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

Oral Substitution Therapy (“OST”) –Law and Policy overview

OST – Policy and PracticeCME, AIIMS

18-19 April 2015Tripti Tandon

Presented at the national CME "OST: Policy and Practice" on 18th-19th April 2015 at AIIMS, New Delhi

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??


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

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?


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”


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


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

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


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)


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..”


DCGI Letters, 1999 and Sept 2010


Punjab Drug Controller Letter, Nov 2014


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’……


Health & Medicine

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