Opioid dependence syndrome management legal and policy aspects

Management of Opioid Us
Disorders in India :
Legal/Policy aspects
Presenter : Dr. Tashi
Tundup
Chairperson : Dr. Atul

Scope of the seminar
Introduction
Management of opioid use disorder
Laws regulating opioids
•International
•Indian
Effect of Laws and Policies on management
of Opioid use disorders in India
Summary
Future Directions

Introduction
 The problem of drug abuse is in existence in most of the
societies over the world since the time Immemorial
 However, the problem has become more complex and
alarming in the recent years
 Of the various substance use disorders, opioid
dependence syndrome has a significantly major impact
on mortality and morbidity
(Gautam S et al 2000)

Introduction
 India has the distinction of being the only country in the world
producing legal opium gum for export and domestic medical
use
 It also has large-scale illegal opium under cultivation, while
being a target for smugglers from both Afghanistan and the
Golden Triangle of Southeast Asia
(GLOBAL
ASIA, 2013)
 3 million people in India are estimated to be opiate users
(CNB and UNODC world Drug
report 2012)

Introduction
 200,000 people in India are injecting drug users (IDUs) of
whom around 7
percent have HIV (this figure rises above 20 percent in
Punjab, and 12
percent in Manipur)
 0.5 million people in India were opioid-dependent in 2004
(UNODC, 2004)

Introduction
 Opioid dependent individuals face a variety of associated
harms, including:
 Poor health ( due to HIV or Hepatitis B and C etc.)
 Poverty – due to the high cost of illicit opioids and the impact
of dependence on person’s capacity to maintain employment
 Engagement in criminal activity –associated with purchase
and possession of illicit substances and crimes committed
under substance effect and/or to finance further use
(WHO, 2004)

Introduction
 Risk of overdose, with the potential for permanent injury or
death
 Social isolation and vulnerability – stress on relationships,
stigmatisation and homelessness
 High mortality: Globally, the mortality rate for dependent
opioid users (either from overdose or other causes) is between
six and 20 times higher than for the general population
(WHO, 2004)

Management of Opioid dependence
 The main objectives of treating and rehabilitating persons
with opioid dependence are:
 To reduce dependence on illicit drugs
 To reduce the morbidity and mortality caused by the use of
illicit opioids, or associated with their use, such as infectious
diseases
 To improve physical and psychological health
 To reduce criminal behavior
 To facilitate reintegration into the workforce and education
system and

Opioid dependence is a chronic, relapsing condition and is
associated with physical changes in the brain, which mean that
overcoming opioid dependence is a complex process that relies on
more than just ‘willpower’ to succeed
(Ritter & Chalmers, 2009)
 There is no single panacea for opioid dependence, though Opioid
Substitution therapy(OST) plays an important role in treatment but
is unlikely to be successful in isolation
 OST reduce the occurrence of relapses, thereby helping people
remain engaged in treatment long enough for their brain to readapt,
to embed new thought patterns and behaviour
 The most important drugs used in the OST are Methadone and
Bupinorphine,; both are under strict control by law
(Mattick et al,

 Historically, most attempts to reduce or eliminate opioid use
have involved the use of social and legal control measures
that aim to reduce the availability of opioid drugs and penal
sanctions that aim to discourage opioid use
(National Research Council, 2001)
 Globally, opioid addiction came to be seen as a social evil that
was best remedied through criminal prosecution of users
and suppliers in an effort to raise heroin price, reduce
availability, punish those caught using the drug, and
strengthen social disapproval of heroin use
(Ling and Compton,
2005)

Historical Background -
INTERNATIONAL
Three International UN Conventions on Drugs
 UN Single Convention on Narcotic Drugs 1961
 UN convention on Psychotropic Substances 1971
Protocol, 1972 amending the Single Convention on
Narcotic drugs
 Un Convention Against Illicit Traﬃcking in Narcotics
and Psychotropic Substances 1988
 India signatory to all three
obliged to eradicate culturally ingrained patterns of
drug use, including those involving cannabis and
opium.
(Law commission of India report,
1997)

The United Nations bodies for drugs
control
1. Commission on Narcotic Drugs: It consists of representatives
of countries and is tasked with establishing policies on drugs
control and implementation of international conventions
2. International Narcotics Control Board (INCB): It is an
independent and quasi-judicial control organ for the
implementation of international conventions on drugs control and
regulation of licit trade in drugs and psychotropic substances
3. United Nations Office on Drugs and Crime (UNODC): It
coordinates international efforts to combat narcotic drugs and
psychotropic substances and raises the capacities of national
bodies in countries to combat drugs and crime

Historical Background – India
 British government tried to control the illicit trade
and consumption of Opioids through a number of
State laws
 Principal central acts
 The Opium Act 1857
 The Opium Act 1878
 The Dangerous Drugs Act 1930
 The Drugs and Cosmetics Act, 1940
 After signing the international conventions
(1961 and 1971, need was felt to enact a
new law 

The Narcotic Drugs and
Psychotropic Substances Act,1985
(NDPS Act, 1985)
(Relevant to opioid use disorders
management)

Chapter I: Preliminary
Definitions
 Psychotropic substance- Any substance, natural or
synthetic or preparation of such substance or material
included in the list of psychotropic substances
specified in the schedule
 Narcotic drug- means coca leaf, cannabis (hemp),
opium, poppy straw and includes all manufactured
goods
 “Addict" means a person who has dependency on

 Manufactured drugs- All coca derivatives, medicinal
cannabis, opium derivatives and poppy straw
concentrate
 Opium- Coagulated juice of opium, any mixture or
preparation containing morphine less than 0.2%
 Opium derivatives- medicinal opium, prepared opium,
morphine, codeine and their salts, diacetyl morphine
and all preparations containing more than 0.2 %
morphine
 Commercial Quantity- Any quantity greater than the
quantity specified by the Central Government in the
official gazette
 Small Quantity- Any Quantity lesser than the quantity
specified by the Central Government in the official

Authorities And Officers
 Sec 4- The Central government has to take measures
for preventing and combating abuse of illicit traffic
 Enforcement- A number of agencies have been
empowered to enforce the provisions of the act.
 These include the
 Department of Customs and Central Excise
 The Directorate of Revenue Intelligence
 The Central Bureau of Narcotics
 The Central Bureau of Investigation
 The Border Security Force at the Central level and
 State Police and Excise Departments at the State
level

The Narcotics Control Bureau
The Narcotics Control Bureau (NCB) is the chief law
enforcement and intelligence agency of India responsible
for fighting drug trafficking and the abuse of illegal
substances
 Affiliated to Ministry of home affairs
 Works in close cooperation with other relevant agencies
 Provides resources and training to law enforcement
agencies in fighting drug trafficking
 Monitors India's frontiers to track down points where
smuggling activities take place with foreign traffickers

Central Bureau of Narcotics(CBN)
 CBN is affiliated with India's Department of Revenue
(IRS), Ministry of Finance
 Main function:
 control opium production and trade,
 to issue licenses for production of legal synthetic
drugs

 Ministry of Health, Government of India, runs several
drug de-addiction centres in the Government hospitals
across the country through DDAP
 Ministry of Social Justice & Empowerment (MSJE),
handles matters pertaining to Drug Demand Reduction.
It supports various NGOs involved in Drug Demand
Reduction
 The State Governments also have their own Health
Departments and Social Welfare Departments each of
which has its own set of activities relating to Drug
Demand Reduction
Other agencies

 Some other organisations, despite having no direct role
under the NDPS Act, are closely connected to the
problem of trafficking and abuse of drugs:
 The National AIDS Control Organisation (NACO)
which is concerned with AIDS has to deal with the
problem of spread of HIV among injecting drug
users
 The staff of prisons have to deal with the problem of
addiction which is much higher among inmates than
among the general population
Other agencies

National Fund for Control of Drug Abuse
 Section 7 A- The Central government may by notification
constitutes a Fund to be called the National Fund for
Control of Drug
National fund
 Combating illicit traffic, abuse of drugs, preventing drug
abuse
 Identifying, treating, rehabilitating addicts
 Educating public against drug abuse
 Supplying drugs to addicts where such supply is a
medical necessity

Drug Control in India
Supply reduction
• Department of Revenue, Ministry of Finance
• Narcotics Control Bureau, Ministry of Home
• Central Bureau of Narcotics, Ministry of Finance
Demand reduction
• Prevention and Rehabilitation:
Ministry of Social Justice and
Empowerment  NGOs
• Medical Treatment: DDAP, Ministry of
Health and Family Welfare  Govt.
Hospitals
Harm reduction (IDU)
• National AIDS Control
Organisation (NACO), MoH&FW
 NGOs and Govt. Hospitals

Offences and Penalties
 Sections 15 to 21- Deals with punishments for offences
involving various Narcotic Drugs
 Drug Use a criminal act
 Section 27: Imposes punishment for consumption of
controlled/illicit substance:
-Morphine, heroin-R.I. upto 1 year or fine upto Rs.20,000 or both
 Provision for treatment in lieu of jail term for Drug Users
 Onus on accused to prove that s/he is a drug user; not a
trafficker !

Amendments cont …..
2001 amendment.
 Punishment based on quantity found
 Further strengthened powers to trace and seize
illegally acquired properties
 Immunity to addicts volunteering for treatment
was given

The NDPS Act- 2014 Amendment
 Contains provisions for treatment and care for people
dependent on drugs, moving away from abstinence
oriented services to treating drug dependence as a
chronic, yet manageable condition
 It adopted a new category of “Essential Narcotic
Drugs” in section 2(viiia)
 The drugs identified as essential will be subject to
Central Rules under section 9(1)(a), which will apply
uniformly throughout the country, bringing to an end
the unwieldy and inept practice of obtaining multiple
State licenses for possession, transport, purchase,
sale, distribution, use and consumption

Section 4, provision, reflects the principle of
‘balance’ between control and availability of
narcotic drugs, which is at the heart of international
drug control but has eluded the NDPS Act so far
Section 71: now allows for “management” of drug
dependence, thereby legitimizing opioid
substitution, maintenance and other harm
reduction services. Secondly, it authorizes the
Government to “recognize and approve”
treatment centres, which currently operate without
license or accreditation, and inflict violence and
torture on drug users

 On the flip side, the amendment has increased the
punishment for small quantity offences from a
maximum of 6 months to 1 year imprisonment
 Consumption of drugs continues to be a punishable
offence, thus branding of substance users as
criminals continues

National Policy on Narcotic Drugs and
Psychotropic Substances, 2012
The Department of Revenue, Ministry of Finance,
has formulated a National Policy on Narcotic Drug
and Psychotropic Substances, 2012
The policy focuses mainly on supply reduction
activities, but it also has various measures for
demand reduction
 It states that the Government’s policy would be to
promote the use of various compounds (narcotic
drugs and psychotropic substances) for medical
and scientific purposes while preventing their
diversion from licit sources and prohibiting illicit
traffic and abuse

 Principle of
regulatory
framework:
“Balance between:
curbing misuse
and
ensuring access for
medical and scientific
purpose”

National Policy for Drug Demand Reduction,
2014
 Goals are :
 To undertake drug demand reduction efforts to address all forms
of drug use
 To create awareness and educate people about the ill-effects of
drugs abuse on the individual, family, workplace and the society
at large
 To provide for a whole range of community based services for
the identification, motivation, counselling, de-addiction, after
care and rehabilitation
 To alleviate the consequences of drug dependence
amongst individuals, family and society at large
 To facilitate research, training, documentation and collection of
relevant information to strengthen the above mentioned
objectives
 To develop human resources and build capacity for working
towards these objectives
 To ensure that stigmatization of and discrimination against,

Specific medications for treating opioid dependence
Methadone
Buprenorphine
Buprenorphine+naloxone
Morphine
Tramadol
Non Opioids (Clonidine;
Naltrexone etc.)

Methadone
Buprenorphine
Morphine
Tramadol
1961 convention
1971 convention
1971 convention
1961 convention
Not under control*
International Control

Methadone
Buprenorphine
Morphine
(Essential) Narcotic
Psychotropic
Psychotropic
(Essential) Narcotic
Indian Law

Methadone
Buprenorphine
Morphine
?
Schedule H1
Schedule H1
Schedule K
Indian Scheduling and
regulations

Specific regulation for Buprenorphine and
Buprenorphine+Naloxone
“The preparation shall be supplied only to
the designated de-addiction centres set up
by the Govt. of India funded by the Ministry
of Health and Ministry of Social Justice and
Empowerment and Hospitals with De-
addiction facilities and a list of the centres to
whom the supply of the drug is made should
be made to this Directorate periodically
indicating the quantities supplied to each
centre.”

List of Essential Narcotic Drugs notified for
medical and scientific use by central
government (5/May/2015)
1. Codeine and Ethyl morphine.
2. Morphine
3. Fentanyl
4. Hydrocodone
5. Methadone
6. Oxy-codone

EFFECT OF LAWS AND POLICIES ON
MANAGEMENT OF OPIOID USE DISORDER IN INDIA

EFFECT OF LAWS AND POLICIES ON MANAGEMENT OF OPIOID USE
DISORDER
 Do our opioid related laws and policies creates
an atmosphere in which easy detection and
seeking help for treatment possible ?
 How branding ‘substance use’ as ‘illegal’ and
users as ‘criminal’ affects management ?
 What are effect of legal and policy issues on
assessment and management of ODS patient in
outpatient and inpatient settings ?
 What are effect of legal and policy issues on type
of management provided by DACs run by NGOs
and private sector ?
 Are our laws and policies relating to opioids,
responsible for non-evidence based treatment
given to patients in non governmental DACs ?

DISORDER
 NDPS Rules make it difficult for hospitals to store and dispense
opioids. Hospitals have to obtain licences for stocking, import,
export, transport etc, each license requiring
 from different departments [Excise, Drugs Control, Health
administration]
 These licenses need to be valid at the same time, though often
the validity period of a license is as short as a month. By the
time the institution gets a second licence, often the first would
have expired validity
 Most institutions solve this problem by not stocking these
medicines at all to avoid legal hassles
 The overall impact is denial of illness of opioid dependence of
lakhs of people

DISORDER
 NDPS Rules make it difficult for hospitals to store and dispense
opioids. Hospitals have to obtain licences for stocking, import,
export, transport etc, each license requiring
 from different departments [Excise, Drugs Control, Health
administration]
 These licenses need to be valid at the same time, though often
the validity period of a license is as short as a month. By the
time the institution gets a second licence, often the first would
have expired validity
 Most institutions solve this problem by not stocking these
medicines at all to avoid legal hassles
 The overall impact is denial of illness of opioid dependence of
lakhs of people
Situation likely to improve with the
2015 Notification – ENDs
Pure agonist like Methadone is more
likely to be available easily
While partial agonist like
Buprenorphine’s easy availability is
still doubtful

Opium registry
 Opium had been a significant part of Indian culture and
was highly valued in many socities. When British East
India Company established itself in India, it enforced
policies that limited consumption of opium
 However for those regular users who cannot do without it
were given limited amount of opium though opium
registry policy
 This policy was discontinued in 1959 under international
pressure, though those who were already registered
continued to get opium under the policy
DISORDER

Opium registry
 As per the reply received
from the CBN under RTI,
opium was supplied to
only 899 opium
dependents registered
under this policy
 spread in 12 states in
2012-13
DISORDER

Opium registry
 A workshop was held on the 31st of August, 2004 in Delhi,
organised by NDDTC of All India Institute of Medical
Sciences, New Delhi under the sponsorship of Ministry of
Health, Government of India
 Emphasized on need to restart the opium registry
considering the large number of persons abusing opium
and their unwillingness to come for treatment
 However nothing has been done after that 2004
meeting
DISORDER

 National Narcotic Drugs and Psychotropic
Substances (NDPS) Policy (2012)
 Does endorse a combination of supply, demand and
“Harm Reduction” approach
 Harm reduction – reluctantly endorsed
 Only for IDUs
DISORDER

DISORDER
 While the government has in theory allowed for the
provision of harm reduction services, its narrow
understanding of the term has been detrimental to its
progression
IDPC,2015
 Harm reduction
 Endorsed by the National AIDS Control Policy
 Implemented under National AIDS Control Programme
 as the "Targeted Interventions" by the government to tackle
the spread of HIV among IDUs, including Needle Syringe
exchange and opioid substitution therapy (OST)
IDPC,2015

DISORDER
 However, despite this progress, harm reduction is far from
being a pillar or principle of drug policy in India
 Harm reduction services continue to operate in a restrictive
legal environment with program staff facing the risk of
prosecution for ‘aiding and abetting’ drug use
 People who inject drugs, the fear of being identified and
harassed by the police constitutes a significant barrier for
accessing prevention and treatment facilities
 Punjab state is probably one of the most striking
examples of India’s contradictions over harm
reduction policy
IDPC,2015

BUPRENORPHINE USE CONTROVERSY IN PUNJAB
DISORDER

DISORDER
 Despite the undeniable and recognized efficacy of OST,
the Punjab government is denying the provision of
essential medicines such as buprenorphine for patients
with problematic drug use

DISORDER
 Despite the undeniable and
recognized efficacy of OST,
the Punjab government is
denying the provision of
essential medicines such as
buprenorphine for patients
with problematic drug use
 Local authorities have even
turned to violence and
punitive actions to prevent
private doctors from
offering OST

DISORDER
Result:
 Private Psychiatrists
stopped prescribing this
medicine at pvt clinics
 Thus futher jeopardizing
the management of
Opioid use disorder

DISORDER
 Another glaring gaps in Indian drug policy is lack of data
about the nature and extent of drug use, dependence and
its attendant health implications
 The first and only survey estimating the extent of drug use
was conducted in 2001-2002
 A Drug Abuse Monitoring System (DAMS) exists for
collecting data from patients seeking treatment for drug
dependence at NGO and government centers but does not
function well

DISORDER
 Drug policy administration is divided not only between
central and state governments but also between ministries
and departments at the same level,this leads to:
 Uneven coordination amongst government agencies
 Confusion, overlap and at times, an abdication of
responsibility
 The Ministry of Social Justice & Empowerment has so far
been following the ‘abstinence only’ policy while the
Ministry of Health and Family Welfare and the National
AIDS Control Organisation (NACO) have been promoting
‘harm reduction’ policy

Summary
 The NDPS Act supports treatment both as an alternative to, and
independent of penal measures
 India has adopted exceedingly harsh measures for drug
control. Many facets of the NDPS Act such as the
criminalization of drug use, punishment for possession of
drugs for personal use and the death penalty are more
strict or severe than those provided by the UN drug control
conventions
 Drug treatment in India largely remains unregulated, this places
the health and safety of patients at risk
 Despite the undeniable and recognized efficacy of OST,
government is Withholding medical therapy such as
buprenorphine for patients with problematic drug use

Summary cont….
 There is an urgent need for drug treatment and law
authorities to collaborate
 NDPS amendment act, 2014 legitimizes OST and other
harm reduction services, thus opening new hope for
people who uses substance and people who are involved
in providing these facilities without the threat of punitive
sanctions such as criminal prosecution and imprisonment

Future Directions
 To ensure the legal provisions on drug treatment are
applied in such a way that patients who seeks evidence
based treatment for substance use can avail services
without the threat of punitive
 To Improve coordination between different central and
state government departments so that policies can be
made and implemented with more clearity
 To consult with civil society groups, including
representatives of people who use drugs, medical
professionals, academics and patient groups specializing
in drugs issues in drug policy formulation

Future Directions
 To apply harm reduction principles to drug policy
formulation with the objective of reducing the harms
associated with drugs, instead of being guided by the
unachievable goal of creating a ‘drug-free’ society.
 To establish regular data collection on drug use,
dependence and related health implications such as HIV
and viral hepatitis prevalence amongst people who inject
drugs.

S No Drug/Psychotrop
ic substance
Small
Quantity
Commercial
Quantity
1 Codeine 10 gm 1 kg
2 Heroin 5 gm 250 gm
3 Morphine 5 gm 250 gm
4 Opium 25 gm 2.5 kg

Opioid dependence syndrome management legal and policy aspects

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