To their great relief, the Narcotic Drugs and Psychotropic Substances Act Amendment Bill was passed by the Rajya Sabha on February 21, the last day of the session, making it easier for millions of patients with cancer, Aids and other chronic illnesses to avail of medicinal morphine for pain management.
Before the Act was amended, the availability of morphine and other opium-derived medical drugs was severely restricted in most states. Numerous licenses were required to manufacture, sell, purchase or store the products. Now, nearly 20 years after palliative care sector began campaigning for the right of patients to pain-relieving drugs, the amendment to the act will simplify the regulations for issuing these licenses.
“The Act was introduced in 1985 with the aim of policing misuse of narcotic drugs, not for regulating its medical use, but the restrictive law led to a huge decline in the demand for medicinal opioids,” said Dr. Nagesh Simha, president of the Indian Association of Palliative Care, one of the non-profit organisations that pushed for the amendment.
In 1998, recognising the disservice that tight regulations did to patients in advanced stages of chronic illnesses, the central government advised all states and union territories to introduce a single-window licensing system for morphine and similar drugs. The Drug Controller of each state was to be responsible for regulating the quota of morphine to be allotted to recognised medical institutions.
However, only 16 states chose to ease their regulations. Often, this made inter-state transport of opioids even more complicated.
“Today, there is a limited number of hospitals that provide morphine pills and it is particularly difficult to avail of them outside metro cities,” said Vandana Gupta, founder of the non-profit V-Care Foundation that provides support to cancer patients.
As a result, in a country where more than one million people are in the advanced stages of very painful cancers – and more than 1.5 million suffer from chronic ailments that causes severe pain – only one per cent of patients actually get access to affordable medicines like morphine.
“My estimate is that India needs around 36,000 kilograms of morphine to cater to the required need,” said Dr. MR Rajagopal, chairman of Pallium India, a charitable trust for palliative care. “But at the moment we are only able to use around 200 kilos.” Ironically, India is one of the largest cultivators of poppy in the world, but most of the opium derived from it is exported.
It is in response to these skewed statistics that palliative care activists filed a public interest litigation in the Supreme Court in 2008 and began to push the central government to amend the law. While the case is still being heard, the legislation has finally come through.
“The amendment essentially introduces uniform regulation across states and scraps the long list of licenses required to obtain and store morphine sulphate by drug makers and hospitals,” said Dr. Priyadarshini Kulkarni, medical director of the Cipla Palliative Care and Training Centre in Pune. “This is a huge step in our efforts to bring dignity and quality to the lives of suffering patients.”
The amendment is not likely to lead to a sudden spurt in the demand for morphine, but Simha believes the demand will rise gradually, and that the Indian poppy industry is more than equipped to cater to this need. However, activists emphasise that availability alone cannot address the needs of patients in pain.
“Since many hospitals have not been stocking morphine for so many years, many doctors have never used or prescribed the drug and are afraid of it,” said Rajagopal. “So education in pain management and palliative care will be a must to train doctors on the use of morphine.”