Palliation Economics: The Industrial Organisation of Morphine in India

Abstract

A shortage of medication for severe pain undermines cancer care—and other treatments—across India and Africa. In India however, the entire supply chain of industrial production of morphine is within the country, yet need remains unmet. This chapter identifies systemic institutional gaps between clinical training, decentralized care, ambition and scope of supply chain management, and difficulty in carving out national autonomy on palliation needs, that are preventing the resolution of this crisis. Tackling these institutional gaps could remove uncertainty for public and private firms making investment decisions, and provide clearer pathways to markets for pain management.

Introduction: From Health Policy to Industrial Policy

Some societies need no new science or manufacturing to solve persistent health problems. Yet these problems persist because institutional gaps between health and industrial policies can create uncertainty for firms in both public and private sectors.

Institutions are the norms, customs, guidelines, standards, regulations or other laws by which societies function or fragment. Institutional gaps can be thought of as the continuing fragmented rule-book even in societies that in principle have the technical capabilities to solve the problem, or have tried to solve the problem but generate more complex and conflicting rules. Identifying and prioritising such institutional gaps, especially in countries that have robust industry, is exercising a problem-solving muscle for development and planning capacity (Srinivas, 2016). The hypothesis at the start of the study was that a series of institutional gaps—especially in regulation—prevents the existing technologies and industrial capabilities from being focused on solving the palliation problem. This chapter looks at the practical economics of palliation, by focusing on how morphine availability is an outcome not of price barriers but of persisting institutional gaps in the morphine supply chain, and a lack of joint goal-setting and execution between health policy and industrial production. A lack of cohesion between national priorities to solve the problem and a focused plan with viable administrative and stakeholder processes can collide with global health policies and recommendations which often lack a discussion on technological capabilities. Policy autonomy and policy clarity go together.

The chapter uses data collected by a part of the ICCA India team. The study includes an extensive secondary data review of Indian and global health literature on palliation delivery, costs of opioids in cancer or other palliation, and opioid trafficking or abuse. The study’s primary data was structured to include 6 detailed individual or team interviews (including one repeated interview) with experts in palliation and/or narcotics control. The interviews were conducted as in-person or group virtual meetings before and during Covid-19, with additional queries followed up by phone and emails. One interview with a multilateral agency was conducted outside India. The experts represented extensive experience with public sector and community health, public manufacturing, private sector manufacturing, and multilateral coordination. Each interview lasted approximately 45 minutes to an hour.

Our research found the initial hypothesis on persisting and conflicting institutional gaps to be valid. Furthermore, generalised LMIC analyses focusing on costs of morphine and other opioids are found to be unhelpful, even misleading in the case of India. Morphine availability requires neither new science nor a sizable technological shift in production capability, but is mired in at least four types of persistent institutional gaps: conflicting norms, technical guidelines, legal requirements, and industrial regulations. These various, conflicting, complex institutions emerge from a lack of clarity about how and why morphine is being produced in India, certainly a gap in its reliable production in the quantity needed for palliation. Furthermore, our findings suggest that the exercise of national policy autonomy in India and other countries should shift away from global health perspectives to long-term clarity on deepening of national industrial capabilities including the reliability of the why and how of morphine production. Our study also pushes towards the need for a multidisciplinary approach beyond medical expertise to set out clear palliation goals with special attention to industrial policies and domestic technological capabilities since morphine formulations are simple to produce.¹ Although medical retraining is certainly needed as the chapter shows, the focus should be on an integrated joint system of administration between health and industrial policies, with iterative planning refinements of opioid production and its availability.

Provision of Palliative Morphine

The life experience of people is shaped by their experience of pain, often even before they are officially diagnosed and designated as cancer patients. Palliative care as a rehabilitative strategy is also an essential part of treatment guidelines, even when the patient survives cancer. It involves not only the morphine that is administered to manage pain generated by cancer, but “psychological, social and spiritual suffering” of the patient and family members.²

The Lancet Commission’s recommendation for access to palliative care and pain relief is to alleviate “serious health-related suffering”. Palliative morphine is part of a wider regimen of palliative care.

Palliative care is required as soon as suffering starts. Sometimes, suffering starts even before the diagnosis. Sometimes, even after the person’s demise, their family suffers and requires palliative care. (Interview with palliative care expert, India)

Palliative morphine is used during palliative care to improve the quality of life of patients and their families (Knaul et al., 2018). In this sense, it is an essential medicine, required for pain and symptom management. 55% of patients report pain during anti-cancer treatment (van den Beuken-van Everdingen et al., 2016). However, considered a strong opioid, morphine is listed in Schedule 1 of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol (United Nations, n.d). It is subjected to control and is prescribed under strict monitoring. The World Health Organisation’s analgesic ladder mentions that morphine can be used when it is not possible to control pain by non-opioid drugs, adjuvant medication or despite the addition of weak opioids (Harris et al., 2003).

India is a signatory to the three international conventions which form the basis of the international drug control regime. The three international conventions are: The Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol; Convention on Psychotropic Substances, 1971; and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (International Narcotics Control Board, 2012). The Narcotic Drugs and Psychotropic Substances Act of 1985 which consolidates and amends narcotics law in India, and subsequent amendments to the Act have been in accordance with the three international conventions.

Resolution 53/4 adopted at the 53rd session of the Commission on Narcotic Drugs, promotes adequate availability of internationally controlled licit drugs for medical and scientific purposes and seeks to prevent their diversion and abuse (United Nations Office on Drugs and Crime, 2011). However, despite international guidelines promoting adequate availability of internationally controlled licit drugs for medical and scientific purposes, morphine is inaccessible to most low-income patients. According to INCB estimates, countries where 17% of the world population live consume 92% of the morphine used worldwide. These countries are primarily United States of America, Canada, New Zealand, Western Europe and Australia (International Narcotics Control Board, 2015). On the other hand, in 2018, people in low-income and low-middle-income countries, forming 79% of the world population consumed only 13% of the total amount of morphine used in pain management (International Narcotics Control Board, 2019). Similarly, inconsistency also arises when countries in South America like Brazil and Colombia with relatively high levels of consumption of opioids for pain management have low provision of palliative care, indicating consumption to be concentrated in certain areas (International Narcotics Control Board, 2015). Thus, even when opioid analgesics are available, the existence of adequate palliative care services in countries is required to prescribe and dispense those substances (International Narcotics Control Board, 2015).

Despite morphine being inexpensive, the amount of morphine-equivalent opioids distributed in mg/patient in low-income and lower–middle-income countries is quite low in comparison to wealthier countries and a high estimated percentage of their need for morphine is unmet during serious health-related suffering (Knaul et al., 2018). The Lancet Commission report’s expert panel has developed an Essential Package of Palliative Care and Pain Relief Health Services for countries that includes a list of essential medicines and equipment that can be administered or safely prescribed in a primary care setting. Unfortunately, the per capita cost of this essential package is lower for richer countries as opposed to low-income and lower-middle-income countries which would pay additional costs in ensuring safe supply chain and training. The report states that access to best international prices could reduce the prices that low- and lower-middle-income countries would pay for the essential package of palliative care and pain relief health services (Knaul et al., 2018).

An Industrial Organsation Approach: Moving Beyond Price and Availability

However, our research shows that while price and availability are often debated together as part of global health inequities, the focus is misplaced. Pricing and availability of morphine to patients are a function of specific industrial organisation and national decisions on policy priority. Furthermore, countries with some technological capabilities may have more trouble exercising autonomy and establishing development priorities than those that are forced to import, precisely because coordinating multiple conflicting spheres of institutions is not easy (Srinivas, 2012).

Our research thus moves the debate to the industrial organisation of morphine as a critical aspect of morphine access. Furthermore, countries are differentiated by their technological capabilities in order to boost production and regulation of the morphine supply chain. Some countries possess technological and supply chain capabilities where palliative economics should focus because it reveals persistent institutional gaps even in “best case” scenarios.

The structure of the chapter is as follows. First, it reviews some of the health policy hurdles. Health policy hurdles directly affect industrial policy since medical professionals convey the demand for medical morphine to industry. Regulatory design shapes the norms and laws of morphine use, which has an impact on demand. The second part of the chapter dives into several aspects of this industrial organization and technology.

Differentiating Countries by Industrial Capabilities

Hurdles in industrial organisation affect the procurement and availability of various formulations of morphine even in recognised medical institutions.

Although a disproportionately high availability of opioid use today for pain management is evident in countries like the United States, Canada, Australia and some countries in Western Europe, it is a reflection in part of the industrial organisation of health and the social minimums and maximums for possible consumption based on production at home or suitable imports. The high consumption of opioids in these countries can be seen in S-DDD³ per million inhabitants per day (International Narcotics Control Board, 2015) and high consumption of morphine in mg/capita for pain management (Connor, 2020) This can be contrasted with the disproportionately low availability of opioids in S-DDD per million inhabitants per day (International Narcotics Control Board, 2015) and low consumption of morphine in mg/capita for pain management in parts of Asia and most of Africa, despite some countries having industrial capabilities.

We argue that countries with disproportionately high and disproportionately low levels of consumption exhibit different industrial supply gaps of opioids and morphine manufacturing, whether they produce such opioids at home or have to import them. Thus, income and pricing may not explain the full issue, but industrial capabilities for morphine do. India is one such country with the technological capability across the supply chain of morphine. The annual Indian need for morphine for people going through severe pain during cancer is estimated to be 36,500 kg (Rajagopal and Joranson, 2007; Rajagopal, 2018). Yet in 2014, the consumption of morphine was 278 kg in India, which is sufficient to adequately treat only 40,000 patients (Jacob and Mathew, 2017). Persisting low consumption and high unmet requirement for morphine for medical purposes can be attributed to industrial supply gaps and health policy issues. Low morphine use in mg per capita in India calls for a focus on industrial policy to address these industrial supply gaps and reduced levels of consumption despite known patient needs and clinical demand. Fundamentally, despite easily manufacturing morphine formulations, India and other countries still lack access to pain relief and have reduced palliative care provision.

Insufficient Health Policy Reform

Notably, regulatory hurdles, penalties faced by doctors in the use of opioids, and out-of-date medical education, all result in doctors being a part of the problem. In practice, doctors should be adequately trained and legally empowered to prescribe morphine so that by prescription, at least morphine that can be orally administered should be accessible at Community Health Centres (WHO, 2018a).

If you ask me, what are the barriers to pain relief or cancer care, I would put up the doctor’s perception of duty of care; the procedural barriers as the second one; the society’s perception and awareness as the third one. (Interview with a medical expert, 2021)

However, interviews indicate doctors’ unease about potential addictions, which are reflected in regulatory design of very strict procurement, stocking, clinical use, disposal, and supervision. The Single Convention on Narcotic Drugs, amended by the 1972 Protocol, set out certain principles which are required to be followed by countries while developing their policies. The first principle is that individuals should have a licence to dispense opioids. The second principle is that opioids should be transferred between authorised parties. The third principle is that a medical prescription is required to dispense morphine (Foley et al., 2006). In India, The Narcotic Substances and Psychotropic Substances (NDPS) Act, 1985 consolidated and amended the law relating to Narcotic Drugs. Due to the non-uniformity of state NDPS rules of 1985 in India, there was a hindrance in the movement of legitimate opioids for medical use (Vallath et al., 2017). Strict regulations like involving multiple rounds of approval to acquire licences made processes lengthier and led to reduction in the procurement and use of morphine across the country. The requirement of six licences for every consignment made stocking and prescribing morphine difficult for hospitals (Jacob and Mathew, 2017). Frequent regulatory procedures also made storage and dispensing of morphine formulations cumbersome, thus, limiting the supply of morphine and the availability of opiate medications in institutions that dispensed it (Vallath et al., 2017).

This regulatory impact is visible in different institutional spheres: the use of morphine for medical purposes reduced from 716 kg in 1995 to 18kg in 2012 after the introduction of the NDPS Act, 1995 (Jacob and Mathew, 2017). Provisions in the Narcotic Substances and Psychotropic Substances Act, 1985, led to institutional gaps pertaining to legal requirements, technical norms and industrial regulations and resulted in this drastic reduction in the use of palliative morphine by patients. In 1998, the Government of India instructed state governments to simplify their narcotic regulations (Khosla et al., 2012) but most states did not do so (WHO, 2016a). Consequently, the lack of availability of oral morphine and limited access to hospitals also resulted in a vicious cycle, including a lack of exposure of medical professionals to the routine use of morphine (Vallath et al., 2017).

After the amendment of NDPS Act in 2014, opioid medication licensing came under the purview of the central government. The amendment made procurement of morphine easier as it reduced the number of licences required to procure and dispense morphine to a single licence (Jacob and Mathew, 2017). It included morphine in the list of essential narcotic drugs and defined “Recognized Medical Institutions”, which are officially recognised by the state drug controller and can stock, purchase, and dispense essential narcotic drugs.

Producers recognise that the demand and delivery systems are crucial for fine-tuning.

Every district should have an accessible cancer care centre. (Interview, India: Expectation of an established firm from the industry body/government)

The presence of Recognized Medical Institutions reduced the need for multiple licences from different government agencies since their authorisation to stock and dispense opioids for three years could be renewed with the same agency (Vallath et al., 2017). However, despite restrictions being lifted, access to palliative care has persisted as a problem: the gap in consumption will take time to be closed (International Narcotics Control Board, 2015) and physicians and medical professionals in India possess insufficient clinical knowledge regarding opioid pain medications due to gaps in medical training.

Besides large Indian metropolises, smaller cities and towns (still, with millions of people in some cases) lack morphine availability and have a dearth of medical oncologists, further compounding consumption and training gaps. The government of India classifies cities into three tiers on the basis of population density and infrastructure facilities (Ranganathan et al., 2021). Tier-1 cities are considered the most densely populated with relatively good infrastructure facilities, followed by comparatively smaller Tier-2 and Tier-3 cities, with Tier-3 cities having the lowest population density and fewer infrastructure facilities (Nagpal et al., 2022).

Medical oncologists are not available in Tier 2 and Tier 3 cities, due to which patients suffer. Hence, government should make policy wherein doctors should be able to serve compulsorily in certain Tier 2 and Tier 3 cities. (Interview, established firm, India)

The NDPS Act, 1985 had added to the negative attitude exhibited by professionals towards the use of opioids. Palliative care was first included in undergraduate medical and nursing curriculum by St. Johns National Academy of Health Sciences in 2001 (Velayudhan et al., 2004). Due to slow progress, training of medical professionals in pain evaluation and correct pain control methods has been limited and there have been misconceptions that cancer pain is inevitable and largely unmanageable. The fear of dependence on a particular drug, form or process has increased doctor’s inhibition from prescribing morphine. Despite high requirements, the demand of patients is not being conveyed and even if it is conveyed, hospitals in Tier-2 and Tier-3 cities lack morphine stock and availability.

Given the worryingly low availability of palliative morphine over decades, policy makers have initiated promising changes with legal amendments in national policies, programs, and medical education (Box 1).

Box 1 Amendment of Law and Programs

• 2012 National program of palliative care

• 2017 Inclusion of palliative care in National Health Policy

• 2010 Acceptance of palliative medicine as a medicine speciality and announcement of postgraduate education in palliative care

• 2019 Inclusion of palliative care in undergraduate medical programs

To summarise, the persisting gap in consumption continues due to demand-side and supply-side issues. On the demand side, lack of exposure and appropriate knowledge among physicians and medical professionals arises because of exaggerated fears of addiction and restricted exposure to injectable opioids that are used in emergency situations (Vallath et al., 2017). This stems from strict regulations from the NDPS Act and inhibits the demand for palliative morphine from those patients who require it. Moreover, due to sociocultural factors, people consider pain medications as toxic (Jacob and Mathew, 2017). On the supply side, lack of governance to ensure consistent supply from the government manufacturer of morphine salts to the producers of oral morphine pose problems (Vallath et al., 2017). If all people who need morphine demand it, better estimates will be provided to the manufacturing industries and improvements in machinery and technology will prove to be beneficial. States that have implemented the amended NDPS Act have shown improvements in palliative care, and it is the duty of the state governments to ensure the implementation of the amended rules in order to reduce the supply gap (Rajagopal, 2015).

At least 96% of India does not have access to opium. Less than 4% have it. Even if you give the hospitals morphine, they don’t know what to do with it. (Interview with a medical expert on palliative care 2021)

The Kerala state model in India has been more successful than other states in terms of providing palliative care, especially through the voluntary involvement of community and community health workers. The Government of Kerala had declared a palliative care policy and integrated it into health care in 2008 (Rajagopal, 2015), resulting in more palliative care centres than in the rest of the country (Jacob and Mathew, 2017) and more than 170 organisations to stock and dispense oral morphine (WHO, 2016a). Micro-donations from the public supplemented by government support contributed to funding for pain and palliative care services (WHO, 2016a). It is a decentralized system through a network of community health workers who aid in delivering morphine (Rajagopal et al., 2017) and requires palliative care training among medical professionals as well as community workers. During 2012 to 2015, the consumption of morphine in Kerala increased by 27% (Rajagopal et al., 2017).

New decentralised networks for palliation are being built out across other Indian states based on Pallium India’s experience. Yet, even in Kerala, the system relies on existing industrial supply chains and has struggled to improve. We turn to the industrial issues next.

Industrial Policy Gaps and Opportunities

As we saw earlier, the consumption of palliative morphine in India is lower than the amount of palliative morphine needed and demanded by people. Yet, India is one of the few countries which has in principle the entire supply chain under its control. It is one of the very few countries where the cultivation of opium is legally permitted and possesses the technological capability to produce opioids and manufacture morphine formulations. This indicates that there is a pressing requirement for an integrative system with an adequate focus on industrial policies, health policies and autonomy on regulatory design. While regulatory barriers, severe gaps in medical training and socio-economic factors are a part of health policy, the industrial policy is equally critical if not foundational. Its institutional gaps include several existing but poorly coordinated technological capabilities: supply chain management, procurement, dispersal and shop-floor and logistics of the manufacture of morphine formulations from raw opium.

Morphine salts can be extracted through opium gum or concentrate of poppy straw produced from opium poppy. India maintains the largest stocks of opium in the world. It accounted for 98% of the global production of opium in 2020 and continues to be the main producer and only licit exporter (International Narcotics Control Board, 2021) of raw opium. Legal cultivation of opium poppy takes place in tracts of the large states of Madhya Pradesh, Uttar Pradesh and Rajasthan in India. Opium can be converted to morphine salts in two ways. In the first method, after the cultivation of the Opium poppy plant (Papaver somniferous), opium gum is extracted by the cultivators through lancing. The poppy plant contains an important organ, known as the capsule, which provides raw opium. During lancing, skilled workers make an incision on the opium capsule and collect latex. The opium gum produced after solidification of the latex is dried and sent to the alkaloid plant for the production of alkaloids (Central Bureau of Narcotics, n.d) The second method of producing morphine is the Concentrate of Poppy Straw (CPS) process. In this method, rather than extracting opium gum, the bulb is cut with 8’’ of the stalk and is processed entirely (Mishra et al., 2013).

India is authorised by the United Nations Single Convention on Narcotics Drugs (1961) to legally produce opium gum. It follows the first method to extract alkaloids. The whole process of cultivation of poppy; production of opium gum by the cultivators and the extraction of alkaloids is done by the government under strict supervision, involving stringent licensing and regulations. After the conversion of opium to alkaloids, morphine salts are sent to private manufacturers who convert them into morphine formulations, as tablets and injections (Jacob and Mathew, 2017). The Narcotics Commissioner allocates quotas to companies that manufacture formulations of morphine and supply them within India. The number of pharma companies that get manufacturing licences varies each year, depending on the availability of stocks. The effectiveness of this quota process procurement requires attention. The amount of morphine salts allocated to pharmaceutical companies is less than the annual need of morphine formulations for medical use.

From 2000–2004, the average annual quantity of morphine salts sold by the Government Opium and Alkaloid Factories to companies that manufacture various formulations of morphine was 142.32 kg (Rajagopal and Joranson, 2007). Between 2011–2012 and 2016–2017, the average domestic sales of morphine and its salts (including Dionine) from the Government Opium and Alkaloid Factories was 265.66 kg (see Table 11.1).

Table 11.1 Sales of Government Opium and Alkaloid Works (GOAW) in India (kg)

Given that the estimated annual need of morphine in India is higher, there needs to be an increase in the manufacturing capacity and the availability of morphine formulations. Many medical institutions in India lack stock of morphine. According to a cross-sectional validated web-based survey conducted from November 2017 to April 2018, across 102 National Cancer Grid Cancer Centres, 72.5% out of all centres had generalist palliative care training, and the licence to dispense, store and procure morphine was available with 84.3% of the centres. Yet only 77.5% of the centres had an uninterrupted supply of oral morphine for patients (Damani et al., 2020). An increase in the average domestic sale from the Government Opium and Alkaloid Works has not been able to resolve the problem of access to opioids. This is partly because the amount of formulations of morphine being produced needs to be gradually increased. At 43 mg, India has only enough morphine-equivalent to satisfy 4% of the need of patients (Knaul et al., 2018).

Figure 11.1 displays recent data for the estimated demand for the top five narcotic drugs in India. There is a high possibility of capacity being reduced due to the impact of Covid-19 and the existence of a significant gap between demand and supply that pre-dated the pandemic.

Fig. 11.1

(Source Estimated world requirements for narcotic drugs in grams for 2022 (May 2022). Available at: https://www.incb.org/documents/Narcotic-Drugs/Status-of-Estimates/2022/EstMay22.pdf)

Estimated Indian top 5 opioid requirements (grams) (May 2022)

The requirement for opioids is the highest for codeine and is followed by morphine (Fig. 11.1).

We can see from Fig. 11.2 that after a massive reduction in the production of opiate raw materials rich in morphine in 2016, there has been a rise in production in 2017, which is positive as compared to the previous two years. Overall, the production of opiate raw materials rich in morphine has seen drastic changes and has been lower in the second half of 2010s in comparison to the first half. Estimates for 2020 and 2021 due to Covid-19 will likely be significantly higher than actual production.

Fig. 11.2

Available at: https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2013/Part_3_supply_E.pdf; International Narcotics Control Board, 2019. Supply for opiate raw materials and demand for opiates for medical and scientific purposes. Available at: International Narcotics Control Board, 2020. Supply for opiate raw materials and demand for opiates for medical and scientific purposes. Available at: Narcotic Drugs — Estimated World Requirements for 2021 — Statistics for 2019 (https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2020/8_NAR_2020_Part_III_Supply_and_Demand_E.pdf); Note: A severe drop in the estimates of Morphine production in India was expected due to Covid-19.)

Opiate raw materials rich in morphine: production in India (in ton) Sources International Narcotics Control Board, 2013. Supply for opiate raw materials and demand for opiates for medical and scientific purposes.

Historically, India has played an important role in exporting opium. Due to an increase in the morphine-producing capacity for export in traditional supply countries in years before 1979 and a resulting mismatch between global demand and supply, the Economic and Social Council of the United Nations had passed a resolution (E/RES/1979/8). It called upon importing countries to support and provide practical assistance to traditional supply countries by expanding imports through them. The resolution was passed to keep excess stocks under check and to restrict over-production (International Narcotics Control Board, 1979).

India along with Turkey were traditional suppliers of narcotic raw materials to the United States. Morphine has always been extracted from opium gum in India. Turkey shifted to extracting morphine through the Concentrate of Poppy Straw process in 1974 (International Narcotics Control Board, 1974). Over time there is declining international demand for opium gum produced in India (International Narcotics Control Board, 2020). In 2020, exports from India were at the lowest levels in twenty years (International Narcotics Control Board, 2021).

The United States, which was a major importer from India in the past, reduced imports significantly in 2015 and 2016. In 2019, Japan switched to importing concentrate of poppy straw and stopped importing raw opium which led to a further increase in stocks of opium in India (International Narcotics Control Board, 2021). Countries are responsible for keeping the amount of stocks of opium in check. Yet despite having large stocks of opium and availability of raw materials, formulations of morphine are still unavailable at many licensed Indian centres which dispense morphine. Increasing the availability of morphine requires greater production of morphine formulations from the extracted alkaloid. This will become fruitful if the translatory gap between the needs and the demand for morphine in India is reduced (Interview with palliative expert, India).

Capacity Utilization and Technology Used

And now India faces some technology choices in processing to increase manufacturing capacity and the availability of morphine via investment in machinery and enhanced technology such as the Concentrate of Poppy Straw Technology. The existing process of lancing is labour intensive, especially when opium is harvested and requires skills, experience and knowledge (Booth, 1999, p.5). Only a fraction of alkaloid content gets utilised and the rest remains in the straw and capsules (Nordal, 1956). Furthermore, extracting opium through lancing involves a greater chance of illicit diversion and therefore greater need for regular checks, reviewing and increasing the Minimum Qualifying Yield. On the other hand, the Concentrate of Poppy Straw process is less labour intensive and reduces the chances of diversion to illicit channels (United Nations Office on Drugs and Crime, 2005). Specific CPS variety seeds can be cultivated. However, shifting to CPS affects farmers currently producing poppy through lancing.

The government has begun providing licences to private manufacturers to produce alkaloids from Indian opium. Private manufacturers use CPS technology to produce the end product. Two private companies were given permission for trial cultivation for two years 2017–2018 and 2018–2019. According to the outcomes submitted, more extraction of alkaloids took place with CPS than with the opium gum method. However, firms faced legal inconveniences when it came to obtaining a possession licence from the state governments concerned (Dhoot, 2021).

Along with the establishment of the public–private partnership model that the Government of India is considering, the use of enhanced technology and the involvement of private manufacturers must not increase the overall price of the drug.

The increased manufacture of morphine formulations would be beneficial if the needs and requirements of people are met through measures like policy implementation of the NDPS Amendment Act across all states, healthcare professionals getting better training in palliative care, greater autonomy in regulatory designs and an increase in awareness.

Policy Priorities for India

Overall, therefore, a persistent fragmentation of institutions exists for morphine production, its network of delivery and consumption, and mixed messages and confusions of goals layered over these within regulation design. The fragmentation of the industrial organization is summarized in Table 11.2.

Table 11.2 Fragmentation of the industrial organization of palliation

We return to the hypothesis that the major hurdles are in systemic institutional gaps that fail to acknowledge the central role of the industrial production capabilities of morphine: diffuse goals set for industrial production, complex industrial relationships of firms and other organisations to demand and delivery, major regulatory gaps in the intermediate services of management and dispersal of regulated substances. The stock of opium and its supply is in principle not a problem in India. India has the cultivation-to-processing capacity and few technology transfer changes are needed. Concentrate of poppy straw processing could help, but even at current technological capabilities with opium gum, diversification of alkaloids is possible and the essential (and cheapest) forms of opioids could be dramatically increased in volume. According to a survey conducted with 26 established drug manufacturers, the key challenges they face are access to raw materials, regulatory or policy gaps and market reach.

Persistent bottlenecks to the production and consumption of morphine thus require policy clarity and no new science or urgent technology transfer. It requires greater focus on industrial policy and enhancing the supply chain capabilities within India for meeting domestic requirements and later if needed, encouraging exports to other LMICs.

As such, even were routine medical training to be improved, the lack of manufacture and availability of morphine formulations is a policy and administrative failure arising from a misunderstanding of the industrial foundations of health policy. Once fully acknowledged, in principle, persistent bottlenecks could be managed from start to finish with simple restructuring and regulatory oversight of a highly fragmented system struggling under regulatory stringency. This requires attention to iterative, intermediate tasks: dynamic consumption estimates, better procurement strategies, creating licensing, regulatory continuity and buying at attractive rates, and finally providing the drug for patients at subsidised rates. Hospitals, their procurement systems and state government oversight of procurement should manage the rest, as quite successful in other areas of both public and private healthcare. Moreover, India is in a unique position relative to most countries, industrialised or wealthier, of having its own agricultural lands for opium-related cultivation, and in principle, can restructure incentives for firms that wish to bid for the small profit margins but potentially high-volume business. Supplier countries with some technological capabilities in morphine must therefore define and exert greater national industrial autonomy to serve their health policies, and health policy designers must recognise the industrial foundations of palliation in order to fine tune its persistent domestic institutional gaps.

There is however one area where global health coordination may yet help such countries, but further research is required. Narcotics-funded terrorism is a parallel growing concern, shaping how future global and within-country industrial supply chains will be regulated from field to patient through the degree of controls over higher value-added synthetic pharmaceuticals. India in particular has an opportunity to exert more industrial autonomy precisely to separate regulation of the illegal drug trade from domestic medical use of opioids. It is positioned between the Golden Crescent, which includes Iran, Afghanistan and Pakistan and the Golden Triangle, which includes Burma, Thailand and Laos. Both, Golden Crescent and Golden Triangle are the two largest areas of illicit opium production in the world (United Nations Office on Drugs and Crime, 2005).⁴ Consequently, India is increasingly targeted as a transit route for illegal drug exports from these regions as well as a destination of illegal drugs. Illicit drug trade, with trafficking from Turkey, Pakistan, and Afghanistan and being driven through India, is also creating more pressure on opioid regulation to attend to narcotics illegality rather than medical needs. Illicit cultivation of opium is also prevalent in certain regions like Manipur, India (Kipgen, 2019). While historically, stringent regulations aimed at preventing addiction and trafficking, the consequences of such regulatory design also affect the availability of morphine formulations for medical use. Given the dominance of Afghanistan production sites, and the Taliban’s new ban on the cultivation of opium poppy, India saw a rise in illegal narcotics trade after Talibani takeover. Contours of their military expansion, spillover in Pakistan, and US departure from the region since, could lead to a further increase in the illegal narcotics trade.

India can exercise more autonomy over its demand and priorities such that regulatory policy does not hinder, but only enhances, the availability of palliative morphine in India. Despite destabilising geopolitics from overconsumption and trafficking and uncertainty of poppy-growing areas, India’s industrial capabilities are well situated to meet domestic palliation consumption needs and growing export demand in the next decade.

Discussion and Conclusion

The economics of morphine for palliation in India is dependent not on cost and pricing of morphine but on recognising the institutional gaps in morphine production, including the reliability of its supply chain. Palliative economics requires policy clarity and industrial simplification, such as a clear clinical-industrial framework as discussed in Chapter 6 or priority analysis of the why and how of minimum Cupboard Full requirements. The morphine case illustrates that delivery and consumption domains face continued supply chain issues and regulatory bottlenecks, compounded by misinformation and clinical hesitation. The gaps can be seen as a result of norms and rules fragmentation and isolation of knowledge sub-systems within Indian healthcare from clinical training to manufacturing.

There is reason for optimism, however. The Choosing Wisely India study makes several practical recommendations such as opting for conventional radiotherapy instead of advanced radiotherapy techniques and a focus on symptom relief and palliative care rather than chemotherapy in specific advanced cancers, in the absence of strong evidence that survival or quality of life will be affected by the measure (Pramesh et al., 2019). A Choosing Wisely India guideline for opioids (Pramesh et al., 2020) and existing material from Pallium India, are building out alongside new palliative care medical training programmes, new networks in primary healthcare across the country, and improved procurement guidelines for national procurement reform. From a production standpoint, India has in principle full control over the entire supply chain for opium to manufacturing morphine formulations for medical use. Policies can therefore now focus more on whether the advantages of shifting to more efficient technologies like the CPS technology and incentivizing private manufacturers to produce morphine formulations can maintain low final prices and strict logistics regulations.

There are also newer geopolitical challenges. Policy priorities in production cannot ignore the challenge of higher-value opioids which are complicating a neat separation between medical incentives versus narcotics trafficking. More morphine rather than fentanyl should perhaps be considered as fentanyl is comparatively more expensive for patients and performs poorly in titration of dose. Methadone is an inexpensive alternative to morphine and fentanyl, however, it is available with its own challenges of danger of accumulation, requiring educational programs and safety measures on storage and dispensing (Rajagopal, 2018). While traditional economics and markets encourage product variety, without an overall health goal or industrial clarity, alternative opioids having higher price and trafficking potential are counterproductive to industrial, health, or national security policies.

Despite these challenges, policy tenacity in improving and stitching existing supply chain capabilities can positively influence the accessibility of morphine per patient, exports to other lower and lower-middle-income countries, and reduce the per capita price that those countries would pay. Within a two-to three-year timeline and with greater policy and administrative focus, India’s integrated solutions to palliative morphine in cancer and other care are possible, and can also make fundamental contributions to global supply and availability.

Notes

• 1. The Cupboard Full, Cupboard Empty (CFCE) approach laid out in Chapter 6 is easily adapted to decide simple guidelines to minimum requirements of morphine stocking for every sizable Indian hospital or rural PHC. As an industrial problem, it is solvable in less than 2 years, but medical systems overhaul is slow.

• 2. “Palliative care is treatment of serious health-related suffering (SHS). It includes management of pain and other symptoms and addresses psychological, social and spiritual suffering of patients and their families” (Pallium India).

• 3. S-DDD: defined daily doses of opiate medication for statistical purposes.

• 4. From hashish to heroin, now more pharmaceutical trafficking including synthetic drugs, and in some cases illicit opium growing and trafficking. News 18 Oct 14 2021 “With Rise of Taliban in AfPak, Narco-Terrorism a Visible Threat to India’s Internal Security” https://www.news18.com/news/opinion/with-rise-of-taliban-in-afpak-narco-terrorism-a-visible-threat-to-indias-internal-security-4321139.html, last accessed 04–05-2020. Zee News. Aug 16 2020. “NCB busts Jharkhand based opium network; seizes Rs 20.8 lakh, 26 kg opium 6 kg opium in Uttar Pradesh's Hardoi”, https://zeenews.india.com/india/ncb-busts-jharkhand-based-opium-network-seizes-rs-20-8-lakh-26-kg-opium-6-kg-opium-in-uttar-pradeshs-hardoi-2303156.html, last accessed 04–05-2020. See also WION “Drug trafficking a challenge to India's security” June 30 2017. https://www.wionews.com/south-asia/drug-trafficking-a-challenge-to-national-security-17448, last accessed 04–05-2022.