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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