On the occasion of World Health Day celebrated on 7th April every year, our Office brings to you an interview with Dr M R Rajagopal, Chairman, Pallium India, where he shares his thoughts on increasing the availability of opiod analgesics for patients in India, through balanced regulatory mechanisms.

India: The principle of balance to make opioids accessible for palliative care

Pharmaceutical preparations containing internationally controlled substances play an essential role in medical treatment to relieve pain and suffering. For instance, opioid analgesics, such as codeine and morphine are essential medicines for the treatment of pain. However due to the risk of their being abused or diverted for illicit purposes, the access to such drugs is regulated and controlled.

According to the International Narcotics Control Board (INCB), opioid analgesics under international control continue to remain unavailable in sufficient quantities to meet the medical requirements of the population in many countries throughout the world, including several countries with very large populations, such as India and Nigeria. Despite numerous efforts by the Board and the World Health Organization (WHO), as well as nongovernmental organizations, their availability in much of the world remains very limited, depriving many patients of essential medicines.

In the state of Kerala in South India, Dr M R Rajagopal has been working in the field of 'Palliative Care' for over twenty years. As the Chairman of Pallium India, he and his team have been working to increase the availability of such drugs for patients. UNODC South Asia interviewed him to understand the dimensions of the situation in India and also some of the effective solutions that have been tried to improve access to these drugs, while ensuring that they are not diverted for illicit purposes.

1) Please explain what is Palliative Care. How does it relate to drug control?

Palliative care is treatment aimed at improving quality of life for patients, whether or not their disease (which could be prolonged and life limiting) is curable or controllable. To a large extent it relates to diseases like cancer and HIV/AIDS, but also other neurological, cardiovascular, renal or respiratory problems. Under palliative care, we identify factors that reduce the patient's quality of life, such as pain and other physical symptoms (vomiting, breathlessness etc) and also assess the psychological, social, and spiritual issues of a patient.  Once they are identified, we optimally treat these symptoms so that quality of life improves for the patient and the family. In many diseases, pain is one of the most common symptoms. And if somebody is rolling in pain, there is no way we can offer them psychological, social or spiritual support. So, the pain has to be controlled and this is not possible without access to essential medication. And one important group of medication for this is opioid drugs. Unfortunately opioid drugs need to be controlled because of the potential of diversion and abuse. This is where the issue of drug control in the context of palliative care comes in.

Now morphine is an opioid drug which is the main stay of cancer pain management. Morphine is produced from the opium poppy plant that is grown in certain Indian states and exported to other countries. Paradoxically, patients in India are denied morphine because of complicated regulatory barriers and other reasons. Apart from morphine, there are other opioid drugs like Methadone which are difficult to access. There are also weaker opioids which are available in the country, but I would particularly mention Morphine and Methadone as one of the most needed drugs today in this country.

2) What is the scenario regarding the availability of these opioid drugs in India?

It is estimated that less than 1% of the needy in the country have access to essential opioids and there are many factors responsible for this. However, if I mention two of the main barriers, they are the lack of professional education of the medical community and the unrealistic barriers to opioid availability. The Narcotic and Psychotropic Substances Act of 1985 laid down strict rules which reduced the supply of opioids in the country. Also, more than a generation of medical and nursing professionals is totally unfamiliar with the use of opioids for treatment of conditions like cancer pain. So it is a vicious circle - the professionals who know how to use these drugs and would like to use it do not have access to it because of regulatory barriers. And since the drugs are not available, people don't have the experience in using it.

My colleagues and I have been trying to address these two barriers that restrict the availability of opioids. The Department of Revenue, Government of India (GOI) has always been very supportive of this and the World Health Organization's (WHO) Collaborative Centre at Madison Wisconsin, USA has been working with the Pain and Palliative Care Society based in Kerala, India. Based on the WHO Collaborative Centre's recommendations and our work, the Department of Revenue, GOI, in 1998, made a recommendation to all Indian states to simplify the narcotic regulations in the states. However, since it's the states' prerogative to amend the rules, only 14 states  in India have simplified and amended regulations.

3) Can you explain what these regulatory procedures are?

As per the older rule, medical institutions and doctors need to apply for various licenses to be able to possess the drugs. This system is still followed in states where the narcotic regulations have not been amended. In the states where the rules have been amended, some recognized medical institutions which deal with palliative care are exempt from the need for licenses, while the old licensing system is applicable for other medical institutions. However, this system has not been very effective in all these states, because only some of them have introduced the simple standard operating procedures. In many states, the amendments have brought in further complications. So even if we say that fourteen states have the amended rules, the access to opioids has not improved in all of them.

4) You have been working in this area for over twenty years. Can you share some of your experiences and some good practices that are being followed?

In a sentence, what we need to do is follow the principle of balance. While control is necessary and essential, it should never become unrealistic and while ensuring adequate control, we also ensure adequate availability for medical purposes. Now this is quite possible as we have demonstrated in the case of Kerala state in India.

In Kerala, according to the amended regulations, only one agency, namely the Drug Controller of the state is involved in the process. Any medical institution approved by him is allowed a quota of morphine. The Drug Controller has approved about 100 palliative care centres in the state and also established Standard Operating Procedures (SOPs) for the safe use of morphine. There is a system ensuring documentation, safe custody of the drug and proper prescription practices to ensure adequate control.

The drug is prescribed for consumption in the home setting, with each patient being given about two weeks supply. Patients and their relatives are asked to return any unused drug to the clinic.  When the patient comes for review, a tablet count is done. The patient is also asked simple questions to check if it is being consumed properly.  Now if there has been a diversion or abuse, there will be a disproportionate escalation of the dose not corresponding to the degree of disease or there would be unaccounted reports of thefts. This usually does not happen. Every year, in the month of November, each recognized medical institution has to submit consumption statistics, for the year. Based on this, the next year's quota is allotted. In some states, particularly in Tamil Nadu and Karnataka, a similar system is functioning. However, it is not so uniform in the rest of the country.

The other important reason for the success in Kerala is that a palliative care programme was started in 1993 in one of the medical colleges. This was concurrent with the work to ease regulatory barriers and in 1998, Kerala's narcotic regulations were amended. Today, we have doctors who are trained in the use of morphine. There are also several centres within the state which offers palliative care education to doctors and nurses. And I might add that advocacy through the media also contributed to greater public awareness.

5) What do you think needs to be done further to increase availability of opioids for palliative care?

Firstly, the State Governments should be persuaded to follow the Central Government's instructions. Secondly, there are still loop holes in the Central Government's instructions which need to be modified. So far, it permits only the use of morphine. This needs to be applied to other opioids also. Today the Central Government's instructions are limited to cancer. They should be extended to many other diseases. But even more importantly, palliative medicine has to be taught to medical and nursing students. On the positive side, just three months back, the Medical Council of India approved of palliative medicine as an independent medical sub specialty and took a decision to start an MD (Doctor of Medicine) in Palliative Medicine program, which is a giant step forward. But we also need to incorporate this in undergraduate medical and nursing education.

At Pallium India, we promote the development of palliative care centres mostly in states which have negligible or no palliative care at all. Our main work has been working with the Central and State Governments to remove the regulatory barriers to opioid access. And we see advocacy as an important part of what we need to do because people need to be sensitised to the issue of pain. They need to understand that most pain can be relieved effectively and a disease like cancer does not mean pain.

Click here to read the article in the Indian Express: Hospitals told to use morphine as pain-killer for cancer patients.