Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus’ Phase III CT Waiver Request for Voclosporin

New Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control Organisation (CDSCO), has rejected Zydus Lifesciences’ proposal to conduct a phase III clinical trial of Voclosporin capsule 7.9 mg.

This came after the firm presented a bioequivalence (BE) study report and justification of the Phase III local clinical trial waiver before the committee.

The Committee considered the BE study results. However, the expert panel noted that the data presented with respect to orphan drug status is anecdotal.

Accordingly, the expert panel requested the firm to submit adequate data to substantiate the orphan drug status in the Indian context.

Voclosporin is a calcineurin inhibitor for the treatment of lupus nephritis (LN) in patients diagnosed with systemic lupus erythematosus (SLE).Through the inhibition of calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses, stabilizing podocytes in the kidneys

Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes.

At the recent SEC meeting the expert panel reviewed the bioequivalence (BE) study report and justification of the Phase III local clinical trial waiverher

Furthermore, there are concerns over the safety profile of the drug in the Indian population, as the published study data included Asian patients but not patients from India specifically, the committee noted.

The committee also noted that dose titration of the drug in the Indian population is required.

In view of the above, the committee is of the opinion that there is a lack of sufficient efficacy and safety data to prove that the dose requirement in Indian population is adequate.

In addition, the data on the course of dose titration is also inadequate considering the safety profile of the drug. Therefore, the expert panel stated that the firm is required to submit data proving that there is no substantial ethnic variability.

After detailed deliberation, the committee didn’t agree to Phase-III CT waiver at this stage.

Also Read: Sun Pharma Fails to Secure CDSCO Nod for BE, Phase III Waiver on Sitagliptin, Glimepiride, Metformin FDC

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Torrent Pharma Brand Misused in Online Investment Scam, Fake Portals Promising High Returns Busted

Ahmedabad: A major cyber fraud has come to light after criminals set up fake websites using the name of Torrent Pharmaceuticals to lure investors with promises of unusually high returns.

The scam was exposed when a resident of Surendranagar contacted Torrent Pharma’s official helpline to inquire about “profits” he was promised from one such investment plan. The company’s legal manager, Siddharth Kale, then filed a complaint with Navrangpura police on Thursday.

According to the FIR, the fraudsters created websites such as torrenthealthier.com, torrentbiotech.com, and torrentbiology.com. These portals used the company’s branding and logo to appear legitimate while promoting investment schemes. One advertisement read: “Invest Rs 670 and earn Rs 275 daily for a total of Rs 14,025 in 51 days.”

Also Read: Hyderabad doctor defrauded of over Rs 30 lakh on pretext of marriage

The fake websites were circulated aggressively on social media platforms, including Instagram, YouTube, and Telegram, tricking multiple people into believing they were official Torrent Pharma initiatives. Kale noted in his complaint, “We discovered that many others were being targeted through different numbers, all connected to these fake websites.”

Police stated the accused exploited Torrent’s brand credibility to build trust with victims. A Navrangpura police officer commented, “This is a serious case of identity theft where criminals exploited a trusted brand to trap people.”

A case has been registered under provisions of the Information Technology Act for identity theft, and investigators are working to trace those behind the scam.

Times of India reports that the authorities have issued an alert urging people not to fall prey to fraudulent investment plans that misuse the names of reputed pharmaceutical companies.

Also Read: Fake NRI Quota Scam: ED busts 18,000 fraudulent MBBS Admissions

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MUHS to close application window for fellowship in integrated family medicine programme 2025

Nashik: The Maharashtra University of Health Sciences (MUHS) is going to close the application process for its Fellowship in Integrated Family Medicine course for the academic year 2025-26 tomorrow.

The last date for submitting applications online is September 14.

According to University Registrar Dr Rajendra Bangal, the new fellowship was launched on the concept of Vice Chancellor Lt. Gen. Madhuri Kanitkar (Retd.) to empower primary healthcare and provide skilled services in urban and rural areas.

The course, which prioritises multi-disciplinary education and the Indian knowledge system in line with the National Education Policy, is open to graduates of medicine and Ayurveda.

Also Read:MUHS invites applications for PG health courses 2025, details

Dr Bangal said the students will be given basic skills in primary examination, screening, and treatment for common diseases, gynaecology, paediatrics, primary emergency management, and mental health. The core of the fellowship is to provide proper advice and treatment of both Ayurveda and modern medicine, which will help reduce pressure on major hospitals, quotes UNI

MPGI Dean Dr Mrinal Patil said that training for modern medicine subjects would be imparted to students at Maharashtra Postgraduate Medical Education and Research Institute in Nashik. For Ayurveda subjects, students will be trained at two affiliated Ayurveda colleges, including Ayurved Seva Sangh Ayurveda College and Shri Saptashrungi Ayurveda College. Dr Patil said the one-year fellowship, consisting of 15 modules, will offer experiential education in various hospital departments.

In May, Medical Dialogues had earlier reported that Highlighting major concerns regarding the quality of medical education in Maharashtra, a recent inspection report by the Maharashtra University of Health Sciences (MUHS), Nashik, revealed an acute shortage of teaching faculty in the government medical colleges across the State.

As per the MUHS inspection report, not a single government medical college and hospital in Maharashtra has 100% of its teaching posts filled. In fact, ten GMCs in the State are reportedly functioning with less than half the sanctioned teaching staff,

Also Read:Medical Education Dept Upholds Suspension in BJ Medical College Ragging Case, But students Allege Evidence Suppression

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Alembic Pharma gets USFDA EIR for 2 API facilities in Panelav

Vadodara: Alembic Pharma has announced that the Company has received Establishment Inspection Report (EIR) for the inspection carried out by the US Food and Drug Administration (USFDA) at its API – I & API – II Facility located at Panelav.

The EIR follows the inspection conducted from 26th May, 2025 to 31st May, 2025.

During the inspection, the facilities initially received four observations. Now EIR has been issued.

Read also: Alembic Pharma gets four USFDA observations for Panelav facility

Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It 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 USFDA.

Read also: Alembic Pharma gets USFDA nod for Phytonadione Injectable Emulsion for hypoprothrombinemia due to vitamin K deficiency

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India witnessed rise in chronic disease deaths between 2010-2019 amid global decline: The Lancet

A recent study published in The Lancet reveals a worrying trend: the risk of dying from non-communicable diseases (NCDs) has increased in India, unlike the global decline observed in most countries. NCDs such as heart disease, chronic respiratory illnesses, and cancers pose growing challenges, particularly affecting Indian women over 40 and men over 55. Between 2010 and 2019, the probability of dying from NCDs rose to 48.7% for women and 57.9% for men in India, with heart disease and diabetes being the top causes.

This contrasts sharply with declines seen in 152 countries for women and 147 for men worldwide during the same period. Experts point to lifestyle factors, pollution, urbanization, and insufficient healthcare access as key drivers. The study also highlights data quality issues in India, making accurate assessments difficult. The findings underscore urgent need for stronger public health policies, improved healthcare infrastructure, and better data collection to combat rising NCD deaths and protect vulnerable populations in India.

REFERENCE: Bennett, James E et al.; Benchmarking progress in non-communicable diseases: a global analysis of cause-specific mortality from 2001 to 2019; The Lancet, Volume 0, Issue 0; doi: 10.1016/S0140-6736(25)01388-1

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Health Bulletin 13/September/2025

Here are the top health stories of the day:

NEET PG 2025: Supreme Court postpones hearing by 2 weeks

The Supreme Court of India has postponed the hearing of the National Eligibility-Entrance Test Postgraduate (NEET-PG) 2025 examination-related case hearing.

The top court bench was supposed to take up all the pending matters related to NEET PG transparency today, but the Court has now adjourned the matter for two weeks.

As per the Supreme Court’s official website, the case has been listed for further hearing on 23.09.2025.

Medical Dialogues had earlier reported that a group of NEET-PG 2025 aspirants filed a plea before the Supreme Court challenging the “corrective notice” issued by the National Board of Examinations in Medical Sciences (NBEMS) on August 21.

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

Supreme Court Delays NEET PG Transparency Case Hearing by Two Weeks

Delhi High Court seeks UPSC reply on reservation for blind, low vision candidates in Combined Medical Services exam

The Delhi High Court recently sought to know the Union Public Service Commission’s (UPSC) stance on a plea seeking one percent reservation for candidates with blindness and low vision in the Combined Medical Services Examination (CMSE).

While considering the matter, the HC bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tushar Rao Degela issued notices to the UPSC, the Department of Personnel and Training (DoPT), the Union Ministry of Health and Family Welfare, and the Department of Empowerment of Persons with Disabilities (DEPwD).

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

Delhi High Court Seeks UPSC Reply on 1% Blind, low vision Reservation in Combined Medical Services exam

Gujarat HC rejects plea to quash charges against Gynaecologist in Childbirth Death Case

Denying to grant relief to a gynaecologist booked for culpable homicide not amounting to murder- IPC 304, the Gujarat High Court recently refused to entertain his plea seeking quashing of the proceedings.

The gynaecologist, along with others, was booked after a woman died during childbirth at a Bavla-based hospital back in May 2024. In this connection, Bavla police registered an FIR on September 2.

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

Patient dies during childbirth, Gujarat HC Rejects Plea to Quash Charges Against Gynaecologist

India witnessed rise in chronic disease deaths between 2010-2019 amid global decline: The Lancet

A recent study published in The Lancet reveals a worrying trend: the risk of dying from non-communicable diseases (NCDs) has increased in India, unlike the global decline observed in most countries. NCDs such as heart disease, chronic respiratory illnesses, and cancers pose growing challenges, particularly affecting Indian women over 40 and men over 55. Between 2010 and 2019, the probability of dying from NCDs rose to 48.7% for women and 57.9% for men in India, with heart disease and diabetes being the top causes.

This contrasts sharply with declines seen in 152 countries for women and 147 for men worldwide during the same period. Experts point to lifestyle factors, pollution, urbanization, and insufficient healthcare access as key drivers. The study also highlights data quality issues in India, making accurate assessments difficult. The findings underscore urgent need for stronger public health policies, improved healthcare infrastructure, and better data collection to combat rising NCD deaths and protect vulnerable populations in India.

REFERENCE: Bennett, James E et al.; Benchmarking progress in non-communicable diseases: a global analysis of cause-specific mortality from 2001 to 2019; The Lancet, Volume 0, Issue 0; doi: 10.1016/S0140-6736(25)01388-1

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VACANCIES! SR Post At Indira Gandhi ESIC Hospital Delhi Via Walk In Interview, Hurry To View Details

New Delhi: The Indira Gandhi Employees State Insurance Hospital (IG ESI Hospital Jhilmil) has announced vacancies for the Senior Resident posts in different departments in this medical institute. 

ESI is a statutory body constituted under an Act of Parliament (ESI Act, 1948) and works under the administrative control of the Ministry of Labour and Employment, Government of India.

ESIC Vacancy Details:-

Total no of Vacancies: 25

The Vacancies are in the Departments of Anesthesia, Gynaecology, Surgery, Radiology, ICU, and Peadiatric.

The date of walk In Interview is 16th SEPTEMBER 2025.

Venue and Reporting Time: The office of the Medical Superintendent, IG ESI Hospital, Jhilmil, New Delhi- 110095 At 9.00 AM.

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link:
https://medicaljob.in/jobs.php?post_type=&job_tags=esic+delhi&location=&job_sector=all

What are the Instructions for Eligible Candidates:-

Applicants are advised to reach the office of the Medical Superintendent, IG ESI Hospital, Delhi on the date of walkin- interview i.e. on 16.09.2025 at 9.00 A.M. as per scheduled interview mentioned in the advertisement along with original documents and one set of photocopies (self-attested) as listed on the application form. No candidate will be entertained after 10.30 A.M

The candidates are advised to bring their all Original Certificates with one set of self-attested photocopies of the following documents during verification: –

1. Identity proof [PAN Card, Passport, Driving License, Voter Card, Aadhar Card etc.]

2. Address Proof [Ration Card, Passport, Driving License, Aadhar Card etc.]

3. Certificate showing date of birth [10th certificate/Birth certificate]

4. Two recent passport size photographs

5. Photocopies of Aadhar/PAN Card and Bank Passbook [At the time of joining for only selected candidates]

6. Class 10th/12th mark sheets and certificates

7. MBBS, MD/MS/DNB/DM and Experience certificates whichever is applicable as per NMC guidelines.

8. Registration with Delhi Medical Council.

9. Internship completion certificate.

10. Reservation category certificate [OBC/SC/ST/PH/EWS] in the format prescribed by Govt. of India.

11. NOC certificate from present employer if applicable

12. Experience certificate if applicable.

13. Income and Asset certificate from issuing Authority as per DOPT letter no. 36039/1/2019. Esst. (Res) dated 31st January 2019 must be submitted for the reservation for EWS Category.

Also Read:64 SR Post VACANCIES At ESIC Hospital Faridabad: Check OUT Walk In Interview Details Here….

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Doctors Urge JnK Govt to Increase Stipend for MBBS Interns

Srinagar: Demanding a stipend hike for the MBBS interns in Jammu and Kashmir, the doctors have urged the Chief Minister, Health Minister, and Director of Health Services of Jammu and Kashmir to intervene. Currently, the MBBS interns in the Union Territory receive Rs 12,000 per month as their stipend.

Highlighting the “urgent need for a significant hike” in the stipend provided to the medical interns in the Union Territory of Jammu and Kashmir, the Democratic Medical Association (DMA) pointed out that “internship is a crucial period in the career of a medical graduate, where they contribute extensively to patient care and public health services under challenging circumstances, often without adequate financial support.”

It pointed out that currently, the J&K medical inerns get insufficient amount of stipend, causing severe financial difficulties and demoralizing young doctors who are serving the healthcare system with dedication.

In its letter, the association mentioned, “It is important to mention here that in the past as well, several efforts and representations have been made regarding this issue, but unfortunately no conclusive action has been taken so far. This prolonged delay has created frustration among young doctors who continue to serve selflessly despite financial constraints.”

Further, the association highlighted how several states across India have already revised the internship stipend in line with the rising cost of living and the contribution of interns. “Unfortunately, the stipend in J&K has not been brought at par, creating disparity and discontent among the young medical workforce,” DMA mentioned in the letter.

“In view of the above, we strongly urge your esteemed office to consider and implement a substantial revision in the internship stipend at the earliest possible time. This step will not only uplift the morale of the young medical workforce but also ensure better healthcare services for the people of Jammu & Kashmir. We remain hopeful that under your leadership, this long-standing demand will be addressed with priority and sensitivity,” it further added.

The letter has been addressed to the Hon’ble Chief Minister Shri Omar Abdullah and Health Minister Smt. Sakeen Masood (Itoo) and it has been jointly drafted and signed by Dr. Amit Vyas (National Chief & National President), Dr. Shubh Pratap Solanki (National General Secretary), Dr. Sheikh Amir (National Faculty), and Dr. Kamal Singh (National Joint Secretary) of DMA.

Commenting on the matter, the National President of DMA, Dr. Amit Vyas said, “We are hopeful that the Hon’ble Chief Minister and Health Minister will take up this long-pending demand with sensitivity and priority.”

Medical Dialogues had earlier reported that recently the Vice President of All India Medical Students Association (AIMSA) , Dr. Mohammad Momin Khan also requested the CM’s intervention to ensure a stipend hike for the MBBS interns in J&K.

Highlighting that the MBBS interns of J&K receive a stipend of only Rs 12,000 per month, Dr. Khan mentioned in a letter addressed to the Chief Minister of J&K, Mr. Omar Abdullah that “Despite repeated assurances over the past six years, no substantial progress has been made, leaving young medical graduates disheartened and financially strained.”

Also Read: JnK CM’s intervention sought for MBBS intern stipend hike

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AI algorithm turns mammograms into a ‘two-for-one’ test for women’s heart health

An AI algorithm based only on routine mammogram images plus age can predict a woman’s risk of major cardiovascular disease as well as standard risk assessment methods, finds research published online in the journal Heart.

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Engineered antibodies can direct T-cells to kill cytomegalovirus-infected cells

A UCLA research team has found a new way to prompt the immune system to kill cells infected with cytomegalovirus (CMV), a life-threatening infection that is particularly deadly in immunocompromised people.

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