Tag: Pharma

Decoding the pharma risk landscape and the case for good governance

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Indian pharmaceutical industry has witnessed resplendent growth over the past three decades, establishing itself as the global pharmacy for generic medicines. It has greatly contributed to economic development of the country and has played a major role in improving healthcare outcomes in India and worldwide.

The industry being ready for robust growth in the next decade with plethora of opportunities for companies of all scales and sizes will face challenges that will need to be addressed strategically and operationally. We operate in a highly regulated environment where there is stringent compliance and rigorous quality controls. Excellent strategic planning, prudent capital allocation, persistent focus on R&D and innovation, and robust operational workflows are not alone sufficient to ensure sustenance and growth, and thus, these elements in isolation fall short of stakeholder expectations and regulatory requirements.

The $50 billion industry which is nearly equally split between exports and domestic market, is expected to grow to at a CAGR of 10% upto 2047 to become $500 billion. In the next 5-10 years, it is well set to touch $73 billion and $120 billion respectively. Quality drives reputation and growth in our noble industry before innovation and commercial excellence. Without focus on quality and risk, the existence of the pharmaceutical industry will always be in grave danger. Quality is seen as first-amongst-equals in the list of management focus items by best of the pharmaceutical companies.

ISO 31000 defines risk as “the effect of uncertainty on objectives, whether positive or negative”. From regulatory compliance to product development, risks inherent in the pharmaceutical industry are multifaceted and ever evolving. However, there is an opportunity for Indian companies especially the small and mid-size companies to embrace good governance to mitigate risks effectively, foster sustainable growth and increase stakeholder confidence. Traversing through the risk landscape is paramount to ensuring not only the success of individual companies but also safety and well-being of patients and consumers.

To ensure quality, pharmaceutical companies invest resources and efforts towards risk management at various points of the value-chain. Some companies take a siloed-approach to risks, while others delve wide and deep to create comprehensive risk management systems which are enterprise-wide led and applicable to the entire gamut of a company’s operations.

Pharmaceutical companies strive to reduce risk and ensure continuity at both strategic and operational levels with risk portfolios and continuity management audits however a robust Enterprise Risk Management (ERM) programme can help build resilience and enhance reputation, compliance and governance for long term growth.

The Institute of Risk Management (IRM) defines ‘ERM’ as an integrated and joined up approach to managing all areas risks across an organisation and its extended networks. This means that ERM goes much beyond the traditional risk approach, covers detailed analysis of the entire risk universe including ESG and has potential to drive risk intelligence in every business vertical and decision across the company.

There is also an interesting concept of ‘Risk Culture’ which the IRM defines as the values, beliefs, knowledge, attitudes and understanding about risk shared by a group of people with a common purpose. One needs to be pragmatic to reckon that risks cannot be escaped but only managed through proactive and reactive mechanisms whilst also setting the tone at the top and defining a clear risk appetite. Every company has different risk profiles and risk management maturity.

In Jun 2012 article “Managing Risks: A New Framework” in Harvard Business Review, Robert S. Kaplan, and Anette Mikes, advocated for rules-based approach for risk management, which is relevant across industries especially more for heavily regulated ones like the pharmaceutical industry. Some companies have evolved to have “risk and resilience” frameworks that encompass risk and crisis management, business continuity, IT, compliance management, and third-party risk management.

Regulatory agencies and international consensus also drive risk management particularly focused on quality in the pharmaceutical industry. For example, the International Conference on Harmonisation (ICH) guideline Q9, Quality Risk Management (QRM), represents the first internationally recognised guideline specifically addressing QRM for the pharmaceutical industry.

Published in June 2005, the guideline offered an overview of general principles, example of a risk management life cycle, discussion around the activities that occur in each life cycle phase, and a list of risk tools and quality system areas to which QRM can be applied. The Government of India has taken proactive and reactive measures to enhance quality in drugs made in India. Risk-based inspections are the order of the day and defaulting companies are rightly receiving show cause notices, closure notices, heavy penalties or fines, product recalls, and irreversible damage to reputation.

The pharmaceutical industry esp. the Indian Drug Manufacturers’ Association (IDMA) has welcomed disciplinary measures from CDSCO and various state government FDA agencies as leaving a handful few non-compliant companies, most of the Indian companies i.e. growth aspirational and serious-for-compliance ones have been earnest in their commitment to improve quality and risk culture in the past, present, and future.

We see quality and risk management not merely from a compliance perspective but a very important element of our strategic decision making and managerial control systems. India’s leading pharmaceutical companies and IDMA transparently discuss risk concerns with regulators to resolve them and elevate their quality systems. Most regulators including US FDA, EMA, and India’s CDSCO are having open and constant dialogue with the industry to address current and potential risks with effective measures.

There are other risks as well that affect the industry often. The long capital-intensive drug development process often yields uncertain clinical trial outcomes and thus, adds tremendously to financial risks of companies. In strategic transactions like M&A, divestments, fundraising, and public listing one must objectively clear on synergies or value-accretion from such often-irreversible actions. Many M&As fail to create value for failure to envisage risks in post-merger integration and other eventual developments.

Another set of risks emerge from intellectual property dimensions of patent expiry and growing threat of generic competition especially from shifting manufacturing base to other emerging countries in Asia and focus on indigenous manufacturing for self-reliance compounds the challenges faced by Indian pharmaceutical companies.

In supply chain, we recently saw disruptions globally on logistics forefront, where COVID-19 and geopolitical tensions, disrupted availability of medicines and created threat to life. A few instances were also reported on IT system breaches and leakage of patient medical records that created chaos for all stakeholders.

An often overlooked and peculiar risk of today is on talent, companies need competent and committed people to ensure softer elements of organisational dynamics do not become an impediment in realising business outcome. Leaders often belatedly realise importance of qualified people only when latter leave their organisations.

Therefore, beyond competitive compensation and benefits and career growth plans, companies have to invest in people and nurture them for greater responsibilities in the long-term. Best companies invest in upskilling their employees ahead of business need and ensure that technology is adopted for improving productivity and enhancing capabilities rather than with the intent of myopically reducing headcount.

A company may have industry’s best SOPs and control mechanisms for quality management; but such elements would be of no utility if employees have a lackadaisical approach or haven’t been aligned with larger organisational purpose. The significance of values and people-centric culture has to be percolated often and that is the responsibility of top management.

Effective ERM requires a top-down approach and patronage by senior leadership. “Out of sight, out of control” is well understood by highest echelons in the industry. Beyond documentation and processes, leadership at a pharmaceutical company are unreservedly responsible for building a culture that identifies, quantifies, and responds to risks of various types.

Some companies themselves or with help of subject matter experts or consultants develop simulation-based models to articulate standalone and cumulative impact of risk on one’s prospects decades into the future.

Developing IRM-certified risk champions who are process owners and business owners across the company and identifying an IRM-qualified Chief Risk Officer can provide huge impetus to the overall risk management maturity. The risk champions can be drivers of change by wearing the risk lens in everything they do whilst reporting and monitoring uncertainties on an ongoing basis.

Anticipating, understanding, and analysing risks improves resource allocation and strengthens monitoring and control. In bygone three-years, the use of tools like IoT and AI/ML has gained traction in the pharmaceutical industry. Digitalisation is bringing science and religion together as companies are addressing data and process integrity concerns with transparency and responsibility.

Transparency is the bedrock of good governance. Drug pricing, operational shop floor data, and clinical trials data are subject to regulatory scrutiny. Best companies set examples by embracing transparency across the organisation and also with external stakeholders.

They establish a culture of risk awareness, make timely and complete disclosures, invest in technology and analytics, stay abreast of regulatory developments, proactively improve their quality systems, regularly conduct risk assessments, and track key risk metrics to drive business decisions.

Good governance is not a choice, but a responsibility in the pharmaceutical industry, a noble industry of serving mankind with safe and effective medicines. Billions of people are dependent on medicines to lead happy and prosperous lives; they discharge their roles and responsibilities to best of their physical and mental well-being.

There are serious consequences for taking quality and risk management for granted. Indian pharmaceutical companies have long ago realised that transparency, accountability, and ethical conduct ensure corporate existence and growth while fostering trust and respect amongst all stakeholders.

Amidst the rapid evolution of the pharmaceutical industry, marked by escalating regulatory intricacies, focus on novel drugs and complex generics, proliferation of technology across the value-chain, and data-centric advancements, the imperative for Indian pharmaceutical companies to enhance their risk management capacities has never been more pressing.

A concentrated and comprehensive effort on risk management will provide Indian pharmaceutical companies with optimal tools to flourish amidst the uncertainties of the contemporary landscape.

Let us pledge to elevate equality, accelerate business performance, and grow our respective companies and entire industry by a sincere and long-term commitment to enterprise risk management by upholding universal principles of ethics to serve and safeguard life on our planet.

The authors, Mehul Shah is Honourary General Secretary at Indian Drug Manufacturers’ Association (IDMA), Managing Director of Encube Ethicals, the global leader in topical pharmaceuticals and Governance Board Member of IRM India Affiliate and Hersh Shah is the CEO of IRM India Affiliate. The views expressed here are personal.

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Centre to inaugurate 40 greenfield plants to transform Indian pharma manufacturing space

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Indian pharmaceutical sector is set to witness a significant transformation as the government prepares to inaugurate 40 greenfield plants dedicated to manufacturing, bulk drugs, and medical devices.

Speaking to CNBC-TV18 on the sidelines of the Zetwork Smart Manufacturing Summit, Arunish Chawla, the Pharma Secretary, emphasised the substantial effort invested in this initiative, dispelling initial scepticism surrounding the endeavour.

Chawla highlighted the pivotal role played by the Production Linked Incentive (PLI) scheme in bringing about this positive change. He expressed confidence that the upcoming inauguration on Saturday, March 2, would showcase the tangible results of the government’s commitment to fostering domestic manufacturing capabilities. These 40 major greenfield plants, previously solely reliant on imports, symbolise a paradigm shift in the Indian pharmaceutical landscape.

“The minister is going to inaugurate 40 greenfield plants—manufacturing, bulk drugs and medical devices—and a lot of hard work has gone into it. The initial scepticism is being proved wrong. The production linked incentive (PLI) scheme is changing the Indian landscape in a big way. You will see on Saturday March 2nd when the minister inaugurates 40 big greenfield plants that were heretofore entirely imported in the country,” Chawla stated.

The government had earlier allocated a budget of ₹6,940 crore for the pharma PLI scheme, and it has witnessed significant progress with funds totalling ₹5,285 crore being allocated by January.

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US FDA official emphasises the need for strong quality culture amidst growing data integrity issues in pharma

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Sarah McMullen, the Country Director at the US Food and Drug Administration (FDA), recently shared insights into the growing concerns about data integrity issues within pharmaceutical facilities. While acknowledging the increased identification of such issues, she emphasised the need for a strong quality culture and proactive measures to address these challenges.

McMullen highlighted that data integrity issues are not isolated incidents but are found throughout manufacturing and laboratory facilities. She emphasised the importance of fostering a robust quality culture within organisations.

“What we want to see from companies is not just a quality motto, which most companies should have and do have; we want to see them empower their employees at every level to make the right decisions regarding product quality and to have the accountability to follow that up. And so that’s maybe one of the pieces that we think could solve some of these data integrity issues,” McMullen said in an interview with CNBC-TV18.

Discussing the broader compliance landscape, McMullen noted an overall improvement in compliance within the pharmaceutical industry in India. Post-COVID, the FDA conducted a significant number of follow-up compliance inspections, followed by an increased focus on surveillance inspections. The number of surveillance inspections conducted in the past year more than doubled compared to the previous year, contributing to enhanced compliance rates, she added.

While it remains challenging to ascertain whether data integrity issues existed before but went unnoticed, McMullen acknowledged the current efforts to discover and address them. The FDA aims to take concerted actions to rectify these issues and ensure the integrity of data across pharmaceutical facilities.

McMullen emphasised that data integrity is not limited to specific locations and urged the entire pharmaceutical industry to engage in improving practices. Recognising the global nature of the issue, she called for collaborative efforts to enhance data integrity standards and practices worldwide.

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Banks remain a value buy for this $60 million PMS fund CEO

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Emkay Investment Managers continues to favor HDFC Bank as a top choice in its investment portfolio. Speaking with CNBC-TV18, Emkay’s Chief Investment Officer, Manish Sonthalia, who manages $60 million in funds, highlighted the bank’s sustained attractiveness as an investment opportunity.

Sothalia pointed out that banks will play a crucial role, and are expected to contribute about one-third of the anticipated 16% earnings growth for the next financial year (FY25). The current direction of stock prices indicates either a miscalculation in earnings forecasts or a significant price-to-earnings (P/E) ratio devaluation among major banks such as HDFC Bank, ICICI Bank, Axis Bank, and Kotak Mahindra Bank.

“As the PE (price to earnings) derating continues to happen, this basket or this space continues to remain a clear value buy,” he noted.

While there is perceived value in investing in these banks, he also noted that the challenge lies in the heavy domestic institutional ownership of these banks. This limits fresh buying opportunities for domestic institutions. He believes until there is increased participation from retail or foreign investors, these banks will continue to offer value but may face limitations.

Public sector banks (PSUs), on the other hand, have value and less complex ownership structures, and are under-owned, making them preferable for investment.

Discussing the selloff in HDFC Bank over the last week, Sonthalia said, “There was value at ₹1,600, it becomes the deeper value at ₹1,400 and even bigger deeper value at ₹1,300, but it remains a buy.”

Also Read | Budget 2024: Healthcare and pharma sectors expect tax incentives and PLI incentives

According to him, the bank stands out as the best-managed large private sector bank, with continually improving valuations. Despite recent underperformance, Sonthalia remains optimistic, asserting, “So, leave aside the recent underperformance that we have seen in the bank, but it remains a buy.”

Also Read | HDFC Bank becomes the first lender to achieve milestone of 2 crore credit cards in force

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Lupin reports three USFDA approvals in less than a week

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The US Food and Drug Administration has approved Propranolol Hydrochloride Extended-Release Capsules (the generic version of Inderal sold by Minnesota-based ANI Pharmaceuticals) made by Lupin, the company said in a filing to the stock exchanges.

This new medicine helps in lowering blood pressure, relaxes the blood vessels in the brain and can prevent migraine headaches. This drug had an annual sales of $71 million in the US, according to data shared by the Mumbai-based drug maker.

It will release the drug (generic Inderal) in four strenghts: 60 milligram (mg), 80 mg, 120 mg, and 160 mg. This is third new launch announced by the company in the last one week.

The other two being Varenicline tablets (recommended in the treatment of smoking addictions and dry eye disease), and bromfenac ophthalmic solution (used to treat inflammation and pain among patients who have undergone cataract surgery).

Shares of Lupin have rallied over 84% in the last one year. In the first fortnight of 2024, investors in Lupin have seen their wealth go up by nearly 6%.

The company is targetting quarterly sales of $250 million in the next 3-4 years, global chief financial officer Ramesh Swaminathan told CNBC-TV18 in an interview on January 4.

In the financial year ending March 2023, the drug maker reported a revenue of $632 million from the US (out of a total revenue of $2 billion).

In the latest second quarter ended September 2023, for the first time in two years, Lupin crossed $200 million in revenue from North America, which made for 38% of the company’s total revenue.

Aside from the new drug approvals, Lupin shares are also cheering the easing stress on the company’s profit margin.

Despite being the third largest pharmaceutical company in the US (by prescriptions), increased competition, and rising cost of inputs, had squeezed the profit margin in recent years.

However, the growing belief on the street is that the margin squeeze is now over. In the first half of the current financial year ending March 2024, the company clocked an EBITDA margin of 19% compared to just 9% in the same period last year.

Global investment bank Nomura increased the target price on Lupin share to ₹1,593 from ₹1,290 per share earlier citing better earnings potential.

Earlier, on December 28, the Mumbai-based broking firm upgraded the rating on Lupin to ‘buy’ with a new target price of ₹1,440.

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India tightens rules to enforce stricter good manufacturing practices at pharma units

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Indian government has officially notified the implementation of updated Schedule M guidelines. These revised guidelines mandate stricter adherence to Good Manufacturing Practices (GMP) by pharmaceutical manufacturing units across the country.

With this revision, the emphasis is placed on enhancing and updating the existing GMP framework to align with international expectations, thereby fortifying the reputation of Indian pharmaceuticals on the global stage.

Schedule M prescribes requirements to the manufacturing plants of pharmaceutical companies for maintenance, manufacturing, control and safety testing, storage and transport of material, written procedures and records, traceability etc.

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Laurus Labs drops nearly 4% after USFDA issues 5 observations for its Visakhapatnam plant

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Shares of Laurus Labs Ltd dropped 4% on Wednesday after the United States Food and Drug Administration (USFDA) issued Form 483 with five observations on the manufacturing facility of the company’s subsidiary in Andhra Pradesh.

The stock is currently trading 10% lower from its 52-week high of ₹417.85.

The USFDA inspection at its manufacturing facility in Parawada, Anakapalli, near Visakhapatnam in Andhra Pradesh, took place between December 4 and December 12, the Hyderabad-based drug maker revealed in a filing sent to the stock exchanges.

According to the USFDA website, issuance of a Form 483 by the regulator indicates that the agency has observed conditions or practices during an inspection that may violate the Food, Drug, and Cosmetic Act or related regulations.

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The company is expected to address and rectify these issues to ensure compliance with regulatory requirements. Laurus Labs assured its stakeholders that the firm is committed to addressing these observations promptly.

After Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the firm will take to resolve the observations made by the USFDA.

At 11.14 am, shares of Laurus Labs were trading at ₹377.9 apiece on BSE, down 2.62% from the previous close.

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Charting the Path Forward: Insights from top CEOs in India’s booming pharma & healthcare industry

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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In a world where the healthcare and pharmaceutical sectors are at the forefront of global attention, one nation has consistently taken centre stage. India, a powerhouse in pharmaceuticals and healthcare, has seen its contributions extend far beyond its borders. The recent confluence of top CEOs and industry stalwarts at CNBC-TV18 and PwC’s “CEO Dialogues” event provided a glimpse into the profound insights and achievements that have propelled India’s healthcare landscape to new heights.

The Unveiling of Remarkable Achievements

The episode, with the theme “Embracing Opportunities & Charting the Path Forward in the Indian Healthcare & Pharma Industry,” served as a tribute to the remarkable growth of these sectors in India. With medicines exported to more than 200 countries, India has firmly established itself as a critical player in the global pharmaceutical landscape. Impressively, it supplies a staggering 50% of all the drugs in Africa and contributes to 40% of the generic medicines consumed in the United States. When it comes to vaccines, India plays a pivotal role, accounting for approximately 60% of the vaccines sourced by the World Health Organization. These statistics paint a picture of an industry on the move, full of promise and potential.

The Indian pharmaceutical industry, currently valued at $50 billion, is set to witness an astonishing leap. Within just six years, projections suggest it will catapult to a staggering $130 billion. A sector characterised by remarkable growth, the private healthcare market in India is pegged at $48 billion, and its valuations continue to expand.

Industry Visionaries at the CEO Dialogues

The illustrious panel of leaders, who have been the architects of this success, gathered to share their experiences, vision, and insights. Shereen Bhan, the esteemed Managing Editor of CNBC-TV18, facilitated a compelling dialogue with these titans of industry.

Luminaries gracing the CEO Dialogues were Sanjeev Krishan, Chairperson of PwC in India, Ameera Shah, Promoter & MD of Metropolis Healthcare Ltd, Gautam Khanna, CEO of Hinduja Hospital, Umang Vohra, MD & Global CEO of Cipla Ltd, Meenakshi Nevatia, Country President & MD of Pfizer India, Sanjiv Navangul, MD & CEO of Bharat Serums & Vaccines Ltd, Raj Gore, CEO of HCG Ltd, Dr. Tarang Gianchandani, Group CEO of Sir HN Reliance Foundation Hospital, Sujay Shetty, Global Health Industries Advisory Leader at PwC and Rahul Purwar, Founder & CEO of ImmunoACT.

Sanjeev Krishan on Private Equity Investments, Consolidation, Sustainability and Digital Transformation

Sanjeev Krishan explored the dynamic Indian market and the ongoing wave of consolidation. He emphasised on how over the last five years, limited private equity investments were observed in the sector due to its capital-intensive nature. However, investments in technology-driven areas, such as online pharmacies, have been increasing.

He further said, “Consolidation is a significant driver for private equity investments as large deals become less common. To attract investments, scale is crucial, and creating platforms for consolidation is seen as promising.”

In continuation he said, “Sustainability in healthcare, as a contributor to environmental pollution, presents another opportunity. And the ongoing digital transformation in the healthcare sector holds the potential for growth and innovation.”

Meenakshi Nevatia Navigated a New Regulatory Landscape

Meenakshi Nevatia emphasised the evolving regulatory landscape for drug approval in India. She underlined the growing transparency and systematisation in the regulatory process. She said, “A lot has changed in the positive direction in India. First, is about how quickly we are able to now bring drugs into the country and make new launches. The acceleration in the drug launch process aligns with India’s growing global connectivity, where both doctors and patients have access to information about the latest developments in the medical field worldwide.”

Sujay Shetty and Umang Vohra Shared The Strategies for Growth, Sustainability and Innovation

Sujay Shetty delved into strategies to solidify India’s prominent position in the United States, considering factors like pricing erosion and specialty pharma. He emphasised the need to make innovation more affordable, especially in areas like cell and gene therapies and biosimilars.

Shetty also touched on the environmental impact of the pharma and health sectors, emphasising the need to meet societal expectations in terms of sustainability and climate action. He also raised the importance of initiatives like AYUSHMAN Digital Mission and the PMJ in elevating the standard of care across the nation, with a focus on making India an attractive destination for clinical trials and medical tourism.

In continuation, Umang Vohra discussed the notable activity in the healthcare sector, emphasising its significance for India. He highlighted several key drivers for potential consolidation – a global shift to preventive healthcare, the move from chemical to biological synthesis, and the growing importance of data utilisation.

“As healthcare evolves, it becomes more biologically sensitive, but innovation is costly. The affordability of healthcare in India needs to expand significantly, and insurance coverage must expand to support innovation. This financial aspect also drives the need for consolidation, as fewer contributors can sustain innovation in the sector”, said Umang Vohra.

Ameera Shah and Gautam Khanna on Future Healthcare Integration and Affordability Challenges

Ameera Shah highlighted the nascent state of genetic testing in India, emphasising the need for affordability and financing, similar to the models found in the US and the western world where insurance companies often cover genetic testing. She feels that, in India, insurance is yet to catch up in this domain, hindering the utilisation of genetic testing insights by doctors.

Ameera Shah envisages a future where healthcare is more integrated for patients, with comprehensive data integration and care coordination, allowing professionals to work seamlessly together. This approach aims to eliminate the fragmentation often seen in healthcare services.

Gautam Khanna discussed the shifting paradigm in healthcare. He said, “Hospitals have historically been focused on sick care, treating patients after they fall ill. However, the industry is transitioning towards wellness care, where healthcare providers like Hinduja Hospital aim to proactively manage the health of the community. This transformation demands robust data collection, predictive analytics, and a shift in the delivery of care from hospitals to homes.”

Furthermore, the digital revolution in healthcare is evolving beyond improving patient convenience and logistics. It’s moving towards digital health delivery, involving data collection, vital sign monitoring, and telemedicine. Khanna stressed the necessity of extending these services to tier 2 and tier 3 regions to enhance healthcare accessibility.

Dr. Tarang Gianchandani on Healthcare in 2032: Accessible, Advanced, and Preventive

Dr. Tarang Gianchandani envisioned the healthcare landscape in a decade as more accessible, advanced, and prevention-oriented. The shift towards prevention (60% focus) rather than cure is a significant trend. Strategies will involve integrating technology for personalised and predictive medicine, utilising AI and data to enhance patient outcomes and overall accessibility.

The impact of the invaluable insights shared by these industry giants continues to reverberate throughout the healthcare and pharmaceutical landscape in India. Their collective vision, accomplishments, and commitment to a brighter future have set a new standard of excellence. The “CEO Dialogues” is a testament to the unyielding spirit of innovation and transformation in the Indian healthcare and pharmaceutical sectors.

To watch the entire discussion, click below:

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Dr Reddy’s Labs gets regulatory nod to study weight loss drug

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Dr Reddy’s has received the Indian drug regulator’s nod to study the safety and efficacy of the weight loss drug Semaglutide.

Semaglutide is the same active ingredient present in the blockbuster diabetes and weight loss drug, Ozempic and Wegovy by Novo Nordisk.

Dr Reddy’s has been given the nod to conduct a bioequivalence study to establish the safety and efficacy of the drug on the Indian population. If the bioequivalence studies meet expectations, it can launch the drug in a year.

Novo Nordisk which has become the most valuable company in Europe raised its guidance for the third time this year and expects sales to rise as much as 40% this year due to money generated from this blockbuster drug.

Ozempic is expected to make $12.5 billion in sales in 2023, a growth of 23% while Wegovy, the drug approved for weight loss netted $1 billion in sales in just one quarter seeing its sales rise 363% in just the first half of 2023.

Currently, Novo Nordisk has launched Oral Semaglutide in India at the price of Rs 10,000 per month.

Dr Reddy’s has been in the limelight of late. The company recently reported that the United States Food and Drug Administration (USFDA) has issued nine observations for its biologics manufacturing facility located in Bachupally, Hyderabad.

DRL’s wholly-owned subsidiary, Dr Reddy’s Laboratories Inc., has also found itself among several pharmaceutical companies named as defendants in a recently filed lawsuit.

“The complaint, filed by Mayo Clinic and Lifepoint Corporate Services, asserts claims under federal and state antitrust laws and other state laws alleging that the defendants improperly restrained competition and maintained a shared monopoly in the sale of brand and generic Revlimid through their respective settlements of patent litigation,” according to a stock exchange filing.

Following the lawsuit, analysts have turned cautious about the stock. “At this juncture, I would rather prefer to exit these stocks because, at current market prices, the risk-reward is not very favourable,” Vishal Manchanda, Pharma Analyst at Systematix Group told CNBC-TV18.

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Venus Remedies gains over 4% after company gets marketing nod for six chemotherapy drugs from Philippines

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The shares of oncology pharmaceutical company Venus Remedies rose more than 4% after the company secured marketing authorisation for six chemotherapy drugs from Philippines.

With this, the pharma company plans to inch closer towards emerging as the top oncology medicine supplier from India in Southeast Asia. The company’s oncology arm also secured marketing authorisation from Myanmar for another chemotherapy drug oxaliplatin.

The company has secured marketing authorisation for Bortezomih, Cisplatin, Doxorubicin, Docetaxel, Flurouracil and Paclitaxel, enabling a significant presence for the company from the Association of Southeast Asian Nation (ASEAN) region. The company said it is expecting to expand its operations in the Asia Pacific region in general, and Southeast Asia in particular through its range of drugs; it has secured marketing approval for 52 products across various segments, so far.

According to the official communication, Philippines represents a $420 billion pharmaceutical market and a growing area for cancer drugs. The market size of cancer drugs in the Philippines was valued at $252 million in 2020 and is expected to grow at a CAGR of 8.7% by 2025.

“While oncology drugs account for 157 of our 205 marketing authorisations in the ASEAN region, we are banking on these product registrations from the Philippines to pave the way for faster approval of these drugs in other Southeast Asian countries as well. Consequently, we will further extend our operations to other ASEAN markets, reaffirming our commitment to provide advanced cancer treatment options with improved outcomes for patients,” Saransh Chaudhary, the CEO of Venus Medicine Research Centre, said.

Venus Remedies has already submitted dossiers to the Philippines health ministry for 45 more marketing authorisations, and most of these pending approvals are for oncology products.

The shares of Venus Remedies were trading 4% higher at Rs 236.3 apiece around 10.10am.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow