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

121/04/23

221/04/23

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.

321/04/23

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-i

ndia

http://www.who.int/cancer/nccp/en/ http://india.gov.in/sectors/health_family/index.php?id=11

421/04/23

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

521/04/23

Primary prevention

Secondary prevention

Tertiary prevention

Diagnosis onwards

621/04/23

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

721/04/23

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/IndianJPalliatCare17452-2108539_055125.pdf821/04/23

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

offered921/04/23

1021/04/23

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

1121/04/23

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

1221/04/23

Is availability of opioid analgesics specifically addressed? NO

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

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

1321/04/23

1421/04/23

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.

1521/04/23

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

1621/04/23

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.

1721/04/23

1821/04/23

Yes – India has a National List of Essential Medicines that includes opioids as essential medicines for Palliative CareRef NLEM 2011

Morphine Sulphate

Secondary, Tertiary levels

Injection 10 mg/ml

Tablets 10 mg

Tramadol Secondary, Tertiary levels

Capsules 50 mg, 100mg

Injection 50 mg/mlFentanyl Secondary,

Tertiary levels

Injection 50 ug/ml2 ml ampoule

1921/04/23

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.

2021/04/23

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 happen2121/04/23

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 2221/04/23

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 medicinesIs 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

2321/04/23

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

2421/04/23

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

2521/04/23

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]

2621/04/23

Distribution Distribution System System in Indiain India

2721/04/23

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

2821/04/23

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

2921/04/23

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

3021/04/23

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 3121/04/23

32

Thank You

aanandini@gmail.com