Annex 1: Model Rule
Special Provisions Relating to the Use of Morphine by Recognized Medical Institutions in the Amended State
1. Notwithstanding any provisions to the contrary in these rules, possession, transport, purchase, sale, import inter-state, export inter-state or use of morphine or any preparation containing morphine in respect of a recognized medical institution shall be as per the following provisions.
2. Definitions: In this chapter, unless the context otherwise requires:
i. morphine includes any preparation containing morphine
ii. “Recognized medical institution” means a hospital or medical institution recognized for the purposes under this chapter. It is the responsibility of the institution so recognized to ensure that morphine obtained by them is used for medical purposes only.
3. Recognition of medical institutions:
i. Every medical institution which intends to be recognized for the purpose under this chapter shall apply in the format at Annexure 1 (Appendix V) to the Drugs Controller appointed by the State Government who shall convey his decision within three months of the receipt of the application.
ii. If it comes to the notice of the Drugs Controller that morphine obtained by a recognized institution was supplied for non-medical use or that any of the rules under this chapter is not complied with, for reasons to be recorded in writing, the Drugs Controller may revoke the recognition accorded under these rules.
4. Duties of a recognized medical institution:
Every recognized medical institution shall
i.Designate one or more qualified medical practitioner who may prescribe morphine for medical purposes. When more than one qualified medical practitioner have been designated, one of them shall be designated as over-all in-charge:
ii. The designated medical practitioner or the overall in charge, as the case may be, shall
a. Endeavour to ensure that the stock of morphine is adequate for patient needs,
b. Maintain adequate security over stock of morphine,
c. Maintain a record of all receipts and disbursements of morphine in the format enclosed as Annexure 2 (Appendix V) and
d. Ensure that estimates and other relevant information required to be sent by the recognized medical institution under this chapter are sent to the authorities concerned
5. Sending of estimates of requirement of morphine by the recognized medical institution
6. Approval of estimates by the Drugs Controller
The Drugs Controller who receives the annual requirement shall consider it, and may if necessary call for necessary clarification. A reply on approved estimates or not accepting the estimates shall be sent before 21st of December of the preceding year. A copy of the communication shall be sent each to the supplier whose name has been given in the estimate, if the supplier is located in another state, the Drugs Controller of that state, the Drugs Controller General of India and the Narcotics Commissioner of India
7. Supplementary estimates
If the requirement of the recognized medical institution exceeds the annual estimate approved by the Drugs Controller, the recognized medical institution may send a supplementary estimate at any time to the Drugs Controller which shall be considered and dealt with by the Drugs Controller in the same manner as the annual estimates.
8. The provisions of these rules in other chapters in respect of possession, transport, sale, import inter-state, export inter-state or use of manufactured drugs shall not apply to possession, transport, purchase, sale, import inter-state, export inter-state or use of morphine in respect to a recognized medical institution. Possession, transport, purchase, sale, import inter-state, export inter-state or use of morphine in respect to a recognized medical institution shall be in accordance with the following provisions:
i. The recognized medical institution shall place orders for purchase to a manufacturer/supplier in the format at Annexure IV (Appendix V) along with a photocopy of the communication of the Drugs Controller vide which the institution was recognized for the purpose of this chapter and a copy of the communication of the Drugs Controller vide which the approved estimates were conveyed. A copy of the order for purchase shall be sent to the Drugs Controller and the Narcotics Commissioner of India.
ii. Any manufacturer or supplier shall send morphine to the recognized medical institution under this chapter only on the basis of an order for purchase received in the format of Annexure IV along with copies of recognition granted by the Drugs Controller and the approved estimates communicated by the Drugs Controller. The manufacturer/supplier shall dispatch the morphine consignment note in quintuplicate in the format given in Annexure V (Appendix V). Copies of the consignment note shall be sent by the manufacturer/supplier to the Drugs Controller of the state in which the manufacturer/supplier is located, the Drugs Controller of the state in which the recognized medical institution is located and the Narcotics Commissioner of India. He shall also keep a copy of the consignment note.
iii. On receipt of the consignment, the medical institution shall enter the quantity received with date in all the copies of the consignment note, retain the original consignment note, send the duplicate to the supplier, triplicate to the Drugs Controller, the quadruplicate to the Drugs Controller of the State (in cases in which the consignment originated outside the State) in which the supplier is located and the quintuplicate to the Narcotics Commissioner of India.
9. Maintenance of records
All records generated under this chapter shall be kept for a period of two years from the date of transaction. They shall be open for inspection by the officers empowered by the State Govt. under Sections 41 and 42 of the Narcotic Drugs and Psychotropic Substances Act 1985.
10. Inspection of stocks of morphine
The stocks of morphine under the custody of a recognized medical institution shall be open for inspection by the Drugs Controller or any other officer subordinate to him or the officers of other departments of the State Goverment empowered under Section 41 and 42 of the Narcotic Drugs and Psychotropic Substances Act 1985.
11. Appeals
Any institution aggrieved by any decision or orders passed by the Drugs Controller elating to recognition, revocation of recognition of any institution or estimates, can appeal to the Secretary, Department of Health of the State Govt. within 90 days from the date of communication of such decision or order.