Drug safety alert: CDSCO flags 58 drug samples

In its latest drug safety alert, the apex drug regulatory body, the Central Standard Control Organisation (CDSCO) has flagged 58 medicine batches for failing to qualify for a random sample test for February 2023, while 2 drug samples have been declared as suprious.

These drugs include Acepik – P (Aceclofenac and Paracetamol Tablets) manufactured by Nexkem Biotech, Amoxycillin Oral Suspension I.P. (Medmoxil 125) manufactured by Laborate Pharmaceuticals, Calcium Carbonate and Vitamin D3 Tablets IP (Calcigiant 500 Tablets) manufactured by Nutra Life Healthcare, Ofloxacin manufactured by Concept Pharmaceutical, Calcium and Vitamin D3 Tablets manufactured by Hanuchem Laboratories, Serratiopeptidase Tablets manufactured by Arnav Research Laboratories.

For more information, click on the link below:

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Karnataka Sex Determination Racket: CID names 3 doctors among 19 suspects in final report

Bengaluru: Following the unearthing of an illegal sex determination-cum-foeticide racket last year, three doctors along with 16 other suspects have been named in the final report filed by the Central Investigation Department (CID). The agency has forwarded the report to the health department as it lacks the authority to file a charge sheet in the matter. 

The 19 suspects included three doctors, two lab technicians, two nurses, one scanning machine vendor and eleven touts. While 18 suspects were arrested and released on bail, one suspect remains at large. 

Dr Swamy, the alleged mastermind was an Ayurvedic doctor who the CID arrested in December 2023 but later released on bail. He has since passed away due to poor health. The doctor allegedly procured four portable scanning machines from a licensed dealer in Mangaluru without submitting the necessary documents. He was believed to be the common link between medical staff and touts.

Also read- Karnataka Doctor Who Allegedly Performed Around 900 Illegal Abortions Arrested

Medical Dialogues team had last year reported the incident where a doctor and his lab technician were arrested for allegedly performing around 900 illegal abortions in the last three years.

Dr Chandan Ballal and his lab technician Nisar allegedly charged around Rs 30,000 for each abortion which they carried out at a hospital in the district headquarters town of Mysuru.

Police busted the sex-determination and female foeticide racket on October 15, 2023, with the arrest of two accused — Shivalinge Gowda and Nayan Kumar — in the district headquarters town of Mandya, near Mysuru, when they were taking a pregnant woman for abortion in a car.

During interrogation, the accused-duo revealed a jaggery unit in Mandya, used as an ultrasound scan centre, from where a police team later seized the scan machine, which did not have valid authorisation or other official documents.

Later, more people came to light and were arrested including another doctor named Dr Tulasiram.

The PCPNDT Act stipulates that only a medical doctor can buy an ultrasound scanning machine by submitting the required documents, and use it in a hospital set-up. However, Swamy failed to submit valid documents to procure the scanning machines.

According to the CID, Gowda, a Mangaluru-based licensed vendor selling ultrasound scanning machines didn’t insist on the documents because he desperately needed money. He told the investigators that Swamy had claimed he had all the documents. Gowda sold Swamy three more machines without documents.

The first machine that Gowda sold to Swamy was a used one. The second was broken. Gowda got both machines replaced by licensed dealers from Kerala. The CID plans to use the dealers as witnesses.

Swamy gave two machines to Siddesh, his cousin, who teamed up with a few others and started performing illegal sex determination. Shiva Nanjegowda, a lab technician from Mysuru, got another machine from Swamy and gave it to a friend, who runs a hospital in Channarayapatna.

Following this, the CID seized all four scanning machines after the racket was busted as reported by Deccan Herald.

The 11 touts who were first arrested but were released on bail spread the word about sex determination in the villages, especially in the Old Mysuru region. They also performed sex determination two days per month in makeshift labs in villages near Mandya.

The touts called the customers at a specific place in Bengaluru. The fact that the illegal sex determination tests increased as individuals who had undergone the procedure shared information, drawing in other curious villagers wanting to know the gender of their unborn child.

The touts from Bengaluru would transport them to Mandya for gender determination, with a price tag of Rs 10,000. In case the parents decided to terminate the fetus, usually female, they were directed to two hospitals in Mysuru – Matha Hospital and Ayurvedic Daycare Centre which were performed by Dr Ballal. 

The nurses were involved in this case after they helped Dr Ballal in carrying out the abortions at a hospital. The hospital’s manager Meena and receptionist Rizma Khan were arrested as reported by the Medical Dialogues team. 

Also Read: Violation of PC PNDT Act: Licence of three ultrasound centres suspended, show cause notice issued

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Health Bulletin 02/ April/ 2024

Here are the top health stories for the day:

CDSCO issues alert for 58 drug samples

In its latest drug safety alert, the apex drug regulatory body, the Central Standard Control Organisation (CDSCO) has flagged 58 medicine batches for failing to qualify for a random sample test for February 2023, while 2 drug samples have been declared as suprious.

These drugs include Acepik – P (Aceclofenac and Paracetamol Tablets) manufactured by Nexkem Biotech, Amoxycillin Oral Suspension I.P. (Medmoxil 125) manufactured by Laborate Pharmaceuticals, Calcium Carbonate and Vitamin D3 Tablets IP (Calcigiant 500 Tablets) manufactured by Nutra Life Healthcare, Ofloxacin manufactured by Concept Pharmaceutical, Calcium and Vitamin D3 Tablets manufactured by Hanuchem Laboratories, Serratiopeptidase Tablets manufactured by Arnav Research Laboratories.

For more information, click on the link below:


NMC panel consensus: Corporate hospitals advert decision heads to Supreme Court

The National Medical Commission’s (NMC) panel, which was formed based on the Supreme Court’s directions to examine the issue of advertising by corporate hospitals, is going to submit its recommendations to the Supreme Court.

Reaching a consensus, the NMC panel has opined that the rules of advertisement shall be the same for the corporate hospitals as well as for the doctors and other health facilities, The Print has reported.

For more information click on the link below:
WHO publishes new guidelines on hepatitis B
In a landmark move, the World Health Organization (WHO) has released groundbreaking guidelines to address the global challenge of chronic hepatitis B (HBV) infection. Unveiled at the 2024 Asian Pacific Conference for the Study of Liver Disease in Kyoto, Japan, these guidelines aim to simplify and expand access to HBV testing and treatment, marking a crucial step towards the WHO’s goal of eliminating viral hepatitis by 2030. With over 250 million people worldwide living with HBV, the new WHO guidelines focus on preventing mother-to-child transmission, a key transmission route, by recommending antiviral treatment for pregnant women and immediate newborn vaccination. This approach not only aims to reduce the global burden of HBV but also prevents liver-related complications, aligning with India’s efforts to curb the disease through its Universal Immunization Program (UIP).
Additionally, they focus on improving HBV diagnostics, addressing hepatitis delta coinfection, and enhancing the delivery of HBV services to ensure long-term adherence to therapy and retention in care.


Almost 50,000 excess deaths estimated globally due to disrupted routine vaccinations: Study

A new modeling study published in The Lancet Global Health journal estimated the health effects of COVID-19-related immunization disruptions in 112 countries during 2020–30.

The researchers used modeling groups from the Vaccine Impact Modelling Consortium from 112 low- and middle-income countries to estimate vaccine effects for 14 disease-causing pathogens. They revealed close to 50,000 additional deaths globally are estimated between 2020 and 2030 due to pandemic-related disruptions to immunization.
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Study finds health care utilization is increased in high-risk children who have a sleep disorder

The risk of increased health care utilization among children with a chronic medical condition is higher for those who also have a sleep disorder, according to a new study that examined Medicaid claims data.

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More than 18,000 excess tuberculosis cases in the US attributable to structural racism: Study

A robust analysis of national tuberculosis (TB) surveillance data found continuing, persistent disparities in TB incidence among U.S.-born racial and ethnic minorities, despite an overall decrease in cases observed during the analysis period. The authors conclude that structural racism is largely to blame. The analysis is published in Annals of Internal Medicine.

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Lower levels of albuminuria associated with increased risk for chronic kidney disease progression and kidney failure

A study of patients with chronic kidney disease (CKD) found a substantial excess risk for CKD progression and kidney failure as albuminuria (protein in the urine) increased, even at levels below 30 mg/g. These findings raise questions about the best time to start treatment to reduce protein in urine, and whether lowering albumin levels further could improve health outcomes in people with CKD who already have relatively low levels of albumin in their urine. The findings are published in Annals of Internal Medicine.

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Little guidance exists for treating inpatients with asymptomatic high blood pressure, review finds

A systematic review of 14 clinical practice guidelines found that guidance on inpatient management of elevated blood pressure (BP) without symptoms is lacking. According to the authors, this lack of guidance may contribute to variable practice patterns. The review is published in Annals of Internal Medicine.

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A Texan has contracted H5N1 bird flu: CDC calls threat to public ‘low’

An unnamed person in Texas had been diagnosed with the H5N1 avian flu after close contact with infected dairy cattle, the U.S. Centers for Disease Control and Prevention reported Monday.

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5 Epilepsy Myths Debunked by Neurologist – Dr Rahul Chawla

Epilepsy is a neurological disorder characterized by
recurrent, unprovoked seizures.

Seizures are sudden, uncontrolled electrical disturbances in
the brain that can manifest in various ways, depending on the part of the brain
affected.

A seizure is the event. Epilepsy is the disease associated
with spontaneously recurring seizures.

Operational Definition of Epilepsy (ILAE 2014)

Epilepsy is a neurological disorder characterized by
recurrent, unprovoked seizures; defined by any of the following conditions:

1. A least two unprovoked (or reflex) seizures occurring
>24 h apart.

2. One unprovoked (or reflex) seizure and a probability of
further seizures similar to the general recurrence risk (at least 60%) after
two unprovoked seizures, occurring over the next 10 years.

3. Diagnosis of an epilepsy syndrome.

There have been a lot of misconceptions in India regarding
epilepsy. Here are 5 Common myths around Epilepsy:

MYTH 1

Epilepsy is caused
by Evil Spirit. It is a Mental Illness.

FACT

  • Epilepsy is a neurological condition.
  • Epilepsy affects mental health and patients may
    have coexisting mental health issues, but it’s not a mental illness.

MYTH 2

Epilepsy Can Be Cured by Home Remedies

FACT

  • Epilepsy requires anti-seizure medications, which
    have to be taken after consultation with a neurologist or physician.
  • Epilepsy cannot be cured by home remedies or
    alternative therapies alone.

MYTH 3

Epilepsy is Contagious

FACT

  • Epilepsy is not contagious.
  • It’s a neurological disorder, not an infectious
    disease.

MYTH 4

Epilepsy Medications Are Addictive

FACT

  • Epilepsy medications are not addictive.
  • Epilepsy medications can effectively control
    seizures, allowing people to lead normal lives.

MYTH 5

Epilepsy requires patients to take life-long medications

FACT

  • The duration of treatment depends on the
    etiology.
  • The duration is likely to extend if the patient
    has seizure despite taking anti-epileptic medication and requires escalation of
    medications.
  • Certain genetic epilepsy syndromes may warrant
    life-long anti-epileptic treatment.

Patients with well controlled seizure and normal EEG and MRI
Brain after 3 years are candidates for tapering and cessation of anti-seizure
medications under supervision.

Epilepsy is a treatable condition. It is important to find
the cause for epilepsy and treat for desired time duration. If not treated,
recurrent seizures predispose patients to status epilepticus, which is a life-threatening
condition.

Patients with uncontrollable epilepsy are also at risk for
SUDEP (sudden unexpected death in epilepsy patients). Hence, it is necessary to
be under regular follow up and strict compliance to medications to be ensured.

Disclaimer: The views expressed in this article are of the author and not of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.

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Alembic Pharma ropes in Manish Kejriwal as Independent Director

Mumbai: Alembic Pharmaceuticals Limited has appointed Manish Kejriwal as an Independent Director of the company for the period of five consecutive years effective from March 31, 2024. Kejriwal brings over 30 years of experience in private equity investments and is currently the founder and Managing Partner of Kedaara Capital.

Prior to founding Kedaara Capital, Kejriwal served as the head of the India office of Temasek Holdings Pte. Ltd., managing all investments and activities. He also held a prominent role as a Partner at McKinsey & Company, Inc., where he co-founded “The Private Equity Practice” and authored influential reports such as the “NASSCOM McKinsey reports.”

Kejriwal holds an AB degree in Engineering Sciences from Dartmouth College and an MBA from Harvard University, where he graduated with high distinction as a Baker Scholar. He currently serves on the boards of Bajaj Finserv Limited, Bajaj Holdings Investment Limited, various Kedaara investee companies, and K Raheja Corp Investment Managers Private Limited.

An active member of the Young Presidents’ Organization (YPO) and a Young Global Leader (YGL) recognized by the World Economic Forum, Kejriwal is deeply involved in education initiatives, including the United World College movement and Ashoka University. He has authored articles on private equity in India, featured in leading publications, and is a sought-after speaker at conferences worldwide.

Read also: Alembic Pharma Gets CDSCO Panel Nod to Study FDC Carbidopa, Levodopa ER Capsule for export purpose only

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the US FDA. 

Read also: Alembic Pharma Slashes the Price of Tofastar by 50% for Benefit of Rheumatoid Arthritis Patients

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