Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Semaglutide Injection for Weight Management

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the Bioequivalence (BE) study report and granted approval to Intas Pharmaceuticals Ltd to conduct a Phase III clinical trial of Semaglutide Injection (Synthetic Origin) for weight management.

The proposal, submitted under file number SND/CT/25/000025, was reviewed during the 10th/25th SEC meeting held on 08 May 2025 at CDSCO headquarters, New Delhi. The firm presented the application with Protocol No. 0131-24, Version 1.0, along with its BE study report.

Semaglutide, a GLP-1 receptor agonist, has been globally recognized for its efficacy in type 2 diabetes treatment and weight reduction. Intas’ proposal focused specifically on the weight management indication, backed by comparative bioequivalence data between its formulation and the reference product.

After detailed deliberation, the expert committee concluded that the bioequivalence data was satisfactory and recommended approval to proceed with the Phase III clinical trial as per the submitted protocol. The upcoming trial will assess the safety and efficacy of various strengths of semaglutide injection in the Indian population.

Also Read: SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification

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Despite overall progress, low birthweight rates still high in certain Indian states

Despite overall progress in bringing down low birthweight numbers across India over the past 30 years, rates remain stubbornly high in certain states, with Uttar Pradesh, Bihar, Maharashtra, and West Bengal accounting for almost half of all such births, finds research published in BMJ Global Health.

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Minutes instead of months: Algorithm rapidly identifies cell types to match patients with effective cancer therapies

Researchers at VCU Massey Comprehensive Cancer Center have developed a novel algorithm that could provide a revolutionary tool for determining the best options for patients—both in the treatment of cancer and in the prescription of medicines.

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Smartphones may improve accuracy of medical devices across skin tones

As concern grows over racial bias in common medical tools like pulse oximeters, a new study shows that smartphones may offer a simple, accessible way to help correct the problem. Researchers at Brown University and Morgan State University have developed a method for using smartphone cameras to objectively measure skin tone, a factor known to affect the accuracy of pulse oximetry—the technique that monitors oxygen levels through the skin.

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Potential Medicaid cuts could lead to more than 16,500 medically-preventable deaths each year

A study published in the Annals of Internal Medicine estimates the potential effects on Medicaid enrollment, uninsurance, financial strain, health care access, and health outcomes from potential Medicaid budget cuts being considered in Congress, including the House reconciliation bill advanced in May.

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Integrative exome sequencing and machine learning identify new genes contributing to systemic sclerosis risk

Systemic sclerosis (SSc) is a severe autoimmune disease with complex genetic causes. Some genetic contributors have been identified, but others remain unknown, which has impeded development of targeted treatments. In a new study published in Annals of the Rheumatic Diseases, researchers at Baylor College of Medicine and collaborating institutions used complementary approaches that integrate exome sequencing and evolutionary action machine learning to identify protein changes and their associated mechanisms in SSc.

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Natco Pharma appoints Yarramshetty Krishna Rao as Senior Vice President – Operations at Mekaguda

Telangana: Natco Pharma has appointed Yarramshetty Krishna Rao as Senior Vice President – Operations
at Mekaguda of the Company.

Yarramshetty Krishna Rao has overall 33 years of
experience in the leading Indian Bulk Drug/API
Manufacturing Industries, with 20 years of experience as Unit
Head. Prior to joining Natco, he served at Dr. Reddy’s Laboratories
Limited, Hyderabad, as Senior Director/Site Head – API
manufacturing unit.

This appointment follows a series of senior leadership changes Natco Pharma unveiled last month, effective from June 1, 2025. As part of its organizational strengthening across various verticals, the company named Dilip Manikchand Dhore as Vice President – Corporate Quality Assurance, and Amber Roy as Associate Vice President – Distribution.

Additionally, Addagada Veeranarayana and Parupalli Sreenivasa Rao were appointed Associate Vice Presidents – Operations, while Kurada Venkata Maruti Ramchander was designated as Associate Vice President – Regulatory Affairs.

Read also: Natco Pharma announces key leadership appointments across quality, operations, regulatory, and distribution teams

Earlier in April, Natco Pharma also announced the superannuation of two key executives: Dr. Ramesh Dandala, Executive Vice President – Technology Transfer, Intellectual Property Rights & Regulatory Affairs (API), and Tummala Venkata Rao, Vice President – Production.

Read also: Natco Pharma Executive VP – Technology Transfer, Intellectual Property Rights & Regulatory Affairs (API), Dr Ramesh Dandala, superannuates

NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.

Read also: Natco Pharma Tummala Venkata Rao supperannuates as Vice President – Production

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Tamil Nadu amends Goondas Act to curb illegal biomedical waste disposal

Chennai: In a significant
move aimed at addressing the illegal dumping of bio-medical waste, Tamil Nadu
Governor R N Ravi has approved an amendment to the Goondas Act, 1982, enabling
authorities to detain individuals involved in such activities under the stringent provisions of the act.

The amendment, passed in
the State Assembly in April 2025, comes in response to recurring incidents of
medical waste being dumped in Tamil Nadu’s border districts by institutions
from neighbouring Kerala.

Also Read:Violation of Biomedical Waste Management rules: Kerala Pollution Control Board serves notice to medical college for unscientific disposal

According to Deccan Herald, the government amended the Tamil Nadu Prevention of Dangerous
Activities of Bootleggers, Cyber Law Offenders, Drug Offenders, Forest
Offenders, Goondas, Immoral Traffic Offenders, Sand Offenders, Sexual
Offenders, Slum-Grabbers and Video Pirates Act, 1982, aligning it with the
Bio-Medical Waste Management Rules, 2016. The state government had argued that
such changes were imperative due to the serious health and environmental
hazards posed by the illegal disposal of bio-medical waste.

According to the amended
provisions, anyone found disposing of or attempting to dispose of bio-medical
waste in violation of the Bio-Medical Waste Management Rules, 2016 — an offence
punishable under the Environment Protection Act, 1986 — can now be detained
under the Goondas Act.

“…for the expression
“bootleggers, cyber law offenders, drug offenders”, the expression
‘bio-medical waste offenders, bootleggers, cyber law offenders, drug
offenders, economic-offenders” shall be substituted,” the bill said.

The backdrop to this
legislative action includes repeated instances of biomedical waste being
transported from Kerala and dumped in Tamil Nadu’s border districts such as
Theni, Kanyakumari, Tenkasi, and Tirunelveli. Despite complaints by landowners
and local residents, the practice has continued, sparking widespread public
outrage. Residents allege that lorries arriving from Kerala, ostensibly to
carry loads from a nearby paper mill, have been clandestinely unloading
biomedical and other hazardous waste in vacant lands across these villages.

Also Read:Tirunelveli Medical College criticized for poor biomedical waste disposal practices

One of the most serious
cases occurred on December 15, 2024, when medical and plastic waste from the
Regional Cancer Centre (RCC) in Thiruvananthapuram was found dumped in
Kodaganallur and Palavoor villages in Tirunelveli district. These acts of
dumping were carried out on privately owned open lands, further creating hazards
for the locals.

The National Green
Tribunal (NGT) previously also directed the Kerala government in December 2024
to retrieve the plastic waste dumped in Tirunelveli and ensure no further
violations. However, the state government of Tamil Nadu has now opted for a
sterner approach, hoping that provisions under the Goondas Act will serve as an
effective deterrent against future violations.

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Newborn dies after sanitary worker allegedly handles delivery at Kakinada Hospital

Kakinada: In a case of alleged medical negligence, a newborn baby died shortly after birth at the Tallarevu Community Health Centre in Kakinada district, after a sanitary worker on duty reportedly handled the delivery of a pregnant woman.  

Although the hospital administration denied the allegation and claimed that the sanitary worker is a trained birth attendant, the incident sparked protests by the family, who accused the doctors and the hospital of medical negligence.

According to doctors, the baby died due to meconium aspiration syndrome – a condition where a newborn inhales a mixture of amniotic fluid and stool during or shortly after birth, leading to serious breathing problems.

Also read- UP doctor arrested for alleged negligence in death of woman and newborn

TOI reported that the incident took place in the early hours of Saturday. The 22-year-old mother was admitted to the hospital on Friday morning and was under constant observation. According to the family, she developed labour pains early Saturday, and with no doctor immediately available, a sanitary worker on duty handled the delivery. Relatives alleged that the sanitary worker performed the delivery, which they believe led to the baby’s death.

However, health officials denied the claim, stating that the sanitary worker was a trained birth attendant and did not carry out the delivery. Instead, they said she helped only after the baby was born suddenly and the umbilical cord began to stretch excessively.

Dr Swapna, the district coordinator for health services, clarified that gynaecologists were present at the hospital until 2 am. At the time of the incident, a paediatrician, two staff nurses, and the sanitary worker were available. She said the sanitary worker clamped the umbilical cord and gave oxygen to the baby before informing the nurse and doctor.

Doctors explained that the baby’s condition worsened quickly due to the respiratory problem. The duty doctor advised the family to take the newborn to the Government General Hospital. Sadly, the baby died on the way.

Following the death, angry family members staged a protest at the health centre, accusing the hospital staff of negligence. The woman’s condition is reported to be stable.

An official inquiry has been ordered into the incident, and authorities have promised strict action if any negligence is found.

Also read- Patient death after doctor administers Spinal Anaesthesia without Specialist: HC says Medical negligence cannot be equated with culpable homicide

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Low Income Tied to Higher Risk of Severe Hypoglycemia in Type 2 Diabetes, Study Finds

South Korea: A large-scale cohort study published in JAMA Network Open highlights a strong connection between income levels and the risk of severe hypoglycemia in individuals with type 2 diabetes. Conducted by Dr. Misook Kim from the Division of Endocrinology and Metabolism, Seoul St Mary’s Hospital, The Catholic University of Korea, and colleagues, the research emphasizes the pressing need to address socioeconomic disparities to enhance diabetes care and reduce adverse outcomes.

The study analyzed data from over 1.8 million adults with type 2 diabetes in South Korea, sourced from the Korean National Health Information Database (NHID), and included a comparative sensitivity analysis of more than 17,000 participants from the UK Biobank (UKBB). All individuals were aged between 40 and 70 years and had valid income and health information.

Researchers explored how both absolute income levels and changes in income over time influenced the likelihood of experiencing severe hypoglycemia, an acute and dangerous drop in blood sugar requiring medical intervention.

The study led to the following findings:

  • Individuals in the lowest income groups had a significantly higher risk of severe hypoglycemia compared to those with higher incomes in both Korean and UK cohorts.
  • In the Korean cohort, low-income individuals had a 2.5-fold increased risk of severe hypoglycemia.
  • In the UK cohort, the risk of severe hypoglycemia was over five times higher among those with low income.
  • The duration of low income was found to be an important factor, with those receiving medical aid or staying in low-income brackets for at least one year showing an even greater risk.
  • Participants whose income improved over five years, from the lowest quartile or medical aid status to the highest income group, had a 26% lower risk of severe hypoglycemia.
  • The link between income and hypoglycemia risk was more prominent in men than in women.
  • The association remained significant among individuals not using insulin therapy.
  • The risk pattern also held true for those without chronic kidney disease.
  • Individuals with a shorter duration of diabetes also showed a stronger income-related risk of hypoglycemia.
  • The findings indicate that both biological factors and disparities in healthcare access may contribute to the increased risk among low-income individuals.

The authors emphasized that socioeconomic status should be considered a critical component in diabetes risk assessment and management strategies. They advocate for policy-level interventions and community-based programs aimed at improving financial stability for low-income individuals with diabetes.

“The extensive study highlights the influence of economic factors on health outcomes in type 2 diabetes. Supporting income mobility and minimizing financial hardship could be pivotal steps in reducing the burden of severe hypoglycemia and improving overall diabetes care,” the authors concluded.

Reference:

Kim M, Han K, Lee K, et al. Income and Severe Hypoglycemia in Type 2 Diabetes. JAMA Netw Open. 2025;8(6):e2513293. doi:10.1001/jamanetworkopen.2025.13293

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