Legislation

For pain relief

Print edition : September 06, 2013

At a palliative care centre in Tiruchi. Photo: M. Srinath

Getting morphine and other opioids for palliative care involves cumbersome licensing procedures. The Narcotics Drugs and Psychotropic Substances, or NDPS, (Amendment) Bill, 2011, which is expected to come up for discussion in the monsoon session of Parliament, is aimed at, among other things, simplifying the process to make morphine available for medicinal purposes.

“Pain relief reaches less than 1 per cent of the needy in India. Though India is a large manufacturer of opium, most of it is exported to the West. There needs to be a uniform national policy to ensure the availability of essential narcotic drugs for medical use of needy patients,” said Dr M.R. Rajagopal, chairman of Pallium India, an organisation working for palliative care and pain relief. Around 2.5 million people in India live with cancer and 2.4 million with HIV (human immunodeficiency virus).

The Bill proposes major changes to the NDPS Act, 1985. For instance, it proposes an amendment to Section 2 of the Act to ensure that a patient using narcotic drugs or psychotropic substances as medicine is not considered an “addict”. A proposed change to Section 4 will enable the Central government to ensure proactively the availability of narcotic drugs and psychotropic substances for medical and scientific use. This involves coordination of actions of various officers, State governments and other authorities and also under international conventions and any other laws in force. Section 4 also has provisions to prevent the abuse of the drugs.

The amendment to Section 9 of the Act seeks to transfer to the Centre from the State government the power to permit and regulate the possession, transport, inter-State import, sale, purchase, consumption or use of manufactured drugs, medicinal opium and any preparation containing any manufactured drug.

Further, the proposed Bill seeks to alter the process of licensing in States by bringing it under the State drugs controller; multiple agencies are involved in the process today. For medical institutions and palliative care units in most States, getting a licence for morphine involves obtaining separate import, export and transport licences as well as permission from the State Health and Excise Departments.

In 1998, the Central government asked the States to simplify their narcotic drugs regulations. “Only 17 States have simplified their regulations so far. Out of these, only Kerala, Karnataka, Tamil Nadu and Delhi have in practice improved access. Even in these States, the level of access is nowhere close to the near optimal level,” said Dr Rajagopal.

In 2007, the Indian Association of Palliative Care filed a public interest petition asking the Centre to frame a palliative care policy, simplify the process of licensing narcotics for medical purposes, and give adequate emphasis on palliative care at the undergraduate and postgraduate levels in medical education. The case is now in the Supreme Court.

Dr Ravinder Mohan, head of training and research of CanSupport, an organisation that provides palliative care in homes to patients in and around Delhi, emphasised the need to train doctors about the use of opioids. “I have visited 30 government dispensaries in north-west Delhi where qualified doctors did not know the use of oral morphine to alleviate pain for cancer patients,” he said.

The efficacy and safety of oral morphine is well established in clinical practice. The World Health Organisation has classified it as a Step 3 analgesic to be prescribed in cases of severe pain.

“With pharmaceutical companies pushing for more expensive medicines, there is a lobby against easing the availability of morphine, which is a cheaper drug,” said Harmala Gupta, the founder of CanSupport. She recommended more modern methods of production be adopted and proper training for medical professionals in palliative care.

Ambika Rajvanshi, the CEO of CanSupport, said, “In medical education, the emphasis is primarily on prevention, diagnosis and cure of diseases. There is not enough training on pain relief and care for medical ailments which are not curable.”

Sagnik Dutta

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