Tag: Pharmaceuticals

How to revolutionise research and innovation in India’s pharma and medtech sectors

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

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India’s pharmaceuticals sector has displayed a steady and progressive trend in the recent past. To put this in perspective, in 1969, Indian drugmakers held a 5% market share in the domestic market, and global pharmaceutical companies held 95%. By 2020, the local industry held an 85% market share in the country, lowering global drugmakers’ share to a mere 15%. This is largely due to India’s strong position in the subsection of generics, vaccines, biosimilars and biologics.

In the current era of growth and development, India’s pharmaceutical and medical technology (MedTech) sectors are poised for a transformation propelled by emerging technologies, innovative research practices, and a supportive regulatory framework. 

Cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), big data analytics and genomics are transforming the landscape of research and development in India’s pharmaceuticals and MedTech sectors. The use of such technologies is speeding up drug discovery, bringing about innovative tools for diagnosis, treatment, and patient care.

AI expenditure in India is projected to reach USD 11.78 billion by 2025 and is likely to add USD 1 trillion to India’s economy by 2035. By using AI and ML, large amounts of data can be analysed to identify new drug targets, detections of diseases, diagnostics, and predictions for health risks. 

The investment and funding landscape in India’s pharmaceutical and MedTech sectors has been vibrant, with both domestic and international players showing a keen interest. According to a report by the India Brand Equity Foundation, India’s pharmaceutical market is expected to reach US$130 million by 2030, with factors such as increasing healthcare awareness, rising disposable incomes and government initiatives to promote this sector, pushing it forward.  The Indian government has launched notable initiatives to promote research and innovation in these sectors, including the establishment of research parks, incubators and funding schemes.

The National Policy on Research and Development and Innovation in the Pharma-MedTech Sector launched on September 26, 2023 (the “Policy”), aims to bolster the domestic production of new drugs and innovative medical devices to aid growth of the pharmaceutical sector in India, and it also focuses on reducing external dependence for active pharmaceutical ingredients (APIs) and key starting materials (KSMs).

One of the main objectives of the Policy is to promote self-reliance through the integration of increased research and ease of investing in the industry. The Scheme for Promotion of Research and Innovation in the Pharma and MedTech Sector (“PRIP”) was launched alongside the Policy to provide momentum to the research infrastructure by linking academia with the industry. 

The Policy aims to incentivise investments, particularly in production of biopharmaceuticals, patented drugs, new technology in medical devices for cancer care, diagnostics, etc. Stakeholders have long faced the issue of adhering to a challenging and cumbersome regulatory framework in India, and accordingly, there has been room for improvement.

It also aims to provide fiscal as well as non-fiscal incentives by way of introduction of direct or indirect funding, including provision for funding of late-stage research. It also aims to facilitate the infusion of funds through blended finance products and a proposed innovation fund for the pharmaceutical sector, which would help in reducing reluctance in investments required for long-term research. 

The structure of PRIP is such that it attempts to promote investments, and enables corporates to benefit from the research and institutional infrastructure present in the country. It is designed to be highly beneficial as it aims to provide financial assistance to companies across various levels of technological readiness under set criteria. This would help corporates across all levels — from start-ups, to established entities, in terms of research opportunities. 

The creation of investment opportunities and streamlining of regulatory procedures will aid in providing short-term and long-term solutions, including by developing a strong foundation (with contribution from the academia) for the MedTech sector. The Policy aims to achieve this by linking the pharmaceutical sector with academia and by setting up institutes for skill development. In addition, owing to the multidisciplinary nature of the MedTech sector, technical institutes will have to collaborate to train manpower, and this will boost employment opportunities. 

The Policy and the PRIP can be viewed as the Indian government’s resolve towards fostering a vibrant and dynamic ecosystem for research and development, thus furthering its vision to build a self-reliant and cutting-edge pharmaceutical sector.

—The authors, Arvind Sharma and Pallavi Mall are Partner and Associate respectively at law firm Shardul Amarchand Mangaldas & Co. The views expressed are personal.  

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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India is ceding ground to its Asian peers in biopharma innovation and manufacturing, warns an open letter to the PM

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

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Despite being recognised as the pharmacy of the world, India is not innovating enough in pharmaceuticals, both in chemistry and biotechnology, and it doesn’t value intellectual property adequately. These have been the two key complaints against India by the developed world as far as healthcare and drug research are concerned.

And now, there is another new revelation that India is slowly but surely ceding ground to its Asian peers in biopharma innovation and manufacturing.  Bernstein, a premier equity research and wealth management firm, in a recent report titled India Healthcare: An open letter to the PM, said that the country is behind its Asian peers such as China and South Korea in biopharmaceutical innovation as well as manufacturing.

Where Is India Lagging

Bernstein’s report warns that there are multiple areas where India lags behind its Asian peers. In the report, Bernstein experts Nithya Balasubrahmanyan and Parth Shah are requesting the PM for a course correction and to set India on its path to be a powerhouse for innovation.

On India’s merits, the report emphasises the following :

• • 1. India’s domestic market is home to thousands of manufacturers providing cost-effective medicines to millions of patients.
  • 2. Indian companies command over 40% Gx (branded generics) prescription share globally.
  • 3. The country’s vaccine dominance came to prominence during the global COVID pandemic.

On the contrary India lags on the following:

• • • 1. The country’s public health expenditure at 3% of GDP, is among the lowest and has been on a downtrend since 2014.
    • 2. Many Chinese and Korean companies invest in biomanufacturing capacities, leaving India far behind.
    • 3. South Korea is also catching up with more biotech startups reaching global markets with their first drugs in the recent past.
    • 4. In biopharma innovation, China has emerged as a global biotech hub.
    • 5. India finds no mention in the Healthcare Innovation index.
    • 6. The country does not feature in top 10 patent publications in any health-related field.
    • 7. Among all the drugs under development, less than 2% would be developed in India.

Market Economics

The Berstein letter to the PM urges that India’s market economics unfortunately don’t work for the pharma companies today. “Spending millions on clinical trials with no pricing power is not a business they want to be in. It is quite telling that the largest pharma company in India has chosen not to market their marquee innovative asset in India so far,” it said.

Even though the insurance coverage for novel drugs provided for by the government will go a long way, India needs to create a domestic market where innovative drugs can hope to command the right price and enjoy profits. Similarly, investing in core research talent, attracting quality talent back to India, easing the availability of funding for biotechs, and harmonising regulatory standards for manufacturing and clinical trials will be required for fostering innovation, the open letter to the PM appeals for.

Additionally, PLI (Production Linked Incentives) schemes and other manufacturing sops need to be extended to more capital intensive biomanufacturing to level the playing field at least initially with Asian peers, the letter requests the Prime Minister.

Conclusion

There is an almost universal consensus that the government of India must allocate more money for public expenditure and offer more support for drug research and development.

Indian companies have been predominantly the makers and marketers of generic drugs — the off-patented drugs made through reverse engineering or copy route.

However, the market economics of pharmaceuticals in India has been structured in a more pragmatic way, looking at various factors specific to the country. The access and affordability issues, a fairly large percentage of out-of-pocket expenditure on healthcare, low penetration of insurance are some of the key factors that prompt the government to keep a middle path as far as pharmaceutical pricing is concerned.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

Laurus Labs shares tank after estimates peg up to 35% fall in stock post earnings

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

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Laurus Labs shares declined more than 7% on Monday, October 23, after analysts projected a downside of up to 35% for the stock over the next 12 months.

The pessimism was triggered by the disappointing earnings reported by the Hyderabad-based company, which makes active pharmaceutical ingredients, a key input that goes into making medicines. This was the third straight quarter the company saw its revenue shrink.

Global brokerage Jefferies has assigned an ‘Underperform’ rating on Laurus Labs with a target price of ₹260 per share, implying a downside of 35% from Friday’s close.

Another brokerage Kotak Institutional Equities assigned ‘Sell’ rating on the stock with a target price of ₹270 per share. That’s 32% less than Friday’s closing price. The analysts also called the earnings ‘insipid’.

Laurus Labs shares dropped by as much as 7.31% to hit a low of ₹370.40 on BSE in early trade on Monday.

This was the fifth time in a row that the earnings from Laurus Labs had been less than what the street had expected, Jefferies said, explaining the rationale for its bearish projections i.e. a 33% cut in earnings estimate for the current financial year, and a 5% cut in the estimate for the next one.

Post these cuts, Jefferies’ estimates are less than the average estimate of all analysts by anywhere between 11% and 30%.

Jefferies expects only a gradual ramp-up in new contract, development, and manufacturing (CDMO) business, which made about 18% of the company’s revenue in the last quarter. This segment was particularly hit by the falling sales of the Paxlovid, a drug used to treat COVID-19 patients.

The sales of Paxlovid was expectedly high in the previous years due to the pandemic. However, now that the infections have receded, the sales have gone down too. The CDMO segment, which made Paxlovid, saw a 69% fall in revenue.

The revenue growth may be better in the second half of the financial year ending March 2024 but the profit margin may face some headwinds, Kotak Institutional Equities said.

The report also worried about the lack of visibility of any other commercial CDMO contract, while calling the two-year long weakness in the core business “certainly unsettling”. Laurus Labs last week announced a 23% year-on-year fall in revenue to ₹2,406 crore for the September quarter. Operating profit dropped 61% on-year to ₹356 crore in the quarter.

One set of analysts disagree though

However, Mirae Asset is still bullish on the company. The analysts called the recovery in both revenue and profitability, compared to the preceding three months, was impressive and the momentum is likely to continue.

While Mirae also cut the earnings estimate for the current financial year by Rs 6 per share, it retained the rating at ‘add’ and set the target price at Rs 455, 13% higher than Friday’s closing price. “This could act as a possible inflection point for Laurus. Improving growth prospects across all segments, capacity expansion plan to support the CDMO business, off-patent drug opportunities are the key positives for Laurus,” analysts at Mirae Asset said.

Speaking to CNBC-TV18 on Monday, Satyanarayana Chava, Founder and CEO of Laurus Labs said, “The only one division which is the one we are very bullish, but we need to have patience on the CDMO division. CDMO division has recorded less sales compared to the corresponding quarter last year.”

Gross margins will definitely remain similar but Chava expects higher sales in the second half. “We are very confident that H2 will be definitely much better than H1 both topline as well as EBITDA numbers.”

Laurus Labs shares 6.94% down at ₹371.90 on BSE at 10.30 AM.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

Leaders Speak | How to transform India’s pharma CDMO space through efficiency

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

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India’s Contract Development and Manufacturing Organisation (CDMO) sector has rapidly emerged as a pivotal player in the global healthcare landscape. Renowned for its position as a leading generics medicines developer and producer and its ability to execute large scale operations with US-FDA approved facilities and processes, India’s pharmaceutical industry has set ambitious targets for growth.

In 2020, the Indian pharmaceutical industry recorded a substantial market size of US$42 billion. India has a growth ambition to achieve a market size of US$130 billion by the year 2030. This goal likely represents India’s total value of its pharmaceutical industry, including both domestic and export revenues. 

India supplies almost 40% of the generic drugs to the United States. As of 2022, it boasts a remarkable milestone with a total of 603 US FDA approved manufacturing sites, making it the country with the largest number of such sites outside of the US. This signifies India’s growing prominence and recognition in the global healthcare landscape.

According to the US Center for Drug Evaluation and Research, 2022 Report on the State of Pharmaceutical Quality, the US drug regulator witnessed a notable increase of 12% in manufacturing sites worldwide and India leads the pack with a remarkable 17% increase. This expansion reflects India’s commitment to maintaining high-quality standards and regulatory compliance in pharmaceutical manufacturing.

India has confidently addressed 483 observations — the issues linked to quality manufacturing practices compliance — from the FDA, demonstrating a strong commitment to continuous improvement and driving the industry towards achieving world-class standards.

This article delves to India’s transformation in the CDMO services ecosystem and explores how the sector’s commitment to compliance, efficiency, and quality has positioned it on the global stage. 

 Investments in compliance and quality 

The strength of India’s regulatory capabilities and deeply ingrained quality culture makes it a reliable partner for delivering fully compliant products and services. The adoption of digital quality systems and automation by the pharmaceutical companies drive efficiency, speed, and easy access to audit trails, further enhancing regulatory compliance. 

Indian government investments in compliance and quality

The Indian government has taken proactive steps to support the healthcare ecosystem and improve the quality of pharmaceutical products. Initiatives such as the launch of the Medical Device Act demonstrate India’s commitment to ensure drug and device safety. The Directorate General of Foreign Trade (DGFT) has mandated quality checks in central labs before exporting drugs, bolstering confidence in Indian pharmaceutical exports.

As part of this mandate, drugs produced for export will be permitted only after rigorous testing at earmarked laboratories by the central government starting from June 1, 2023. The government has also increased surveillance to improve Good Manufacturing Practices (GMP) adherence to be on par with international standards set by the World Health Organization

Additionally, the new Promote Research in Pharma (PRIP) scheme is set to play a crucial role in fostering innovation and research within the pharmaceutical sector by upskilling the talent base available to the industry. Such moves from the government benefit the entire industry but specifically support the CRO-CDMO sector where innovative research is conducted.

Fostering self-sufficiency

The Production Linked Incentive (PLI) Scheme, 100% Foreign Direct Investment (FDI), Jan Aushadhi Yojana and Ayushman Bharat are among the measures aimed at enhancing medicinal drug production within the country. India currently relies on imports for approximately 95% of its Active Pharmaceutical Ingredients (APIs) from China.

To address this dependency and promote domestic production, the government introduced the PLI scheme, encouraging the production of 38 key bulk drugs domestically. Such a move has multiple benefits.  It helps build self-reliance, adds more API capacity into India and develops a talent base.  All of these help the pharma industry in India while also strengthening the CDMO sector.

Capabilities of Indian CDMO 

Many Indian CDMOs have successfully cleared several significant regulatory inspections including those from the US FDA. This highlights India’s commitment to regulatory excellence and adherence to global standards in the CDMO sector. 

According to a recent market report, the U.S. drug regulator completed the good manufacturing practices and pre-approval inspection of Piramal Pharma’s Pithampur facility with no Form 483 observations. Similarly, another news on Ajanta Pharma shows that it recently cleared a USFDA inspection for their facility in Dahej and Cadila Pharmaceuticals’ manufacturing facility received zero 483 observations.

A 483 observation is issued when there are compliance issues in the current Good Manufacturing Practices (cGMP) regulations enforced by USFDA. Syngene received US FDA approval for its API plant in Mangalore, recently. Syngene has a state-of-the-art facility compliant with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) quality systems.

These facilities have earned global accreditations, showcasing India’s commitment to delivering quality services. This is possible through a strong commitment to patient safety, product quality and efficacy.  Additionally, investments in the integration of digital quality systems and automation, such as a trackwise system, electronic documentation management system, electronic batch manufacturing record, electronic lab notebook, and enterprise management system has elevated the speed and rigor of operations, further increasing efficiency and accuracy. 

Challenges and the road ahead

The positive progress made in regulatory norms suggests the need to continuously revisit and refine and strengthen regulations to ensure better quality, safety, and compliance in the pharmaceutical sector.   As manufacturing technologies evolve and AI-ML (artificial intelligence and machine learning) gets embedded more strongly, the current regulatory framework may not be fully effective or comprehensive enough to address all emerging challenges and advancements in the industry. 

There is a need for open dialogues between the pharmaceutical industry and regulatory authorities as the sector expands its scope beyond generics to novel APIs (Active Pharmaceutical Ingredients), addressing regulatory challenges will be essential to maintaining India’s competitive edge on the global stage.

This will propel the pharmaceutical and biopharmaceutical industry towards a future that not only meets the growing global healthcare needs but also enables transformative breakthroughs and delivers innovative therapies to patients.

—The author, Dr Mahesh Bhalgat, is COO at Syngene International. The views expressed are personal. 

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Why Elara Securities bets on these stocks and sectors

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

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Bino Pathiparampil, Head of Research at Elara Securities shared his views with CNBC-TV18 on a host of sectors such as pharmaceutical, banking and finance, power, and real estate.

Talking about the pharma space, he started with his outlook on Sun Pharmaceutical Industries. He said the company’s specialty business has been doing extremely well over the last few years primarily driven by the largest drug ILUMYA.

“Other drugs like Cequa have added to the momentum. It is a major booster for the market potential of the drug because it has shown efficacy which is superior to the standard of treatment that was in the market,” he said.

The drug is used to treat dry eye disease. Phase 4 shows sustained improvement in dry eye disease in patients who switched from Restasis.

Pathiparampil was not much worried about the nine USFDA observations on Dr Reddy’s Laboratories (DRL) biological facility.

“DRL is still in the early phases of putting in place their biologics manufacturing for related markets. So a few observations from USFDA is to be expected in the early stages and as long as these are not major, serious issues, I would think that these can be sorted out as we go along over the next few months,” he said.

He believes the generic Xywav oral solution for which Lupin received a tentative USFDA nod could prove to be a very good product for Lupin. However, he doesn’t expect this product to hit the market in the next couple of years. “It is a slightly medium-term opportunity,” he said

Xywav is calcium, magnesium, potassium, and sodium oxybates oral solution.

Pathiparampil also shared his views on the financial space. He believes most of the large banks will start seeing some increasing cost of funds going ahead and they will be a little weak in the near term.

“We are expecting some new compression in the banking space and this will be more pronounced in the larger banks which is why we are expecting the larger banks to be a little weak in the near term,” he explained.

He remains positive on the non-banking financial companies (NBFCs) space where he has seen continued growth momentum, which helps the companies absorb some of the increased cost of funds. Bajaj Finance is a preferred pick.

From the power sector, he likes PFC and REC.

From the real estate development sector, he is positive on Mahindra Lifespace, Macrotech Developers, and Brigade Enterprises.

For more details, watch the accompanying video

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Health Ministry highlights steps taken to ensure cough syrup and drug quality in India

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

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The Rajya Sabha on Wednesday, August 8, witnessed two written responses highlighting the steps taken by the Indian government to ensure that the quality of drugs, especially cough syrups, in the nation is maintained.

In his response, Minister of State for Chemicals and Fertilisers Bhagwanth Khuba pointed at provisions under the Drugs and Cosmetics (Amendment) Act, 2008 which lay out regulatory measures to ensure the quality of medicines in India. These include:

# Stringent penalties for manufacturers of spurious and adulterated drugs

# Cognisable and non-bailable offences

# Special courts in states and Union Territories for the trial of offences under the acts for speedy disposal

# Required submission of bioequivalence study results along with applications for manufacturing licenses of oral dosage form drugs

# Mandatory joint inspection of manufacturing establishments by the Drugs Inspectors of the Central Government and State Government

# Required submission of evidence of stability and safety of excipients to the State Licensing Authority before being granted a manufacturing license by the authority

# Increased number of sanctioned posts in the Central Drugs Standard Control Organisation (CDSCO) in the last 10 years

# Expert advice and activity coordination by the CDSCO, State Drug Control Organisations, Drugs Consultive Committee, and State Drug Controllers

Furthermore, Health Minister Mansukh Mandaviya wrote specifically about cough syrups and regulatory measures by the administration to ensure their quality. He noted that manufacturers are required to comply with the conditions of the licence granted under the Drugs and Cosmetics Act to manufacture any drugs for sale and distribution in India

In numbers, these are the updates Mandaviya provided:

Mandaviya also pointed out that the Ministry of Commerce and Industry on May 22 issued a notification mandating cough syrup manufacturers to get a certificate of analysis from a government-approved laboratory before exporting their products.

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NPPA to consider amnesty scheme for pharma companies facing overpricing allegations

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

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India’s drug pricing authority might be on the brink of unveiling an amnesty scheme to resolve pending cases of overpricing, sources have told CNBC Awaaz, thus clearing the path for the recovery of thousands of crores of rupees for some pharma companies.

The move is in response to over 2,200 registered cases of alleged overpricing, involving major players like Cipla, Sun Pharma and Lupin, as well as smaller firms within the pharmaceutical landscape. Sources indicate that these cases collectively amount to a staggering sum of nearly Rs 13,000 crore. The figure encompasses not only the primary overpricing amounts but also accrued interest and penalties.

The NPPA, which oversees pharmaceutical pricing regulations in India, serves as a watchdog for such financial discrepancies in the industry.

While the specifics of the amnesty scheme are yet to be officially disclosed, experts suggest that it could potentially bring substantial relief to the accused pharmaceutical companies. There is a possibility of the accrued interest and penalties being waived, thereby mitigating some of the financial burdens these companies currently face.

According to the sources, there are instances where pharmaceutical companies have exceeded the regulated price points for essential drugs, resulting in unjust profits.

In certain cases, apart from the principal amount that exceeds the set drug prices, the authority also imposes additional interest and penalties.

It is projected that the government could recover about Rs 5,000-6,000 crore from the amnesty scheme.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

Poison found in Indian-made cough syrup sold in Iraq, tests reveal

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

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A cold medication made in India and sold in Iraq is tainted with toxic chemicals, a test commissioned by Bloomberg News shows, the latest in a series of alarming revelations about syrup medicines used by children around the world.

A bottle of Cold Out purchased at a pharmacy in Baghdad in March contains 2.1 percent ethylene glycol, according to Valisure LLC, an independent US laboratory. That’s about 21 times the widely accepted limit. The compound is lethal to humans in small amounts and played a role in mass child deaths caused by Indian-made cough syrups in Gambia and Uzbekistan last year.

Bloomberg shared the test results with the World Health Organization as well as Iraqi and Indian officials on July 8. The WHO told Bloomberg that it found Valisure’s test results to be “acceptable” and that it will issue an alert if the Iraqi government confirms the product was sold there. No public alert or recall has been announced yet.

Saif al-Bader, a spokesman for Iraq’s health ministry, said in an interview that the ministry has “strict regulations for the import, sale and distribution of medicines.” He declined to answer specific questions about Cold Out.

It’s the fifth time in a year that testing has found an Indian exporter’s drugs to contain excessive levels of ethylene glycol. In addition to the Gambia and Uzbekistan outbreaks, testing by government laboratories has identified other contaminated products in the Marshall Islands and Liberia, although there were no reported illnesses associated with those drugs.

The Cold Out label indicates it was made by Fourrts (India) Pvt. Ltd., a Chennai-based manufacturer that exports medicines to more than 50 countries, including the UK, Germany and Canada. A vice president there, Bala Surendran, said that Fourrts subcontracted the manufacture of Cold Out to another Indian company, Puducherry-based Sharun Pharmaceuticals Pvt. Ltd.

After Bloomberg’s inquiries, Fourrts tested a sample of Cold Out it had on hand and found it untainted, Surendran said. He said Indian regulators seized other samples from Sharun’s plant and that Fourrts hasn’t been informed of the results of those tests. Officials at the national drug agency and two local regulators either did not respond to requests for comment or said they had no information to share. Sharun executives did not respond to requests for comment.

The outbreak last year in Gambia killed more than 60 children, and the one in Uzbekistan killed about 20. The incidents raised fresh questions about the quality of drug exports from India, which is the largest generic drugmaker and calls itself the ”pharmacy of the world.”

The WHO said this month that a cough syrup blamed for 12 child deaths in Cameroon this year contained unsafe levels of diethylene glycol, a similar toxic compound. In that case, the medicine packaging doesn’t name a maker but bears the manufacturing license number of another Indian company.

Earlier this year, as part of an investigation into the global trade in unsafe drugs, Bloomberg purchased 33 samples of Indian-made syrups from pharmacies in Cambodia, Georgia, Ghana, India, Iraq and Kenya. The drugs were tested by New Haven, Connecticut-based Valisure using gas chromatography-mass spectrometry. The lab found four samples, all different brands, that contained either ethylene glycol, diethylene glycol, or both.

In considering whether a drug product contains unsafe levels of ethylene glycol or diethylene glycol, the WHO uses a guideline of 0.1 percent. Levels above that “would be considered non-compliant and therefore a health risk,” Rutendo Kuwana, head of the organization’s substandard medicines team, said in an email. Sarah Sheppard, a WHO spokeswoman, pointed to guidance from the US Food and Drug Administration that uses the 0.1 percent limit for tests of raw materials used in syrup production.

Valisure tested the Cold Out sample five times and found, on average, ethylene glycol content of 2.1 percent and diethylene glycol content of 0.25 percent. The diethylene glycol content is more than twice the limit. None of the other syrups with contaminants exceeded the 0.1 percent level.

Bloomberg provided WHO and Iraqi authorities with test results and the name and location of the Baghdad pharmacy where the syrup was purchased. The WHO’s Sheppard said in an email this week that Iraq continues “to attempt to source samples to confirm (or not) whether the product is in their country and where else it could be on sale. To raise a definitive alert, WHO and the Member State would need to be satisfied that it was on sale in a particular location.”

“We will issue an alert as soon as we have confirmation of the information from Iraq,” Sheppard continued.

Syrup medications consist of a small amount of active ingredient suspended in a watery solution. To cause the active ingredients to dissolve, manufacturers add a solvent such as propylene glycol — a harmless, clear, sweet-tasting liquid.

Ethylene glycol and diethylene glycol are chemically similar to propylene glycol but are cheaper and highly toxic, used in industrial applications such as antifreeze and brake fluid. Typically, contamination takes place when a chemical trader mislabels one of these chemicals as propylene glycol. Drug manufacturers are supposed to test propylene glycol for contamination prior to using it, but that doesn’t always happen.

In response to the contamination episodes that came to light over the past year, Indian drug authorities in June began requiring the testing of cough syrups in a government lab prior to export.

The packaging of the Cold Out obtained in Iraq indicates it was manufactured in January 2022. The WHO has said that it’s exploring whether a spike in prices of propylene glycol contributed to the recent contamination cases. In addition to those linked to Indian medication, an outbreak last year in Indonesia, caused by medication manufactured domestically, killed about 200 children.

Propylene glycol prices tripled in China in 2020 and in India in 2021 and remained elevated for more than a year, according to ChemAnalyst, a market research firm in India. That increased the potential profit from mislabeling a cheaper solvent as propylene glycol.

Valisure is known for finding dangerous chemicals in drugs and personal-care products. Its 2019 research on contamination in the blockbuster heartburn drug Zantac led to recalls and eventual market withdrawal. Valisure works with health-care companies including Kaiser Permanente to test drug products for quality.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

Roche halts drug projects amid US prescription medicine price cuts

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

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Roche on Thursday announced that it has abandoned several drug development projects and potential acquisitions due to the expected price reductions for its popular prescription medicines in the United States.

Roche CEO Thomas Schinecker revealed during a media call on July 27 following the release of first-half results that the company is not taking legal action against the US government’s Inflation Reduction Act (IRA) like some other large drugmakers are doing.

Nevertheless, Roche’s work on new drugs has still been affected, Reuters reported.

Schinecker stated, “We have decided that we are not going to do certain trials, or that we are not going to do a merger or acquisition or licensing (deal) because it is becoming financially not viable,” without providing further details.

This decision comes in the wake of legal challenges initiated by some drug manufacturers, such as Merck & Co and Bristol Myers Squibb, against the Biden administration’s proposal to allow Medicare to negotiate drug prices.

Despite the setbacks, Roche recognises the importance of advancing its drug development projects to boost the company’s stock market value.

CFO Alan Hippe emphasised that after facing challenges in the late-stage pipeline last year, their focus now is to replenish the pipeline and demonstrate a robust late-stage pipeline to investors.

Hippe stated during a press conference that progress has already been made in this regard, and the company’s share price, which took a hit when the demand for COVID-19-related tests and treatments diminished, is expected to improve with the advancement of its drug development initiatives.

“The point is really the setbacks we had last year in the late-stage pipeline… we have to now fill up the pipeline again and prove ourselves that we really have a strong late-stage pipeline. Once that happens I’m not concerned about the share price,” Hippe said, per a Reuters report.

With agency inputs.

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Unichem Laboratories Q1: Net loss narrows to Rs 66 lakhs versus Rs 23 crore YoY

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

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Pharmaceuticals major, Unichem Laboratories posted strong growth in the first quarter of financial year 2023-24. The revenues jumped 36 percent year to Rs 423 crore versus Rs 310 crore in the same quarter of last year.

The net loss narrowed to Rs 66 lakhs versus Rs 23 crore year on year. The earnings before interest, tax, depreciation and amortisation (EBITDA) is at Rs 29 crore and EBITDA margins stood at 6.9 percent.

In FY23, the company posted a net loss of Rs 202 crore, with revenues of Rs 1,343 crore. In April 2023, IPCA Labs announced the acquisition of a 33.38 percent stake in Unichem Labs for Rs 1,034.06 crore.

In June 2023, Dr. Prakash A. Mody was reappointed as the Chairman and Managing Director of the company for a period of three years commencing from July 1, 2023.

Unichem Laboratories closed the trading session at Rs 385 per share on July 14 with gains of 1.5 percent. The stock has gained 25 percent since the start of the ongoing calendar year.

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