narcotic, Gwalior.

Sch-I,II & III of NDPS Rules are the list of these

controlled substances

Accredited Consultants Pvt Ltd

Manufacturing Licence/Renewal of Manufacturing licence

Any company/applicant desirous to manufacture any synthetic narcotic drugs shall applied to the Narcotics Commissioner in a

prescribed manner and shall submit the documents detailed at (I) of Annexure.

The manufacture of Narcotic drugs is governed by estimate system. While allowing the manufacturing licence, it is ensured that the total quantity of drug allowed to be manufactured during any year does not exceed the annual estimated requirements of India as furnished and subsequently published by to the International Narcotics Control Board, Vienna, Austria.

As regards renewal of manufacturing licence, the manufacturers are required to apply to the Narcotics Commissioner at least 30 days before the expiry of his license alongwith documents detailed at (II) of Annexure.

On the basis of the demand made by the manufacturers and keeping in view of their performance i.e. internal consumption and export of the drug, the manufacturing licenses are renewed for the suitable quantities within the estimates of that drug for the year.



Any company/applicant desirous of obtaining Export Authorisation shall apply to the Narcotics Commissioner in a prescribed manner

and shall submit the documents detailed at (III) of Annexure.

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of such Export Authorisations shall also be submitted along with the application which are detailed at (VII) of Annexure.

The export of narcotic drugs and Psychotropic substances are governed by estimate system. While allowing Export Authorisation, it is ensured that the annual estimated requirement in respect of a particular narcotic drugs and psychotropic substances ( as published by INCB, Vienna, Austria) does not exceed the estimated requirement in respect of the importing country. Such export authorisation are allowed by Central Bureau of Narcotics subject to following conditions :-

a. Any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.

b. The shipment should be made in one consignment within the validity of the Export Authorisation.

c. The exporter are required to submit export details immediately after effecting export.

Export Authorisations for export of

Narcotic Drugs and Psychotropic

Substances

Import Certificate for Import of Narcotic Drugs and Psychotropic Substances

Any company/applicant desirous of obtaining import certificate shall apply in a prescribed manner submitting the documents detailed at (IV) of Annexure.

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of import Certificates shall also submit the documents detailed at (VII) of Annexure.

The import of narcotic drugs and Psychotropic substances are governed by estimate system. While allowing Import Certificate, it is ensured that the estimated requirement of a particular narcotic drug and psychotropic substance ( as reported to the INCB and subsequently published by INCB) does not exceed the requirement in respect of India. Such import Certificates are granted subject to condition that the importer will submit the import details immediately after effecting import and any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.



No Objection Certificate (NOC) for export of

Precursor Chemicals

Any company/applicant desirous of obtaining NOC for export of select precursor Chemicals are required to apply to the Narcotics

Commissioner in a prescribed manner submitting the documents detailed at (V) of Annexure.

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of such

NOC shall also submit the documents detailed at (VII) of Annexure.

The export of Precursor Chemicals are governed by 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. Such NOCs are allowed by Central Bureau of Narcotics subject to following conditions :-

a. Any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.

b. The shipment should be made in one consignment within the validity of the NOC.

c. The exporter are required to submit export details immediately after effecting export.

No Objection Certificate (NOC) for import of Precursor Chemicals


Any company/applicant desirous of obtaining NOC for import of a select number of precursor chemical, are required to apply to the

Narcotics Commissioner in a prescribed manner along with the documents detailed at (VI) of Annexure.

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of such

NOC shall also be submitted which are detailed at (VII) of Annexure.

Such import NOC's are granted subject to condition that the importer will submit the import details immediately after effecting import and

any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.


Registration for import of Poppy Seeds

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) of Annexure.

Apart from the above documents, additional information / documents in respect of applicants approaching this office for the first time for

registration are also required to submit documents detailed at (IX) of Annexure.

While registering contracts for import of poppy seed, it is ensured that the conditions of the Ministry of Commerce and Indus try,

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.

Annexure (I) List of Documents to be submitted for grant of Manufacturing Licence

Accredited Consltants Pvt Ltd

1.Application form in the prescribed format.

2.Copy of licence granted under the rules framed under section 10 of the State Narcotic Drugs and Psychotropic Substances Act by the State Govt.

of the State in which the company have place of business, for the possession, sale, and distribution of the drugs.

3.Copy of valid Drug Manufacturing Licence issued by the State Drug Controller/ Food and Drug Administration (FDA) under the Drugs and

Cosmetics Act/ Rules.

4.List of approved technical person in the production and quality control.

5.List of Directors.

6.List of Laboratory equipments and raw materials.

7.Copy of site plants.

8.Original National Saving Certificate of Rs. 5000/- as Security Deposit.

9.A fee of Rs.5000/- in form of a Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior. 10.Balance Sheet of Company for the last 3 years.

11.Flow Chart of manufacturing process and per annum capacity

http://cbn.nic.in/html/SyNDMfg.pdf

Annexure (II) List of Documents to be submitted for Renewal of Manufacturing licence


1.Application form for renewal of manufacturing licence in prescribed format.

2.Renewal fee of Rs. 5000/ - in favour of Drawing and Disbursing Officer, Central Bureau of Narcotics,

Gwalior.

3.Renewed licence granted to the manufacturer under the Drugs and Cosmetics Act, 1940 (23 of 1940) for

the manufacture of the drug.

4.Renewed licence granted to the manufacturer under the rules framed under Section 10 of the Act by the

State Govt. of the state in which the manufacturer has place of business, for the possession, sale and

distribution of the drug.

5.Statement of annual production & consumption in prescribed format.

Annexure (III) List of Documents to be submitted for grant of Export Authorisations for export of

Narcotic Drugs and Psychotropic Substances


1.Application form and the Background information in the prescribed format for export of Narcotic Drugs

or Psychotropic Substances and their salts.

2.Original Import Certificate issued by the Govt. of the importing country certifying the official approval of

the concerned Govt.

3.Licence Fee of Rs. 1000/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office,

Central Bureau of Narcotics, Gwalior.

4.Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer on loan

licence) and copy of valid drug licence for sale, distribution or exhibit (in case of merchant exporter).

5.Copy of the purchase order placed by the foreign buyer for the proposed import.

6.Original Transport permit issued by the State Excise Authority (in case of Narcotic Drugs)

Annexure (IV) List of Documents to be submitted for grant of Import Certificate for Import of Narcotic Drugs and Psychotropic Substances


1.Application form and the Background information in the prescribed format for import of

Narcotic Drugs or Psychotropic Substances and their salts.

2.Licence Fee of Rs. 1000/- in form of Demand Draft drawn in favour of Drawing and

3.Disbursing Office, Central Bureau of Narcotics, Gwalior.

4.Copy of valid drug manufacturing licence possessed by the exporter (in case of

manufacturer on loan licence) and copy of valid drug licence for sale, distribution or exhibit (in

case of merchant exporter).

5.Original Test Licence/Import Licence from Drug Controller General (India) for the proposed

import.

6.Copy of import-export contract with the overseas supplier.

7.Original Transport permit issued by the State Excise Authority (in case of Narcotic Drugs).

Annexure (V) List of Documents to be submitted for grant of No Objection Certificate (NOC) for export of Precursor Chemicals


1.Application form and the Background information in the prescribed format for export of select precursor chemicals

and their salts.

2.Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau

of Narcotics, Gwalior.

3.Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer) and copy of valid drug

licence for sale, distribution or exhibit (in case of merchant exporter).

4.Copy of the purchase order placed by the foreign buyer for the proposed import.

5.Original Import Certificate issued by the Govt. of the importing country certifying the official approval of the

concerned Govt.

Annexure (VI) List of Documents to be submitted for grant of No Objection Certificate (NOC) for import of notified Precursor Chemicals


1. Application form and the Background information in the prescribed format for import of select Precursor Chemicals

and their salts.

2.Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of

Narcotics, Gwalior.

3.Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer) and copy of valid drug

licence for sale, distribution or exhibit (in case of merchant exporter).

4.Original Test Licence/Import Licence from Drug Controller General (India) for the proposed import.

5.Copy of import-export contract with the overseas supplier.

Annexure (VII) List of Documents to be submitted by first time exporter/import of Narcotic Drugs, Psychotropic Substances and Precursor Chemicals.


1. Complete postal address and telephone, fax no. of various factories of the company manufacturing Narcotic Drugs and

Psychotropic Substances including Jurisdictional Central Excise division and Central Excise Commissionerate and Zonal office

of Narcotics Control Bureau in respect of factories.

2.List of Narcotic drugs and Psychotropic Substances being manufactured by the company and details of manufacture of

Narcotic drugs and Psychotropic Substances by the company in the last three calendar years (1st January to 31st December).

3.Details of export/import of Narcotic drugs and Psychotropic Substances by the company during the last three calendar years

(1st January to 31st December).

4.Name, address, telephone Nos. and Fax No. of the Chairman, Managing Director and other Directors, proprietor/ partners, in

charge of production and finance.

5.Name of concerned Jurisdictional Commissionerate of Customs and Central Excise.

6.Balance Sheet of Company for last 3 years.

7.Amount of Excise Duties paid by company during last three years.

8.Profile of the company.

9.Sales Tax Registration No., Central Excise Registration No. and Company s PAN No. (Attested copies of these

documents shall also be submitted.)

Annexure (VIII) List of Documents to be submitted for grant of Registration for import of Poppy Seeds


1.Application form and the Background information in the prescribed format.

2.Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

3.Original Sales Contract/ Export-Import Contract

Annexure (IX) List of Documents to be submitted by first time importer of Poppy Seeds


1. Whether the firm have imported poppy seed earlier . If, yes mention the year, quantity and name of exporting country.

2.Annual turn-over of the firm.

3.The items, in which the firm deals with.

4.Name of the Jurisdictional Commissionerate of Central Excise under which the firm lies. In case registered with

Central Excise, the copy of registration may also be submitted.

5.Full address of the company, factory and warehouse.

6.Income Tax return for last three years with PAN Number (certified copies shall be submitted)


OUR HEARTFUL THANKS

WE BELIEVE OUR CLIENTS ARE OUR

KINGS!!!

D-29, First Floor, Acharyaniketan, Mayur Vihar, Phase-1, Delhi-91, India.

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