Conference Lectures

Morphine – Recent Update on Narcotic Rule

 

Dr J.Rajesh
Consultant Pain Physician
Meenakshi Mission Hospital & Research Centre
Madurai

Introduction

Opioid analgesic medication is the mainstay of pain treatment in cancer patients, according to theguidelines of the World Health Organization (WHO) for cancer pain relief. The WHO ladder approach was found effective and safe in 70–90% of advanced cancer patients. However, various reports indicate that over 50% of cancer patients worldwide do not receive adequate pain relief or are untreated, and theunrelieved cancer pain persists as a significant public health concern.Several factors are reported to contribute to the inappropriate use of opioid analgesics in cancer pain, e.g., insufficient education of doctors and nurses, exaggerated concerns about the risks of abuse and diversion of opioids, fear of side effects, and inappropriate attitudes among physicians, patients, and the family members of cancer patients. Furthermore, existing national legislations and policies can be of potential impediment to adequate opioid use. Unavailability of Opioids is one of the biggest obstacles for providing quality pain relief for the sufferers. Nowadays, Opioids play a good role not only in relieving cancer pain but also in noncancerous chronic pain conditions.

The Narcotics and Psychotropic Substances (NDPS) Act  was made in 1985 . NDPS act governs control and availability of groups of drugs called “narcotics” like Morphine and “psychotropics” like Amphetamine which have medical value. Opioids are derivatives of opium like Morphine and similar synthetic substances like Fentanyl. They are most helpful in treating severe pain conditions. When used correctly, they relieve pain so that the person can get back to normal activities. The term “narcotic” is used to mean "opioid" in our NDPS act. The scope of the Act did not adequately address the accessibility and availability issues of these drugs for medical treatment of patients in pain.
Patients with severe pain in India are not able to get opioid medicines for pain relief because the state NDPS Rules make it difficult for hospitals to store and dispense opioids. Hospitals have to obtain licenses for stocking, import, export, transport etc, each license requiring concurrence from different departments [Excise, Drugs Control, Health administration]. These licenses need to be valid at the same time, though often the validity period of a license is as short as a month. By the time the institution gets a second license, often the first would have expired validity. Most institutions solve this problem by not stocking these medicines at all to avoid legal hassles. This includes even medical colleges, and hence generations of doctors pass out, who do not have any experience of using this medicine.
The overall impact is denial of pain relief to millions of people in India.

Actions  taken in the past to solve this problem

Joint action taken by palliative care activists in collaboration with Mr. David Joranson of Pain and Policy Studies Group (PPSG) resulted in an instruction by the Department of Revenue of Government of India to simplify state rules in 1998. Persistent work with state governments resulted in simplification of rules in 16 states over 15 years.
A Public interest litigation was filed in 2007 by The Indian Association of Palliative Care1 [IAPC] (1) along with Ms Poonam Bagai(2) and Dr Ravi Ghooi(3 )pleading for adequate access to pain relief for cancer patients in the country. This case is presently with the Supreme Court awaiting final hearing.

  • The national association for Palliative Care.
  • A cancer survivor, vice-chair of Pallium India and chairperson of Cankids..Kidscan.
  • A pharmacologist who had got a favorable verdict earlier from the High Court of Delhi asking for Morphine for his mother with cancer.
  • A charitable trust working to increase access to pain relief and palliative care all over India.
  • A NGO working in this area.

 

The opioid availability committee of IAPC and Pallium India (4), in collaboration with Lawyer’s collective (5) filed representations with the Department of Revenue, Ministry of Finance and the Standing Committee on Finance [June 2012] with regard to necessary amendments required. This has been scrutinized, analyzed and incorporated in the NDPS (Amendment) Bill 2011, which was finally passed by Lok Sabha on 20th and by Rajya Sabha on the 21st of February 2014.
The amendment is aimed at ensuring availability of Essential opioid medicines for medical use for needy patients.

 

 

Important provisions of the amendment
There will be a uniform national policy on these few selected medicines and the power to amend the rules will be vested with the Government of India.

  • Currently, each state has its own regulations which vary from state to state. The amendment will make them uniform for all states and union territories.
  • The power to amend the rules of Essential Narcotic Drugs (Morphine, Fentanyl and Methadone) will be vested with Central Government, ensuring uniformity.
  • Each institution will require only a single order approving them as a Recognized Medical Institution (RMI) instead of the current system of 4-5 different licenses.

 

  • In each state, instead of multiple agencies being involved in the process of licensing, there will be only one – the drugs controller, thus eliminating the interdepartmental red tape.
  • The overall expected impact would be improved availability of pain medications for use within hospitals from where patients with severe pain can access them.

With the amendment, the process of narcotics control WILL NOT get transferred from the States to the Central Government.The licensing and monitoring will continue to be done by the State Drugs Controller.
Enough control measures have been put in the amendment of the Act to prevent the chance of diversion of the opioid medicines to illicit channels thus increasing addiction among our populationand such a consequence. The amendment brings in the principle of balance, that is, while preventing diversion and abuse, availability of opioids for pain relief is permitted.

 

 

 

The amendment will come into force when the President of India signs the document, but for it to cause change there are several additional requirements.

 

  • Standard operating procedures (which have already been drawn up) will have to be sent by Department of Revenue to state governments.
  • We shall have to work at the state level to ensure implementation of the amended Act with no cumbersome procedures brought in.
  • We shall have to work through Medical and Nursing Colleges to ensure that assessment and management of pain is taught to them and that in-service training is given to professionals.
  • We shall need to work with state National Health Mission and Health authorities for integration of palliative care in health care as envisaged in the National Program for Palliative Care and to ensure submission of "program implementation plan (PIP) to Ministry of Health of Government of India.

 

Acknowledgement

Sincere Thanks to Prof.Dr.M.R.Rajagopal, Chairman, Pallium India.

References

Opioid-prescribing Practices in Chronic Cancer Pain
in a Tertiary Care Pain Clinic - Raghu S Thota etal, India Indian Journal of Palliative Care / Sep-Dec 2011 / Vol-17 / Issue-3