opioid dependence syndrome management legal and policy aspects

Management of Opioid Us Disorders in India : Legal/Policy aspects

Presenter : Dr. Tashi TundupChairperson : Dr. Atul Ambekar

Scope of the seminar

IntroductionManagement of opioid use disorderLaws regulating opioids• International• Indian

Effect of Laws and Policies on management of Opioid use disorders in IndiaSummary 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 dependenceThe 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

To improve Social Functioning

Management of Opioid dependenceOpioid 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, 2003)

Management of Opioid dependence 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)

LAWS REGULATING OPIOIDS

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 ND/PS

Chapter I: Preliminary 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 gazette

(Included after 2001 amendment)

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 substancesAffiliated to Ministry of home affairsWorks 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 FinanceMain 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

(Included after

1989 amendment)

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

The NDPS Act- 2014 Amendment

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

The NDPS Act- 2014 Amendment 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, groups and individuals dependent on drugs is actively discouraged in order to integrate them back into the society

Specific medications for treating opioid dependence

Methadone Buprenorphine Buprenorphine+naloxone Morphine Tramadol Non Opioids (Clonidine; Naltrexone etc.)


Methadone Buprenorphine Buprenorphine+naloxone Morphine Tramadol

1961 convention1971 convention 1971 convention 1961 conventionNot under control*

International Control


Methadone Buprenorphine Buprenorphine+naloxone Morphine

(Essential) Narcotic Psychotropic Psychotropic (Essential) Narcotic

Indian Law


Methadone Buprenorphine Buprenorphine+naloxone Morphine

?Schedule H1Schedule H1Schedule 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. Fentanyl4. Hydrocodone5. Methadone6. 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 ?


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


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


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


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


National Narcotic Drugs and Psychotropic Substances (NDPS) Policy (2012)Does endorse a combination of supply,

demand and “Harm Reduction” approachHarm reduction – reluctantly endorsed Only for IDUs



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


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



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


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


Result: Private Psychiatrists

stopped prescribing this medicine at pvt clinics

Thus futher jeopardizing the management of Opioid use 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


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.

Thank you

Chapter I: Preliminary

S No Drug/Psychotropic 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

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