How to get Hospital registered as RMI

Also read how to destroy / destruct the drugs by RMI, Chemist shop and manufacturers of drugs

Rakesh Dahiya

December 23, 2019

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

How to get Hospital registered as RMI

Hospital registered as RMI: If a hospital or institute uses the following essential narcotic drugs, registration is required under the Narcotic Drugs and Psychotropic Substances (Third Amendment) Rules, 2015, which have come into force vide Gazette Notification GSR 359(E) dated 5th May 2015.

Download Notification No. GSR 359(E) dated 5th May 2015

RMI – Recognised Medical Institute

Notified Essential Narcotic Drugs (END)

● Morphine
● Codeine
● Methadone
● Hydrocodone
● Oxycodone
● Fentanyl

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The hospital or institute is required to get itself registered as a recognized medical institute by the State Drugs Controller of the state.

Abbreviations:

NDPS: Narcotic Drugs and Psychotropic Substances
RMI: Recognized Medical Institute
DMP: Designated Medical Practitioner
RMP: Regd. Medical Practitioner
END: Essential Narcotics Drugs
SDC: State Drugs Controller
ASDC: Asstt. State Drugs Controller
SDCO: Senior Drugs Control Officer
DCO: Drugs Control Officer

Govt. Hospitals: Deemed RMI

Rule 52N: Govt. hospital, dispensary, etc. to be deemed a recognized medical institution: Government or Municipal Corporation or Municipal Council or Zilla Parishad hospital, dispensary or medical institution, with at least one registered medical practitioner possessing a minimum qualification of a degree in medicine or dentistry and who has undergone training in pain relief and palliative care for prescription of essential narcotic drugs for pain relief and palliative care or training in opioid substitution therapy for prescription of essential narcotic drugs for treatment of opioid dependence, who shall prescribe and dispense essential narcotic drugs, shall be deemed to be a recognised medical institution under these rules for possessing,
dispensing or selling essential narcotic drugs for medical purposes.

Explanation: For the removal of doubts, it is hereby clarified that the government or Municipal corporation, municipal Municipal council, or Zilla Parishad hospital, dispensary, and medical institution, shall be exempt only from making application to the Controller of Drugs for recognition as recognized medical institutions, but all other provisions of this Chapter shall be equally applicable to such deemed recognized medical institutions as are applicable to other recognized medical institutions.

How to obtain registration of RMI

The list of documents required for obtaining registration as a recognized medical institute is provided below.

Procedure for how to get Hospital registered as RMI

The hospital or institute shall submit the original application for registration or renewal of the Certificate of Recognition as RMI in Form 3F, duly filled out and with the requisite documents, to the State Drug Controller of the state.

A copy of the same shall be forwarded to the concerned Asstt. State Drugs Controller / Senior Drugs Control Officer, or Drugs Control Officer (as the case may be) of the area.

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Documents required for registration of Hospital as RMI

The application shall be accompanied by:

a covering letter addressed to the SDC signed by the Medical Officer in charge of the Hospital / Institute.
Application for issue / renewal of Certificate of Recognition as RMI in Form 3F.
Estimate of annual requirement of Essential Narcotic Drugs (END) in Form 3J.
Constitution of Hospital / Institute.
ROC certificate of Hospital / Institute.
List of Directors / Partners with address
Affidavits of Directors / Partners / Proprietor
MoA of Hospital / Institute

DIR-12 of all directors
Partnership deed
BOD Resolution
Authorization letter for In-Charge
Affidavit of In-Charge
Authorization letter for Designated Medical Practitioner (DMP)
Affidavit of DMP
List of Regd. Medical Practitioners (RMP) with Qlf., Regn. No. Mobile No etc.
Self attested copies of Registration and Qualification Certificates of the in-charge / DMP / RMPs of RMI (in case of Fresh RMI application / change in Medical Officer).
Copy of the certificate of training in pain relief and palliative care training as notified in NDPS Rules (in case of Fresh RMI application / change in DMP).

Storage of END ( Cupboard with double lock system)
Blue print map of the premises.
Ownership / rent / lease deed
Electricity bill of Hospital / Institute
Pan card of the Hospital / Institute
Fire safety certificate
Genset
Other medical certificate ( PNDT, MTP etc)
Annual return of procurement / disbursement of END in Form 3-I (in case of Renewal of RMI).
Original of RMI certificate in Form 3G (in case of renewal of RMI).
Details of suppliers from whom the END are procured.

Submit your application to the State Drugs Controller/Licensing Authority in your area after completing all the required documents.

Note: Requirements of some of the documents and procedure for submission of application may vary from State to State

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Checklist for RMI

Download the checklist in a pdf file for obtaining registration as Recognized Medical Institute. Click below link

NDPS-RMI-Checklist

Forms

Download the below pdf files for various Forms which are required after obtaining registration as Recognized Medical Institute.

Form-3F

Form-3J

Submit your application to the State Drugs Controller/Licensing Authority of your area after completing all the required documents.

Specimen Affidavits for RMI

Download the below pdf files for specimen affidavits which are required after obtaining registration as Recognized Medical Institute.

Affidavits-for-RMI

Note: Requirements of some of the documents and procedures for submission of application may vary from State to State

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Conditions for RMI:

The Certificate of Recognition (RMI) shall be valid up to 3 years.
Applications for the renewal of RMI shall be made to the SDC at least 60 days before the expiration.
Every RMI shall be liable to periodic inspections by the ASDC / SDCO / DCO authorized by the SDC.
In the event of change in constitution of RMI, the current Recognition shall shall be deemed to be valid for a maximum period of 90 days of such change.
A change in DMP of the RMI shall be intimated to the SDC within 7 days.
A change in name of the RMI shall be intimated to the SDC immediately.
A copy of every consignment note of END in Form 3C dully filled and signed by both the consigner and consignee, shall be forwarded to the SDC. Original of the same shall be retained by the RMIs for a period of 2 years from the date of transaction, and such records shall be produced before the officer on demand during inspection.
Every RMI shall also maintain a separate record as per Form 3E for each patient, and such records shall be retained for period of 2 years from the date of last entry. This record shall be produced before the officer on demand during inspection.
Every RMI shall maintain daily accounts of all receipts and dispensed quantities for each END as per Form 3H, which shall be retained for a period of 2 years from the date of last entry. This record shall be produced before the officer on demand during inspection.
Every RMI shall submit an estimate of its annual requirement of END in Form 3-J by 30^th November of the proceeding calendar year to the SDC.
If the disbursement of the END exceeds the estimate of annual requirement in Form 3J, a revised estimate shall be submitted in Form 3J in due course.
Details of suppliers of END other than regular suppliers shall be intimated in due course.
RMIs shall file annual return of procurement / disbursement of essential narcotic drugs for a calendar year on or before 31st of March of the subsequent year in Form 3 I to the SDC.
The Medical Officer in charge of the RMI shall record a brief justification were the annual disbursement is more than 10% of the estimate or revised estimate along with Form 3 I.
RMI may surrender its recognition by giving not less than 30 days notice in writing to the SDC.

Forms for regular reporting

A list of forms for regular reporting to the authorities is provided below. Download the PDF file and prepare the reports accordingly.

Form-3E

Form-3H

Form-3-I

For notifications of RMI, click below link:

Notifications – NDPS

Disposal of Essential Narcotic drugs

By a registered RMI (Hospital)

Rule 52S: Disposal of drugs on surrender of recognition:

On surrender of the recognition, the essential narcotic drugs as may be in the possession of the RMI shall be disposed of in such manner, including transfer to another RMI, as may be specified by the Controller of Drugs

By a manufacturer

Rule 45A: Destruction of Drugs:

(1) A licensee seeking to destroy the drug shall apply to the Narcotic Commissioner in such form and manner as may be specified by the Narcotic Commissioner

(2) The Narcotic Commissioner shall, within a period of thirty days from the date of receipt of an application under sub-rule (1), appoint a committee consisting of a Gazetted Officer in the office of the Narcotic Commissioner, or Narcotic Control Bureau constituted vide notification No. S.O. 96(E) dated 17-03-1986, the Superintendent of Central Excise of the concerned range, and an authorized representative of the applicant for supervising the destruction of the drug and such destruction shall be carried out within a period of thirty days from the appointment of the committee.

(3) The destruction of the drug shall be carried out in accordance with the provisions of the relevant laws for the time being in force.

Download notification No. S.O. 96(E) dated 17-03-1986

By an Authorized person or registered medical practitioner

Rule 52M: Disposal of stocks of essential narcotic drugs on expiry, surrender, cancellation of authorization:

(1) On the expiry, cancellation, or surrender of an authorized person’s authorization, any stock of essential narcotic drugs in his possession shall be disposed of in the manner specified by the Controller of Drugs.

(2) The expired stock of essential narcotic drugs as may be in the possession of an authorized person or a registered practitioner shall be destroyed in such manner as may be specified by the Controller of Drugs.