FDA now providing daily updates on adverse events

The U.S. Food and Drug Administration is now providing real-time, daily publication updates on adverse event data from its reporting system.

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Childhood trauma linked to mental health problems and chronic pain in later life

New research from the University of Aberdeen challenges the current view that trauma in childhood increases the risk of all health conditions. The study found instead that some conditions are more affected than others and women are more affected than men.

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‘We need to look after our grand-friends’: How childcare in aged care can help young and old

An experimental aged-care model in South Australia, where purpose-built independent retirement living apartments are co-located with an early learning center, is seeking to foster connections between residents and children.

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Sun Pharma Gets CDSCO Panel Nod for Phase IV Trial of Esomeprazole Dual Release Tablets 80 mg

New Delhi: Sun Pharma has received approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg, based on its revised study protocol.

According to the minutes of the 12th/25 SEC (Gastroenterology & Hepatology) meeting held on August 20, 2025, at CDSCO headquarters, the proposal was taken up under the SND Division.

In continuation with earlier SEC (Gastroenterology & Hepatology) recommendation dated 27/02/2025, the firm presented revised protocol for Phase-IV clinical trial of Esomeprazole Dual release gastro-resistant tablets 80 mg before the Committee.

The committee carefully examined the revised Phase IV clinical trial protocol presented by Sun Pharma. After detailed deliberation, the SEC issued its recommendation, stating:

“After detailed deliberation, the Committee recommended to grant the permission to conduct Phase IV clinical trial as per protocol presented by the firm.”

Esomeprazole is a proton pump inhibitor (PPI) widely used to reduce gastric acid secretion. Dual release formulations are designed to offer prolonged acid suppression, potentially improving therapeutic outcomes in acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and peptic ulcer disease.

The Phase IV trial represents a post-marketing clinical investigation intended to generate additional safety and efficacy data under routine clinical use conditions. This aligns with regulatory requirements for monitoring the real-world performance of higher-dose or specialized formulations.

The SEC’s decision clears the way for Sun Pharma Laboratories Limited to move forward with its Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg in accordance with the approved study protocol.

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Pharmacy Institutions Failing to Submit Data by Aug 31 to Lose 2025-26 Approval: PCI

New Delhi: The Pharmacy Council of India (PCI) has issued a final reminder to pharmacy institutions seeking approval under Section 12 for the 2025-26 academic session, directing them to submit complete additional information between August 26 and August 31, 2025.

The Council noted that despite repeated opportunities, some institutions have failed to provide the required details. As a result, such institutions were placed in the category of “Not to make admissions in the first year for 2025–26.”

According to the latest circular, several institutions had failed to submit the complete documents within the stipulated time, despite earlier notifications dated 3 July 2025 and 24 July 2025.

In this connection, the Pharmacy Council of India (PCI) informs that—

a) Some institutions have failed to submit the complete additional information regarding u/s 12 approval after repeated opportunities given.

b) Council has conveyed the decision to the institutions to not grant approval u/S 12 for the 2025-2026 academic session and the institutions for said course are placed under the category of “Not to make admission in 1st year” for the 2025-2026 academic session.

However, PCI has now given a last opportunity for compliance. Institutions must ensure that all required tabs on the PCI portal are completely filled within the specified window.

In view of the above, through the recent circular, it is stated,

“The last opportunity to submit the complete additional information and ensure that each and every tab should be filled for considering approval u/s 12 for the 2025-2026 academic session and the portal will be open from 26.8.2025 to 31.8.2025.”

The Council has cautioned that failure to meet this deadline will result in applications being summarily rejected and not considered for approval under Section 12 for 2025–26.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/14-56circular2025-26-299193.pdf

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Bombay HC Grants Conditional Bail to Pharma Manager in Rs 1.25 Crore Suspected Mephedrone Case

Aurangabad: A 57-year old environment, safety, and health manager at a multinational pharmaceutical company has been granted conditional bail by the Bombay High Court, in a high-profile suspected mephedrone seizure case.

Justice Sanjay Deshmukh ordered Kishor Pawar’s (57), in Waluj MIDC release on a ₹50,000 personal bond, with strict instructions not to tamper with evidence or influence witnesses.

As per a media report in the Times of India, Pawar was arrested in June when police intercepted trucks carrying scrap material and reportedly recovered 2.5 kg of suspected mephedrone valued at ₹1.25 crore. An additional 961 grams of a similar substance were allegedly found at the company’s warehouse. He is the first among six accused to secure bail in the ongoing investigation.

The defence team, led by Rohit Kochar along with Abhaysinh Bhosale and Nachiketa Goyal, argued that Pawar was not named in the FIR and no narcotics were recovered from his personal possession. They emphasized that the company manufactures only export-oriented antihypertensive drugs. Forensic reports reportedly identified the seized powder as Valsartan and Hydrochlorothiazide, legitimate pharmaceutical ingredients rather than banned substances.

Also Read: Chhattisgarh HC denies bail in Rs 411 crore Medical Equipment Scam

The legal team also pointed out procedural irregularities during the investigation, such as the absence of a magistrate during sample collection, lack of videography, and delays in forensic lab reports, arguing that these lapses weakened the case against Pawar.

Times of India reports that the bail order highlights growing judicial scrutiny over narcotics-related investigations, especially where procedural and testing lapses raise doubts about the authenticity of alleged drug seizures.

The investigation continues, with five other accused still in custody.

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DNB Surgery course soon at Lok Bandhu hospital Lucknow

Lucknow- In a major development in the field of medical education, Lok Bandhu Raj Narayan Samyukta Chikitsalaya, Lucknow, is soon going to start a new Diplomate of National Board (DNB) course in surgery.

For this, the hospital had also received recognition from the National Board of Medical Examination (NBEMS), New Delhi last month, according to Dr Arun Tiwari, nodal officer of DNB at the hospital.

In this regard, Lokbandhu Hospital has signed a Memorandum of Understanding (MoU) with King George Medical University (KGMU) for rotational posting of DNB students in super-speciality departments. Under this, students will receive this training at KGMU at the end of their first year.

On this, Dr Arun Tiwari said, “We have received permission from NBEMS to start the new course. The hospital has the required infrastructure and is fully equipped with modern facilities for the students, including smart boards, projectors, a library, seminar rooms and a wide stock of subject-related books. We have also applied for subscription to national and international journals to assist students in research and dissertation”, report TH.

Meanwhile, six months ago, the hospital had launched four DNB courses- general medicine (two seats), paediatrics (four seats), orthopaedics (one seat), and obstetrics and gynaecology (two seats). With the addition of the surgery course, the hospital will now offer a total of 12 seats in five DNB subjects.

DNB is a postgraduate and postdoctoral medical qualification offered by NBEMS, an autonomous body under the Union Ministry of Health and Family Welfare. Recognised as equivalent to MD/MS, DNB is a full-time speciality training programme that qualifies doctors to serve as specialists and faculty across India.

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Legible Prescriptions a Fundamental Right: Punjab and Haryana HC directs doctors to use capital letters

Chandigarh: Observing that legible medical prescriptions and diagnosis form an essential part of a patient’s right to health under Article 21 of the Constitution, the Punjab and Haryana High Court directed doctors to write prescriptions and diagnosis notes in capital letters until computerisation or typed prescriptions become the norm. 

The directive follows a shocking incident where the court was unable to understand a single word from a medico-legal report concerning a rape case due to the illegible handwriting of the doctors involved. 

While considering the plea, the court noted that unclear or illegible handwriting in prescriptions can endanger patients’ lives and compromise their right to know what treatment is being given. It further noted that in the age of digital health and artificial intelligence, legible prescriptions are indispensable to ensure that the Fundamental Rights of the people of India are duly safeguarded.

Also read- Punjab Mandates 48-Hour Deadline for Submission of Medico-Legal Reports

Suggesting preventive measures, Single Bench Justice Jasgurpreet Singh Puri asked the National Medical Commission (NMC) to include the importance of clear and legible handwriting in medical prescriptions as part of the curriculum in all medical colleges. The Court said that digital or typed prescriptions should be made a priority across the country.

Holding that the right of patients to clearly understand their treatment is an integral part of the fundamental right to life under Article 21, the bench observed,

“This court is of the considered view that Right to Life and Personal Liberty guaranteed under Article 21 of the Constitution of India encompasses the Right to Health, which further includes the Right to Know one’s legible medical prescription, diagnosis, medical documents and treatment.”

As per a media report by Bar and Bench, the matter came up when the Court, while hearing a bail plea earlier this year, encountered an illegible medico-legal report. Taking suo motu cognizance, the bench sought responses from Punjab, Haryana, and the Union Territory of Chandigarh. Although the Indian Medical Association was asked to assist, it chose not to appear in the matter.

In subsequent hearings, the States informed the Court that doctors had already been directed to write prescriptions and diagnosis in capital or bold letters until computerised or typed prescriptions are fully implemented. 

In its final order, the Court directed that a comprehensive policy be framed to ensure complete computerisation of prescriptions within two years. It further emphasised that financial assistance must be provided to doctors and clinical establishments wherever required.

The Court remarked,

“While looking at the medico-legal report filed by the respondent-State along with reply as Annexure R-1, it shook the conscience of this Court as not even a word or a letter was legible. It is very surprising and shocking to note that in this era of technology and accessibility of computers, the notes on the medical history and prescriptions by Government doctors are still handwritten in a manner that cannot be read by anybody except perhaps some chemists.”

It further observed, “Everyone in today’s time is well informed and aware of as to how technology can be put to use in their day to day lives. In such progression of informed citizens, it becomes likely for most of us to check the medical prescription/diagnosis which has been provided by the doctor in order to lookout for any relevant information which might be available regarding the same on digital platforms. This practice has been further aided by the introduction of Artificial Intelligence, where all the curated information on any subject lies just a click away.”

The Court made it clear that this move is not about replacing doctors’ expertise with technology, but about ensuring patients’ safety and rights. It added that if prescriptions are unclear, it jeopardises the quality and safety of patients, hindering broader access to care and patients’ right to give free consent without having any knowledge as to what has been prescribed to them.

“The issue involved herein is not an issue of substitution, which otherwise could be counter productive to the health of patients, but the issue involved is only a right to know about the treatment being carried on towards him. Illegibility leads to ambiguity and confusion, which can in turn take on a patient’s life or health,” the Court said.

While acknowledging the hard work and dedication of doctors, the Court said,

“This Court holds the highest respect and regard for doctors and the medical profession, acknowledging their dedication to national service, but at the same time, it is equally important to ensure that the Fundamental Rights of the people of India are duly safeguarded.”

Also read- Right to Medical Reimbursement linked to Right to Life: HC

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100 Additional Delhi Hospitals to be added under Ayushman Bharat soon

Delhi Health Minister Dr Pankaj Singh on Thursday announced that the government will add 100 more hospitals under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) in the next 10 days. This move will increase the total number of empanelled hospitals in the capital to 165.

The updated list is expected to include prominent private hospitals such as Fortis Healthcare. A formal launch of the expanded network is scheduled for the first week of September.

According to the National Health Authority (NHA), which oversees the implementation of AB-PMJAY across India, 151 hospitals in Delhi are currently empanelled under the scheme—107 private and 44 government-run.

For more details, check out the full story on the link below:

Delhi Govt to empanel 100 additional hospitals under Ayushman Bharat

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Health Bulletin 30/August/2025

Here are the top health stories of the day:

Doctors, Legal Experts Oppose Lowering Age of Consent

Several doctors, psychologists, rights activists and lawyers on Thursday strongly opposed any move to reduce the age of consent from 18 to 16 years, warning that it could adversely impact the social, psychological and physical well-being of adolescents.

NHRC member Priyank Kanoongo, terming the move a ”time bomb”, which, if ”not defused”, will ”explode inside families”.

For more details, check out the full story on the link below:

Doctors, Rights Experts raise alarm over proposal to lower age of consent

Delhi HC Issues Notice to NBE, Centre Over DNB Revaluation Clause Challenge

The Delhi High Court has sought a response from the National Board of Examination (NBE) and the Centre on a plea filed by a DNB trainee doctor from Gangaram Hospital challenging the evaluation rules in the Diplomate National Board exam.

The petitioner argued that the current clause allows revaluation only if an answer is wrongly marked “not attempted,” leaving no scope to challenge ‘arbitrary’ evaluation. She claimed her answer sheets showed discrepancies, and denial of revaluation had unjustly barred her from the practical exam, jeopardizing her career.

For more details, check out the full story on the link below:

Doctor challenges ‘arbitrary’ revaluation clause in DNB exam- Delhi HC issues notice to NBE, Centre

100 Additional Delhi Hospitals to Be Added Under Ayushman Bharat Soon

Delhi Health Minister Dr Pankaj Singh on Thursday announced that the government will add 100 more hospitals under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) in the next 10 days. This move will increase the total number of empanelled hospitals in the capital to 165.

The updated list is expected to include prominent private hospitals such as Fortis Healthcare. A formal launch of the expanded network is scheduled for the first week of September.

According to the National Health Authority (NHA), which oversees the implementation of AB-PMJAY across India, 151 hospitals in Delhi are currently empanelled under the scheme—107 private and 44 government-run.

For more details, check out the full story on the link below:

Delhi Govt to empanel 100 additional hospitals under Ayushman Bharat

CDSCO Flags 46 Drug Batches for Failing Quality Tests in July

The Central Drugs Standard Control Organization (CDSCO) has declared 46 batches of medicines as “Not of Standard Quality” (NSQ) after drug samples tested by its regional and central laboratories in July 2025 failed to meet required pharmacopeial standards.

The flagged medicines include widely prescribed formulations such as antibiotics, cardiac drugs, gastrointestinal medicines, hormonal injections, and pain relief products.

These include Azithromycin Tablets IP (Aziventis-500) manufactured by Gnosis Pharmaceuticals, Heparin Injection IP 1000 IU/ml (Flagorin) manufactured by Divine Laboratories, Amikacin Sulphate Injection manufactured by SAI Parenterals, Amoxycillin and Potassium Clavulanate Tablets I.P. 625 mg manufactured by Hindustan Antibiotics, Dexamethasone Tablets IP 4mg (Dexatore-4) manufactured by United Bioceuticals, and others.

For more details, check out the full story on the link below:

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