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24 August, 2014, Ludhiana
• Is it working ?
International
Drug
regulatory
framework
• Implications for
mental health
professionals
The Indian
Scene
» About 1 in 20 persons between the ages
of 15 and 64 uses an illicit drug at least
once a year
˃ Large majority of them use CANNABIS
» Fewer than 1 in 160 are “problem drug
users”
» Overall value of the illicit drug market:
about $320 billion (0.9 % of global GDP)
Alcohol
Tobacco
Illicit Drugs
35%
25%
2.50%
Global Prevalence of 'past month' use
» Today’s ‘narcotics’ have had a long history of
use throughout the world
» Plants have been major source of drugs:
˃ Opioids
˃ Cannabis
˃ Cocaine
» Drugs have been used as medicines, for
recreation and as part of social / cultural
rituals
19th Century:
Indian Opium
exports to China
1909:
Shanghai
Opium
Commission
1912: Hague
Convention
UN
Conventions:
1961, 1971,
1988
International Drug treaties
Opiates Cocaine Cannabis
12.9 13.4
147.4
17.35 17
160
Number of users in millions
1998 2008
"Sadly, the illicit
manufacture and
illicit consumption
of drugs occur
everywhere.”
Yury Fedotov, Executive
Director, UNODC, 2012
Pettus, 2014
“Evil” reflects influence of missionaries in early prohibition policy”
» The stated intention behind the establishment
of the global drug prohibition regime was to
protect the world from the dangers of drugs.
» At different points in history, drug production,
use and supply have all been presented as
threats to security:
˃ human,
˃ national or
˃ international security.
“Menace”
“Social evil”
“Existential
threat”
Creation of a
criminal black
market
Policy
displacement
Geographical
displacement
Substance
displacement
Marginalization
of drug users
from social
mainstream
UNODC 2008
Decrease
from
14.1 % in
2001
to
10.6 % in
2006
http://www.globalcommissionondrugs.org/
“The war on
drugs has
failed”
» Drug policies must be based on scientific
evidence human rights and public health
principles ..
» …legal regulation of drugs …
» …evidence-based prevention ...
treatment and care for drug dependence..
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
 Major ‘players’
 Additionally, ‘Alternate approaches’: AA, spiritual /
religious groups etc.
Availability of treatment services in India
» 124 in number
» Established by the Union MOHFW (DDAP division)
» Attached with district hospitals and medical
colleges (Department of Psychiatry)
Only a few get recurring grant from the
central government
Rest, dependent on the state governments
Drug dependence treatment is often seen as
a low priority area by the local state
governments
At some places, buildings meant for De-
addiction centers are being used for other
purposes!
» ‘Minimum standards of
care’ exist
» No structured, regular
system for M & E
˃ DAMS for new patients
» Capacity Building:
Through institutions
located regionally
» Supported by the MSJE
» About 450 in number
» Get funding from the ministry
˃ Mainly residential (in-patient) treatment
˃ Stand alone services – not a part of general health care
» Recent revision of guidelines / scheme
» Functioning status?
» Capacity Building – through RRTCs
» Number: unknown
» Qualifications of service providers: unknown
˃ ranges from MD Psychiatry to no professional
qualification (just an experience of having gone through
the treatment)
» Whether follow some standards / norms:
unknown
» Highly variable status for evaluation /
functioning
Gaps in service demand and service provision
» Conservative
estimate of
number of
Alcohol / drug
dependent
individuals
= 1 crore
(10000000)
» Conservative
estimate of
number of
Alcohol / drug
dependent
individuals
= 1 crore
(10000000)
» Liberal estimates of Number of
beds available for drug
treatment
NGO sector 400 X 15 6000
Government sector 100 X 10 1000
Private sector --- 5000
Total 12000
Assuming minimum duration of
acute-phase treatment = 1 month
144000
10000000
144000
Gaps in service demand and service provision
10000000 versus
Gaps in service demand and service provision
144000
Clearly, reliance only on the existing
number of services and the in-patient,
‘de-addiction’ model is not enough!
Do our laws and
policies facilitate
treatment of opioid
dependence ?
» Principle of regulatory
framework:
“Balance between:
curbing misuse
and
ensuring access for
medical and scientific
purpose”
» Principle of regulatory
framework:
“Balance between:
curbing misuse
and
ensuring access for
medical and scientific
purpose”
» Drug Use a criminal act
» 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 !
» Three amendments: 1988, 2001, 2014
» 1988 amendment
˃ Stringent punishment for harboring offenders and
financing illicit traffic including death
˃ Forfeiture of property derived from/ used in illicit
traffic
» 2001 amendment
˃ Punishment based on quantity found
˃ Further strengthened powers to trace and seize
illegally acquired properties
2014 amendment
» ‘Essential Narcotic Drugs’ for medical use
» Subject to central rules; state licenses not
needed
» Government to recognize and approve
treatment centres to regulate illegal /
unethical practices
» Punishment for users & traffickers increased!
» 28 July 2014: National Workshop on
drafting NDPS rules
» All stakeholders welcomed the proposals:
˃ A uniform national set of regulations (as opposed to
state-specific rules)
˃ Recognition that easy access and availability of
medications as important as stringent regulations
˃ ENDs – indicated for both – Pain relief and treatment
of Opioid Dependence
» National Narcotic Drugs and Psychotropic
Substances (NDPS) Policy (2012)
˃ Talks about a combination of supply, demand and
“Harm Reduction” approaches
˃ Harm reduction – reluctantly endorsed; Only for
IDUs
»National Drug and Alcohol
Demand Reduction Policy
(DRAFT)
˃(Was) Being Developed by the MSJE
˃? Draft under the process of review and
refinement
˃No clear stand on evidence-based
pharmacological treatment of opioid
addiction
Methadone
Buprenorphine
Buprenorphine+naloxone
Morphine
Tramadol
Non Opioids (Clonidine;
Naltrexone etc.)
Methadone
Buprenorphine
Buprenorphine+naloxone
Morphine
Tramadol
1961 convention
1971 convention
1971 convention
1961 convention
Not under control*
International
Control
Methadone
Buprenorphine
Buprenorphine+naloxone
Morphine
(Essential) Narcotic
Psychotropic
Psychotropic
(Essential) Narcotic
Indian Law
Methadone
Buprenorphine
Buprenorphine+naloxone
Morphine
?
Schedule H1
Schedule H1
Schedule K
Indian Scheduling
and regulations
“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.”
» The Punjab chaos spreads to other parts of the
country. Some over-zealous official proposes to
totally ban Buprenorphine
» Methadone and Morphine get listed as ENDs (and
become available easily, even with prescription).
Buprenorphine remains tightly regulated.
» Buprenorphine becomes de-regulated and starts
being available in the pharmacy shops. Soon, it
becomes OTC (like practically everything else) and
we see a fresh epidemic.
» The ideal scenario 
» Buprenorphine or Methadone are not available in
pharmacies.
» They are available only through licensed and
accredited facilities:
˃ Drug Treatment centres / Clinics (Govt. / NGO / Private)
˃ Prescribed by specifically trained doctors
˃ Records are maintained; M & E framework exists
» Methadone and plain Buprenorphine available only
as DOTS
» Buprenorphine + Naloxone available as ‘take-home’
option (with standard procedures, and an upper limit)
Conceptual basis for a ‘rational drug
policy’
» Prevention
» Supply reduction
» Treatment and harm reduction
» Criminal sanctions and decriminalisation
» Control of the legal market through
prescription drug regimes
Drug policy and the public good, Babor et al, 2010
Is there
something we
can do?
» Ensuring only evidence-based practice
» Advocacy
˃Realizing that our role goes much beyond
the service provision
˃Making our presence felt as professional
bodies
˃Generating the discourse on policy
reforms
˃Pressurizing our governments to take right
stand in the International forums
Acknowledgement:
Dr. Sathya Prakash
Senior Resident,
AIIMS, New Delhi

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International Drug Regulatory Frameworks and the Indian Scene

  • 1. 24 August, 2014, Ludhiana
  • 2. • Is it working ? International Drug regulatory framework • Implications for mental health professionals The Indian Scene
  • 3. » About 1 in 20 persons between the ages of 15 and 64 uses an illicit drug at least once a year ˃ Large majority of them use CANNABIS » Fewer than 1 in 160 are “problem drug users” » Overall value of the illicit drug market: about $320 billion (0.9 % of global GDP)
  • 4.
  • 6.
  • 7. » Today’s ‘narcotics’ have had a long history of use throughout the world » Plants have been major source of drugs: ˃ Opioids ˃ Cannabis ˃ Cocaine » Drugs have been used as medicines, for recreation and as part of social / cultural rituals
  • 8. 19th Century: Indian Opium exports to China 1909: Shanghai Opium Commission 1912: Hague Convention UN Conventions: 1961, 1971, 1988
  • 10. Opiates Cocaine Cannabis 12.9 13.4 147.4 17.35 17 160 Number of users in millions 1998 2008
  • 11. "Sadly, the illicit manufacture and illicit consumption of drugs occur everywhere.” Yury Fedotov, Executive Director, UNODC, 2012
  • 12. Pettus, 2014 “Evil” reflects influence of missionaries in early prohibition policy”
  • 13. » The stated intention behind the establishment of the global drug prohibition regime was to protect the world from the dangers of drugs. » At different points in history, drug production, use and supply have all been presented as threats to security: ˃ human, ˃ national or ˃ international security. “Menace” “Social evil” “Existential threat”
  • 14.
  • 15.
  • 16.
  • 17.
  • 18. Creation of a criminal black market Policy displacement Geographical displacement Substance displacement Marginalization of drug users from social mainstream UNODC 2008
  • 19.
  • 20.
  • 21.
  • 23.
  • 24.
  • 26. “The war on drugs has failed”
  • 27. » Drug policies must be based on scientific evidence human rights and public health principles .. » …legal regulation of drugs … » …evidence-based prevention ... treatment and care for drug dependence..
  • 28.
  • 29. 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
  • 30.  Major ‘players’  Additionally, ‘Alternate approaches’: AA, spiritual / religious groups etc. Availability of treatment services in India
  • 31. » 124 in number » Established by the Union MOHFW (DDAP division) » Attached with district hospitals and medical colleges (Department of Psychiatry)
  • 32. Only a few get recurring grant from the central government Rest, dependent on the state governments Drug dependence treatment is often seen as a low priority area by the local state governments At some places, buildings meant for De- addiction centers are being used for other purposes!
  • 33. » ‘Minimum standards of care’ exist » No structured, regular system for M & E ˃ DAMS for new patients » Capacity Building: Through institutions located regionally
  • 34. » Supported by the MSJE » About 450 in number » Get funding from the ministry ˃ Mainly residential (in-patient) treatment ˃ Stand alone services – not a part of general health care » Recent revision of guidelines / scheme » Functioning status? » Capacity Building – through RRTCs
  • 35. » Number: unknown » Qualifications of service providers: unknown ˃ ranges from MD Psychiatry to no professional qualification (just an experience of having gone through the treatment) » Whether follow some standards / norms: unknown » Highly variable status for evaluation / functioning
  • 36. Gaps in service demand and service provision » Conservative estimate of number of Alcohol / drug dependent individuals = 1 crore (10000000)
  • 37. » Conservative estimate of number of Alcohol / drug dependent individuals = 1 crore (10000000) » Liberal estimates of Number of beds available for drug treatment NGO sector 400 X 15 6000 Government sector 100 X 10 1000 Private sector --- 5000 Total 12000 Assuming minimum duration of acute-phase treatment = 1 month 144000 10000000 144000 Gaps in service demand and service provision
  • 38. 10000000 versus Gaps in service demand and service provision 144000 Clearly, reliance only on the existing number of services and the in-patient, ‘de-addiction’ model is not enough!
  • 39. Do our laws and policies facilitate treatment of opioid dependence ?
  • 40. » Principle of regulatory framework: “Balance between: curbing misuse and ensuring access for medical and scientific purpose”
  • 41. » Principle of regulatory framework: “Balance between: curbing misuse and ensuring access for medical and scientific purpose”
  • 42. » Drug Use a criminal act » 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 !
  • 43. » Three amendments: 1988, 2001, 2014 » 1988 amendment ˃ Stringent punishment for harboring offenders and financing illicit traffic including death ˃ Forfeiture of property derived from/ used in illicit traffic » 2001 amendment ˃ Punishment based on quantity found ˃ Further strengthened powers to trace and seize illegally acquired properties
  • 44. 2014 amendment » ‘Essential Narcotic Drugs’ for medical use » Subject to central rules; state licenses not needed » Government to recognize and approve treatment centres to regulate illegal / unethical practices » Punishment for users & traffickers increased!
  • 45. » 28 July 2014: National Workshop on drafting NDPS rules » All stakeholders welcomed the proposals: ˃ A uniform national set of regulations (as opposed to state-specific rules) ˃ Recognition that easy access and availability of medications as important as stringent regulations ˃ ENDs – indicated for both – Pain relief and treatment of Opioid Dependence
  • 46. » National Narcotic Drugs and Psychotropic Substances (NDPS) Policy (2012) ˃ Talks about a combination of supply, demand and “Harm Reduction” approaches ˃ Harm reduction – reluctantly endorsed; Only for IDUs
  • 47. »National Drug and Alcohol Demand Reduction Policy (DRAFT) ˃(Was) Being Developed by the MSJE ˃? Draft under the process of review and refinement ˃No clear stand on evidence-based pharmacological treatment of opioid addiction
  • 49. Methadone Buprenorphine Buprenorphine+naloxone Morphine Tramadol 1961 convention 1971 convention 1971 convention 1961 convention Not under control* International Control
  • 52. “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.”
  • 53. » The Punjab chaos spreads to other parts of the country. Some over-zealous official proposes to totally ban Buprenorphine » Methadone and Morphine get listed as ENDs (and become available easily, even with prescription). Buprenorphine remains tightly regulated. » Buprenorphine becomes de-regulated and starts being available in the pharmacy shops. Soon, it becomes OTC (like practically everything else) and we see a fresh epidemic. » The ideal scenario 
  • 54. » Buprenorphine or Methadone are not available in pharmacies. » They are available only through licensed and accredited facilities: ˃ Drug Treatment centres / Clinics (Govt. / NGO / Private) ˃ Prescribed by specifically trained doctors ˃ Records are maintained; M & E framework exists » Methadone and plain Buprenorphine available only as DOTS » Buprenorphine + Naloxone available as ‘take-home’ option (with standard procedures, and an upper limit)
  • 55.
  • 56. Conceptual basis for a ‘rational drug policy’ » Prevention » Supply reduction » Treatment and harm reduction » Criminal sanctions and decriminalisation » Control of the legal market through prescription drug regimes Drug policy and the public good, Babor et al, 2010
  • 58. » Ensuring only evidence-based practice » Advocacy ˃Realizing that our role goes much beyond the service provision ˃Making our presence felt as professional bodies ˃Generating the discourse on policy reforms ˃Pressurizing our governments to take right stand in the International forums
  • 59.
  • 60. Acknowledgement: Dr. Sathya Prakash Senior Resident, AIIMS, New Delhi