Opioid substitution therapy: Legal challenges

Abstract

Drug dependence syndrome is a medical condition classified as a multifactorial health disorder that often follows the course of a relapsing and remitting chronic disease. Opioid substitution therapy (OST) is one of the established standard treatments for opioid dependence syndrome. OST, a process in which opioid-dependent injecting drug users, is provided with long-acting opioid agonist medications for a long period under medical supervision along with psychosocial interventions. OST service provider may have to deal with issues of license/registration/recognition/permission under various legislations such as the Drugs and Cosmetic Act, 1940; Narcotic Drugs and Psychotropic Substances Act, 1985; Rights of person with disability Act, 2016 and Mental Healthcare Act, 2017 depending on the drug prescribed, type of services provided, procuring, transportation, storage, and prescribing these narcotics and psychotropic medicines. The narcotics and psychotropic drugs are administered through various ministries and departments causing huge confusion, lack of coordination, overlapping roles and responsibilities, and various laws/rules and gives an opportunity for the abdication of the responsibilities. The “public mental health issue,” where the number of opioid users in the country is approximately two million and opioid dependence syndrome is approximately 0.5 million. The number of beds in the public governed deaddiction centers is abysmally low, number of psychiatrist, or trained medical practitioners in OST are also few in number to face this humongous challenge. Against this background, this article focuses on the legal issues surrounding the OST.

INTRODUCTION

Drug dependence syndrome is a medical condition classified as a multifactorial health disorder that often follows the course of a relapsing and remitting chronic disease.[1] India and many other countries have endorsed and ratified the following three international conventions on drug-related matters; (a) Single Convention on Narcotic Drugs, 1961 (b) Convention on Psychotropic Substances, 1971, and (c) the UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.[2] India's commitment to prevention of drug abuse and trafficking was in the form of drafting and enacting the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act 1985) and Rules, which was subsequently amended in 1989, 2001 and 2014.[3]

India's approach toward narcotic drugs and psychotropic substances is enshrined in the Constitution of India under Article 47, the Directive Principles, which directs the State to raise the level of nutrition and the standard of living and to improve public health as among its primary duties and in particular emphasis that the State shall endeavor to bring about prohibition of intoxicating drinks and drugs which are injurious to health.[4] Although these Directive Principles of State Policy are nonenforceable, this provision is frequently invoked to justify punitive drug policies. The Constitution of India also has earmarked subjects on which either Center or State Legislatures could make laws either exclusively or concurrently. “Drugs and poisons” were placed in the concurrent list allowing both the center and the states to legislate matters related to drugs. The division of legislative powers has played a significant role in multiple drug-related laws, rules, and policies drafted by various States apart from the Centre's National drug policies. Further, adding to this confusion, administration dealing with Supply Reduction is divided not only between central and state governments but also between ministries and departments at the same level. At present the Ministry of Social Justice and Empowerment handles demand reduction (National Institute of Social Defense, Drug De-Addiction Program, Social welfare), the Ministry of Health and Family Welfare (National AIDS Control Organization, Drugs Controller General of India), Ministry of Finance (Department of Revenue, Central Bureau of Narcotics, Customs, and Excise), and Ministry of Home and Defense (Narcotics Control Bureau, Police, BSF, and other paramilitary forces),[5] and besides these, their counterparts at the state level too are responsible for supply reduction. The narcotics and psychotropic drugs are administered through various ministries and departments causing huge confusion due to lack of coordination, overlapping roles and responsibilities, various laws/rules resulting in abdication of the responsibilities.[5]

The NDPS Act, 1985,[6] was drafted to consolidate laws regarding manufacturing/growing, possession, trafficking, sale, and consumption of drugs through stringent provisions for the control and regulation of operations as per the international and national obligations. Further, Section 8 of the NDPS Act, articulates that no person shall produce, possess, sell, purchase, transport and consume any narcotic drug or psychotropic substance, except for medical or scientific purposes.[6] For the purpose of the medical and scientific use the Act/rules, imposes requirements, standards, terms and conditions by way of license, permit, or authorization. The NDPS Act has failed to meet its objectives and is slowly losing its battle on drug abuse because of various reasons. One of the main contributing factors is the intent and approach of the law that emphasizes total prohibition, which is idealistic but not pragmatic. The practical approach requires a paradigm shift from “prohibition” to “harm reduction” in the form of opioid substitution therapy (OST). Given the “public mental health impact” of opioid abuse, where the number of opioid users in the country is approximately two million and opioid dependence syndrome is approximately 0.5 million.[7,8] The number of beds in public governed deaddiction centers is abysmally low. In addition, the number of psychiatrist or trained medical practitioners in OST are also few in number to face this humongous challenge.[7,8] Against this background, this article focuses on the legal issues around OST.[7]

CONTROVERSIES IN OPIOID SUBSTITUTION THERAPY; TIME TO TAKE EVIDENCE-BASED DECISION

Heroin and other opioid dependence cause significant morbidity and mortality; it is a chronic and enduring condition that often requires long-term treatment and care. Opioid Substitution treatment is a safe and cost-effective modality for the management of opioid dependence.[7] Scientific evidence suggests that opioid substitution treatment can help reduce criminality, morbidity and mortality as well as improve the physical, psychological, and social well-being of dependent users.[7,8] The medications commonly used for OST are buprenorphine, buprenorphine-Naloxone (combination), and methadone all of which are available in India.[7,8,9] Although slow-release oral morphine is available, it is used infrequently. OST is commonly used for purposes of management of withdrawal from opioids. However, the opioid maintenance treatment strategy is used less frequently than what is recommended. Substitution therapy is often considered and looked upon with suspicion by the policymakers and others. Although efficacious, effective, evidence-based, and cost-effective, the use of OST is not widespread and greater expansion is needed. OST in India is very economical when compared to the costs of illicit drugs use on the society in the form of criminalization and health morbidity and mortality.[7] However, incidents of reported misuse/diversion of these medications by the patients, pharmacist, practitioners, or by other healthcare professionals and also aggressive marketing by pharmaceutical companies often create negative perceptions for this important lifesaving treatment.[9,10]

There are two schools of thoughts with regard to the treatment of opioid dependence syndrome (a) complete abstinence and (b) harm reduction (acute and maintenance). Those who follow and advocate “abstinence only” approach believe that is the only option to deaddiction. Unfortunately, the ruthless craving, severity of withdrawal symptoms, drug-seeking behavior, and failure of treatment often forces to adopt the harm reduction approach.[7,8,9,10] There are strong advocates of both schools of thought in psychiatric fraternity. However, some patients do well in complete abstinence, and some require maintenance OST.

A meta-analysis of comparing the OST versus no-substitution therapy done by Cochrane Review (2009)[11] supports the effectiveness in the form of reducing the use of heroin in dependent people, and keep them in treatment program. Cochrane review (2017) found that buprenorphine probably keeps more people in treatment, may reduce the use of opioids and has fewer side effects compared to other maintenance agents or psychological treatment alone.[12] The evidence-based medical research across the world endorses OST beyond doubt. From the legal perspective, OST provided through either inpatient, outpatient, acute, maintenance, supervised, or take-home opioid gets affirmation under Section 8 of the NDPS act.[6]

LEGAL ISSUES FROM THE PERSPECTIVE OF PERSON WHO USES DRUGS

The drug abusers are faced with double discrimination in the form of being the primary victim (i.e., the drug user) leading to the deterioration of physical and mental health, and impact on family and society, and then, they face secondary victimization of the drug use and possession being an illegal activity and criminalized, stigmatization, and discrimination by the legal institutions, medical institutions, family, community, and the society.[13]

Criminalizing the opioid use/dependence

Criminalizing the consumption of substances or possession of small quantity raises several questions regarding the pragmatic approach of dealing with this menace. The Section 27 of the NDPS act criminalizes illegal possession in small quantity (e.g., for personal consumption) of any narcotic drug or psychotropic substance by prescribing punishment. If the consumed substance is cocaine, morphine, diacetylmorphine or any other substance as may be specified by the Central Government by notification in the Official Gazette with rigorous imprisonment for a term which may extend to 1 year or with fine which may extend to 20000 rupees; or with both. However, for any other substance, the prescribed punishment of imprisonment for a term which may extend to 6 months or with fine which may extend to ten thousand rupees or with both is the penalty. However, there is immunity from prosecution to addicts volunteering for treatment under Section 64 A of the NDPS Act, 1985.[6] If a person with substance use is accused with consumption of drugs under Section 27 or with offense of possession of little quantities, they will be exempted or protected from any prosecution if they volunteer for deaddiction. Further, the law prescribes that the conviction would stand and the sentence remains in abeyance to enable the users to report back on successful completion of deaddiction treatment within 1 year. The court may direct the release of the offender after successful completion of deaddiction treatment and abstaining from the commission of any offense for 3 years. On failure to do so, the immunity from prosecution may be withdrawn, if the addict does not undergo the complete treatment for de-addiction.[6] This provision does not recognize the chronic relapsing nature of addiction and places an additional stringent burden on the dependent patient to “complete” the process of “deaddiction.” It also places emphasis on the “abstinence” model, which is not pragmatic in many patients.

NDPS Act criminalizes possession (small quantities)/consumption of the illicit substance use; hence, such persons who use drugs are inherently vulnerable to violation of their rights and liberties such as police interference and harassment, being publicly searched, being arrested, and being imprisoned.[13,14] This act enables State machinery to arbitrarily detain, harass, abuse, arrest, or incarcerate the users. Further, people with drug dependence/users are frequently viewed as criminals, pathological, not worthy of trust, weak minded, and unable to exercise agency or self-determination in their decision. This often leads to forced admission in deaddiction centers, involuntary treatment, physical abuse, and denial of human rights. Criminalizing the substance use will act as a deterrent to help seeking and they are denied the access to the service and healthcare provision which is their human right.[13,14,15]

Decriminalizing opioid consumption

A recent review by Vidhi Centre for Legal Policy on the NDPS Act in Punjab State has found that Section 64A is underutilized and many substance users are languishing in jail without any proper treatment.[16] However, the Central Rules of Mental Healthcare Act, 2017, schedule on Minimum Standard for Mental Health Care in Prisons mandates availability of OST. Considering the public health issue of opioid use and the fact that it is a medical illness necessitating treatment, there is an urgent need to decriminalize the opioid substance consumption and enable treatment including OST.[7,8,9,10]

LEGAL ISSUES FROM THE PERSPECTIVE OF OPIOID SUBSTITUTION THERAPY PROVIDERS

Very often the medical and legal practitioners are often confronted with the question, which law regulates OST? and how laws regulate OST? OST service provider may have to deal with issues of license/registration/recognition/permission under various legislations such as the Drugs and Cosmetic Act, 1940;[17] NDPS Act, 1985;[6] Rights of person with disability Act, 2016;[18] and Mental Healthcare Act, 2017[19] depending on the drug prescribed, type of services provided, procuring, transportation, storage, and prescribing these narcotics and psychotropic medicines. Further, varying minimum standards for establishing de-addiction centers across laws and State creates chaos. For example, the Punjab Substance Use Disorder Treatment and counseling and Rehabilitation Centre Rules, 2011 was notified by the State of Punjab on January 16, 2011, under NDPS act 1985, 76 (2) (f) and 78 (2)(b).[20] The State of Haryana also had formed similar rules in 2010.[21] Adding to this Section 80 of the NDPS Act, which articulates that provisions of this Act or the rules made thereunder shall be in addition to, and not in derogation of the Drugs and Cosmetics Act, 1940[17] or the rules made thereunder. This dual law regulations adds to the confusion. The law governing narcotics and psychotropic drugs are very “complex.” Many implementing and monitoring agencies and lot of gray areas increase the scope for errors in interpretation of the law. These challenges have come upon heavily on the service providers in the form of psychiatrists being arrested under NDPS act and doctors languishing in jail for more than 1 year. These complex, varied rules coupled with the harsh punishments prescribed by NDPS Act, 1985 pose challenges and a serious threat to operationalize OST, treatment, and rehabilitation of drug users.

From the service providers' perspective, thus the following issues need to be highlighted and resolved.

1. How are medications for OST governed as per law?

2. Does a psychiatrist require an additional license or registration to procure and dispense the medications?

3. Can OST be administered on an outpatient basis?

Since this article primarily focuses on the legal perspective, we would attempt to restrict the answers from the legal perspective only and leave aside the ethical and operational issues for now.

How are medication for opioid substitution therapy governed?

Methadone and buprenorphine, the commonly used medications for OST, are governed differently. Here, the provisions as mentioned in the statutes will be elaborated.

1. Buprenorphine: As mentioned earlier, buprenorphine is a psychotropic drug in the schedule of psychotropic substances. It is also a Schedule H1 drug in the Drug and Cosmetics Act 1940, and Rules 1945. There are no specific provisions mentioned in the NDPS Act regarding the type use of buprenorphine. The Drug Controller General (India) had initially approved buprenorphine with the condition “for supply to Deaddiction Centres only” through certain letters and internal communications. However, it is pertinent to mention that neither in the NDPS Act nor the Drugs and Cosmetics Act, is it mentioned that Buprenorphine is to be supplied to deaddiction centers only. To the best of our best knowledge, there is no notification for the same too. Hence, the condition “for supply to deaddiction centers only: Is a debatable issue. In fact, the term deaddiction center itself has not been qualified in either of these Acts and much of the confusion relates to the definition and interpretation of this term. On the other hand, NDPS Act permits the use of Psychotropic Drugs for Medical and Scientific Purposes. In the Drugs and Cosmetics Act, vide a gazette notification in 2013, all Schedule H1 drugs including buprenorphine can be procured, stocked, and dispensed by a registered medical practitioner with certain mandated record keeping to reduce incidences of misuse. This apparent contradiction leads to varied interpretation by law enforcement agencies and consequent harassment and even incarceration by them

2. Methadone: Methadone has recently been designated as an Essential Narcotic Drug by notification after the amendment in 2014 called the NDPS (Third Amendment) Rules, 2015.[22] These amendments transferred the power to regulate essential narcotic drugs (ENDs)[23] to the Central Government so that uniform regulations are applicable across India. This amendment also defined “recognized medical institutions” (RMIs) for stocking and dispensing opioids for medical use. Further, this amendment also conferred the powers for authorizing medical institutions as RMIs, to a single state agency the State Drug Controller/Commissioner, Food and Drug Administration.[23] As per the amended NDPS Act, the medical institutions are any hospital, dispensary, a clinic or an institution that offers services or facilities requiring diagnosis, treatment or care of illness, disease, injury, deformity or abnormality, established, administered, or maintained by the government or Municipal Corporation, Municipal Council, or Zilla Parishad or any person or body of persons.[23] These medical institutions, wishing to get recognized and those fulfills the criteria, may apply to the appropriate authorities for permission to procure and dispense these drugs and will be termed as “recognized medical institution.” However, under the NDPS rule 52(N), the Government or Municipal Corporation or Municipal Council or Zilla Parishad hospital, dispensary and medical institution, shall be exempted from making application to the Controller of Drugs for recognized medical institution, but all other provisions of the act/rules shall be applicable. As per the amended NDPS Rule 57A (7), a recognized medical institution may possess essential narcotic drug in such a quantity and in such manner as specified in the rules or by a special order from the Controller of Drugs.[23] Methadone is one such END.

Although the NDPS Act 1985 was amended in 2014 to ease the process for licensing, stocking, and dispensing, this appears to be short lived because there were two new legislations passed by the parliament namely Rights of the Person with Disability Act, 2016[18] and Mental Healthcare Act, 2017[19] added a further layer of complexity. Section 65 (1) of the Mental Healthcare Act, 2017 and Section 50 of the Rights of Persons with Disability Act, 2016 which state that no person or organization shall establish or run a mental health establishment/establish or maintain any institution for persons with disabilities unless it has been registered with the Authority under the provisions of the respective Act. In case a mental health establishment (ordinarily to be registered under the Mental healthcare Act) had earlier registered under the Clinical Establishments (Registration and Regulation) Act, 2010 or any other law for the time being in force in a State, such mental health establishment shall submit a copy of the said registration and fulfill the minimum standards prescribed norms. However, the Rights of persons with disability Act, 2016 state that an institution for care of mentally ill persons, which holds a valid license under Section 8 of the Mental Health Act, 1987 or any other Act for the time being in force, shall not be required to be registered under this Act. Although both these new legislation provide some kind of independence regarding registration the State rules/regulations, notifications and minimum norms notified under these legislations should not bring in new bureaucratic processes to harass these deaddiction centers and service providers.

Does a psychiatrist require an additional license or registration to procure and dispense the medications?

OST falls under various domains of laws in India. The NDPS Act is specific to OST, and it is essentially divided into two parts; (a) “Narcotic Drugs” and (b) “Psychotropic Substances” The drugs prescribed under OST usually falls under the NDPS Act.

1. Buprenorphine is listed at Serial No. 92 of “The Schedule” of the NDPS Act as a Psychotropic substance as against methadone which is a narcotic substance. The NDPS Act does not prescribe licenses for the use of buprenorphine

   In fact, Rule 65-A of the NDPS Rules, 1985 reads as: Sale, purchase, consumption, or use of psychotropic substances: No person shall sell, purchase, consume, or use any psychotropic substance except in accordance with the Drugs and Cosmetics Rules, 1945. Regarding the Drugs and Cosmetic Act, 1940 in Section 97 (c) articulates that a substance specified in Schedule H1, and which comes within the purview of the 2 (Narcotic Drugs and Psychotropic Substances Act, 1985) should be labeled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with “to be sold by retail on the prescription of a Registered Medical Practitioner only.” Rule 65 provides for ”Condition of Licenses” and in terms of Rule 65(3)(1)(h) thereof whenever the drugs specified in Schedule H-1 are supplied, a separate register has to be made containing the name and address of the prescriber, the name of the patient, the name of the drug, and the quantity supplied. Further Rule 65(9)(b) read as under:-“The supply of drugs specified in [Schedule H and Schedule H1] or Schedule X 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 2 years”

2. Methadone: The law mandates that “registered medical practitioners” after undergoing adequate training in OST can prescribe essential narcotic drugs from recognized medical institutions. A registered medical practitioner may possess essential narcotic drugs for use in his practice (but not for sale or distribution by the practitioners) for a period not exceeding 3 years at a time. Further, the amended rule makes the qualification that the expression “for use in his practice” covers only the actual direct administration of the drugs to a patient under the care of the registered medical practitioner in accordance with established medical standards and practices. NDPS Rule 52H(2), (3) and 52R mandates every registered medical practitioner shall register, maintain a separate record in Form No. 3E for each patient. He also shall maintain day-to-day accounts in respect of all transactions of essential narcotic drug in Form No. 3D, maintain record of all receipts and disbursements of essential drugs in Forms No. 3H, and also file return for a calendar year on or before the March 31, of the subsequent year in Form No. 3-I to the Controller of Drugs. All the above documents, records of the daily accounts, and medical records shall be preserved for a minimum period of 2 years from the date of last entry.

The central government by the power conferred by clause (viii a) Section 2 of the NDPS Act, 1985 notified the essential narcotic drugs on 5 May 2015 for medical and scientific use under Section 8 of the NDPS Act. The essential narcotic notified drugs include morphine, methadone, codeine, hydrocodone, oxycodone, and fentanyl. Unfortunately, buprenorphine failed to make to the list. This notification encourages the methadone use rather than buprenorphine, which is a paradoxical approach compared to international standard practice, where methadone prescription is highly regulated and buprenorphine allowed for use as out-patient prescription. The policymakers need to have wide consultation and evidence-based policy practice before such notification is issued. There is an urgent need to form Essential Psychotropic Drugs list and to include buprenorphine in essential list. This will help in upscaling of the OST program in the government, NGO, as well as private sectors both inpatient and outpatient.[24]

Can opioid substitution therapy be administered on an outpatient basis?

The law does not mention that the treatment setup has to be mandatorily as having indoor facilities. The law is somewhat silent on this issue. In fact, the Drugs and Cosmetics Act permits procurement of medications by Registered Medical Practitioners and the NDPS act only permits for use in his practice, but not for sale. The amended NDPS rule clarifies that “for use in his practice” covers only the actual direct administration of the narcotic drugs to a patient under the care of the registered medical practitioner and home care treatment shall not be provided for treatment of opioid dependence under the NDPS Rule (2015) 52W. This appears to be discrimination against the people with opioid dependence syndrome. This is applicable to essential narcotic drugs; however, the law is silent regarding psychotropic (such as buprenorphine). Further, the prescription of buprenorphine on an outpatient basis is allowed in some states. However, some states prohibit this practice. From the public health perspective, the inpatient treatment of OST is simply impractical and not advisable for two million opioid drug users across the country. The NDPS Act 1985 reflects the derogatory, punitive, prohibitory tone, discriminatory practice, and language for the people with opioid substance users/dependence, which needs to be amended and should enable users to seek help.

Recommendations and future directions

The Indian Psychiatric Society and Indian Association of Private Practitioners-Task Force Recommendations for Organizing, Implementing, and Scaling up of OST in India were published in 2017 which made certain recommendations.[24] Further, Independent research initiative from Vidhi Centre for Legal Policy's research paper titled- “from addict to convict” (April 2018) and a report titled “Comprehensive Action Against Drug Abuse” from the special group on drugs constituted by Government of Punjab (August 2018) made some important observations, serious drawbacks and made certain recommendations.

1. Opioid dependence must be treated more as a health issue rather than an enforcement one and policies must reflect such a view such that patients are dealt with humanely without violating their rights

2. OST should become part of public health policy and to be embedded firmly in the national drug policy

3. Single license/registration/recognized centers mechanism needs to be put in place

4. OST should become part of the District Mental Health Program

5. Private psychiatrist and other (adequately trained) registered medical practitioners should be encouraged to provide OST

6. Out-patient basis OST needs to be encouraged to address this public health issue

7. OST governing laws needs to be simplified and uniform across the country

8. All significant barriers to OST access by people who use opioids must be addressed and removed. This can be achieved by:

   1. Upscaling of the OST program is the need of the hour
   2. Reducing legal, policy, and administrative hurdles
   3. Developing a system of accreditation for practitioners who will dispense OST
   4. Free OST treatment at every PHC level.

9. Essential psychotropic drugs list needs to be formulated (similar to essential narcotics drugs list) and to be revised periodically based on the evidence-based medical practice

10. The police, enforcement, and legal agency should stop harassing psychiatrists providing deaddiction centers/services. Appropriate orders/law should be passed on similar lines of Supreme Court Judgement Jacob Mathew versus State of Punjab (2005), stipulates the guidelines to be followed before launching a prosecution against a doctor.[25]

To conclude, the NDPS Act seeks to achieve the deterrence of drug trafficking through severe punishments and criminalizing drug consumption, appears to be a failure model from public health perspective. Opioids substitution therapy is safe, economical, and effective in the management of Opioid dependence syndrome specifically in selected groups of patients. The government needs to adopt a multi-tier, multidimensional, multisystem public health approach toward OST, which is easily accessible, affordable, and at the community level. There needs to be coordination between various stakeholders, agencies, and the need for requisite legislative and policy changes. There is an urgent need to facilitate and to improve access to opioids substitution therapy both inpatient and outpatient medical use while having adequate checks and balances to control misuse and diversion. There should be simple uniform standard procedures required to be made for registration/recognition/licensing, procurement, transportation, storage, and prescription of opioids substitution treatment across India to address this epidemic of opioid dependence syndrome before it is too late.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.