Oral substitution therapy (“ost”) – law and policy overview

1. Oral Substitution Therapy (“OST”) –
Law and Policy overview
OST – Policy and Practice
CME, AIIMS
18-19 April 2015
Tripti Tandon
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

2. OST: Proof ‘beyond reasonable doubt’?
• Effectiveness of OST supported by evidence
– Is OST effective only in reducing injecting of opioids??
Or also in reducing the use of illegal opioids??
• OST must be administrated ‘regularly’
– Does ‘regular use’ mean dependence?? Or is it
management of a pre-existing dependence on illegal
opioids??
• OST is liable to misuse and diversion
– Does the patient continue using illegal drugs?? Or are
OST medicines sold illegally??
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

3. NDPS: Legal or illegal?
• Narcotic and psychotropic drugs are not illegal per se
• What is unlawful is their use for reasons other than medical and
scientific
• Narcotic Drugs and Psychotropic Substances Act, 1985 (“NDPS Act”)
- based on International drug conventions, which recognise:
– “that the medical use of narcotic drugs continues to be indispensable
….and that adequate provision must be made to ensure the availability
of narcotic drugs for such purposes”
– “Desiring to conclude a generally acceptable international
convention…, limiting such drugs to medical and scientific use,…”
(Preamble to the Single Convention on Narcotic Drugs, 1961)
– “Subject to the provisions of this Convention, to limit exclusively to
medical and scientific purposes, the production, manufacture, export,
import, distribution of, trade in, use and possession of drugs”
(Article 4, 1961 Convention)
– “Recognising that the use of psychotropic substances for medical and
scientific purposes is indispensable and that their availability for such
purposes should not be unduly restricted ”
(Preamble to the Convention on Psychotropic Substances, 1971)
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

4. Medical Use
• Medical use – “to prevent, treat, cure, manage or
mitigate”
– Drug is a medicine?
– Involvement of a medical professional?
– Used by a ‘sick’ person?
• Is OST - medical use?
– Just because its not part of the government’s drug de-
addiction programme – does it mean it is not treatment for
drug dependence?
– Because it is part of the National AIDS Control Programme,
it is only for preventing HIV among persons who inject
drugs?
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

5. NDPS Act: Medical and scientific use
• Sec 8(c): “except for medical or scientific purposes
and in the manner and to the extent provided by the
provisions of the Act or rules or orders made
thereunder and in a case where any such provision
imposes any requirement by way of
license/permit/authorisation, in accordance with
terms and conditions of such
license/permit/authorisation”
• Sec 15,17,18,20,21,22,23: punishment for acts “in
contravention of any provisions of the Act or rule or
order made or condition of license thereunder”
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

6. Medical use and NDPS Act
• Medical use – not defined in the Act
• Sec 9 and 10 – confer powers on the Central and State
governments respectively to “permit, control and regulate”
by Rules for “medical and scientific purposes”
• Only medical use alluded to in the NDPS Act is: “supplying
drugs to addicts where such supply is a medical necessity”
(Sec 7A (2)(f) and 71(1)and (2); sec 76(2)(e) and 78(2)(a) – power to make rules)
• This is not exhaustive – excludes other medical conditions
for which narcotic and psychotropic drugs are used
• Is OST part of ‘supply to addicts as a medical necessity’?
• No specific Rules have been framed for this, whether by
Central or State governments
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

7. Medical use and NDPS Rules
• Rules of the Central Government (‘NDPS Rules’, 1985) and State
governments (eg, ‘Maharashtra NDPS Rules’, 1985)
• Section 70, NDPS Act – Governments to “have regard to provisions of
international drug conventions while making Rules”
• International Conventions:
– encourage treatment for people who use drugs and;
– wrt psychotropic substances, provide different measures of control,
depending on the schedule that the drug is placed in (eg: Buprenorphine in
schedule III – only requires supply on medical prescription)
• Psychotropic substances covered under Chapter VII, NDPS Rules, 1985
• Rules 65A and 66 deal with use, consumption and possession (in
accordance with DCR)
• No separate NDPS license for use and possession (Supreme Court order dated
22.8.2013 in SLP (Crl) No. 9730/2012)
• NDPS Rules, 1985 recently amended –March 25, 2015
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

8. NDPS Act and other laws
• NDPS Act and Rules apply “in addition to, and not in derogation of
the Drugs and Cosmetics Act, 1940 (“DCA”) and the Drugs and
Cosmetics Rules, 1945 (“DCR”)”(sec 80, NDPS Act)
• In Union of India v Sanjeev Deshpande AIR 2014 SC 3625, Supreme
Court declined to interpret and give meaning to this provision
• Drug Controller General of India (DCGI) approves drugs for specific
‘indications’ (eg: Buprenorphine for ‘de-addiction’; Methadone for management of
opioid dependence)
• Narcotic and psychotropic drugs covered under different schedules
to the DCR (H, H1, K, X); Rules may differ accordingly
• Also, subject to licenses and conditions imposed under DCR
• Any ambiguity or infraction for narcotic and psychotropic medicines
– prosecution under NDPS Act may ensue
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

9. NDPS (Amendment) Act, 2014
• Bring ‘medical use’ to the forefront, through:
– New category of “essential narcotic drugs”(“ENDs”), which
the Central Government can notify for medical and
scientific use (sec 2(viiia)) Methadone likely to be notified as END
– Central Government to make Rules for possession,
transport, purchase, sale, import inter-state, export inter-
state, use and consumption of ENDs (sec 9(1)(a)(va) & 9(2)(ha)
– Broadened scope/object of the law to include ‘promoting
the medical and scientific use of narcotic drugs and
psychotropic substances’(sec 4)
– Allows for “management” of drug dependence; not just
‘de-addiction’ (sec 71)
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

10. Buprenorphine controversy in Punjab
• Buprenorphine is a psychotropic substance under the
NDPS Act (sec 2(xxiii); sec 22)
• Also listed in schedule H1 of DCR, which, as per Rule 65
of the DCR:
– “shall not be sold by retail except on and in accordance
with the prescription of a Registered Medical
Practitioner..”
– “the supply to Registered Medical Practitioners,
Hospitals, Dispensaries and Nursing Homes shall be made
only against the signed order in writing which shall be
preserved by the licensee for a period of two years..”
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

11. DCGI Letters, 1999 and Sept 2010
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

12. Punjab Drug Controller Letter, Nov 2014
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

13. Heart of the controversy…
• Besides indicating the condition for which a drug is
approved, can DCGI also direct where it must be supplied?
(eg: ‘designated de-addiction centres set up by the Govt. of India funded by the Ministry of Social Justice
and Empowerment and Hospitals with de-addiction facilities’)
– OST under NACO is neither provided for de-addiction nor at de-
addiction centres
• Can such a condition override provisions of the DCA and
DCR?
• Can ‘letters’ – purportedly issued without statutory basis,
trigger prosecution of medical personnel under the NDPS
Act?
• Controversy not just due to law, but the ‘proof’ and the
‘reasonable doubt’……
Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi