Category Archives: Pharma

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.

No Compromise: India Protects Patents Act in High-Stakes UK Trade Pact

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India, the “pharmacy of the world,” has long been a lifeline for millions, churning out affordable generic medicines that make healthcare accessible across the Global South. With over $25 billion generic drug industry exporting half its production, India’s commitment to low-cost medicine is a global game-changer. Yet, this role has often pitted it against pharmaceutical giants and developed nations pushing for tighter intellectual property (IP) rules. The India-UK Free Trade Agreement (FTA), finalized on July 24, 2025, showcases India’s firm stand in safeguarding its generic drug industry while navigating complex trade dynamics. By rejecting patent evergreening and data exclusivity—tactics Big Pharma uses to prolong monopolies—India has struck a bold balance between public health and international trade. This article dives into how India’s resolute stance, as highlighted in a July 29, 2025, Economic Times report, reflects its dedication to affordable healthcare while addressing foreign pressures and trade opportunities.

The Stakes: Evergreening and Data Exclusivity:

Evergreening is a clever ploy: pharmaceutical companies tweak existing drugs—think new dosages or slight formula changes—and secure fresh patents to extend their market control beyond the standard 20 years. These tweaks rarely add meaningful therapeutic value but delay cheaper generics, keeping prices sky-high. Data exclusivity, meanwhile, blocks generic makers from using original clinical trial data for regulatory approval, forcing them to run costly, redundant trials. This stalls generic drug launches, hitting hardest in poorer nations where every dollar counts.

The Economic Times noted on July 29, 2025, that “the India-UK free trade agreement (FTA) does not mandate patent term extensions or data exclusivity, which are two common tools of evergreening of patents, the commerce and industry ministry said Monday, adding that this would protect the interests of the domestic generic drugs industry.” This clarity from the ministry signals India’s triumph in shielding its generic sector from provisions that could favor multinational giants like AstraZeneca or GSK, ensuring medicines remain within reach for millions.

Facing Down Foreign Pressure:

The UK, a hub for pharmaceutical innovation, pushed hard for data exclusivity during FTA talks, echoing demands made by the European Free Trade Association (EFTA) in 2024. These “TRIPS-plus” provisions, which go beyond the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, prioritize innovator companies but threaten India’s ability to supply affordable generics to its 1.4 billion people and countless others globally. An expert quoted in The Economic Times emphasized that “data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO,” giving India solid ground to push back.

India’s resistance isn’t just about principle—it’s about lives. The country’s generic industry has slashed costs dramatically, like when compulsory licensing in 2012 dropped Bayer’s cancer drug Nexavar from $5,500 to $175 a month. By rejecting data exclusivity and preserving Section 3(d) of the Indian Patent Act, which bars patents for minor drug tweaks unless they significantly improve efficacy, India ensures generics hit the market faster. The commerce ministry’s statement that “India’s patent law provisions on patentability criteria under Section 3(d) remain fully protected” is a clear signal: India won’t bend to foreign advocacy at the expense of public health.

A Global Health Lifeline:

India’s firm stand resonates far beyond its borders. Developing nations rely on its generics to combat diseases like tuberculosis and HIV. Médecins Sans Frontières (MSF) has flagged data exclusivity as a threat to drugs like delamanid, critical for multi-drug-resistant tuberculosis. In 2022, leaked FTA drafts raised red flags among activists, hinting at provisions that could curb pre-grant patent oppositions or weaken anti-evergreening measures. MSF’s Leena Menghaney warned, “India should stay vigilant and not allow barriers to affordable medicines to be written into FTA negotiations.” The final agreement’s rejection of these provisions proves India listened, cementing its role as a global health champion.

But the fight isn’t one-sided. The UK and other developed nations argue that stronger IP protections fuel innovation, enabling the development of new drugs. Without patents or data exclusivity, they claim, companies might hesitate to invest billions in research. India, however, counters that innovation shouldn’t come at the cost of access. The TRIPS agreement already balances these interests, and India’s generics don’t stop innovation—they democratize its benefits.

Trade Wins Without Compromise:

The FTA isn’t just about medicine; it’s a masterclass in balancing priorities. India secured zero-duty access for over 95% of its agricultural exports to the UK, boosting farmers and traders, while granting duty concessions on British niche products like cranberries and durians, which don’t compete with Indian crops. This give-and-take shows India’s knack for negotiating trade gains without sacrificing its generic industry.

Still, there’s a shadow of concern. Some experts worry the FTA’s focus on voluntary licensing—where generic makers negotiate with patent holders—could weaken compulsory licensing, a TRIPS tool allowing governments to authorize generic production in emergencies. The agreement’s nod to “adequate remuneration” for patent holders raises questions about potential hurdles. While the government insists compulsory licensing rights are untouched, full transparency in the IP chapter’s terms would ease these concerns.

Conclusion:

A Purposeful Advance – Guiding Progress with Balance:

India’s firm stand in the UK FTA is a compelling narrative of principle meeting pragmatism. By blocking evergreening and data exclusivity, India protects not just its citizens but millions worldwide who depend on its generics. Yet, the tension between trade and health equity looms large. Can India keep fending off Big Pharma’s influence while forging global partnerships? The UK FTA suggests it can, blending trade wins with a fierce defense of affordable healthcare.

This isn’t just a policy win—it’s a moral statement. ‘India’s vigilance is critical to keeping medicines accessible’. In a world where healthcare is often a luxury, India’s fight to make it a right is both a challenge to global powers and an inspiration. As more FTAs loom, India’s ability to hold this line will shape not just its future but the health of nations worldwide.

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.

Unaccredited ‘Honorary Doctorates’: Seeking Prestige with Questionable Credentials…2

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Following the interest in my earlier article on this topic, I’d like to expand on it further. As previously noted, the title “Dr.” has become highly sought-after in India in recent years, especially among professionals aiming to boost their social and professional stature, particularly on social media. While globally renowned universities confer such honors on distinguished individuals for exceptional achievements, a parallel trend has emerged in India where questionable entities and unaccredited organizations provide “honorary doctorates” for a fee. These, often illegitimate titles are increasingly adopted by ordinary individuals, including those in the Indian pharmaceutical industry, to gain professional relevance and prestige. In this article, I will again explore this phenomenon, its implications, and the ethical concerns it raises.

The appeal of the ‘Dr.’ title:

In India, the title “Dr.” carries high social capital, symbolizing expertise, authority, and respect. For professionals in competitive fields like pharmaceuticals, where credibility can influence business dealings, partnerships, or public perception, an honorary doctorate can seem like a shortcut to prominence. Unlike earned doctorates, which require years of research and academic rigor, honorary doctorates from certain entities can be obtained with minimal effort – often just a payment and a cursory application process. This accessibility has made such titles particularly attractive to ordinary individuals, including small-scale entrepreneurs, mid-level professionals, and even those with modest achievements, who seek to elevate their status.

The role of deceptively named entities:

An increasing number of organizations worldwide, often registered as non-profits or councils, promote honorary doctorates with promises of prestige and career enhancement. These entities frequently adopt impressive-sounding names to seem credible. However, many lack accreditation from recognized bodies such as the University Grants Commission (UGC) or international academic authorities. The lack of thorough evaluation processes and the transactional nature of these awards—reportedly ranging from INR 20,000 to over INR 6,50,000—cast serious doubts on their legitimacy. Some organizations further complicate matters by offering online or international honorary doctorates, claiming global recognition without verifiable academic credibility.

Exploitation even in the Indian Pharma Industry:

The Indian pharmaceutical industry, a global powerhouse worth over $50 billion, is highly competitive, with professionals striving for influence in areas such as drug production, research, marketing, and regulatory affairs. In this context, an honorary doctorate can be a way to stand out, particularly for those without advanced academic credentials, who may use the “Dr.” title to project expertise at industry events or on platforms like LinkedIn. However, the use of such titles in the pharma sector poses ethical challenges. The industry relies on trust, scientific integrity, and regulatory compliance. When individuals use dubious “honorary doctorates” to exaggerate their qualifications, they risk deceiving stakeholders about their expertise. Moreover, the growing prevalence of these titles undermines the value of genuine academic achievements, devaluing the efforts of researchers, scientists, and marketers who have earned legitimate doctorates through rigorous academic work.

These titles lack recognition from the UGC:

It’s important to highlight that these titles lack recognition from the UGC or other academic authorities in India, making them invalid for academic or professional advancement in regulated sectors. Nevertheless, the social allure of the title frequently outweighs its lack of official credibility.

Ethical and social implications:

The commodification of ‘honorary doctorates’ raises significant ethical concerns. First, it undermines the integrity of academic honors by equating purchased titles with earned degrees. This can mislead the public, particularly in fields like pharmaceuticals, where expertise is critical.Second, it perpetuates a culture of instant gratification, where individuals prioritize superficial accolades over substantive skill development. Third, it exploits aspirational professionals, particularly those from less privileged backgrounds, who may see the title as a way to overcome systemic barriers to recognition.

In the pharma industry, the misuse of such titles can have broader consequences. Regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and international partners rely on accurate representations of expertise. Misleading credentials could erode trust, affect India’s reputation in global markets, and even lead to legal repercussions if used to secure contracts or approvals under false pretenses.

Regulatory gaps and the way forward:

The UGC has, reportedly, clarified that honorary PhDs are not valid academic qualifications, but enforcement is weak, and public awareness is low. This enables organizations to exploit legal loopholes, using terms like “government-approved” to mislead applicants.

To address this issue, several steps are needed:

  1. Stricter Regulation: The UGC or Ministry of Education should establish clear guidelines prohibiting unaccredited entities from awarding honorary doctorates and impose penalties for misrepresentation.
  2. Public Awareness: Campaigns to educate professionals and the public about the difference between earned and honorary doctorates can reduce the allure of purchased titles.
  3. Industry Standards: Pharma industry bodies like the Indian Pharmaceutical Alliance should discourage the use of unverified titles in professional settings and promote transparency in credentials.
  4. Ethical Recognition: Universities and legitimate institutions should maintain rigorous, transparent processes for awarding honorary doctorates, ensuring they are reserved for truly exceptional contributions.

Conclusion:

The proliferation of ‘honorary doctorates’ from deceptively named and unaccredited entities in India reflects a broader societal obsession with titles and status. While these awards may offer short-term professional relevance, particularly in industries like pharmaceuticals, they come at the cost of ethical integrity and long-term credibility. For India to maintain its standing as a global leader in pharmaceuticals and other fields, it must address this misuse of honorary titles through regulation, awareness, and a renewed focus on merit-based recognition. Genuine professional credibility stems from expertise and meaningful contributions, not bought titles.

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.

Honorary Doctorates in India: Prestige, Purpose, and Perceptions

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Today I shall dwell on a very sensitive issue that is coming under many professional discussions, including drugs and pharmaceutical industry in India. This concerns the growing trend of honorary doctorates in the country, particularly those acquired for a fee, and their impact on professional credibility.

Honorary Doctorates in India: 

In India, a noticeable trend has emerged: many individuals, often with average professional track records, are receiving communications from various institutions offering honorary doctorates for a fee. Many readily embrace these offers, subsequently using these titles extensively in their communications, social media, and public messages. This phenomenon adds a complex layer to the nuanced landscape of honorary doctorates, which were traditionally symbols of profound societal contribution. These unearned academic titles, typically Doctor of Letters (D.Litt.), Doctor of Science (D.Sc.), or Doctor of Laws (LL.D.), are meant to recognize outstanding contributions to society, arts, science, literature, public service, or philanthropy. The motivations behind both their conferment and acceptance, their actual value on a CV, and the discernment between genuine recognition and mere self-promotion are critical facets of the Indian socio-academic scenario.

Why They’re Sought and Conferred:

The reasons for the proliferation of honorary doctorates are multifaceted. For recipients, especially those acquiring them through less conventional means, an honorary doctorate offers a seemingly quick pathway to enhanced public acknowledgment. In a society that reveres education and titles, appending “Dr.” before one’s name can instantly create an impression of intellectual gravitas and authority. It’s perceived as a powerful tool for elevating professional profiles, expanding networks, and boosting credibility in public discourse, even opening doors to new opportunities or aiding advocacy.

From the institutions’ perspective, particularly those offering degrees for a fee, the motivation is often financial. While legitimate universities use honorary degrees to associate with eminent personalities and enhance their reputation, some lesser-known or unaccredited entities view it as a revenue stream, gaining a superficial semblance of legitimacy by associating with individuals who then promote the institution.

Do They Add Real Value to a CV?

The “real value addition” of an honorary doctorate to a CV is nuanced, especially with the rise of fee-based awards. In a purely academic or research context, an honorary doctorate holds little direct academic weight. It doesn’t qualify an individual to teach, supervise Ph.D. students, or conduct research as a credentialed scholar; these roles require earned doctorates (Ph.D. or equivalent) demonstrating rigorous research training.

However, outside strict academic roles, an honorary doctorate can offer significant perceptual value. On a CV, it signals:

  • Distinction and Recognition: For genuine awards, it signifies high-level success and recognition by a reputable academic institution. For questionable awards, it attempts to create this perception.
  • Networking and Influence: It can open doors to high-level networking, particularly in corporate, philanthropic, or public service sectors, where the title traditionally commands respect.
  • Brand Building: For entrepreneurs, consultants, or public speakers, it enhances their personal brand, lending an air of authority.
  • Social Capital: In India, where titles confer social capital, an honorary doctorate can elevate one’s standing in various social and professional circles, regardless of how it was obtained.

Thus, while a genuine honorary degree endorses societal impact, the proliferation of easily acquired titles risks diluting this value, making it harder to discern true merit from manufactured prestige.

Distinguishing Genuine vs. “Relevance-Seeking” Doctorates:

Discerning the true intent behind an honorary doctorate requires careful consideration, as the line between legitimate recognition and a “relevance-seeking” award has blurred.

Indicators of a Genuine Honorary Doctorate:

  1. Recipient’s Established, Unique and outstanding Reputation: The individual should have a long, verifiable record of significant, impactful contributions, widely recognized and respected, warranting the honor without needing the title for validation.
  2. Credibility of the Awarding Institution: The university must be reputable, with strong academic standing and a transparent, well-documented selection process. Awards from new, lesser-known, or unaccredited institutions raise questions.
  3. Clear Justification: The institution should articulate a compelling reason, directly linking it to the recipient’s exceptional contributions aligned with the university’s values.
  4. Infrequent, Selective Conferment: Reputable institutions award these sparingly, emphasizing exclusivity. Frequent awards by a university might indicate motives beyond pure merit.
  5. Absence of Commercial Undertones: Crucially, there should be no monetary exchange or quid pro quo. Instances where degrees are seemingly “bought” severely undermine their credibility.

Indicators of a “Relevance-Seeking” or Less Credible Honorary Doctorate:

  1. Obscure or Unaccredited Institutions: Awards from institutions with questionable accreditation, lack of academic rigor, or those primarily known for offering degrees for a fee are red flags. These often operate outside mainstream academic recognition.
  2. Recipient’s Lack of Substantive Achievement: If the recipient’s public achievements are minimal, unverified, or disproportionate to the honor, it suggests the degree is for self-aggrandizement.
  3. High Frequency of Awards: Institutions frequently conferring honorary doctorates might be using them as a revenue stream or for superficial prestige.
  4.  Overemphasis and Misrepresentation: If the recipient heavily publicizes the “doctorate” in academically irrelevant contexts or implies earned credentials they don’t possess (e.g., claiming to be a “Ph.D.”), it clearly indicates a motive of seeking relevance.
  5. Controversy or Ethical Questions: Any past controversies surrounding the institution’s awarding practices or the recipient’s ethical conduct warrant scrutiny.

In India, the regulatory landscape for honorary degrees is less stringent than for earned degrees, sometimes leading to misuse. The University Grants Commission (UGC) provides guidelines, but enforcement varies, making it challenging to curb dubious awards. Public perception and media scrutiny often play a crucial role in validating or questioning their legitimacy.

Conclusion

Honorary doctorates in India, at their best, are a dignified acknowledgment of exceptional societal contributions, bridging academia and public impact. They can indeed add significant non-academic value to a CV where influence, leadership, and public recognition are paramount. However, the burgeoning trend of fee-based honorary degrees significantly challenges the integrity of this tradition. The onus is increasingly on both awarding institutions to maintain the sanctity of the honor through rigorous selection and transparency, and on the public and professional bodies to critically evaluate the context and recipient’s true merit. As India’s academic and professional spheres continue to mature, greater scrutiny, transparency, and adherence to ethical practices will be crucial in ensuring that honorary doctorates remain symbols of genuine distinction rather than mere tools for superficial relevance.

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.

 

The Great Indian Pharma Consolidation: A Strategic Imperative for Global Ambition

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The Indian pharmaceutical industry, long characterized by its formidable generic manufacturing capabilities, has decisively entered a robust phase of consolidation. In a landmark development, Torrent Pharmaceuticals has announced definitive agreements to acquire a controlling stake in JB Chemicals & Pharmaceuticals for an equity valuation of ₹25,689 crore. This momentous deal, one of the largest in Indian pharma history after Sun Pharma’s acquisition of Ranbaxy, will significantly reshape the domestic landscape and propel the combined entity into the top tier of Indian pharma.

The acquisition, structured in two phases and involving a subsequent merger, underscores the ongoing, aggressive drive within the industry to achieve greater scale, enhance market reach, and diversify product portfolios through strategic mergers and acquisitions (M&A). This move by Torrent not only bolsters its presence in chronic therapy segments and opens up new areas like ophthalmology but also marks its entry into the high-potential Contract Development and Manufacturing Organization (CDMO) space.

Evolution through M&A: A Snapshot:

Historically, the Indian pharma landscape was characterized by a large number of small to medium-sized companies, primarily focused on generic drug manufacturing for the domestic market. The liberalization of the Indian economy in the early 1990s and the adoption of product patents in 2005 spurred a wave of M&A activities.

Key examples of this evolution include:

- Sun Pharma’s acquisition of Ranbaxy (2014): This landmark $4 billion deal was one of the biggest in Indian pharma, creating a powerhouse with a vast product portfolio and global reach. It aimed to expand market penetration and diversify product lines, as both companies had complementary strengths.

- Abbott’s acquisition of Piramal Healthcare’s domestic formulations business (2010): This significant inbound M&A deal showcased the interest of global giants in the lucrative Indian domestic market and its strong generic capabilities.

- Daiichi Sankyo’s acquisition of Ranbaxy (2008) and its subsequent sale to Sun Pharma: This demonstrates both the influx of foreign investment seeking access to low-cost R&D and manufacturing, and the eventual re-consolidation within Indian hands.

- Lupin’s numerous outbound acquisitions: Lupin has actively acquired companies in the US (e.g., GAVIS Pharmaceuticals in 2015) and Russia (ZAO “Biocom”) to expand its international footprint and product offerings, particularly in key markets.

- Mankind Pharma’s acquisition of Bharat Serums & Vaccines (2024): This recent deal highlights the strategic intent of Indian companies to diversify into high-growth segments like biologics and specialty care.

Increasing Dominance of Top Companies:

While precise historical market share data for the top 10 over many decades is complex to aggregate, the trend is clear: consolidation has significantly increased the contribution of the top pharmaceutical companies to the total market.

Today, companies like Sun Pharmaceutical Industries, Divi’s Laboratories, Cipla, Dr. Reddy’s Laboratories, and Torrent Pharmaceuticals are consistently at the top of the market capitalization and revenue charts. For instance, as of June 2025, Sun Pharma alone holds a substantial market share, and the top 10 companies collectively command a significant portion of the overall Indian pharmaceutical market. This is a stark contrast to the highly fragmented landscape of previous decades where market leadership was far less concentrated. The proposed Torrent-JB Chemicals merger is expected to further solidify this trend, potentially placing the combined entity among India’s top five pharma companies by market capitalization.

An Assessment: Benefits and Challenges:

Experts generally agree that this consolidation has benefited the Indian Pharmaceutical industry in several ways:

- Enhanced Scale and Efficiency: Larger entities can achieve economies of scale in manufacturing, R&D, and distribution, leading to cost efficiencies and improved profitability.

- Global Competitiveness: Mergers have enabled Indian companies to expand their geographical reach, acquire advanced technologies, and strengthen their product pipelines, making them more competitive on the global stage. India is now the third largest in production volume and a major supplier of affordable generics and vaccines worldwide.

 - Increased R&D Investment: While concerns about innovation decline post-merger exist, larger companies often have greater financial muscle to invest in research and development, particularly in high-value areas like biologics, biosimilars, and specialty drugs, moving beyond traditional generics.

- Improved Quality and Compliance: Consolidation can lead to better adherence to stringent international quality standards (like USFDA and EU-GMP), as larger companies have the resources and infrastructure to implement robust quality control measures.

- Portfolio Diversification: M&A allows companies to broaden their therapeutic areas and product offerings, reducing reliance on a few key drugs and mitigating risks. The potential acquisition of JB Chemicals would add several established domestic brands to Torrent’s portfolio and also provide an entry into the Contract Development and Manufacturing Organization (CDMO) business.

Challenges and potential downsides also exist:

- Potential for Reduced Competition (in specific segments): While the overall market may not be concentrated, specific therapeutic categories or drug molecules can experience high concentration ratios, raising concerns about potential monopolistic practices and impact on drug affordability.

- Innovation vs. Cost Savings: The focus on integration and cost synergies post-merger can sometimes lead to a reduction in R&D spending or the elimination of overlapping research projects, potentially impacting overall innovation in the short term.

- Impact on Smaller Players: Consolidation can make it harder for smaller, independent players to compete, potentially stifling new entrants and diverse approaches to drug development.

Defining the Strategic Imperatives:

As of today, the Indian pharmaceutical industry is poised for continued growth and evolution, with the following key trends and strategies envisaged:

- Focus on High-Value Products: The industry is actively shifting from a heavy reliance on generic formulations to investing in complex generics, biosimilars, biologics, and specialty drugs, which offer higher margins and greater innovation opportunities.

- Strengthening API and KSM Manufacturing: To reduce import dependence, particularly on China, there’s a strong push for self-reliance in Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) through government initiatives like Production-Linked Incentive (PLI) schemes.

- Digital Integration and Technology Adoption: Leveraging digital technologies, AI, and data analytics in R&D, manufacturing, supply chain management, and patient engagement is crucial for future growth and efficiency.

- Global Collaboration and Partnerships: Strategic alliances, joint ventures, and targeted acquisitions, both inbound and outbound, will continue to be vital for market access, technology transfer, and portfolio expansion.

- Quality and Regulatory Compliance: Continued emphasis on stringent quality control measures and adherence to global regulatory standards is paramount to maintain India’s reputation as a reliable pharmaceutical supplier.

- Talent Development: Addressing skill gaps and fostering a highly skilled workforce, particularly in areas of advanced research and digital technologies, will be critical for sustained growth.

Conclusion: 

The Indian pharmaceutical industry’s journey of consolidation has largely been a positive one, fostering scale, global competitiveness, and increased R&D capabilities. The path ahead involves a strategic shift towards innovation, self-reliance in key materials, and leveraging technology to solidify its position as a global pharmaceutical leader, with ongoing M&A activities like the potential Torrent-JB Chemicals deal serving as key catalysts in this transformative journey.

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.

Pills and Payments: India’s Unethical Drug Marketing Problem

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The recent exposé by The Economic Times, titled “Rx Name Unethical practitioners,” published on June 19, 2025, which brought to light allegations of a prominent global pharmaceutical company sponsoring extravagant foreign trips for doctors in violation of ethical codes, serves as an urgent reminder, yet again, of the persistent and deeply entrenched malpractices plaguing India’s pharmaceutical marketing landscape. While India proudly holds the title of “pharmacy of the world,” this distinction is increasingly overshadowed by unethical practices that jeopardize public health, distort prescribing patterns, and erode trust in the medical profession.

The Anatomy of Malpractice: A Systemic Issue:

The incident, highlighting the Department of Pharmaceuticals (DoP) apparently shielding names despite clear breaches, underscores a systemic failure in accountability. Unethical marketing manifests in various forms:

  • “Freebies” and Inducements: Offering gifts, money, travel, and hospitality directly influences prescribing behavior. This leads to unnecessary prescriptions, a preference for expensive branded drugs, and the over-medicalization of minor ailments.
  • Misleading Claims: Companies make unsubstantiated or false claims, misleading both professionals and the public, often with dangerous health impacts as highlighted by the Supreme Court.
  • Undue Influence in CME: Company-sponsored educational events often serve as thinly veiled marketing opportunities, subtly promoting specific products.
  • Lack of Transparency: The refusal to disclose names of doctors involved in unethical practices exemplifies pervasive opacity, shielding wrongdoers.

Why Self-Governance (UCPMP) Is Not Working and Malpractices Persist:

Despite the notification of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024, malpractices continue to thrive. This is primarily because the UCPMP, even in its revised form, relies heavily on self-governance, which has proven ineffective.

Why Self-Governance Fails:

  1. Not a Full Law: While the UCPMP 2024 has moved from “voluntary” to “quasi-statutory,” it still isn’t a strong, legally binding law passed by Parliament. This means there are no direct legal punishments for violations. The DoP can only “recommend” action to other bodies or associations, lacking the power to impose immediate, significant fines or sanctions. Companies know this, which reduces their incentive to fully comply.
  2. Weak Punishments and Enforcement: The penalties under the UCPMP are often too light to deter large pharmaceutical companies, for whom the profits from unethical practices far outweigh a mere reprimand or expulsion from an industry association. Enforcement relies heavily on industry associations themselves (through Ethics Committees for Pharmaceutical Marketing Practices – ECPMPs). This creates a conflict of interest, as these associations are made up of the very companies they are supposed to regulate. There’s a natural tendency for these committees to be lenient or prioritize industry interests over stricter compliance.
  3. Lack of Proactive Investigation: Enforcement largely depends on complaints being filed. This means many unethical practices go unreported or unaddressed, especially when there’s an imbalance of power, making whistleblowing risky. The system isn’t designed for active investigation, but rather reactive response.
  4. Deep-Rooted Culture of Incentives: The Indian pharmaceutical market is highly competitive. Companies face immense pressure to push their products. The ingrained culture of offering incentives, even subtle ones, has become a “cost of doing business.” When competition is fierce, relying on competitors to self-regulate fairly is often wishful thinking.
  5. Loopholes and Vague Rules: Despite revisions, the code may still have gaps, or new, indirect ways companies promote drugs might not be clearly covered. For instance, the lack of mandatory public disclosure for payments made to doctors for research or advisory roles is a significant loophole that allows conflicts of interest to remain hidden.

In essence, self-governance simply isn’t strong enough to counter the massive financial incentives driving unethical marketing. It relies on goodwill and internal discipline in an industry where competitive pressures are intense, leading to a situation where the rules exist, but the teeth to enforce them are missing.

The Ripple Effect: Impact on Public Health and Trust:

These malpractices inflict significant harm: patients receive inappropriate or excessive treatments, leading to higher healthcare costs. Public trust in doctors and drug companies erodes, and market competition is distorted.

Moving Ahead: A Stronger Path to Ethical Marketing for Viksit Bharat:

Ensuring ethical pharmaceutical marketing practices is not just a matter of professional integrity; it is a fundamental pillar for achieving India’s cherished vision of Viksit Bharat by 2047. A developed nation thrives on a healthy, productive populace and a healthcare system rooted in trust and equity, free from commercial exploitation. The UCPMP 2024 is a vital starting point, but its success – and indeed, its contribution to this national ambition – hinges on taking critical next steps:

  1. Make UCPMP a Full Law: The code must become legally binding with clear, stringent punishments directly under a parliamentary act. This means no more personal benefits for healthcare professionals, strictly enforced by law.
  2. Stronger Oversight and Enforcement: Create an independent, empowered regulatory body with real power to investigate, impose significant penalties, and ensure timely resolution of complaints. Regular, proactive audits of marketing expenses, strong whistleblower protection, and, crucially, publicly naming companies and professionals found guilty are vital for accountability. Inspired by global best practices such as the US Physician Payments Sunshine Act, which mandates public disclosure of payments to healthcare providers, this level of transparency is critical. Better coordination between the DoP, National Medical Commission (NMC), Income Tax Department, and Competition Commission is also essential.
  3. Empower Doctors and Promote Ethics: Medical schools must focus more on ethical practice. The NMC and State Medical Councils must consistently act against doctors who break rules. Encouraging doctors to prescribe generic drugs and supporting independent medical education are key steps.
  4. Industry Must Adapt to Real Regulation: While industry associations can support compliance, the primary responsibility for enforcement must shift from self-regulation to an external, statutory body. Companies must be mandated to comply, not just encouraged.
  5. Educate the Public: Inform people about their rights, how marketing can influence prescriptions, and the importance of generic alternatives. Also, encourage reporting of misleading drug ads.

Conclusion:

The path to ethical pharmaceutical marketing in India is challenging but vital. It needs a united effort from the government, regulators, drug companies, doctors, and the public. The June 19, 2025, revelations, as brought forth by The Economic Times, serve as a critical turning point. By committing to transform the UCPMP into a fully statutory and robustly enforced framework through the vital steps outlined above, we can effectively turn the bitter pill of malpractices into the sweet success of ethical healthcare, laying a crucial groundwork for a healthier, more prosperous, and truly developed ‘Viksit Bharat’ by 2047.

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.

 

 

India’s Pharmacy Frontier: Blurring Lines and Battling for Balance

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As we witness, India’s pharmaceutical landscape is undergoing a profound transformation, driven by technological advancements and shifting consumer preferences. The traditional brick-and-mortar retail pharmacy, a familiar fixture in every neighborhood, now faces a formidable challenger: the burgeoning online pharmacy sector. This evolving scenario is not merely a commercial rivalry but a complex interplay of accessibility, economics, regulatory lacunae, and deep-seated concerns over public health, frequently drawing the ire of established chemist bodies.

The Evolving Scenario: A Digital Shift:

For decades, the retail pharmacy has been the cornerstone of medicine dispensing in India. Its strengths lie in immediate access for acute needs, personalized advice from local chemists, and the trust built through long-standing community relationships. However, this largely unorganized sector, comprising millions of fragmented outlets, often grapples with wafer-thin margins and the pressures of price control.

Enter the online pharmacy, a disruptor propelled by India’s soaring internet penetration and smartphone adoption. E-pharmacies offer unparalleled convenience, allowing consumers to order medicines from the comfort of their homes and receive doorstep delivery, a service that proved indispensable during the COVID-19 pandemic. They often entice customers with deep discounts, a wider range of medicines (including those hard to find locally), and value-added services like e-consultations and diagnostic bookings. The sector has witnessed remarkable growth, with projections indicating it will capture a significant share of the overall pharmaceutical market. Major players like Tata 1mg, PharmEasy, Netmeds (backed by Reliance Retail), Apollo Pharmacy (with its Apollo 24×7 platform), Amazon Pharmacy, and Flipkart Health+ have rapidly expanded their reach, with Amazon Pharmacy recently announcing shipments to every functional pin code in the nation, including remote areas. This reach is particularly beneficial for those in rural or underserved regions with limited access to physical drugstores.

Beyond mere delivery, online platforms excel in digital record-keeping, which can enhance traceability and potentially reduce the circulation of counterfeit drugs if properly regulated. They also foster a growing demand for over-the-counter (OTC) products and wellness supplements, aligning with a national shift towards preventive healthcare.

AIOCD’s Ardent Objections:

The rapid ascent of online pharmacies has not been without significant resistance, primarily from the AIOCD, the powerful representative body for retail chemists. Their objections stem from a fundamental concern for patient safety and the perceived existential threat to traditional businesses.

The AIOCD consistently argues that online pharmacies operate in a legal gray area. They highlight that the existing Drugs and Cosmetics Act, 1940, and its Rules, 1945, do not specifically govern online drug sales. The permission for doorstep delivery granted in March 2020 was a temporary measure for the pandemic, which the AIOCD claims is now being “misused by online platforms” and should be revoked. In April 2025, the Drugs Technical Advisory Board (DTAB) was reportedly set to review the continuation of home medicine delivery following AIOCD’s strong objections.

Some of the reported AIOCD concerns include:

  • Lack of Prescription Validation: A central worry is the potential for medicines, especially Schedule H and X drugs (requiring strict prescription), to be dispensed without proper verification, leading to self-medication, drug addiction, and misuse.
  • Quality and Authenticity: Fears abound regarding the sale of fake, expired, or unlicensed products, with traditional chemists arguing that rapid delivery models, such as Swiggy-PharmEasy’s proposed 10-minute delivery, could compromise quality control and thorough checks.
  • Data Privacy: The handling of sensitive patient health data by online platforms raises significant privacy concerns.
  • Unfair Competition: Deep discounting by e-pharmacies is seen as an unfair trade practice, creating an uneven playing field and severely impacting the livelihoods of millions of traditional chemists.
  • Regulatory Loophole: The AIOCD contends that online pharmacies are circumventing established laws that mandate physical licensed premises for drug distribution. Their recent opposition to RailTel Corporation’s proposal to invite bids from online pharmacies for home delivery to railway hospitals underscores their stance that online pharmacies remain illegal in India.

The Regulatory Landscape: A Work in Progress:

The legal status of online pharmacies in India remains ambiguous, leading to frequent legal tussles. While the Drugs and Cosmetics Act and Rules vaguely apply, a dedicated framework is conspicuously absent.

In August 2018, the Union Health Ministry published Draft Rules for the “sale of drugs by e-pharmacy” to amend the Drugs and Cosmetics Rules, 1945. As my knowledge goes, these draft rules, though yet to be finalized and notified, proposed significant provisions:

  • Mandatory Registration: E-pharmacies would require registration with the Central Drugs Standard Control Organization (CDSCO) and pay a fee.
  • Periodic Inspection: Premises would be inspected every two years.
  • Data Localization: Patient data would need to be stored in India and kept confidential.
  • Prohibition of Advertising: E-pharmacies would be barred from advertising drugs.
  • Customer Support and Grievance Redressal: Mandatory 24/7 customer support with a registered pharmacist for queries.
  • Prohibition of Schedule X Drugs: Sale of tranquilizers, psychotropic drugs, narcotics, and habit-forming drugs would be prohibited.

Despite these drafts, finalization seems to have been repeatedly delayed due to stakeholder objections and legal challenges. Various High Courts, including the Delhi High Court, have intervened, urging the government to expedite the policy formulation. The CDSCO has also issued show-cause notices to several online firms for alleged violations.

Simultaneously, government initiatives like Digital India, Ayushman Bharat, and the National Digital Health Mission (NDHM) are actively promoting digital healthcare solutions, indirectly fueling the growth of e-pharmacies by fostering a more digitally savvy healthcare ecosystem. This creates a dichotomy: a push for digital adoption on one hand, and a lack of clear regulation on the other.

The Way Forward: Coexistence and Comprehensive Governance:

In my view, the path ahead for India’s pharmacy sector demands a nuanced approach that acknowledges the benefits of digital innovation while robustly safeguarding public health and ensuring fair competition, such as.

  1. Expeditious Finalization of E-Pharmacy Regulations: The most critical step is the immediate finalization and notification of a comprehensive regulatory framework. This framework must clearly define the operational guidelines for online pharmacies, including stringent norms for prescription verification, drug storage, logistics, data security, and accountability. It should also establish a clear distinction between aggregator models and inventory-based models.
  2. Addressing Safety and Quality Concerns: Regulations must incorporate mechanisms to prevent the sale of spurious or expired drugs online. This could involve mandating blockchain technology for drug authenticity tracking, stricter penalties for non-compliance, and transparent track-and-trace systems for all online dispensed medicines. The concerns regarding “10-minute deliveries” need specific guidelines to ensure patient safety is not compromised for speed.
  3. Leveling the Playing Field: While online pharmacies offer discounts, a balanced approach is needed. Regulations could explore ways to mitigate predatory pricing practices that disproportionately harm traditional chemists, perhaps through floor prices for certain drug categories or by promoting fair trade practices.
  4. Promoting Omnichannel Healthcare: The future likely lies in a hybrid model. Many e-pharmacies are now opening physical stores, while traditional chains like Apollo have embraced online platforms. This omnichannel strategy allows businesses to combine the convenience of online services with the trust and immediate access of physical outlets, creating a more holistic patient experience.
  5. Leveraging Technology for All: Technology should not be exclusive to online players. Initiatives to digitize retail pharmacies, provide them with better inventory management systems, and integrate them into national digital health ecosystems can empower them to compete effectively and serve their communities better.
  6. Public Awareness and Education: Educating consumers about the risks and benefits of both online and offline channels is vital. Campaigns should highlight the importance of valid prescriptions, verifying drug authenticity, and understanding return policies.

Conclusion:

The online versus retail pharmacy debate in India is a microcosm of a larger digital transformation. The evolving scenario demands a regulatory compass that navigates the complexities of innovation, competition, and public welfare. Only through a well-defined, robust, and adaptable regulatory framework can India truly harness the potential of digital healthcare, ensuring that accessibility, affordability, crucially and patient safety are not compromised in the race to the digital frontier. The coexistence of both online and retail models, operating under a clear and equitable legal regime, will ultimately best serve the diverse healthcare needs of the Indian populace.

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.