Tuesday, 25 February 2014

Palliative Care, a Reality: Easing Curbs on Morphine



The 15th Lok Sabha will go down the legislative history for the unusually painful experiences, blackouts, pepper spray attacks, disruptive business proceedings and for its corruption riddled legislators. But on the penultimate day post-Telangana bill, two bills Whistle blowers bill and amendments to the Narcotic Drugs and Psychotropic Substances Act (NDPS) 1985 were approved by Rajya Sabha on 21st Feb following the recommendations of the lower house. The new NDPS (Amendment) Bill 2011 is hailed by the human right activists as it will provide relief to millions of terminally-ill patients suffering from acute to chronic pain as the accessibility of morphine based drugs would increase. As per the amendments, the restrictions on the use of the narcotic drugs like Morphine used for medical purposes especially in pain management and relief is eased. The India Association for Palliative Care (IAPC) have been pushing for passage of the amendment in parliament. Earlier, hospitals and pharmaceutical companies are required to obtain multiple clearances of varying validity periods from different government agencies for the purchase and storage of Morphine or other opioids. The amendments will prescribe forms and conditions of licence or permits for manufacture, possession, transport, interstate import and export, sale, purchase, and consumption or use of essential narcotic drugs. Earlier the law even mandated a severe punishment of 10 years imprisonment if a person was found to possess 250 gm of morphine without adequate licence.

Opioids are world’s oldest drugs known for their promising analgesic (pain relieving) properties. They are derivatives of Opium and similar synthetic substances like Morphine. They are found to be invaluable in palliative care to alleviate severe, chronic and disabling pain of terminal conditions like cancer, muscular dystrophy, dementia, and rheumatoid arthritis. They are notoriously popular for their contradictive properties of being not only addictive but also for causing euphoria in users. Hence their use had been so stringently monitored by government agencies. These inexpensive drugs can be now accessible to the terminally ill patients. India has 24 lakh cancer patients of them 15 lakh patients in the advanced stage experience excruciating pain further 1 million HIV/AIDS patients also suffer from mild to severe pain. This bill would ensure the availability of the Opioids for the medical use of all the patients. The new changes would offer great succour to the millions of the patients and their families suffering from severe pain. Because of strict vigilance regarding the sale, purchase and availability of morphine based drugs; they were highly inaccessible to the patients till now.

Morphine based pain killers are classified as controlled medicines, essential for pain treatment by World Health Organisation (WHO). These are medicines which have therapeutic use but they can be subject to abuse through non-medical uses. According to WHO study by 2003 six developing countries accounted to 79% of total global morphine consumption, while developing countries with 80% population amounted to just 6%. Hence it called on all countries to integrate palliative care, a service which aims at improving the quality of life for patients suffering with life-limiting diseases with the health systems. This implied, among other changes countries should review drug policy so that the pain relieving drugs are more accessible to the terminally–ill patients. In 2011, Medical Council of India recognised palliative care as specialisation of medicine paving way for improved training of health workers. In 2012, Ministry of Health and Family Welfare has approved a national palliative care strategy.

 To spare millions from needless suffering, doctors engaged in palliative care of cancer patients have been vociferously advocating use of the morphine based drugs as the cheapest and the most effective relief available from the painful effects of chemotherapy and radiation. They believe that pain relief is human right and any law depriving the access of pain-relievers is a violation of that right. Sadly almost 90% of patients are deprived of pain relief.

Turkey, India, Australia, France, Spain and Hungary are major legal cultivators of opium poppy in the World. India is the largest producer of Opium but exports most of it foreign countries. Licensed farmers are allowed to grow poppy and government procures from them strictly under the vigilance of the Central Narcotics Bureau. They are then shipped to two processing plants in Neemuch (M.P) and Ghazipur (U.P). Poppy cultivation and domestic use are highly regulated. India produces 250 kg as against the estimated requirement of 30,000 to 40,000 kg per year.

 A report by the Global Opioid Policy initiative indicates that nearly half of the world population lives in countries where regulations aimed at containing the misuse of drugs have left several cancer patients devoid of the drugs containing the opioids for palliative cure. Kerala and Maharashtra are the two states which use more morphine for cancer patients than rest of the country. In seven years following the enactment of NDPS act in 1985 morphine use in India has plummeted by 97%. Human rights watch estimated that the amount of morphine used in India in 2008 was just sufficient for 4% of patients in advanced stage of cancer.

New amendments would enable central government with the authority to regulate the narcotic drugs. A single licence can now be obtained from one government agency, State Food and Drug Administration and the power to regulate and frame rules will be vested with the Drug Controller General of India. Government is now contemplating on allowing the participation of private pharmaceutical companies to extract the alkaloids morphine and codeine. There are still glitches to the newly amended bill as certain aspects of the bill are still not salubrious for the entry of private players into the trade. Till now government has been exporting the opium gum, the precursor for all active ingredients as we don’t have the capacity. Even if industry is privatised immediately, it will take at least 5-7 years to develop the technology for indigenous manufacture of opioids. Though the government had made a humble beginning, pain relief would elude cancer patients for few more years.
 
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