Submission of feedback on On-line Registration and submission of returns by manufacturers and wholesalers of bulk and formulations of psychotropic substances

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1.  Introduction

2. Objectives

3. Brief Description of the system

4. Activities for users



India being signatory to the UN Convention on Psychotropic Substances,1971 is obligated to put in place the control mechanism as provided for in the Convention. It is also required to submit periodical statistical data on manufacture, stock, acquisition, utilization, import / export,   and consumption of psychotropic substances to the International Narcotics Control Board (INCB), Vienna every year by 30th June.  This data is also used by the INCB for fixing the assessment of psychotropic substances for a country.

Since the administrative structure for Drug Control  in India is divided between various ministries/department under the Central and State Government, the collection of data from the trade take a considerable time and also inconsistency are found in the information collected, which delays the submission of statutory reports to the INCB and affecting the country’s image.

In order to overcome these difficulties the Government of India has decided to develop a web based software for online registration of manufacturers and wholesalers of psychotropic substances and collection of the statistical information on manufacture, utilization, stock, trade and consumption of psychotropic substances in the country. This system will provide for online registration of manufacturers/ wholesalers and online filing of returns of psychotropic substances.

The type of information which will be required to be submitted online by different user groups is available on CBN website http://cbn.nic.in/html/whatnew3.htm

The stake holders are welcome to offer their feed back and suggestion on the type of information to be furnished to the Central Bureau of Narcotics through email at feedback-cbn@nic.in  latest by 15th August, 2011


1.  Introduction

The Central Bureau of Narcotics (CBN) under the Department of Revenue, Ministry of Finance, intends to implement a web enabled system to 

  • Register manufacturers/wholesalers of bulk drugs/preparations of psychotropic substances
  • Facilitate them to submit quarterly returns on manufacture/ usage/ purchase/ sale/ import/ export/ stocks of psychotropic substances

2. Objectives

The objectives of this system are as follows:

  • To create a centralized database of all manufacturers/wholesalers of psychotropic substances (bulk drugs as well as preparations) in India by registering and issuing them   Registration Number  (RN) and renew them every year.
  • To obtain returns of sale/purchase of psychotropic substances at RN level.
  • To monitor the psychotropic substances from manufacturing/stock/consumption/ sale point of view.
  • To enable import/export authorization of psychotropic substances, generate authorization number  and keep track of such authorizations.
  • Apex Requirement - Single source repository with all data that is required by CBN, Gwalior to share information with INCB and generate Form P and Form B/P in the format   prescribed by INCB.

3. Brief Description of the system

It will be mandatory for all the users as above, to register with CBN. Then CBN will issue a unique Registration Number (RN) to each manufacturer/wholesaler, licenced by State Drugs Controller/ FDA.

 In case, a user is involved in more than one activity (i.e. manufacturer of bluk drug; manufacturer of preparartion; wholesaler of bluk drug or wholesaler of preparartion) , user has to apply for Registration Number separately for each activity in a prescribed format shown in Annexure-I  i.e. one for each type of activity.

This RN will not be treated as the license to manufacture or wholesale the psychotropic substances, for which the user has to obtain license from other agencies such as state drug control authority, excise department etc.

The RN will be mandatory for the said activities. The validity of this RN will be 1 Year (ending at 31 December of that year). Later on, it may be renewed at user request.

 All RN holders will have to file the psychotropic substance-wise quarterly return in the prescribed format (shown in Annexure-II) to estimate the volume of manufacturing/consumption/stock/sale of the items. It will also be mandatory for all users to indicate the RN of the buyer/seller in all their buy/sell transactions. In case of import/export they have to indicate the RN for each transaction and obtain consignment wise import/export certificate no. from CBN, after due verification of concerned importer/exporter from INCB.

4. Activities for users

Activities for the users will be  as follows:-

  1. Registration - The Manufacturers/Wholesalers will apply online to get registration number from CBN. If an applicant is involved in more than one type of activity, it has to apply separately for each type.  The system will capture the required details for further processing and include uploading of relevant documents.

  2. Return Filing - Registered users (Manufacturers/ Wholesalers of Bulk Drugs/ Preparations) need to submit transaction wise return every quarter, psychotropic substances wise. The registered users are required to enter all the transactions of buying/ selling/ import/ export the user has made in that quarter indicating the registration number of the buyer/seller for that transaction.

  3. Import/ Export Permission - This will allow the registered users (Manufacturers/Wholesalers of Bulk Drugs/Preparations) to obtain consignment wise import/export certificate no. from CBN. The registered users need to quote the already issued RN in each transaction.



Application form for Registration of Manufacturers/ Wholesalers of Psychotropic Substances

Quarterly Return Form for Wholesalers of Bulk Psychotropic Substances 

Quarterly Return Form for Wholesalers of Preparations of Psychotropic Substances

Quarterly Return Form for Manufacturers of Bulk Psychotropic Substances

Quarterly Return Form for Manufacturers of Preparations of Psychotropic Substances

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