Opioids are one of the best known analgesics and euphoriants known to humankind. Their
widespread use globally for such purposes has also led to opioids topping the list
of “problem drugs.” In India, opium and its variants have been cultivated and used
as household remedies, in medicinal preparations and as intoxicants for centuries.
Advent of high potency, synthetic opioid preparations like heroin however, has changed
the scenario drastically. Especially in the Northern and Northeastern parts of the
country, the opioid use epidemic is well-established and opioid use disorders are
among the commonest illicit-drug-related conditions, bringing patients to health care
providers. Use of injectable opioids has added yet another grave dimension in the
harms caused by opioids. In India, almost all injecting drug users (IDUs) are opioid
dependent[1] and the prevalence of HIV among this group is the highest (more than
9%) among all the high risk groups.[2]
For addiction treatment professionals, opioid use disorders present certain unique
challenges. Short-term, stand-alone treatment of acute withdrawal symptoms (or “detoxification”)
is almost invariably associated with relapse to opioid use.[3
4] Consequently most patients require a long-term, combined psychosocial and pharmacological
approach for treatment. Two distinct approaches exist for the long term pharmacological
treatment (1) agonist maintenance treatment or opioid substitution treatment (OST)
and (2) antagonist treatment. The latter, involves long-term maintenance of opioid-dependent
patients on an antagonist like naltrexone. This traditional approach is marred by
poor evidence of its effectiveness. Naltrexone maintenance has been found to work
in only a select sub-population of opioid dependence patients, mainly on account of
poor compliance and retention in treatment.[5] As a consequence, and with emergence
of stronger evidence-base, agonist treatment or OST, is now the universally accepted
treatment modality. Consequently, most treatment guidelines, including those of the
Indian Psychiatric Society (IPS), recommend OST as the preferable option for long-term
pharmacological treatment of opioid dependence.[6] Globally, the most common treatment
agents used for OST are methadone and buprenorphine. Methadone, as the agonist treatment
option has existed for many decades and is widely used in many countries around the
world, as compared to buprenorphine.[7]
Curiously, in India, it is buprenorphine which has been available as an analgesic
and maintenance agent for OST for a very long time while methadone has been introduced
only recently.[8] Despite being available for around three decades, use of buprenorphine
as OST has remained low in India. In this article, we discuss the reasons behind this
and recommend certain steps, which would help in scaling-up this most evidence-based
and effective treatment for opioid dependence in India.
OPIOID SUBSTITUTION TREATMENT IN INDIA: EXISTING SITUATION
Buprenorphine was launched as an analgesic in the late 1980s. Soon after the emergence
of evidence regarding its effectiveness in international literature,[9] some academic
institutes as well as nongovernmental organizations (NGOs) started using the low-strength,
sublingual buprenorphine tablets for treatment of opioid dependence. Use of buprenorphine
got a further boost in India with the launch of higher strength (2 mg) tablets in
1999 and subsequently launch of buprenorphine and naloxone fixed dose combination
(FDC) in 2004–2005. A big turning point however, was inclusion of OST as one of the
components of National AIDS Control Programme (NACP) in 2007. Since then, the National
AIDS Control Organization has been scaling-up OST in the country as a measure to prevent
HIV/AIDS. There are currently around 140-odd facilities providing free-of-cost buprenorphine
tablets (only as daily observed treatment) to thousands of IDUs. Outside the AIDS
program however, it is difficult to reliably estimate the extent of coverage of this
intervention. Certain academic institutions have been implementing OST and gathering
and disseminating their clinical and research experience, encouraging others to adopt
this practice.[10
11
12] However, by all accounts, very few health facilities in India – either in the
government sector or private – provide this treatment. The situation in Punjab provides
an illustrative example of the poor penetration of OST. While it has been perceived
(without any structured data) that a large number of psychiatric facilities in the
private sector in Punjab provide OST to their patients using buprenorphine – naloxone,
epidemiological data paint a different picture. As per the “Punjab Opioid Dependence
Survey,” only about 15% of opioid dependent people in the state have received any
form of medical treatment “ever” (including OST).[13] Indeed, a number of publications
have been highlighting the inadequate coverage of OST in India.[7
8
14]
SCALE-UP OF OPIOID SUBSTITUTION TREATMENT: CHALLENGES RELATED TO SERVICE PROVIDERS
It is a widely accepted fact that availability of human resources for mental health
care is pathetically low in India.[15] This shortage of trained professionals is even
graver for the addiction treatment sector. In addition, even among the specialists
(like psychiatrists) the exposure to OST during the training phase is grossly inadequate.
This is not surprising, since very few teaching institutes offer this treatment and
hence there are hardly any opportunities for the trainee psychiatrists to gain knowledge
and skills on OST. The problem is further compounded by an attitude of looking at
OST as “just substituting one addiction for another” – displayed unfortunately by
some members of the psychiatric fraternity. It is also a misconception that only psychiatrists
can deliver OST. The clinical and program-implementation experience in India is a
testimony to the fact that even the nonspecialist physicians can be effectively trained
to deliver OST.[16] Thus, one of the most formidable challenges in the country is
related to inadequate number of professionals and inadequate capacities of existing
professionals.
SCALE UP OF OPIOID SUBSTITUTION TREATMENT: CHALLENGES RELATED TO LEGAL AND POLICY
FRAMEWORK
Medications used for OST can themselves be addictive. Consequently, world-over, including
in India, their procurement, storage, trade and dispensing needs to be, and are, highly
regulated. Of the two commonly used medications for OST – methadone and buprenorphine
– the former (being a pure agonist at opioid receptors) has been categorized as a
“narcotic” in the international regulatory framework. Buprenorphine on the other hand
(being a partial agonist) has been placed in the list of “psychotropics” and thus
is subject to less stringent regulations. Similarly, under the Indian regulatory framework,
buprenorphine has been labeled as a psychotropic in the Narcotic Drugs and Psychotropic
Substances (NDPS) Act, 1985. In addition, being a pharmaceutical product, it is also
subject to regulations under the Drugs and Cosmetics Act, 1940 and Rules (1945). However,
the FDC of buprenorphine-naloxone adds another layer of complexity to the regulatory
framework. The Drug Controller of India had initially imposed a condition that these
tablets be supplied only to certain specific facilities (in effect, “de-addiction
centres” supported or authorized by the government). Unfortunately, the phrase “de-addiction
centre” has not been adequately defined. In addition, the legal position of this additional
condition imposed by the Drug Controller also remains doubtful. Involvement of a large
number of enforcement agencies with little inter-department coordination, adds to
the complexity. The complex regulatory regime has ensured that it is very difficult
for health care providers (including psychiatrists) to procure, stock and dispense
buprenorphine to their patients. These troublesome and sometimes contrary positions
of regulatory authorities and service providers has led to some psychiatrists in Punjab
being arrested and jailed for charges of stocking and dispensing buprenorphine.[17
18] While the cases remain sub-judice, it is worth noting that the existing legal
and policy environment in India is not conducive to provide OST to the large population
of untreated opioid dependent patients. Although one of the driving motives of legislation
has been to prevent the illegal diversion of pharmaceutical opioids from the legal
market, the present regulations have only led to the inadequate provision of treatment
for needy patients.[19]
The same legal and policy framework however, appears to be much less stringent for
methadone, a pure opioid agonist, narcotic medication. The recent amendment to the
NDPS Act (2014) has placed methadone in the category of “Essential Narcotic Drug,”
paving the way for its smoother and easier availability with almost any registered
physician choosing to provide it.[20] While such legal and policy reforms should be
welcomed from an addiction treatment perspective, it appears strange that a pure agonist
opioid is being subjected to much simpler regulations (aimed at promoting its wider
and easier availability), while a safer partial agonist (buprenorphine) with documented
effectiveness and safety in India has been placed under such stringent regulations.
THE ROAD AHEAD
India has a large number of people with opioid dependence, many of whom would need
long term pharmacological treatment with agonists. As a signatory to the three UN
Conventions and as enshrined in the NDPS Act (1985), the government needs to fulfill
its commitment to curb the illicit use of drugs and at the same time make the relevant
narcotic and psychotropic drugs available for legitimate medical and scientific use.
To this end, we propose the following recommendations.
1. Enhancing the capacities of health professionals
Professional associations (like the IPS) are mandated to assist and guide their members
in providing evidence-based and effective treatments. At the same time, these societies
are also expected to be a collective voice of its members when they are seen as being
treated unfairly by the drug control/other enforcement authorities. It is high time
that professional associations of psychiatrists in India take a lead in building capacities
of their members on OST through designing and implementing professional development
courses/training programmes. Indeed, creation of the Task Force on OST jointly by
the IPS and Indian Association of Private Psychiatry (IAPP) on this issue is a welcome
step. The document produced by this task force “OST using Buprenorphine: IPS-IAPP
Task Force recommendations…” could prove to be a useful advocacy tool. For conducting
training on OST, there are a number of experienced academic institutions in India
which could be engaged. Besides conventional, in-person training programs, innovative
use of information technology could make such initiatives reach a large number of
participants very effectively. Some early initiatives such as the Virtual Knowledge
Network of NIMHANS, Bengaluru[21] or the AIIMS-PHFI online OST Training Program[22]
appear very promising. If such training programmes are accredited by the relevant
authorities, these could also fulfil the procedural requirement for eligibility to
provide OST.
Since medications used for OST possess abuse liability and are regulated, it is imperative
to have in place mechanisms to ensure their safe storage, dispensing and monitoring.
There are models of “Standard Operating Procedures” and “Quality Assurance” mechanisms
for OST developed under the NACP.[23] Such procedures and mechanisms must be developed
and implemented for all the categories of OST providers.
2. Legal and policy reforms
Sustained and persistent advocacy by the palliative care professionals played a key
role in bringing about the necessary (and welcome) amendment to the NDPS Act (Amendment
2014), which would now result in easier availability of “essential” opioid narcotics
as analgesics.[24] Such advocacy is also required on the part of psychiatrists, to
bring about policy reforms, paving the way for easier and wider availability of buprenorphine
as OST. Specifically, the drug controller should be requested to modify the special
condition attached to buprenorphine; any qualified medical professional delivering
addiction-treatment services irrespective of the type of setting, should be eligible
to provide this treatment. Mechanisms need to be in place to ensure the compliance
of the service providers with the standard procedures and regulations.
It is also important to sensitize and orient the law enforcement officers to the benefits
of providing OST to opioid dependent people. The evidence that OST brings about a
reduction in criminality could bring about a sea change in perception of law enforcers
to this treatment.[25]
3. Bringing ost into the mainstream of addiction treatment
As of now, the only large scale health program in India providing OST is the NACP,
which – true to its mandate – provides this treatment to only opioid dependent IDUs.
A vast majority of opioid dependent persons in India use opioid through noninjecting
route. Many of them would need to be brought under the treatment coverage. For this,
the Drug De-addiction Programme of the Union Ministry of Health (for government hospitals)
as well as the program for assistance to NGOs to implement Integrated Rehabilitation
Centre for Addicts by Union Ministry of Social Justice and Empowerment, must make
OST available at their respective addiction treatment facilities. Indeed, if the teaching
institutes in the country adopt OST as one of the treatment strategies on an adequate
scale, it would have a cascading effect, resulting in more trainee psychiatrists getting
exposed to and trained in OST and then implementing it responsibly at their places
of work. In addition, effectively communicating the principles of evidence-based addiction
treatments, including harm reduction and OST to the public, treating professionals,
policy makers and regulators will be needed to create acceptance and better uptake
of this evidence-based approach which has the potential to save lives and make opioid
dependent individuals functional members of our society.
CONCLUSION
India has a rich clinical, research and programme-level experience of implementing
OST. Unfortunately this experience and expertise has remained concentrated at a few
institutions and with a few professionals. There are a number of attitudinal and policy-level
hurdles blocking the way of providing this treatment on an adequate scale. “Science,”
“Evidence,” “Health” are key operative words on which drug policies should be based.
A concerted effort by the professionals, activists and consumers is needed in these
areas to advocate for the reforms which could make OST available, affordable and accessible
to the large number of opioid dependent persons in India.