How to get Hospital registered as RMIRMI – Recognised Medical Institute

If a Hospital uses the following Essential Narcotics Drugs, registration is required under Narcotic Drugs & Psychotropic Substance (Third Amendment) Rules, 2015 which has come into force vide Gazette notification GSR 359(E) dated 5th May 2015.

Notified Essential Narcotic Drugs (END)

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

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The hospital 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 SubstancesRMI: Recognized Medical InstituteDMP: Designated Medical PractitionerRMP: Regd. Medical PractitionerEND: Essential Narcotics DrugsSDC: State Drugs ControllerASDC: Asstt. State Drugs ControllerSDCO: Senior Drugs Control Officer DCO: Drugs Control Officer

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

RMIs shall submit the original application for registration/renewal of Certificate of Recognition as RMI in Form 3F dully filled along with requisite documents to the State Drugs Controller of the state.

Copy of the same shall be forwarded to the concerned Asstt. State Drugs Controller / Senior Drugs Control Officer / 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:

- 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

Conditions for RMI:

- Certificate of Recognition (RMI) shall be valid up to 3 years.

- Application for the renewal of RMI shall be made to the SDC at least 60 days before the expiry.

- 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.

- Change in DMP of the RMI shall be intimated to the SDC within 7 days.

- Change in name of the RMI shall be intimated to the SDC immediately.

- 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 30th 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

List of Forms for for regular reporting to the authorities are 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 – RMI

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 comprising of a Gazetted Officer in the office of the Narcotic Commissioner, or Narcotic Control Bureau constituted vide notification number 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 provision of the relevant laws for the time being in force.

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.

Click below link to download the notification

Narcotic Drugs & Psychotropic Substance (Third Amendment) Rules, 2015 which has come into force vide Gazette notification GSR 359(E) dated 5th May 2015

GSR-359-E-Dt.-05-05-15-Recognised-Medical-Institute

To download the checklist, forms and notification in pdf file. Click here

Compiled by:Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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