Last Updated on March 23, 2025 by The Health Master
Essential Narcotic Drugs
The Karnataka government has taken important action and notified the State Narcotic Drugs and Psychotropic Substances (NDPS) Rules, effectively aligning state regulations with the central regulations for medical institutions.
This move, set to take effect from May 5, 2025, focuses on the possession, transport, sale, purchase, consumption, and use of Essential Narcotic Drugs for medical and scientific purposes, promising to ease access for patients requiring these crucial medications.
Central Regulation for Essential Narcotics:
The crux of this notification lies in the decision to subject drugs identified as Essential Narcotic Drugs to the regulations under the Central Narcotic Drugs and Psychotropic Substances Act.
Now onwards, recognized medical institutions (RMI) will operate under a unified national standard.
This includes crucial medications:
- Methyl morphine (codeine),
- Ethyl morphine,
- Fentanyl,
- Hydrocodone,
- Methadone,
- Morphine,
- Oxycodone,
- Di-hydroxycodeinone,
All vital chemical compounds used for:
- Analgesia,
- Antitussive purposes, and
- The treatment of drug abuse and alcohol addiction.
Addressing Hospital Concerns:
Harsh Gupta, Principal Secretary of the Karnataka Health and Family Welfare Department, addressed the concerns of hospitals and medical institutions facing conflicting regulations.
He clarified that previously, institutions stocking morphine and fentanyl, both classified as Essential Narcotic Drugs, were being asked to comply with the Karnataka NDPS Act.
“It has been brought to the notice of the government that hospitals and medical institutions in the State wanting to stock morphine and fentanyl, which have been notified as Essential Narcotic Drugs, are still being asked to comply with the provisions of the Karnataka NDPS Act,” he stated.
“Therefore, it is clarified that drugs notified by the Central government as Essential Narcotic Drugs will be regulated as the provisions of the Chapter V-A and B of the Central NDPS Rules and accordingly Karnataka NDPS Rules cease to apply to these categories.”
Continued State Oversight:
While the Central NDPS Rules will govern Essential Narcotic Drugs, the Karnataka NDPS Rules will continue to regulate the medical access to other manufactured drugs within the state. Notably, authorized medical institutions can stock and dispense morphine tablets and solutions.
Recognized Medical Institutions (RMI):
A committee comprising of the following is responsible for determining the status of “recognized medical institutions” (RMI):
- State Drug Controller,
- Excise Commissioner, and
- Director of the Kidwai Memorial Institute of Oncology, Bengaluru.
This committee ensures a standardized and rigorous evaluation process.
Furthermore, the Karnataka NDPS Rules stipulate a 90-day period for processing applications for recognized medical institution status.
This time period is extending the timeframe from the 60 days specified in the Central NDPS Rules.
Benefits of the Regulatory Shift:
This regulatory change brings significant benefits, particularly for hospitals prescribing opioid painkillers for cancer patients.
It also includes the validity of the recognized medical institution certificate and the appointment of a designated medical practitioner (DMP).
The quantity of opioids that these institutions can possess is determined by the Drugs Control Department, based on submitted estimates.
Q. What are Essential Narcotic Drugs?
A. These are drugs used for medical and scientific purposes, i.e., codeine, morphine, and fentanyl.
Q. Who regulates these drugs in Karnataka now?
A. The Central NDPS Rules will regulate Essential Narcotic Drugs, while the Karnataka NDPS Rules will continue to regulate other manufactured drugs.
Q. What is the benefit of this change?
A. It simplifies compliance for medical institutions and ensures smoother access to essential medications for patients.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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