This section reviews the Center’s ongoing activities in India in collaboration with the WHO Demonstration Project (WHODP) in Calicut, an Indian non-governmental organization, several agencies of the Central Government of India, and several state government Ministries of Health. An historical summary of these activities is presented first, followed by an update for 2001.
Objective:
To overcome regulatory barriers and to improve availability and access to opioid
analgesics for Indian patients with cancer and pain.
Situation:
It is estimated that more than one million people a year in India suffer from
pain due to cancer. Cancer is usually diagnosed when the disease is late-stage,
which is when pain is severe and sometimes excruciating. Despite India’s
heavy cancer burden, the country uses little morphine -- an essential drug for
cancer pain management.7
From 1986 to 1998, the consumption of morphine for medical purposes decreased
by more than 90%, due in part to a plethora of state excise requirements and
to a tough anti-narcotics law adopted in 1985. Ironically, this decrease occurred
while there were increasing efforts to improve awareness of pain management
and palliative care and to educate and train health-care professionals according
to the WHO Three-Step Analgesic Ladder. Although these educational efforts have
enhanced the willingness of physicians to use opioids for pain relief, the reality
is that many hospitals and palliative care programs have great difficulty obtaining
a continuous supply of these drugs.
Method:
The Center developed a method to identify the barriers to morphine availability,
devised a plan for policy and systems change, developed collaboration with governmental
and non-governmental organizations; and, with leadership from the WHODP in Calicut,
is implementing a plan to simplify regulation of morphine in India.
Cooperation:
The Center has collaborated with the Narcotics Commissioner of India, and through
him with the Secretary of the Department of Revenue of the Government of India,
as well as with the WHO Office-India and the South-East Asia Regional Office
of WHO (SEARO). The Center also worked closely with the Indian Association for
Palliative Care (IAPC), which appointed a Committee on Morphine Availability
and Control to review and comment on our work.
Problem Identification:
In 1995 and 1996, members of the Center visited India several times to participate
in meetings and workshops with government officials to study the policies that
govern the availability and use of opioid analgesics as well as relevant systems
for delivery of health-care and distribution of drugs. We gained a thorough
understanding of the requirements for obtaining morphine by conducting an evaluation
of the India Narcotic Drugs and Psychotropic Substances Act, including the regulations
of each state. This review showed that the licensing of morphine for medical
purposes was principally a state function rather than a central government function,
that the states required as many as five licenses for each medical institution
wanting morphine, and that these must often be obtained from more than one branch
of state government. The period of validity for some licenses was so short that
they would likely expire before all necessary licenses could be obtained.
Action Plan:
The Center prepared an action plan that included (1) development of guidelines
for obtaining morphine, (2) preparation of a plan for simplifying regulations
over morphine, and (3) sponsorship of workshops on morphine availability with
state governments. The WHO Cancer and Palliative Care Unit in Geneva had also
designated a Demonstration Project to make morphine available at the District
Hospital level in the state of Madhya Pradesh (in cooperation with the Regional
Cancer Center in Gwalior). This was the only part of the action plan that became
part of the National Cancer Control Program (NCCP). In addition, the Center
designated a WHODP to be a source of national expertise and leadership in opioid
availability at the Pain and Palliative Care Society (PPCS), Calicut, in the
State of Kerala (see map, Figure 1) on the use and control of morphine. The
PPCS was already a WHODP for providing cost-effective community-based home care
for late-stage cancer patients. The PPCS is directed by Dr. M.R. Rajagopal,
Professor of Anesthesiology at the Medical College, Calicut, State of Kerala.
Outcomes:
In July 2001, the Directors of the Center and the PPCS/WHODP held several meetings
with Indian government representatives. (1) They provided an update to the Narcotics
Commissioner on the current status of opioid availability in India. He agreed
to assist with introducing them to the Health Secretary of Guwahati, with the
hope of planning an opioid availability meeting in that state in September 2001.
(2) They met with representatives of the Revenue Department to discuss the current
status of state amendments to narcotics regulations. They discussed plans to
encourage other Indian states to amend their regulations with the simplified
rule. (3) The Directors also met with Dr. Walia of the WHO-India to discuss
recent developments in the WHO-India office and the advisability of providing
free morphine to Regional Cancer Centres. Finally, (4) they met with the Drugs
Controller General of India and (5) the Health Secretary of India to discuss
the strengths and weaknesses of the current distribution system for opioid analgesics
in India. The Director of the Center presented a certificate to the Bankmen’s
Club of Calicut recognizing their support of the PPCS/WHODP. This ceremony received
press coverage (see Figure 2).
Two staff members from the Center helped to organize and participated in a national workshop on morphine availability in New Delhi on 10 September 2001. The workshop included palliative care professionals, WHO-India, and representatives from the Government of India Departments of Revenue and Health and state governments. The workshop recommended that palliative care and morphine availability should become higher priorities of the Health Ministry, the NCCP, and state governments, and that each state should be encouraged, once again, to adopt and implement the simplified morphine licensing rules and make use of a Standard Operating Procedure for approving Recognized Medical Institutions.
On 11 September 2001, the Center and the PPCS/WHODP met with governmental officials from the New Delhi Union Territory government to discuss and encourage adoption of the simplified morphine licensing rule through amendment of their rules. The Center and the PPCS/WHODP also met with officials of the Government of India to assess progress and consider next steps.
The PPCS/WHODP, the Center, and the United States Cancer Pain Relief Committee sponsored a workshop on morphine availability in Guwahati, Assam (14 September 2001). Outcomes from this workshop include an increased awareness of the importance of palliative care and opioid analgesics, assistance to the Guwahati Pain and Palliative Care Society, and an increased likelihood that the Assam rules for morphine licensing will be amended. It is also possible that the Assam effort may spread to other northeast states.
In 2001, the Center assisted the PPCS/WHODP to prepare and submit an application to WHO to become designated as a WHO Collaborating Center in India. SEARO and WHO-Geneva are reviewing the application.
Evaluation:
In 2001, the Collaborators published an article in Lancet demonstrating the
successful use and availability of morphine for cancer pain at the community
level that was accomplished without diversion of the medications.8
The authors included the Directors of the PPCS/WHODP and the Center. Data indicate
that the decreasing consumption trend was finally reversed due to the collaborative
efforts of the Center, PPCS/WHODP, and a number of cooperating organizations
in India. Morphine consumption data in 1999 (the most recent year for which
the Indian government has reported to the INCB) increased to its highest level
in more than a decade (see Figure 3).
Another article in 2001, authored by Dr. Rajagopal, describes palliative care in India; its history, challenges, and recent efforts by the IAPC and the Center to simplify narcotic regulations.9 It also describes the activities of the PPCS in the State of Kerala.
The use of specialized workshops reflects the value of bringing together senior officials from the concerned government departments with doctors to facilitate changes in opioid policy and system administration. Physicians gained valuable information about the morphine licensing and control system, which will enable them to work more effectively with government in the future. The government officials learned about palliative care and the need for opioids.