Why endurance events like marathons should have weight divisions for heavier runners
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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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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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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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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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