Akshay Narayanan

Opioid Substitution Therapy Works. India Isn’t Doing Enough

December 25, 2025

Epistemic status: Low-to-medium. This document is a shallow investigation on opioid substitution therapy (OST) access in India, focusing on buprenorphine as the primary treatment medication. I spent approximately 15 hours reviewing academic literature, policy documents, and procurement data. I haven’t talked to any experts about this yet. I welcome comments via akshaygn@hsph.harvard.edu

Uncertainty: It seems worth flagging two major uncertainties that this shallow review does not resolve

Executive Summary: India has 7.7 million people with opioid use disorders, but only 3%-5% of people who inject drugs, and even fewer who use opioids w/o injecting receive opioid agonist/substitution therapy (OAT/OST) despite strong clinical evidence and relatively clear government willingness. OST uses long-acting opioids like buprenorphine and methadone to stabilize patients, reduce illicit drug use, and enable HIV/HCV treatment. Buprenorphine is generally safer than methadone due to its partial-agonist ‘ceiling effect,’ and NACO’s OST program in India primarily uses buprenorphine. 

Some barriers to accessing OST treatment in India:

What should we look at? 

The most relevant interventions appear to be regulatory advocacy, workforce training systems, and service delivery model innovation. These require technical assistance, convening power, and regulatory policy influence more than product-specific financing mechanisms. There may be a role for impact investment in private clinic networks if regulatory clarity improves, but that's highly contingent on policy changes. 

This looks quite different from typical market shaping work on commodity products.

Some questions:

  1. Are the reported buprenorphine shortages in Manipur and other locations isolated incidents or symptoms of systemic procurement/distribution problems? Is this a last-mile distribution issue, a budget release timing problem, poor forecasting at state level, or something else?
  2. Why do we not rely on buprenorphine-naloxone combinations, if they’re similar in potency/ reduce misuse risk? Is this driven by a manufacturing/cost constraint?
  3. What specific efforts have been made or are currently underway to enable private psychiatrists and clinics to provide MOUD? Are there test cases in courts challenging the "de-addiction center only" interpretation? What is the Indian Psychiatric Society or other professional bodies doing to advocate for clearer regulations? 
  4. Punjab demonstrates that large-scale outpatient OST is operationally feasible. What specifically prevents other states from replicating this model? Is it budget constraints, lack of trained staff, political will, regulatory interpretation differences, or something else? Why does NACO's program remain focused primarily on IDUs when the broader opioid-dependent population is much larger?
  5. Why hasn't Probuphine or similar buprenorphine implants achieved commercial uptake anywhere, including in high-income settings where regulatory barriers would presumably be lower? Is it a pricing issue, clinical acceptance, patient preference, or business model problem? Have any LMICs piloted or adopted long-acting MOUD products, and if not, why not?

Extended review:

Public Health Problem: National surveys estimate that approximately 23 million Indians used opioids in the past year, with 7.7 million meeting criteria for opioid use disorders. This represents 2.1% of the Indian population, which is three times the global average. Heroin is the most commonly used opioid (1.14% of the population), followed by pharmaceutical opioids (0.96%) and opium (0.52%).

The geographic distribution is highly uneven. By absolute numbers, the highest burden falls on Uttar Pradesh, Punjab, Haryana, Delhi, Maharashtra, Rajasthan, Andhra Pradesh, and Gujarat. However, by prevalence rates, the northeastern states of Mizoram, Nagaland, Arunachal Pradesh, Sikkim, and Manipur show the highest rates of opioid use, along with Punjab, Haryana, and Delhi. In Punjab specifically, opioid dependence affects approximately 2.5% of the population, with an estimated 270,000 opioid-dependent individuals.

The injecting drug use epidemic is particularly concentrated in the northern and northeastern parts of the country. Almost all injecting drug users in India are opioid dependent, and this population faces severe health consequences. The prevalence of HIV among people who inject drugs is 9.9%; the highest of any risk group in the country. Hepatitis C prevalence among this population in India is also high, with multiple sites reporting prevalence above 60% (and higher in some settings).

The treatment gap is enormous. A household survey in Punjab found that only about 15% of people with opioid dependence had "ever" received any form of medical treatment. Current OST coverage through NACO programs reaches only 3-5 per 100 people who inject drugs, which the WHO categorizes as "low coverage" (defined as less than 20 per 100). When considering the broader population of 7.7 million with opioid use disorders, current programs cover perhaps 3-4% of those in need.

What is Opioid Substitution Therapy? Opioid substitution therapy (or opioid agonist therapy) involves providing long-acting opioid medications like methadone or buprenorphine to people with opioid dependence. Rather than producing a high, these medications occupy opioid receptors at a steady level, preventing withdrawal symptoms and reducing cravings without causing euphoria. 

The effectiveness of opioid substitution therapy is well-established in the international literature, and growing evidence from India supports its effectiveness in the local context. A Cochrane review concluded 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. It also showed that methadone may keep more people in treatment than buprenorphine. The evidence shows that treatment outcomes are better with adequate dosing; usually 60mg of methadone or 8-16mg of buprenorphine daily.

OST provides multiple public health benefits beyond individual treatment outcomes. It reduces mortality in people who inject drugs and improves their quality of life. The intervention increases hepatitis C testing rates and treatment uptake with direct-acting antivirals. Similarly, it boosts antiretroviral therapy enrollment, adherence, and viral suppression in HIV-positive people who inject drugs.

A study of integrated care models that combine pharmacological treatment with psychosocial interventions found that patients receiving integrated care had higher rates of treatment retention and abstinence at 12 months compared to those receiving standard care. 

Buprenorphine vs Methadone. A comparison of methadone and buprenorphine in Indian inpatient settings found both medications effective for acute opioid withdrawal management. Indian guidelines note buprenorphine can be initiated in outpatient or inpatient settings; as a partial agonist with a ceiling effect, it has lower respiratory-depression/overdose risk than methadone and lower abuse liability than full agonists, and many studies find less cognitive impairment on buprenorphine than methadone; supporting efforts to expand access where feasible.

Current infrastructure for OST: The existing service delivery landscape is fragmented across multiple government programs.

Barriers to OST access

Manufacturing and pricing: This doesn't appear to be a classic supply constraint problem. 

So the manufacturers exist, the API production is there, and the pricing in government procurement appears quite affordable. Methadone costs are nearly equal to buprenorphine currently and could fall further with more suppliers entering the market. This suggests the typical market shaping interventions around supplier entry, volume guarantees, or price negotiations may not be the primary levers here.

Coverage & stockouts: While manufacturing capacity appears adequate, there's scattered evidence of actual supply chain failures at the service delivery level. 

These are anecdotal reports from news sources, not systematic data. It's unclear whether these represent isolated procurement failures in specific states, or whether there are underlying supply chain inefficiencies despite adequate manufacturing.

Funding landscape: Total OST funding in India is difficult to estimate precisely but appears quite limited relative to the scale of need. The funding landscape is dominated by government programs. I couldn’t find any evidence of international philanthropic engagement, barring work with wraparound services (awareness, counselling etc). There are NGO implementation partners for NACO programs, but I haven't identified substantial independent philanthropic investment in addiction treatment infrastructure or policy reform. This is in stark contrast to other health areas like tuberculosis, HIV, or malaria, which receive significant international donor attention.

NACO operates as the primary funder for approximately 393 OST centers, but their exact budget allocation for OST specifically is unclear. It's embedded within broader HIV prevention spending. The Drug De-Addiction Programme faces chronic underfunding. 

The regulatory environment effectively blocks greater private sector participation at scale, and there's no evidence of corporate social responsibility initiatives or pharmaceutical company access programs addressing this gap.

Regulation: The real barrier appears to be regulatory confusion that creates provider fear/genuine legal bottlenecks for expanding access to OST services. 

Buprenorphine sits in what is described as a ‘legal grey zone’. It's regulated under both the NDPS Act (as a psychotropic substance) and the Drugs and Cosmetics Act (as a Schedule H1 drug), and these frameworks don't align neatly. The Drug Controller General initially approved buprenorphine "for supply to de-addiction centres only" through internal communications, but this term isn't actually defined in either the NDPS Act or the Drugs and Cosmetics Act. So different officials interpret it differently. 

Insufficient delivery channels:  Regulatory constraints described above severely limit how OST can be delivered. NACO's OST program is "focused heavily upon injecting drug users" despite many opioid-dependent people not injecting, leaving a large unmet need. This is because OST coming under NACO makes it a focus on AIDS prevention. A large proportion of people with substance use disorders can be provided help in the outpatient settings. 

Diversion concerns: Part of the regulatory anxiety stems from legitimate concerns about diversion and abuse. India is believed to account for significant large-scale diversion within South Asia and beyond through poor regulation of illicit opioid production and pharmacies. There's documented evidence of buprenorphine tablets being injected rather than used sublingually, which both misses the therapeutic intent and creates health risks. 

Long-acting formulations - R&D Gaps: Long-acting formulations could theoretically address multiple problems at once. Improving adherence, reducing diversion risk, and reducing accidental exposure compared to pills that need to be taken home or dispensed daily. A 2016 JAMA trial tested Probuphine, a six-month buprenorphine implant, against continued daily sublingual buprenorphine in patients who were already stable on treatment. The implant group met non-inferiority targets with very high response rates and similar withdrawal/craving scores to the sublingual group.

However, Indian reviewers raised important caveats about generalizability. 

Workforce Capacity and Training: The shortage of trained providers represents a bottleneck to scale-up. 

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