Granules India gets Zero 483’s from USFDA for Unit V facility in AP

Telangana: Granules India has informed in a BSE filing that the Company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra
Pradesh, India gets Zero 483’s from U.S. Food and Drug Administration (USFDA).

The inspection was held from 8th April 2024 to 12th April 2024.

This audit was
a Pre Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and
Formulations (FDs); oncology and non-oncology. 
This facility manufactures APIs & formulations of oncology and non-oncology products.

Read also: USFDA classifies Granules Pharma facility as Voluntary Action Indicated

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

Read also: Granules Pharma facility gets 5 USFDA observations

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UK and Portuguese study strongly suggests ‘superbugs’ are being passed from pets to owners

Pet dogs and cats play an important role in the spread of antibiotic-resistant bacteria, says new research presented at the ESCMID Global Congress (formerly ECCMID) in Barcelona, Spain (27–30 April).

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Study suggests staying current with COVID-19 vaccinations helps combat emerging variants

New research using live SARS-CoV-2 virus reveals an updated vaccine provides a strong immune response against previous strains and emerging variants.

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Choosing sugary drinks over fruit juice for toddlers linked to risk of adult obesity

Consuming sugar-sweetened drinks in the first few years of childhood can be linked to poor diet patterns that increase the risk of obesity in later life, according to a new study by the School of Psychology at Swansea University.

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Study reveals potential to reverse lung fibrosis using the body’s own healing technique

The most common type of lung fibrosis—scarring of the lungs—is idiopathic, meaning of unknown cause. Researchers are urgently trying to find ways to prevent or slow idiopathic pulmonary fibrosis (IPF) and related lung conditions, which can cause worsening shortness of breath, dry cough, and extreme fatigue. Average survival following diagnosis of IPF is just three to five years, and the disease has no cure.

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A third of women found to experience migraines associated with menstruation, most commonly when premenopausal

A third of the nearly 20 million women who participated in a national health survey report migraines during menstruation, and of them, 11.8 million, or 52.5%, were premenopausal. The analysis was conducted by researchers at Georgetown University Medical Center and Pfizer, Inc., which makes a migraine medication.

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USFDA concludes inspection of Lupin Dabhasa facility with no observations

Mumbai: Global pharma major Lupin Limited has announced that the
United States Food and Drug Administration (U.S. FDA) has completed a GMP Inspection of its API
manufacturing facility located at Dabhasa, India.

The inspection was conducted from April 8 to April
12, 2024 and concluded with no observations.


“We are pleased to announce the successful completion of the U.S. FDA inspection of our Dabhasa
facility,” said Nilesh Gupta, Managing Director, Lupin. “This accomplishment underscores our
unwavering dedication to maintaining the highest standards of quality and compliance in all aspects of
our operations. This reaffirms our pursuit of excellence in delivering high-quality, affordable healthcare
for all.”

Read also: Lupin names Dr Ranjana Pathak as Chief Quality Officer

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and
has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and
women’s health areas. The
company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin unveils first generic version of Oracea in US

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Renowned Cardiothoracic Surgeon Dr Lokeswara Rao Sajja featured in American Association for Thoracic Surgery

Hyderabad: In a significant recognition that highlights the growing influence of Indian surgeons on the global stage, Dr Lokeswara Rao Sajja, renowned Cardiothoracic Surgeon becomes the fourth Indian cardiothoracic surgeon to be featured in the American Association for Thoracic Surgery (AATS) Member Spotlight. 

At the heart of Dr Sajja’s illustrious career lies a legacy of groundbreaking achievements and pioneering contributions that have earned him a prominent place in the AATS Member Spotlight. As the first cardiothoracic surgeon practising in India to be featured in this esteemed platform, Dr Sajja’s recognition underscores his work’s global impact and his invaluable role in shaping the future of cardiothoracic surgery. 

Dr Sajja’s ascent to the ranks of the AATS exemplifies a rare feat, as he becomes only the fourth cardiothoracic surgeon from India to achieve this prestigious honour since the association’s inception. His remarkable journey is a testament to his unwavering commitment to excellence and his tireless pursuit of innovation in the field of cardiothoracic surgery.

Also read- Renowned Virologist Dr Gagandeep Kang Bags John Dirks Canada Gairdner Global Health Award 2024

Established in 1917, the American Association for Thoracic Surgery (AATS) has been a symbol of excellence in cardiothoracic surgery. With over 1,500 (7 Surgeons from India) members across 46 countries, AATS stands as a testament to the commitment of its members to advancing the treatment of cardiothoracic diseases globally.

In recognition of exceptional skill and dedication, AATS introduced the Member Spotlight initiative last year. This platform highlights individuals who have made significant contributions to the field. During the AATS 103rd Annual Meeting held from May 6 to 9, 2023, in Los Angeles, California, experts in thoracic surgery gathered to exchange knowledge and shape the future of the field.

The event featured renowned speakers and moderators, including Sir Magdi Yacoub, Shinichi Fukuhara, Ismail El-Hamamsy, and others. Moderated by experts like Ismail El-Hamamsy from Mount Sinai Hospital, the event covered a range of topics in adult cardiac surgery.

Among those recognized is Dr Lokeswara Rao Sajja, an esteemed member from India. 

Throughout his tenure as an AATS member, Dr Sajja has distinguished himself through his prolific contributions to the discourse and practice of cardiothoracic surgery. His presentations, discussions, and publications at the AATS Annual Meetings and the Journal of Thoracic and Cardiovascular Surgery (JTCVS) have not only advanced the boundaries of knowledge but have also served as catalysts for innovation within the field.

He attained his MBBS from Guntur Medical College, Guntur, AP, followed by MS in General Surgery from JIPMER, Pondicherry, and M.Ch in Cardiothoracic and Vascular Surgery from the All-India Institute of Medical Sciences (AIIMS), New Delhi.  

As a pioneer and innovator in cardiothoracic surgery, Dr Sajja’s dedication and expertise continue to inspire excellence within the global medical community. His unwavering commitment to advancing the frontiers of cardiothoracic surgery serves as a beacon of hope for patients worldwide, and his induction into the AATS Member Spotlight is a testament to the profound impact of his contributions on the field and beyond, reports IANS. 

According to a statement issued by AATS, Dr Lokeswara Rao Sajja is a pioneering Cardiothoracic Surgeon in India, rising from humble beginnings in Andhra Pradesh. His educational journey took him through prestigious institutions, culminating in advanced cardiovascular training under the guidance of Prof Denton A Cooley at the Texas Heart Institute in the USA. 

Dr Sajja’s impact on Cardiothoracic Surgery is profound. He founded the Society of Coronary Surgeons, dedicated to advancing coronary surgery in India. As Chairman of the Sajja Heart Foundation, he received recognition as a Scientific and Industrial Research Organization (SIRO) by the Government of India in 2019.

His innovative spirit led to the development of a mechanical prosthetic heart valve, eliminating the need for long-term anticoagulation (US and Indian patents awarded). He also designed the Mammary Artery Support Platform (MASP) to enhance BITA usage in CABG surgery. Dr Sajja’s surgical expertise spans around 20,000 open heart operations, and he spearheads multicenter randomized trials in Cardiac Surgery in India. 

His “PROMOTE Patency Study” gained global recognition as India’s first multicenter randomized controlled trial in cardiac surgery. He currently leads the “PREDICT Study” with support from the Indian Council of Medical Research. His influence transcends borders, as he actively participates in Multi-Centre International trials, contributing to global advancements in cardiac surgery. 

An active member of prestigious international societies, including AATS, STS, EACTS, and ASCVS, Dr Sajja has presented numerous original research papers at international meetings. He has authored over 110 articles in peer-reviewed journals, serves as a guest reviewer for prominent journals, and holds editorial roles in respected publications. 

Dr Sajja’s journey from a rural village to a trailblazing Cardiothoracic Surgeon is a testament to his dedication, innovation, and commitment to advancing cardiac care and research. As the President of the Indian Association of Cardiovascular-Thoracic Surgeons (IACTS) 2023, he continues to shape the future of cardiac surgery, benefiting countless patients.

Also read- Renowned Ophthalmologist Dr Atul Kamath Bags Ophthalmic Heroes Of India Award

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Neutrophil-to-lymphocyte ratio may predict potential complications among type 2 diabetes patients: Study

India: A recent study published in Cureus has shown the usefulness of neutrophil-to-lymphocyte ratio (NLR) in the management of type 2 diabetes mellitus (T2DM) and in predicting long-term complications.

The researchers revealed the equivalent efficacy of NLR to glycated hemoglobin (HbA1c) in predicting glycemic control. They suggest that since diabetes affects different body organs, NLR evaluation probably predicts inflammation.

Diabetes is a chronic disease that causes blood glucose dysregulation. Type 2 diabetes could result in long-term inflammatory conditions that impact different body organs. Despite the availability of diagnostic markers like HbA1c for T2DM, it is essential to find an appropriate marker that could predict long-term complications.

Against the above background, Qader A. Jalily, Microbiology, Mahavir Institute of Medical Sciences, Vikarabad, India, and colleagues evaluated the potential role of neutrophil-to-lymphocyte ratio in predicting disease progression and treatment responses.

For this purpose, the researchers conducted a case-control study among 160 T2DM patients with 132 non-diabetic persons. Blood samples were collected from each participant and were processed for HbA1c, hemoglobin, ferritin, iron, and complete blood picture (NLR).

The researchers reported the following findings:

  • There was a significant variation in the serum levels of ferritin (264.8±611.6 ng/ml versus 168.3±364.7 ng/ml), iron (4.095±8.851 mcg/dl versus 55.20±37.62 mcg/dl), and HbA1c (8.169±1.635% versus 5.668±0.5260%) among T2DM patients compared to non-diabetic persons.
  • The NLR values (4.189±4.154 versus 4.095±8.851) among patients with T2DM significantly varied from those of non-diabetic persons.
  • There was a significant negative correlation between the serum levels of iron and NLR (r=-0.17), and a positive correlation existed between HbA1c and NLR (r=0.19).
  • The serum levels of iron revealed a significant positive correlation with the serum levels of ferritin (r=0.24) and hemoglobin percentage (r=0.41).
  • HbA1c revealed a significant positive correlation with NLR (r=0.19).
  • There was a significant negative correlation between iron with NLR (r=-0.17) and hemoglobin percentage with NLR (r=-0.30). However, no such correlation was demonstrated among non-diabetic persons.
  • With an accuracy of 89.85% and high sensitivity and specificity, NLR showed diagnostic accuracy like HbA1c.

In conclusion, despite the availability of traditional markers like blood glucose and HbA1c to diagnose type 2 diabetes patients, they may be inappropriate to assess the overall health and predict long-term T2D complications.

The study found a significant correlation between HbA1c and NLR among T2DM patients. Moreover, there was a significant variation in NLR between T2DM patients and non-diabetic persons.

“The study results support the role played by the NLR to manage T2DM patients,” the researchers wrote.

“Alternatively, a more comprehensive evaluation of patients with type 2 diabetes is possible with NLR estimation. Unlike the traditional biomarkers, NLR could be used to predict potential complications among T2DM patients.”

Reference:

Mohammed A, Khaleel M, R. M. P, et al. (February 29, 2024) Neutrophil-to-Lymphocyte Ratio as a Potential Biomarker to Managing Type 2 Diabetes Mellitus and Predicting Disease Progression. Cureus 16(2): e55227. doi:10.7759/cureus.55227

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Salt substitution reduces cardiovascular mortality in the high-risk population

A recent comprehensive review highlights the potential health benefits of salt substitution for cardiovascular outcomes. This research found that replacing regular salt with substitutes could lead to a reduction in mortality and major cardiovascular events among the high-risk populations. The crucial findings were published in the Annals of Internal Medicine.

The study synthesized data from 16 randomized controlled trials (RCTs) and focused on the effects of salt substitutes on adults for durations of six months or longer. The study data were primarily sourced from databases such as PubMed, EMBASE, Cochrane CENTRAL and CINAHL to compile the most relevant information up to the date of search completion.

Also, the meta-analysis showed that salt substitutes might reduce the risk of all-cause mortality by 12% and cardiovascular mortality by 17% according to the data from trials that involved a total of 27,710 and 25,050 participants, respectively. Most of the studies reviewed were conducted in China or Taiwan, focusing primarily on older populations with an average age of 62 years and higher-than-average cardiovascular risks. The potential reduction in major cardiovascular events (MACE) was observed with very low certainty.

The evidence highlighted an increase in the risk of serious adverse events associated with salt substitutes which was not statistically significant. This aspect underlines the need for careful consideration in balancing the benefits and potential risks of salt substitution among different global populations.

The study employed the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to assess the certainty of the evidence, which generally ranged from low to very low across different outcomes. This necessitates the need for further high-quality studies to confirm these potential benefits and establish clearer guidelines for their application.

The dominance of the data by a single, large RCT and the concentration of studies in Asian countries with high cardiovascular risk profiles pose significant limitations to the generalizability of this study. It indicates that while the initial results are encouraging for the populations in China or Taiwan which were studied.

While salt substitution appears to be a promising strategy for improving cardiovascular health outcomes (reducing mortality rates among high-risk groups), further research is mandatory to fully understand its benefits and risks across different populations and this will encourage to consider the context of broader dietary and health management strategies.

Source:

Greenwood, H., Barnes, K., Clark, J., Ball, L., & Albarqouni, L. (2024). Long-Term Effect of Salt Substitution for Cardiovascular Outcomes. In Annals of Internal Medicine. American College of Physicians. https://doi.org/10.7326/m23-2626

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