Tag Archives: Medicines

India’s Push for Affordable Mental Health Meds: Triumphs and Challenges in 2025

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In June 2025, a small clinic in rural Ghana celebrated a milestone: it provided affordable antidepressants to 500 patients, thanks to India’s generic sertraline, costing just $2 a month per person. This was unimaginable a decade ago, when branded versions cost $30 – far beyond reach for most. As the world grapples with a mental health crisis, with 1 in 8 people facing disorders like depression or anxiety, India’s role as the “pharmacy of the world” is saving lives. Its affordable generic medications are a beacon of hope for millions in low-income countries. Yet, while India has made remarkable strides, significant hurdles remain.

Since long, I have been deliberating on this growing concern in this Blog. For example, on January 17, 2017, I wrote: ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India’. However, in today’s article, let’s explore what India has achieved, what’s left to do, and why this matters to us all.

India’s Game-Changing Achievements:

India’s ability to deliver mental health medications at a fraction of global prices is nothing short of revolutionary. Supplying 40% of the world’s generic antidepressants and antipsychotics, companies like Cipla and Sun Pharma make drugs like fluoxetine (Prozac’s generic) and risperidone accessible to millions. For example, a month’s supply of fluoxetine costs under $1 in India, compared to $15-$20 in the US or Europe. This affordability transforms lives, like that of Priya, a fictional but representative single mother in rural India, who manages her depression with generic escitalopram for $3 a month, allowing her to work and support her family.

The backbone of this success:

The backbone of this success is India’s 1970 Patents Act, which blocks “evergreening” – minor drug tweaks by big pharma to extend patents and keep prices high. This policy ensures generics hit markets fast, benefiting not just India but countries like Nigeria and Bangladesh. In 2022, during UK-India free trade agreement talks, leaked drafts suggested “data exclusivity” clauses that could delay generics for years. Health policy researcher Kavya Shah, reportedly warned, “Such rules could choke access to mental health drugs.” India’s firm rejection of these clauses in the 2023 FTA ensured that drugs like quetiapine, used for bipolar disorder, remained affordable globally. Another report highlighted – Dr. Kanica Rakhra, an Asia Global Fellow, calls this “a masterstroke for health equity,” cementing India’s role as a global health champion.

India’s recent efforts go beyond generics: 

The 2025 Mental Health Mission, launched with a $300 million budget, has boosted production of psychotropic drugs and trained 10,000 community health workers to identify and treat mental health issues early. Public awareness campaigns, like nationwide ads featuring relatable stories of recovery, are chipping away at stigma. Partnerships with the World Health Organization have also scaled up access to drugs like aripiprazole for schizophrenia, reaching patients in Nepal and South Africa. These steps show India’s commitment to leading the global mental health conversation.

The Challenges India Still Faces:

Despite these triumphs, India’s work is far from done. Domestically, the country’s mental health infrastructure is strained. A 2025 Indian Council of Medical Research study reveals only one psychiatrist for every 130,000 people, leaving millions without specialized care. Over-the-counter sales of psychotropic drugs, often misused due to lax regulation, fuel risks like dependency. For instance, in urban India, easy access to unprescribed benzodiazepines has led to rising misuse cases, a problem the government is yet to tackle effectively.

Globally, trade pressures loom large. The EU’s 2024 imposition of a 15% tariff on Indian pharmaceuticals has raised costs for African nations reliant on India’s generics, making drugs like sertraline less affordable. Ongoing EU-India FTA talks in 2025 still carry risks of stricter intellectual property rules that could limit generic production. Developing new mental health drugs is another hurdle. With global investment in psychotropic medications lagging – only 10 new drugs approved since 2015, per WHO – India’s R&D sector needs more funding to innovate.

Access gaps persist even within India. Rural areas, where 70% of the population lives, often lack pharmacies stocking mental health meds. Take Raj, a fictional farmer in Uttar Pradesh, who travels 50 kilometers to find generic citalopram for his anxiety, only to face stockouts. Scaling up distribution and enforcing stricter regulations on drug sales are critical steps India has yet to fully implement.

Conclusion:

India’s leadership in delivering affordable mental health medications in 2025 is a global triumph, transforming lives from rural Ghana to urban India with generics like sertraline and risperidone. Yet, challenges like strained infrastructure, trade tariffs, and innovation gaps demand action. By strengthening domestic systems and resisting restrictive trade policies, India can solidify its role as a health equity pioneer. Join the movement – share these stories, advocate for access, and use #MentalHealthForAll to amplify India’s promise of hope for a healthier world.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Access Denied, Ethics Demanded: India’s Pharma Detailing at a Turning Point

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June 11, 2025 — The Economic Times reports that a prominent pharmaceutical industry association has urged the Union Health Ministry to reconsider its directive that bars medical representatives (MRs) from physically meeting doctors in central government hospitals. The industry argues that the move could restrict vital information flow and undermine drug accessibility, especially in remote regions.

This reaction comes just days after the Directorate General of Health Services (DGHS), through a circular dated June 4, 2025, issued a policy prohibiting in-person MR interactions in government hospitals. Instead, it mandates that all product-related communication occur via digital means—email or secure portals.

While some may see this as a step toward dismantling the traditional MR role, that interpretation misses the point.

In my view, this is not about eliminating medical representatives. It’s about transforming their role to match the ethical, digital, and scientific expectations of modern healthcare.

A System Already Poised for Change:

For decades, medical reps have been the primary channel through which pharmaceutical companies reached doctors—armed with product samples, promotional material, and persuasion tactics. In a market dominated by branded generics, this model shaped prescribing patterns significantly.

But the rules of the game are changing.

Doctors today demand data, not just messaging. Patients expect affordability and transparency. Regulators are watching. And the public increasingly values ethics over incentives in medical decision-making.

The DGHS circular doesn’t disrupt an efficient system—it corrects an imbalance that had gone unaddressed for far too long.

The Realities Behind Branded Generics:

Branded generics – off-patent drugs sold under specific brand names – make up over 70% of India’s domestic pharma market. These are often promoted aggressively through MRs, which:

  • Reinforces prescriber loyalty to brands
  • Contributes to higher out-of-pocket costs for patients
  • Distorts rational prescribing by emphasizing brand recall over clinical evidence

While these drugs have expanded access, the promotional tactics surrounding them need a serious reset.

Patented Drugs and the Innovation Dilemma:

At the other end are patented drugs – cutting-edge, research-driven therapies. These often remain inaccessible due to cost, late launches, and barriers in public procurement.

India’s Section 3(d) of the Patent Act rightly filters out frivolous patents, curbing “evergreening” strategies. But challenges around access, affordability, and information persist—even with innovative treatments.

In both generics and patented drugs, the way pharma communicates with doctors has come under scrutiny – and rightfully so.

The DGHS Directive: A Paradigm Shift:

The DGHS ban marks a fundamental policy shift, especially in government healthcare institutions that serve millions. Its goals are clear:

  • Ensure doctors’ prescribing decisions remain scientifically neutral
  • Reduce brand-driven influence in public hospitals
  • Promote evidence-based and peer-reviewed sources of drug information

This is not an anti-industry move. It’s a pro-patient, pro-transparency, and pro-science correction.

Not the End – but the Reinvention – of Medical Reps:

Let me say it plainly:

This is not the end of medical representatives. It is the beginning of their evolution.

The policy signals that the old “brand-push” model is obsolete—but the need for credible, well-trained, scientifically literate pharma liaisons remains stronger than ever.

What the New MR Must Look Like:

  • From Pitch to Precision:
    Reps must transition from product promoters to scientific communicators—sharing real-world evidence, safety data, and treatment comparisons.
  • From Doorstep to Digital:
    With hospitals restricting physical visits, MRs must now master digital communication tools—email, webinars, and secure doctor platforms.
  • From Prescription Goals to Knowledge Sharing:
    Companies should measure reps on their ability to engage ethically, not push volume. Focus must shift to educational impact.
  • From Influence to Integrity:
    Upskilling in medical writing, therapeutic areas, and regulatory guidelines can reposition MRs as Medical Science Liaisons (MSLs) or digital medical educators.

Pharma’s Call to Action:

To thrive in this changing landscape, companies must:

  • Launch non-promotional CME programs
  • Organize hospital-approved scientific sessions
  • Build secure, compliant digital channels
  • Train MRs in ethical engagement, clinical literacy, and communication skills
  • Collaborate with medical councils and regulators to rebuild trust

Conclusion:

Industry resistance is expected. But clinging to outdated methods won’t work in a system demanding credibility over convenience.

The DGHS directive is not a crackdown. It’s a wake-up call. A moment to reflect, restructure, and reimagine how pharma and medicine should interact in a digital-first, ethics-forward India.

Medical representatives are not being shown the door. They are being shown a new direction—toward greater respect, responsibility, and relevance.

The future of pharma lies not in access at any cost, but in engagement with integrity.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Robust Patents, Not Tweaked Monopolies: India’s Practical Route to Affordable Medicines

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In April 2025, the United States Trade Representative (USTR) released its annual Special 301 Report, once again placing India on its “Priority Watch List” for intellectual property (IP) concerns. The report highlights persistent issues, particularly in the pharmaceutical sector, citing challenges such as potential patent revocations, discretionary application of patentability criteria under the Indian Patents Act, and prolonged patent grant processes.

While the USTR acknowledges India’s efforts to modernize its patent system—such as the finalization of the Patents (Amendment) Rules, 2024, aimed at reducing burdens on patent applicants—it maintains that significant concerns remain. These include high customs duties on IP-intensive products and inadequate IP enforcement mechanisms.

India, however, defends its stance, emphasizing that its IP regime is fully compliant with the World Trade Organization’s TRIPS Agreement and is designed to balance innovation incentives with public health needs. The country asserts that its legal provisions, particularly Section 3(d) of the Patents Act, are crucial in preventing “evergreening” – a practice where pharmaceutical companies make minor modifications to existing drugs to extend patent monopolies without significant therapeutic benefits.

Balancing Innovation and Access:

India’s approach to pharmaceutical patents is rooted in its commitment to public health. The Patents Act, 1970, particularly Section 3(d), prevents the patenting of new forms of known substances unless they result in enhanced efficacy. This provision aims to curb “evergreening,” where minor modifications are used to extend patent monopolies without significant therapeutic benefits.

India’s patent regime also includes mechanisms like pre-grant opposition, allowing stakeholders to challenge patent applications, ensuring that only genuine innovations receive protection.

Some Recent Case Studies: Upholding the Balance:

1. Johnson & Johnson’s Bedaquiline Patent Rejection (2023):
The Indian Patent Office rejected J&J’s attempt to extend its patent on bedaquiline, a critical tuberculosis drug, citing lack of enhanced efficacy. This decision paved the way for generic versions, improving access for patients.

2. Novartis’ Entresto Application Denied (2022):
Novartis’ patent application for the heart failure drug Entresto was denied due to lack of inventive step, preventing potential market monopolization.

3. Roche’s Trastuzumab (Herceptin) Patent Lapse:
Facing legal challenges, Roche allowed its patent on the breast cancer drug Herceptin to lapse in India, enabling the production of affordable biosimilars by Indian companies.

Global Pressures vs. Domestic Realities:

Despite international pressure, India’s IP policies prioritize access to affordable medicines. The country’s stance is not anti-innovation but seeks to prevent monopolistic practices that hinder public health.

India’s role as a major supplier of generic medicines globally underscores the importance of its balanced IP approach. Diluting these safeguards could adversely affect access to essential medicines worldwide.

The Way Forward:

To strengthen its position, India should:

  • Enhance R&D Investment: Boost funding for pharmaceutical research, particularly in neglected diseases.
  • Streamline Patent Processes: Implement measures to reduce patent grant delays while maintaining rigorous examination standards.
  • Maintain Legal Safeguards: Preserve provisions like Section 3(d) to prevent patent evergreening. It ensures that only real therapeutic advances get patents, preserving access to affordable medicines while still rewarding meaningful R&D.
  • Engage Internationally: Continue constructive dialogues with global partners to address IP concerns without compromising public health priorities.

Conclusion:

Let me reemphasize here that Section 3(d) does not prohibit incremental innovation – it simply filters out superficial tweaks that offer no therapeutic benefit and are aimed primarily at extending monopolies and delaying broader patient access to medicines.

Thus, in my view, India’s pharmaceutical IP regime exemplifies a pragmatic approach that balances the protection of genuine innovations with the imperative of public health. By resisting patent abuses and ensuring access to affordable medicines, India sets a precedent for equitable healthcare globally.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

To Reduce Disease Burden India Launches A New Study On Access to Affordable Drugs

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As India is struggling hard to come out of economic meltdown, and more – while navigating through the Covid-19 pandemic, the issue of reducing the National Disease Burden (NDP) with comprehensive measures resurfaces. According to a World Bank study, with ’17.5% of the global population, India bears 20% of the global disease burden.’

It’s also a well-reported fact that one such critical measure in this area is expanding access to affordable medicines to a vast Indian population. This is essential, despite some laudable measures taken by the country in this space. Which is why, it has attracted the government’s focus – yet again, even in the new normal.

This is evident from the Notification of the Department of Pharmaceuticals (DoP) dated 13.01.2022. This pertains to the DoP’s request for Proposal (RFP) from reputed companies, “To study the drug pricing policies of different countries/ region and lessons learnt from these countries/ regions in terms of access to medicine at affordable prices.” The selected company will conduct the study, on behalf of the government to understand the drug pricing methodology adopted in at least 10 countries, it said.

According to the RFP document, a minimum of ten countries/regions that should be covered are – Sri Lanka, Bangladesh, China, EU, UK, Australia, USA, Brazil, South Africa, and Thailand. It also mentioned, after selection – the chosen company has to submit its final report in four months, besides quarterly progress report during this period.

This article will focus on the relevance of a renewed government focus on access to affordable medicines, after the third wave of the pandemic, even after various recent measures undertaken by the government in this direction.

What does ‘access’ mean in the healthcare context – a recap:

Although, ‘access’ is a well-used word in the health care scenario, let me recapitulate the same to be on the same page with my readers in this discourse. According to the Agency for Healthcare Research and Quality (AHRQ): Access to health care means having “the timely use of personal health services to achieve the best health outcomes.” It has four components, namely:

  • Coverage: facilitates entry into the health care system. Uninsured people are less likely to receive medical care and more likely to have poor health status.
  • Services: provides a source of care, associated with adults receiving recommended screening and prevention services.
  • Timeliness: ability to provide health care when the need is recognized.
  • Workforce: capable, qualified, culturally competent health care personnel.

Let me emphasize again that the purpose of recapitulating what does healthcare ‘access’ mean, is to give a sense of how are we positioned in India, in this regard.

Key reasons for inadequate access to healthcare, especially in India:

Following are three fundamental reasons for lack, or inadequate access to healthcare, as relevant to India:

  • A large section of the population cannot access healthcare owing its cost relative to their respective income.
  • Many others can’t access, as no quality and affordable facilities are located nearby where they live.
  • Most importantly, a large Indian population can’t have adequate access to quality health care, because they don’t have any healthcare coverage. This point was flagged by the AHRQ, as well.

It is, therefore, noteworthy that to ensure access to quality healthcare, either free or affordable, health coverage for all – public or private, is critical for any nation. Whereas a large Indian population still remains without any health coverage, as the recent government publications vindicate.

Despite high OOPE a large population is still without any health coverage:

On this issue, NITI Aayog report, published in October 2021, shared some important facts. A staggering number of over 400 million Indians, still live without any financial protection for health. This is despite the launch of ‘Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY)’ launched in September 2018, and State Government extension schemes, the paper says. Notably, ‘the actual uncovered population is higher due to existing coverage gaps in PMJAY and overlap between schemes,’ the report added.

Interestingly, the paper acknowledged: “Low Government expenditure on health has constrained the capacity and quality of healthcare services in the public sector. It diverts most individuals – about two-thirds – to seek treatment in the costlier private sector. “As low financial protection leads to high out-of-pocket expenditure (OOPE). India’s population is vulnerable to catastrophic spending, and impoverishment from expensive trips to hospitals and other health facilities,” it observed.

The government spending on public health at 1.5% of GDP, remains among the lowest in the world impacting reach, capacity, and quality of public healthcare services. It is compelling people to seek treatment in the costlier private sector. Almost 60% of all hospitalizations, and 70% of outpatient services are delivered by the high-cost private sector, NITI Aayog highlighted.

Major part of OOPE goes for buying drugs:

According to the W.H.O’s health financing profile 2017, 67.78% of total expenditure on health in India was paid out of pocket, while the world average is just 18.2%. Moreover, the Union Health ministry had also reported that ‘medicines are the biggest financial burden on Indian households.’ Around 43% of OOPE towards health, reportedly, went for buying medicines and 28% in private hospitals.

Thus: ‘Much of this problem of debt can be solved if medicines are made available to people at affordable prices. The National Health Policy 2017 also highlighted the need for providing free medicines in public health facilities by stepping up funding and improving drug procurement and supply chain mechanisms,” the report added.

Access to affordable drugs continues to remain a top priority today:

The above point was also emphasized in the Annual Report 2020-21 of the Department of Pharmaceuticals. It underscored: ‘The Government is now contemplating to introduce a new National Pharmaceutical Policy, where – ‘Making essential drugs accessible at affordable prices to the common masses,’ featured at the top of the policy objectives, as follows:

  • Making essential drugs accessible at affordable prices to the common masses.
  • Providing a long-term stable policy environment for the pharmaceutical sector.
  • Making India sufficiently self-reliant in end-to-end indigenous drug manufacturing.
  • Ensuring world class quality of drugs for domestic consumption & exports.
  • Creating an environment for R & D to produce innovator drugs;
    Ensuring the growth and development of the Indian Pharma Industry.

What happens when all will come under health coverage, if at all:

Even when, and if, all Indians comes under health coverage – public or private – drug cost will continue to play a major role even to the institutional payers. This is mostly to ensure the cost of health coverage remains reasonable, and affordable to all. This can possibly be done either through:

  • Price negotiation with the manufacturers, or
  • Price control by the government

In any case, there needs to be a transparent mechanism for either of above two, which the government seems to be refocusing on, as it appears today.

Conclusion:

Thus, to reduce the burden of disease in India, especially after going through a harrowing experience of the Covid-19 pandemic, where co-morbidity posed a major threat to life, India is likely to up the ante, as we move into the new normal.

From this viewpoint, a brand-new study, as mentioned above, initiated by the government to facilitate expanded access to affordable medicines, is a laudable initiative for all Indians. It’s a noteworthy point for the drug industry, as well, especially, the research-based pharma and biotech companies. As I wrote before, they should also pick this signal to focus on all 3 areas of innovation for affordable access to innovative drugs, not just on costly patented drugs for only those who can afford.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

Reaping Rich Harvest With Orphan Drugs

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A set of perplexing questions on the drug industry has been haunting many, since long. One such area is intimately associated with the core purpose of this business, as enunciated by each company, often publicly. Just to give a feel of it, let me quote what one of the largest global pharma players – Pfizer articulated in this regard, on April 5, 2019: “Health for All is at the core of our company’s purpose. We advance breakthroughs that change patients’ lives by ensuring they have access to quality health care services and Pfizer’s medicines and vaccines.”

Publicly expressed core purpose of any pharma business being generally similar, it may be construed as the same of the industry, at large. Hence, some baffling questions – not ethical, but purely commercial in nature, float at the top of mind, such as:

  • How the core purpose of business – “Health for All”, gets served when companies bring to the market mostly exorbitantly high-priced drugs, having access only to a minuscule patient population?
  • How are these companies growing at a faster pace and doing better commercially, by focusing more on orphan drugs approved for the treatment of rare diseases, affecting a very small patient population.

At this point, it will be worthwhile to have a quick recap on ‘orphan drug’ and ‘rare disease’. According to MedicineNet, orphan drugs are those which are developed to specifically treat rare medical condition. This rare medical condition is also referred to as an orphan disease. With that preamble, I shall now focus on this knotty area in search of evidence-based answers to – Is it possible to reap a rich harvest in business with orphan drugs for rare disease? And, if so, how?

Is the focus on high priced orphan a strategic business move?

Regardless of an affirmative or negative answer to the above questions, many people are head scratching with anguish while observing this trend in the drug industry. Mainly because, it is possibly the most important industry for most patients, not only while suffering from an ailment, but also before and after it happens, for various reasons.

The anguish increases manifold, when top manufacturers of popular mass-market drugs, such as, the cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin, and rheumatoid arthritis drug Humira, the best-selling medicine in the world, at a later stage seek and receive orphan drug status for these products reaping a rich harvest. The underlying intent being leveraging ‘additional advantages’ for exorbitant pricing and lesser competition. Hence, it is a strategic business move. I shall discuss this point in greater details, as was raised in a Kaiser Health News (KHN) investigation, in this article.

The same feeling gets resonated in several articles and papers, such as the one titled ‘Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up,’ published in The Atlantic on March 23, 2019. It questioned, ‘How is it that pharmaceutical companies can charge patients $100,000, $200,000, or even $500,000 a year for drugs – many of which are not even curative?’ Nonetheless, the strategy is working well, as we shall find below.

More drugs for rare diseases entering the market at a higher price:

Another article, titled ‘Drug Prices for Rare Diseases Skyrocket While Big Pharma Makes Record Profits,’ published by America’s Health Insurance Plans (AHIP) on September 10, 2019 wrote, drugs for rare diseases are now entering the market at higher prices than ever before, ranging from tens-of-thousands to hundreds-of-thousands of dollars per patient. It further wrote, according to a new report by AHIP, ‘out-of-control drug prices mean too many patients are forced to choose between paying for their prescriptions or paying their mortgage. The prices for drugs to treat rare medical conditions are 25 times more expensive than traditional drugs. That is 26-fold increase in two decades.

The rationale behind so high pricing:

To explore the rationale behind the exorbitant pricing of such drugs, let’s examine what the expert organizations, such as the Tufts Center for the Study of Drug Development (CSSD) said in this regard. Quoting a senior research fellow of CSDD, the article - ‘The High Cost of Rare Disease Drugs,’ published by the Genetic Engineering & Biotechnology News (GEN) on March 04, 2014 reported, although biopharma players generally set higher prices for orphan drugs, there is no causal link between cost of development and pricing. Instead, rare-disease drug prices reflect typical supply and demand situation: ‘Few treatment alternatives allow companies to charge what they can, knowing that payers will often ultimately foot the bill.’

It further explained: “The rarity of the disease means that few people are affected. Generally, the fewer disease sufferers there are, the higher the price of the drug. Companies that invest the same amount of money or more in orphan drugs as they would non-orphan drugs, want to recoup their investment.”

The situation in India for such drugs:

The January 05, 2019 issue of The Pharma Letter captures it all in its headline – ‘India lifts price caps on innovative and orphan drugs; major fillip for Big Pharma.’ It said, with the new legislation announced on January 4, 2019, the Indian government has decided to remove price restrictions on new and innovative drugs developed by foreign pharmaceutical companies for the first five years. In a rider, the government notification also states, the provisions of the Drug Price Control Order (DPCO) 2013 will not apply to drugs for treating orphan diseases (rare diseases).

How will it impact Indian patients?

Consequent to the above government decision, as the report indicated: ‘Orphan drugs to treat rare disease, like Myozyme (alglucosidase alfa) and Fabrazyme (agalsidase beta), both from Genzyme, which are used in the treatment of rare genetic diseases, are among a host of medicines that are to be kept out of price control.’

Quoting officials, the paper pointed out, the most challenging part in the fight against rare diseases is access to affordable treatment. As on date, the prices of these drugs tend to vary, e.g., the cost of treatment with enzyme replacement therapies may reach more than $150,000 per treatment per year. Whereas, in some other areas it may even be as much as $400,000 annually. Moreover, most of these drugs are rarely available in India. As a result, Indian patients suffering from rare diseases have to import these drugs directly. This makes affordability of medicines with an orphan drug regulatory status, a major issue for different stakeholders.

Why patient groups are not generally too vocal about this issue?

An interesting paper of 2008-09 brought to the fore the importance of patient organizations to further patient interest in various areas of health care. With the example of rare diseases and orphan drugs, it aptly expressed: ‘by changing the scale of their organizational efforts, patients’ organizations have managed to integrate themselves into the relays of power through which matters of health are thought about and acted upon. Through their formation into coalitions, patients’ organizations have been able to assume a number of important functions in relation to the government of health.’ The paper further added that the orphan drug problem can be thought of as having changed the scale and organizational form of rare disease patients’ groups.

Regrettably, a recent report of October 09, 2019, raised a big question in this area with a startling headline - ‘Big Pharma’s shelling out big-time to patient organizations. Is there any quid pro quo?’ It said, the Senate Finance Committee of the United States, while looking into the drug pricing decisions, ‘is digging into pharma funding for patient advocacy groups, which have been known to speak in tune that are music to the industry’s ears.’ It added, some Big Pharma constituents together contributed more than $ 680 million to hundreds of patient groups and other nonprofits last year.

It’s worth noting, earlier this year, several patient advocacy groups rallied in objection to a Trump-administration plan that would introduce step therapy requiring patients to try cheaper drugs before moving to more costly ones. ‘A Kaiser Health News analysis found that about half of the groups that objected had received funding from the pharmaceutical industry.’ Be that it may, rallying behind high drug prices by patient groups would help the industry only at the cost of patients’ interest. This is beyond an iota of doubt.

The motivation behind marketing more drugs for rare diseases:

There are several motivating factors to market drugs, which also treat rare disease, attaching startling price tags. The top drivers are generally considered, as follows:

  • The company gets seven years of market exclusive rights with the drug marketing approval for a rare or orphan disease. Interestingly, many drugs that now have an orphan status aren’t entirely new, either. Even if, the product patent runs out, USFDA won’t approve another version to treat that rare disease for seven years. This exclusivity is compensation for developing a drug, designed for a small number of patients whose total sales weren’t expected to be that profitable, otherwise.
  • Market exclusivity rights granted by the ‘Orphan Drug Act’ in the United States, can be a vital part of the protective shield that companies create.
  • Leveraging associated free pricing incentive, the concerned company can attach any price tag of its choice to the orphan drug, sans any competition.
  • Interestingly, more than 80 orphan drugs won USFDA approval for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drug manufacturer is qualified for a fresh batch of incentives. 

The system ‘is being manipulated by many drug makers’:

That this system is being manipulated by many drug makers was also established by the Kaiser Health News (KHN) investigation dated January 17, 2017 titled, ‘Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies.’ The analysis brought out that ‘the system intended to help desperate patients, is being manipulated by most drug makers. It reiterated, the key driver is to maximize profits, besides protecting niche markets for even those medicines, which are already being taken by millions. Thus, many orphan drugs, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.’

Even some familiar brands were later approved as orphan drugs:

The KHN’s investigation also uncovered that many drugs that now have an orphan status aren’t entirely new. Over 70 were drugs first approved by the USFDA for mass market use. These medicines, some with familiar brand names, were later approved as orphans. ‘In each case, their manufacturers received millions of dollars in government incentives plus seven years of exclusive rights to treat that rare disease, or a monopoly’, the investigation revealed.

The same KHN study also cited the example of AbbVie’s Humira – the best-selling drug in the world. ‘Humira was approved by the USFDA in late 2002 to treat millions of people who suffer from rheumatoid arthritis. Three years later, AbbVie asked the FDA to designate it as an orphan to treat juvenile rheumatoid arthritis, which they told the FDA affects between 30,000 and 50,000 Americans. That pediatric use was approved in 2008, and Humira subsequently was approved for four more rare diseases, including Crohn’s and uveitis, an inflammatory disease affecting the eyes. The ophthalmologic approval would extend the market exclusivity for Humira for that disease until 2023, the report highlighted.

The report also indicated, much touted Gleevec of Novartis, a drug that revolutionized the treatment of chronic myeloid leukemia, has nine orphan approvals. Similarly, Botox, started out as a drug to treat painful muscle spasms of the eye and has three orphan drug approvals. It’s also approved as a drug for mass-market for a variety of ailments, including chronic migraines and wrinkles. Despite humongous pricing, recent reports show that drugs with orphan status are eclipsing many new drugs with outstanding commercial success.

Companies focus on orphan drugs for better financial results:

Many top global companies’ sharp strategic focus on orphan drugs, presumably for the above reasons, is paying a rich dividend. This is evident from a number of recent reports, such as, ‘Orphan Drug Report 2019’ of Evaluate Pharma, released in April. The report says, orphan drugs will make up one-fifth of worldwide prescription sales, amounting to $242bn in spending by 2024 – much of it is going to either big pharma or big biotech players. It also found that the drugs prescribed for the treatment of rare diseases now account for seven of the 10 top-selling drugs of any kind, ranked by annual sales.

Another study of October 2019 by Prime Therapeutics LLC (Prime) shows, with more of ultra-expensive drug treatments coming to market, there is a sharp jump in the number of drug super spenders. While small in number, this group of drug super spenders grew 63 percent, which resulted in $800 million in additional drug costs. In the same period, the number of drug super spenders with drug costs over $750,000 increased 38 percent. This explains, why many companies are focusing on orphan drugs for better financial results.

Conclusion:

As the above quoted report of AHIP articulated, the regulators’ primary intent behind creating lucrative incentives for orphan drugs, was to encourage drug makers to develop treatments for rare diseases by earning a modest profit. ‘Unfortunately, drug makers have responded by building lucrative business models that empower them to achieve a gross profit margin of more than 80 percent – compared to an average gross profit margin of 16 percent for the rest of the pharmaceutical industry,’ the report said.

The AHIP study also finds, from 1998 to 2017, orphan drugs were 25 times more expensive than non-orphan drugs, resulting 26-fold increase in average per-patient annual cost, while the cost of specialty and traditional drugs merely doubled. Today, 88 percent of orphan drugs cost more than $10,000 per year per patient, which will be no different even when Indian patients import the same. The paper also revealed, in 2017, seven out of ten best-selling drugs had orphan indications. And among newly launched drugs, the share of orphan drugs increased more than 4-fold, from 10 percent to 44 percent, over a 20-year period.

Coming back to the core purpose of the pharma and biotech business, as defined by the pharma organizations themselves, one would have expected the situation to be much different. Their stated business purpose – ‘Health for All’, does not seem to recognize: “Every patient deserves to get the medications they need at a cost they can afford,’ as AHIP reiterates. Whereas, “drug makers are gaming well-intentioned legislation to generate outsized profits from drugs intended to treat a small population of patients with rare diseases.” In this scenario, reaping a rich harvest with the orphan drug status seems to have become a new normal.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Dynamics of Cancer Therapy Segment Remain Enigmatic

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Currently, cancer is likely to occupy the center stage on any discussion related to the fastest growing therapy segments in the pharma or biotech industries. There are several reasons behind such probability, some of which include:

  • Cancer is not only the second leading cause of death globally, but also offer outstanding new drug treatment options, though, mostly to those who can afford.
  • Consequently, these drugs are in high demand for saving lives, but not accessible to a vast majority of those who need them the most.
  • Alongside, oncology is one of the fastest growing therapy segments in sales in many countries, including the largest and most attractive global pharma market - the United States.
  • New cancer drugs being complex, involves highly sophisticated cutting-edge technology – creating an entry barrier for many, and are generally high priced, fetching a lucrative profit margin.

These are only a few basic dynamics of the segment. Nevertheless, understanding these dynamics, in a holistic way, is indeed an enigma – caused mostly by directly conflicting arguments on many related issues, within the key stakeholders. Thus, I reckon, this issue will be an interesting area to explore in this article. Later in this discussion, I shall try to substantiate all the points raised, backed by credible data. Let me start with some causative factors, that may make comprehensive understanding of the dynamics of this segment enigmatic.

Some causative factors for triggering the enigma:

Close overlap of several contentious factors is associated with this head-scratcher. These come in a package of reasoning and counter reasoning, a few examples of which may be seen below:

  • When increasing incidence of cancer related deaths are a global problem, fast growing oncology segment, regularly adding novel drugs in its portfolio, ideally should be a signal for containing this problem. Whereas, the World Health Organization (W.H.O) reports, cancer drugs are beyond reach to millions, for high cost. Nonetheless, the cancer drug sales keep shooting north.
  • Nearer home, while Indian anti-cancer drug market growth has, reportedly, ‘outstripped that of all other leading countries in recent years and is set to go on doing so,’ another study report underscores, ‘Indians have poor access to essential anti-cancer drugs.’
  • Although, a 2019 report of W.H.O highlights: Expensive cancer drugs ‘impairing’ access to cure, innovator companies also have their counter argument ready. They claim, higher prices ‘are necessary to fund expensive research projects to generate new drugs.’
  • When innovator companies keep touting that many new therapies are path-breaking concepts, researchers don’t find these drugs much superior to the existing ones in outcomes, except jaw-dropping prices.
  • Despite the above argument of research-based drug players to justify unreasonable pricing, several studies have established that the development cost of new cancer drugs is more than recouped in a short period, and some companies are making even more than a 10-fold higher revenue than R&D spending.
  • While several pharma companies claim that they are providing patients with access to a wide variety of cancer medication through Patient Assistance Programs (PAPs), the findings of several published research on the same concluded, ‘the extent to which these programs provide a safety net to patients is poorly understood.’

Let me now briefly substantiate each of the above points raised in this article.

Incidence of cancer and the oncology market:

Now, while substantiating the above points, let me go back to where I started from. According to the W.H.O fact sheet of September 12, 2018, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018 – about 1 in 6 deaths was due to cancer. Approximately 70 percent of deaths from cancer occur in low- and middle-income countries. The Indian Council for Medical Research (ICMR) estimated around 1.4 million new cancer cases in 2016, which is expected to rise to 1.7 million cases by 2020.

According to ‘World Preview 2019, Outlook to 2024’ of Evaluate Pharma, ‘Oncology prevails as the leading therapy segment in 2024, with a 19.4 percent market share and sales reaching USD 237bn.’ The report also highlights: ‘Oncology is the area with the largest proportion of clinical development spending with 40 percent of total pipeline expenditure.’

Similarly, the Indian Oncology market is found to be growing at 20 percent every year and is likely to remain so for the coming 3-5years. In 2012 the cancer market was valued at USD 172m (quoted from Frost & Sullivan). Another report also reiterates, the oncology market in India has outstripped that of all other leading countries in recent years and is set to go on doing so.

Poor access to cancer drugs:

Despite the impressive growth of oncology segment, ‘high prices for cancer medicines are “impairing the capacity of health care systems to provide affordable, population wide access,” emphasizes a recent ‘Technical Report’ of W.H.O. I shall further elaborate on this report in just a bit. However, before that, let me cite an India specific example of the same. The March 2019 study, published in the BMJ Global Health, also highlighted, the mean availability of essential anti-cancer medicines across all hospitals and pharmacies surveyed in India was less than the WHO’s target of 80 percent.

Cancer drug pricing conundrum:

The recent ‘Technical Report of W.H.O – ‘Pricing of cancer medicines and its impacts’ confronts this issue head on. It clearly articulates, the enduring debates on the unaffordability of cancer medicines and the ever-growing list of medicines and combination therapies with annual costs in the hundreds of thousands, suggests that the status quo is not acceptable. The global community must find a way to correct the irrational behaviors that have led to unsustainable prices of cancer medicines. Thus, correction of unaffordable prices is fundamental to the sustainability of access to cancer medicines. Further inertia on this issue and half-hearted commitments from all stakeholders, including governments and the pharmaceutical industry, will only invite distrust and disengagement from the public, the report emphasized.

Another 2019 WHO report says expensive cancer drugs ‘impairing’ access to cure. It pinpointed: “Pharmaceutical companies set prices according to their commercial goals, with a focus on extracting the maximum amount that a buyer is willing to pay for a medicine.” It also reiterated that the standard treatment for breast cancer can drain 10 years of average annual income in India. Unaffordable pricing of cancer medicines set by such intent often prevents their full benefits being realized by scores of cancer patients, the report adds. Yet another paper expressed similar concern about ‘the unsustainability of the high costs of cancer care, and how that affects not only individual patients, but also society at large.

What does the industry say?

The industry holds a different view altogether. According to another recent news, one such company quoted their 2017 Janssen U.S. Transparency Report,” which states: “We have an obligation to ensure that the sale of our medicines provides us with the resources necessary to invest in future research and development.” This is interesting, as it means that even higher pricing may be necessary to fund expensive research projects to generate new drugs for life threatening ailments, such as cancer.

What do research studies reveal?

There are several research studies often disputing the industry quoted claim of R&D spend of over a couple of billion dollar to bring a new molecule to the market. They also keep repeating, this is an arduous and time-intensive process, involving humongous financial risk of failure. One such ‘Original investigation’ titled, ‘Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval,’ published by JAMA Internal Medicine in its November 2017 issue, presents some interesting facts.

The study brings to the fore: ‘The cost to develop a cancer drug is USD 648.0 million, a figure significantly lower than prior estimates. The revenue since approval is substantial (median, USD 1658.4 million; range, USD 204.1 million to USD 22 275.0 million). This analysis provides a transparent estimate of R&D spending on cancer drugs and has implications for the current debate on drug pricing.’ Thus, the cost of new cancer drug development is more than recovered in a short period, with as much as over 10-fold higher revenue than R&D spending, in many cases, as the analysis concluded.

Even top oncologists, such as Dr. Peter Bach, the Director of Memorial Sloan Kettering’s (MSK)Center for Health Policy and Outcomes, along with other physicians at MSK drew attention to the high price of a newly approved cancer drug. According to available reports, ‘two recently approved CAR-T cell drugs – one is USD 373,000 for a single dose, the other USD 475,000 - are benchmarks on the road to ever-higher cancer drug price tags.’

It happens in India too:

Although, on May 19, 2019, NPPA announced almost 90 percent price reduction of nine anti-cancer drugs, curiously even those cancer drugs, which are not patent protected, continued to be sold at a high price. For example, according to the September 2018 Working Paper Series, of the Indian Institute of management Calcutta (IIM C), the maximum price for Pemetrexed, a ‘not patented’ cancer product was Rs 73,660, though, it is also available at Rs 4,500. Similarly, the price of Bortezomib was between Rs 60,360 and Rs 12,500 and Paclitaxel between Rs 19, 825.57 and Rs 7,380.95. It is intriguing to note that no pricing policy for patented drugs, as promised in the current Drug Policy document, hasn’t been implemented, as yet. 

Does Pharma’s ‘Patient Assistance Programs (PAPs) work? 

Different pharma companies claim their addressing access to cancer care in developing countries. A report also mentions: ‘16 of the world’s largest pharmaceutical companies are engaged in 129 diverse access initiatives in low- and middle-income countries.’ Whereas, a research study, questioning the transparency of these initiatives, concluded, ‘our results suggest that numerous drug company sponsored PAPs exist to provide patients with access to a wide variety of medications but that many details about these programs remain unclear. As a result, the extent to which these programs provide a safety net to patients is poorly understood.’

During the famous Glivec patent case, which went against Novartis at the Supreme Court of India, the company’s PAP for Glivec in the country, also came under focus. Many articles, with mutually conflicting views of the company and independent experts were published regarding this program. One such write-up emphasized with eulogy, “Novartis provides Glivec free of charge to 16,000 patients in India, roughly 95 percent of those who need it via the Novartis – Glivec International Patient Assistance Program. The remaining 5 percent is either reimbursed, insured, or participate in a very generous co-payment program. Thus, not granting a patent for Glivec really hasn’t prevented patients from getting this life-saving medication.”

However, many were, reportedly, not convinced by Novartis’ claims and counter-argued: “Our calculation says there are estimated 20,000 new patients every year suffering from cancer, this means after ten years there will be two lakh (200,000) patients, hence the program is not enough.” The views of many independent global experts on the same are not very different. For example, even Professor Carlos M. Correa had articulated: “The reported donation of Glivec by Novartis to ‘eligible patients’ under the ‘Glivec International Patient Assistance Program’ (GIPAP) may be a palliative but does not ensure a sustainable supply of the product to those in need.” Be that as it may, new studies now question whether novel anti-cancer drugs are worth their extra cost.

Are novel cancer drugs worth the extra cost?

According to a September 26, 2019 report, the results of two studies investigating the links between clinical benefit and pricing in Europe and the USA, reported at the European Society for Medical Oncology (ESMO) Congress, September 2019, reveal an interesting finding. It found, many new anti-cancer medicines add little value for patients compared to standard treatment and are rarely worth the extra cost. Interestingly, in the midst of this imbroglio, the world continues taking a vow globally to mitigate the cancer patient related issues on February the fourth, every year.

A vow is taken globally on every 4th February, but…:

On every February 04 – The World Cancer Day - an initiative of the Union for International Cancer Control (UICC), the world takes a noble vow. Everybody agrees on its broad goal that: ‘Life-saving cancer diagnosis and treatment should be equal for all – no matter who you are, your level of education, level of income or where you live in the world. By closing the equity gap, we can save millions of lives.’

UICC also noted, as many cancers are now preventable or can be cured, more and more people are surviving the disease. However, for the vast majority people, the chances of surviving cancer are not getting better. Socioeconomic status of individuals leaves a significant impact on whether one’s cancer is diagnosed, treated and cared for, in an appropriate and cost-effective manner. A customer-focused understanding of the dynamics of the cancer therapy segment, although may help effective ground action, but the status quo continues for various critical reasons. Even on the World Cancer Day 2019, the oncology pricing debate continued.

Conclusion:

The business dynamics for the cancer therapy segment, continues to remain enigmatic regardless of public emotion and sentiments attached to these drugs. Patients access and affordability to the most effective drug at the right time can save or take lives. Surprisingly, despite healthy growth of anti-cancer drugs, especially the newer and pricey ones, the number of deaths due to cancer is also fast increasing, and is the second largest cause of death today.

The pricing conundrum of cancer drugs remains the subject of a raging debate, globally. Nevertheless, the drug industry keeps justifying the mind-boggling prices, with the same sets of contentious reasons, even when various investigative research studies negate those claims. Moreover, when general public expects the drug industry to innovate both in the new drug discovery and also on making the drug prices affordable to a large section of the population, the industry doesn’t exhibit any interest to talk about the latter. Instead, they talk about PAP initiatives for improving access to such drugs. Notwithstanding independent research studies concluding that PAPs lack transparency, and is not an alternative for all those who want to fight the disease, in the most effective way.

The arguments and counterarguments continue. More effective cancer drugs keep coming with lesser number of cancer patients having access to those medicines, as patents prevail over the patients. The reverberation of the power of Big Pharma to stay in the chosen course – come what may, can also be felt from the reported statement of politically the most powerful person in the world – the President of the United States. In view of this, both the business and market dynamics of the cancer therapy segment is likely to remain enigmatic – at least, in the foreseeable future?

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

OTC Drugs in India: ‘Where Art Thou?’

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It is now a widely accepted fact that responsible self-medication plays an important role in health care, facilitating greater access to medicines and reducing overall health care cost. With continued improvement in people’s education, general knowledge and socioeconomic conditions, self-medication has been successfully integrated into many health care systems, throughout the world.This was emphasized in the paper “The benefits and risks of self-medication,” published by the World Health Organization (WHO) based on a presentation of the WHO Coordinator, Quality Assurance and Safety: Medicines, way back in March 2000.

Which is why, calibrated deregulation of prescription drugs for ‘Over the Counter (OTC)’ sale, are helping many countries to expand drug access in a cost-effective manner, facilitating overall health care, through responsible self-medication.

In this article, I shall try to explore the OTC drug issue in India, against the backdrop of the veracity of dangerous and virtually uncontrolled self-medication in the country. It will be interesting to recap where India stands in this area, despite the enactment of so many relevant laws and rules to eliminate this menace. In tandem, it will be worthwhile to fathom why is India still keeping away from promoting responsible self-medication through OTC drugs? Even when this is widely considered as one of the effective ways to improve access to drugs for specified common ailments at a reduced treatment cost for patients.

OTC Drug in India: ‘Where Art Thou?’ – becomes a relevant question in this context. Let me pick up the thread of this discussion from the general belief among a large number of domain experts that OTC drugs facilitate responsible self-medication.

OTC drugs facilitate responsible self-medication:

For greater clarity in this area, it will be worthwhile to first recapitulate the definition of self-medication. The W.H.O has defined itas, ‘the practice whereby, individuals treat their ailments and conditions with medicines which are approved and available without prescription, and which are safe and effective when used as directed.’

Whereas, self-medication with prescription drugs is not only an irresponsible act, it can often be dangerous to health for the users. On the other hand, OTC drugs facilitate responsible self-medication, as the drug regulators of respective countries have included under this category, with clear guidelines, only those medicines, which:

  • Are of proven safety, efficacy and quality standard.
  • And indicated only for conditions that are self-recognizable, and some common chronic or recurrent disorders.
  • Should be specifically designed for the purpose, will require appropriate dose and dosage forms and necessarily supported by information, which describes: how to take or use the medicines; effects and possible side-effects; how the effects of the medicine should be monitored; possible interactions; precautions and warnings; duration of use; and when to seek professional advice.

Since, OTC drugs facilitate responsible self-medication, it will be interesting to know how the constituents of Big Pharma, such as Pfizer, view the social impact of legally recognized OTC drugs.

Social impact of self-medication with OTC drugs:

Like many other large global pharma players, Pfizer also believes: “OTC medicines provide easier access to treatment options for common conditions, offering not only convenience, but also timely treatment and relief for sudden symptoms or minor ailments.” The company also acknowledges, OTC medicines, as classified so by the drug regulators of a country, “provide consumers safe and effective treatments for commonly occurring conditions, saving them time and money that might otherwise be invested in other, more expensive health services.”

To substantiate the point, Pfizer communique referred to the U.S. study, which by analyzing the seven most common acute and chronic, self-treatable conditions found that 92 percent of those who use OTC medicines in a given year are likely to seek more expensive treatment elsewhere, if OTCs were not available.

The above may be construed as a generally accepted view of both, the drug regulators and a large number of drug companies, globally. Thus, it won’t be a bad idea to quickly have a glance at the process followed by the drug regulators of the major countries, such as US-FDA, for OTC classification of medicines.

US-FDA classification of OTC medicines:

In most countries of the world, as many of us would know, those who are permitted to sell drugs under a license, can sell two types of drugs, namely: prescription drugs and nonprescription drugs. OTC medicines, obviously, fall under the nonprescription category.

Briefly speaking, US-FDA defines OTC drugs as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.”The Agency reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example, analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of ‘recipe book’ covering acceptable ingredients, doses, formulations and labeling.

Many of these monographs are found in section 300 of the Code of Federal Regulations. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness and labeling of all marketing OTC active ingredients. While this is the scenario in the United States and a large number of other countries, let’s have also a glimpse of this aspect in India.

‘OTC drugs’ in India:

As on date, legally approved as OTC drugs along with the guidelines, for responsible self-medication during pre-defined common illnesses, doesn’t exist in India. Accordingly, neither drugs & Cosmetics Act, 1940 nor the Drugs & Cosmetics Rules, find any mention of OTC drugs, as yet. While even responsible self-medication is not legally allowed or encouraged in the country, ‘self-medication’ of all kinds and of all nature are rampant in India, possibly due to gross operational inefficiency on the ground.

Several research papers vindicate this point. One such study that was done with 500 participants, reported 93.8 percent self-medication with no gender difference. The most common reasons for self-medication were found to be – 45.84 percent for fever, 18.34 percent for pain, and 10.87 percent of headache, among others. While the common medications used were listed as nonsteroidal anti-inflammatory drugs 49.4 percent, followed by antibiotics 11.6 percent, besides other drugs.

Among those participants who took self-medication were of the opinion that self-medication resulted in quick cure of illness – 50.75 percent, saved their time – 17.46 percent, and gave them a sense of independence – 17.06 percent. The most common source of information was found to be a local chemist/pharmacy – 39 percent.

Raising a flag of concern that indiscriminate self-medication is dangerous for the population, the study suggested that public health policies need to find a way of reducing unnecessary burden on healthcare services by decreasing the visits for minor ailments. One such way is a well-defined OTC category of medicines, as are being created in many countries, including the United States. However, it appears, the Indian drug regulators are still apprehensive about giving a formal recognition of OTC drugs in the country, to prevent self-medication that is, unfortunately, rampant in the country, even otherwise.

Self-medication rampant, although illegal in India:

Regardless of all drugs laws and rules being in place to prevent self-medication with prescription drugs, these seem to be just on paper, the ground reality is just the opposite in India. In the absence of a clearly defined category of OTC drugs with guidelines, most medicines falling under the drug act, are prescription drugs, except a few drugs on the Schedule K of the Drugs & Cosmetics Act. Currently, non-pharmacy stores can sell a few Schedule K drugs classified as ‘household remedies’ onlyin villages with less than 1,000 populations, and where there is no licensed dealer under the Drugs and Cosmetics Act.

Primarily to prevent self-medication and also to ensure maintenance of specified storage conditions, among others, the D&C Act requires all other drugs to be sold by a retail drug license holder and sold only against the prescriptions of registered medical practitioners. Such drugs are labeled with a symbol ‘Rx’ on the left-hand corner of the pack and the symbol ‘NRx’, if drugs fall under Narcotic Drugs and Psychotropic Substance Act.

Additionally, these are also labeled with a warning – ‘To be sold on the prescription of a registered medical practitioner only.’ All retailers, pharmacy/medical store are supposed to strictly abide by this directive. But in reality, who cares? One can possibly get most prescription drugs that one wants, without a doctor’s prescription.

The same holds good for virtually unregulated advertising of some self-categorized ‘OTC drugs’, many of which fall under the prescription drug category. I re-emphasize, the terminology of OTC drugs does not exist, at all, in the D&C Act of India, not as yet.

Virtually uncontrolled advertisements of some so called ‘OTC’ drugs: 

Media reports indicate, widespread complaints received in the drug controller general of India (DCGI)’s office that vitamin tablets and capsule formulations are being marketed in the country as dietary/food supplements to circumvent the Drugs Price Control Order (DPCO).

Curiously, to resolve this issue – way back on July 24, 2012, the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, deliberated on the OTC drug issue in India. After detailed discussion, the DTAB has given its green signal to amend Schedule K of the Drugs and Cosmetics Rules in this regard.

But Food safety watchdog Food Safety and Standards Association of India (FSSAI) did act promptly on this matter. On September 24, 2016, FSSAI), reportedly, issued new guidelines clearly specifying that health supplements should not be sold as medicines and also fixed the permissible limits of various ingredients used in the products. It further said: “Every package of health supplement should carry the words health supplement as well as an advisory warning not for medicinal use prominently written.

“The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by the international food standards body namely the Codex Alimentarius Commission shall apply,” FSSAI added.

The juggernaut moves on:

The point worth noting here that all laws, rules and regulations are in place to discourage both, self-medication and surreptitious way to sell products sans medicinal values, as medicines. Despite the enacted laws and rules being reasonably robust to achieve the intended objective, inefficient implementation of the same keeps the juggernaut moving, perhaps gaining a momentum.

Is OTC Drug Category coming now or just another good intent?

The good news is: On September 18, 2017, the Drug Consultative Committee (DCC), in principle approved to amend rules on Drugs and Cosmetics Act to include a separate schedule for OTC drugs for minor illnesses like fevers, colds and certain types of allergies. However, in the meeting of February 20, 2019, the DCC constituted another subcommittee under the chairmanship of Drugs Controller, Haryana to examine the report on OTC drugs. The final decision is still awaited without any prescribed timeframe for the same.

Conclusion:

Creation of separate schedule for OTC drugs in India, is still a contentious issue for some. Nonetheless, such a long overdue amendment in the D&C Act, along with well-regulated OTC guideline as and when it comes,I reckon,will expand drug access to patients. Alongside, the drug makers must ensure that these OTC medicines are safe, effective and offering good value for money.

As the author of the above W.H.O articled emphasized: ‘High ethical standards should be applied to the provision of information, promotional practices and advertising. The content and quality of such information and its mode of communication remains a key element in educating consumers in responsible self-medication.’ Thus, in the Indian context, it will be equally essential for drug companies to make sure that OTC medicinesare always accompanied by complete and relevant information that consumers can understand without any ambiguity.

Be that as it may, I agree, even responsible self-medication is not totally risk-free – not even with OTC drugs, just as many other things that we choose to do in life. The risks associated with the use of OTC medicines may include, risks of misdiagnosis, excessive drug consumption and for a prolonged duration, precipitating drug interactions, side-effects and polypharmacy.

This discussion will remain theoretical until the D&C law and rules are appropriately amended to accommodate much awaited OTC category of medicines. Till then one can possibly ask in India: ‘OTC drugs, where art thou?’

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.