Transcript Country Report for India - Pain & Policy Studies Group

M.R.Rajagopal, Chairman, Pallium India, Trivandrum
Nandini Vallath – Palliative Care Physician, Bangalore
Priyadarshini Kulkarni – Medical Director, Cipla Palliative Care Centre, Pune
Rajesh Nandan Srivastava – Director NC - DOR
Shalini Vallabhan – Trustee, Pallium India, Mumbai
Sudhir Gupta – Additional Deputy Director General, MOH
13-04-2015
1
13-04-2015
2

Estimated prevalence and type of cancer in India

incidence ~ 11 lakh per year, prevalence 27-28 lakh per year, deaths about 5 lakh per year

2.5 million cancer cases at any given point of time

Age-standardized death for cancer is 78.8

Most Prevalent forms in men are lung, oral, larynx, esophagus, and pharynx

Most prevalent forms in women, in addition to tobacco-related cancers are cervix, breast, and
ovarian cancers

Estimated prevalence and type of pain in India

More than 1 million cancer patients suffer from severe pain every year
http://www.indiaenvironmentportal.org.in/files/file/PHFI_NCD_Report_Sep_2011.pdf
http://www.who.int/nmh/publications/ncd_report_full_en.pdf.
13-04-2015
3

There is a National cancer control Policy. NCCP- started in 1975-76.

Office: Dr. R. K. Srivastava, DGHS, Ministry of Health and Family
welfare, GOI

NCCP got merged with NPCDCS with effect from July 2010.

Its goals and objectives include pain relief and palliative care

Availability of opioids are not specifically addressed
http://www.indg.in/india/sitemap-1/health/national_health_programmes/national-cancer-control-programme-current-status-strategies-in-india
http://www.who.int/cancer/nccp/en/
13-04-2015
http://india.gov.in/sectors/health_family/index.php?id=11
4

NCD cell at State, Districts, CHC and Sub Centre level

Palliative care, home based care as essential features of care

Funding for awareness, training , personnel, equipment, NLEM

Convergence with
 National Cancer Control Program
 National Rural Health Mission (NRHM)
 National Tobacco Control Programme (NTCP)
 National Programme for Health Care of Elderly (NPHCE)
 Other programs with similar theme
13-04-2015
5
Behavioural Risk
Factors
Physiological
Risk Factors
• Positive health
• BMI (obesity)
• Heart disease
• Quality of life
• Tobacco
• Blood pressure
• Stroke
• Pain relief
• Alcohol
• Blood glucose
• Diabetes
• Symptom relief
• Physical
• Cholesterol
• Cancer
• Psychosocial
• inactivity
• Chronic
• Diet
Primary
prevention
13-04-2015
Disease
Outcomes
Secondary
prevention
Palliative Care
support
resp.disease
• Rehabilitation
Tertiary
prevention
Diagnosis
onwards
6

Yes, Government has endorsed WHO method for relief of cancer pain

In 1994 Government of India and WHOCC and PPSG conducted 2 workshops to understand
and simplify narcotic rules – resulted in recommendation of modified model NDPS rules for
states

Currently 13 states and 1 union territory have simplified rules

The state of Kerala declared its Palliative Care policy in April 2008


It has “Aarogya Keralam” project under which there are 614 nurse led home care projects
PC department in Government institutions e.g. AIIMS Delhi, PGI Chandigarh,
SGPGI Lucknow, Few Regional Cancer Centres

Palliative Medicine has recently got recognition as medical specialty - MD
http://www.whoindia.org/en/Section1_1894.asp
http://www.painpolicy.wisc.edu/publicat/07jpsm/india07.pdf
13-04-2015
7

Many of the cancer hospitals have opioid availability and the relevant license; but pain relief is unknown
field to majority of oncologists

There are about 250 palliative care centres, majority run by NGOs with about 180 of them in the state of
Kerala. These centres have either inpatient, out patient or home based facilities

16 out of India's 28 states and 7 union territories do not have any palliative care services at all

Pain management is a poorly taught skill and 2 generations of doctors have graduated without training to
understand pain nor any exposure to opioid usage for moderate to severe pains; including government run
medical colleges
How well is pediatric cancer pain treated? Do pediatric patients have access to opioid analgesics in the
class of morphine?

About 3 lakh children with various life limiting conditions need palliative care in India. The facilities are
very poor for paediatric pain patients
http://www.palliativecare.in/ http://www.jpalliativecare.com/temp/IndianJPalliatCare174522108539_055125.pdf
13-04-2015
8

The Indian Association of Palliative care was formed in 1994 in consultation with World Health
Organisation and Government of India

Activities are aimed at the care of people with life limiting illness such as Cancer, AIDS and end-stage chronic medical diseases including access
to pain relief, palliative care capacity building and advocacy.

Children’s Palliative Care program was launched by IAPC in 2010, which focuses on pain relief in HIV positive children

Pallium India – is an NGO and a WHOCC working on capacity building and opioid availability issues

International Association of Study of Pain, Indian Chapter has 1525 members and 14 state chapters

Cansupport, Cankids, Karunashraya trust, Cipla Palliative Care Centre and many other NGOs work
through clinical service or supporting capacity building in their chosen population

Departments of Palliative Medicine in private medical colleges and hospitals e.g. CMC Vellore, St
John’s Medical College Hospital, HCG – BIO, Bangalore, Baptist Hospital Bangalore

There are also pain clinics in metros through efforts of anaesthesiologists, but mostly focused on
regional nerve blocks – need to merge WHO analgesic ladder into services offered
13-04-2015
9
13-04-2015
10

Prevalence: The adult (15-49 years) HIV prevalence in India is estimated at 0.32% in 2008 and
0.31% in 2009 with approximately 2.4 million people living with HIV.

High prevalence states - Manipur (1.4%); followed by Andhra Pradesh (0.90%), Mizoram (0.81%), Nagaland
(0.78%), Karnataka (0.63%) and Maharashtra (0.55%). Delhi, Orissa, West Bengal, Chhattisgarh and
Pondicherry have an estimated adult HIV prevalence of 0.28 to 0.30% whilst HIV prevalence in other states is
less than 0.28%.

Mortality - Approximately 172,000 people died of AIDS related causes in 2009 in India. 2008/2009
HIV estimates highlight the declining trend of annual AIDS deaths post 2004

Pain Prevalence: 66.7% in admitted patients and 24.5% out patients. Average 35.5% Ref: IJPC
Jan-June 2009, Vol 15 Issue 1

Approximately 1.2 million HIV patients suffer from pain each year (30 -80% of HIV patient have pain) UNAID
13-04-2015
11

National AIDS Control Organisation is a division of the Ministry of Health
and Family Welfare - 35 HIV/AIDS Prevention and Control Societies

If so, when did it start? In 1986, following the detection of the first AIDS
case in the country, the National AIDS Committee was constituted in the
Ministry of Health and Family Welfare

Office: National AIDS Control Organisation (NACO) was constituted in
1992 to implement the national program.

Person In charge: Secretary & Director General NACO - Shri Sayan
Chatterjee
13-04-2015
12

Is availability of opioid analgesics specifically addressed?


Has the government endorsed the WHO method for relief of HIV/AIDS
pain? Has the government sponsored or endorsed training programs in
pain relief, palliative care and the medical use of opioid analgesics?


NO
NO
Describe in brief terms the availability of pain relief and palliative care
services in the country for HIV/AIDS patients and comment on the extent
to which the needy population has access to such services, including
children. How well is pediatric pain treated? Do pediatric patients have
access to opioid analgesics in the class of morphine?

NOT AVAILABLE
13-04-2015
13
13-04-2015
14

Two National Competent Authorities for different aspects of narcotics control

Narcotics Control Bureau (NCB) Ministry of Home Affairs


Coordinating action among other drug law enforcement agencies
Central Bureau of Narcotics (CBN) Department of Revenue, MO Finance

Allots the estimates received from INCB as quotas to manufacturing companies in the country

Collects consumption figures from such companies and arrives at ‘estimates’ and sends statistics to
INCB through the NCB

The mandate of CBN or NCB does not include aspects regarding medical use of
opioids

Officer in charge


Director General of NCB and Narcotics Commissioner CBN
Mr. Rajesh Nandan Srivastava, Director (Narcotics Control) is here.
13-04-2015
15

Manufacturers send data of Morphine Sulphate [base]
consumed from the allotted quota to the Narcotics
Commissioner. This is the opioid consumption statistics.
Does it address unmet actual needs for opioid analgesics?

The awareness and usage of opioids by the health care
professionals is very low. The real needs are unnoticed and
hence there are no unmet needs
13-04-2015
16

Yes, however the country has experienced difficulties in reporting
the statistics of ‘consumption’ as defined in the 1961 Convention.
 It was with the DCGI.
 Possibilities for error exists e.g. small quantities are exported to Nepal.
 There is certainty that all the morphine has not really reached retail levels
as significant quantities may be idling with manufacturers.

Since 2010, the responsibility of collection of consumption
statistics has been given to the Narcotics Commissioner.
13-04-2015
17
13-04-2015
18
Yes – India has a National List of Essential Medicines that
includes opioids as essential medicines for Palliative Care
Ref NLEM 2011
Morphine
Sulphate
Tramadol
Fentanyl
13-04-2015
Secondary,
Injection
Tertiary levels
Tablets
Secondary,
Capsules
Tertiary levels Injection
Secondary,
Injection
Tertiary levels
10 mg/ml
10 mg
50 mg, 100mg
50 mg/ml
50 ug/ml
2 ml ampoule
19

Morphine

Tab - 5, 10, 20, 30, 60 mgs IR & SR

Solution 1mg/ml

Injection 10 or 15 mg/ml

Fentanyl
 100 ug inj, 200 ug OTFC,
12, 25, 50 ug/Hour patch

26 Manufacturers; most
make only injections

Methadone is needed
 no oral alternative to
morphine presently
 not available for use for
pain relief.
13-04-2015
20

No. These drugs are not readily available and
accessible at the retail level for professionals or
patients to access even with valid prescriptions

Are there shortages or “stock-outs” so that prescriptions cannot be
dispensed?
 Yes, stock outs do happen
13-04-2015
21
What licenses or authorizations are required by the government and medical institutions?
There are 2 situations.

In 13 states with modified rules, State Drug Controller is a single contact authorisation nodus (at
least in theory) for inspecting and granting an institution a status of “Recognised Medical
Institution” which allows transaction on opioids through an approved medical practitioner who
has undergone hands-on training in the use of opioids is recommended

In other states, there is need for institutions to have individual licenses for possession, import,
export and transport from excise department, Collector. Each of them have validity periods.

Even states that adopt model rules have problems as differences in regulations still
exist across state lines. Ideally, uniform rules are needed
13-04-2015
22
Are special prescription forms required? Are they easy to complete, and are
they easily accessible?
 No. The drug, dosage, format and duration have to be specified along with
details of the patient and signature and name of the approved medical
practitioner.
 Model rule recommends duplicate prescription (one stays with the institution,
the other with the patient)
Is special training required for opioid prescribing?
 Any approved medical doctor, dentist or veterinary doctor may prescribe opioid
for their patients.
 Model rules stipulate 10 days of training in pain management to stock the
medicines
Is prescribing limited to only certain types of doctors?
 NOT according Act. But the model rules recommend 10 days of training.
Are (specially trained) nurses authorized to prescribe? NO
13-04-2015
23
Is there a maximum amount that can be prescribed at one time, for example
a limitation on the number of dosage units or number of days?
No
Is there a maximum length of time that a patient can receive opioids?
No
What is the period of time that a prescription for an opioid such as morphine
is valid?
Once pain relief is achieved and is stable on a dosage, a prescription may be
given for 100 dosages, which usually lasts for over 2 weeks.
Do prescribing regulations exclude patient populations or diagnoses?


No there are no strict exclusions. Although not stipulated as such, opioids are used
mostly for cancer patients.
Some states restrict it to cancer in the new model rules, however
13-04-2015
24
Are there different legal requirements for prescribing, dispensing or
purchasing different dosage forms of the same opioid, i.e., oral,
transdermal, injectable?

If an institution is licensed for a certain formulation of a certain drug (e.g. inj
morphine), one will need additional permissions to get Tab Morphine /
solution etc.
What is the minimum and maximum penalty for a physician or pharmacist
who violates the prescribing laws or regulations?
6 months / Rs.10,000 for possession of quantity < 5 gms up to 10 years of
rigorous imprisonment for quantity > 250 gms
 physicians or pharmacists are not specifically mentioned in the law

Does the national law or regulation require reporting names of patients who
receive opioid prescriptions to the government?
No
13-04-2015
25

1998 – Central Government developed Model rules to modify state rules
 Allowed a single licensing entity of State Drug Controller that would help ensure
that “registered medical institutions” can access opioids through a streamlined
process. This has helped to a limited extent

13 states have modified rules
 Arunachal Pradesh, Jammu and Kashmir, Kerala, Mizoram, Sikkim, Andhra
Pradesh, Goa, Karnataka, Madhya Pradesh, Orissa, Tamilnadu, Maharashtra, Delhi,
Dadra-Nagarhaveli and Tripura.

Workshops ongoing

July 2012 –formation of Technical Resource Group [MOH, DOR and HC
professionals]
13-04-2015
26
International Narcotics Control Board
National Competent Authority 1
( Narcotic Commissioner, Dept of Revenue
Ministry of Finance)
Chief controller of
Factories
Government opium and
Alkaloid Works
Manufacturers
13-04-2015
Allot quotas approved by
INCB to Manufacturers
and Collect consumption
figures & reporting to
INCB
Retail
National Competent
Authority 2
(Director General,
Narcotics control board,
Ministry of Home Affairs)
Enforcement of drug laws
Distribution System
in India
27

Cost is a factor although medicines are available at different cost ranges.
E.g. 10 mg if bought as a strip is Rs 5/tab and as a tin is Rs 1/tab. Cost also
varies between different manufacturers

Also, many palliative care initiatives and cancer support organisations
make the medicines available free. Also, two RCCs produce solutions
directly from Morphine powder that is very cheap [e.g. one time
registration of Rs 75/-]

Many of the national insurance policies [ECHS, CGHS, ESIS] do not cover
the cost of supportive care medicines or pain relief medicines.

Marketing and research is cost driven e.g. Transdermal fentanyl patches
are very expensive and well marketed
13-04-2015
28

Lack of balance in the NDPS Act

Lack of awareness amongst policy makers

Concerned personnel are unaware of the actual purpose of cultivating poppy plants in India –
there is no shortage of base drug in India

No identified central coordinating body and hence related roles and responsibilities are
unclear

3 ministries are to be involved for result – Finance, Health and Home

Inadequately composed National Competent Authority.; lack of clear understanding of the
INCB/WHO guidelines

The mandates of neither the NCAs ; CBN, NCB or any other agency include role for medical
use of opioids

Complex regulations and lack of uniformity across states
13-04-2015
29

Different rules for inter state transport

Quota for within country market and outside country market are
separate.

Harsh punishments for minor errors

Policies tend to cause wastage

Tedious documentation - quarterly reports to 2 agencies in 2 different
formats; possibility of errors in consumption and estimates

Expiry date of raw powder and tablets made from them is separate-
results in wastage
13-04-2015
30

Poor healthcare delivery systems . Public: Private : : 20: 80

Poor awareness regarding usage and misconceptions regarding addiction amongst
professionals

Lack of knowledge regarding WHO ladder drugs

Even in states with “Model Rules “ availability continues to be poor.

Even in institutions where opioids are available, acknowledging , assessing pain and prescribing
practices poor, leading to untreated pain

Poor awareness and myths amongst needy patients leading to low demand

Cost

> 80% health related expenses in India are Out Of Pocket

Pharma companies do not market the cheaper alternatives nor support them entering market e.g.
Methodone availability for medical usage is delayed due to lack of will to complete a 200 patient
survey
13-04-2015
31
Thank
You
[email protected]
32