CDSCO Panel Approves Novartis Protocol Amendment Proposal for Ruxolitinib study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by Novartis to study anticancer drug INC424 (Ruxolitinib).

This came after the firm presented Protocol Amendment Version 06 dated 29 Aug 2024, protocol no. CINC424A2X01B. This is an open-label, multi-center Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte-sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study and are judged by the investigator to benefit from continued treatment.

Ruxolitinib, formerly known as INCB018424 or INC424, is an anticancer drug and a Janus kinase (JAK) inhibitor. It is a potent and selective inhibitor of JAK1 and JAK2, which are tyrosine kinases involved in cytokine signalling and hematopoiesis.

Myeloproliferative neoplasms, such as myelofibrosis and polycythemia vera, are often characterized by aberrant activation of the JAK-STAT pathway, leading to abnormal blood cell counts and thrombotic complications. By inhibiting JAK1 and JAK2, ruxolitinib works to block the dysregulated cell signalling pathways and prevent abnormal blood cell proliferation. Due to a large number of patients with myeloproliferative neoplasms who have JAK2 mutations, ruxolitinib was the first ATP-competitive inhibitor of JAK1 and JAK2 ever developed.

At the recent SEC meeting for Oncology held on 19th December 2024, the expert panel reviewed the Protocol Amendment Version 06 dated 29 Aug 2024 protocol no. CINC424A2X01B.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: Miqnaf: CDSCO nod to Wockhardt 3-day treatment for Community-Acquired Bacterial Pneumonia

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Health Bulletin 04/ January/ 2025

Here are the top health news for the day:

Yet to Receive DoP Intimation to Take Action Against 30 Doctors Accepting Pharma Freebies, says NMC

New Delhi: The National Medical Commission (NMC) is yet to receive the intimation from the Department of Pharmaceutical (DoP) asking it to take action against 30 offending doctors who allegedly took pharma freebies in the form of travel and hospitality expenses from AbbVie Healthcare, a senior NMC official recently informed the Medical Dialogues team.

DoP received a complaint stating that the pharma company AbbVie provided travel tickets and hotel accommodations for extravagant pleasure trips under the guise of conferences (Aesthetics 86 Anti-Aging Medicine World Congress 2024), which took place from February 1 to 3, 2024, and from March 26 to 29, 2024, in Monaco and Paris, respectively, for 30 doctors connected to the medical aesthetics/anti-ageing products (Botox and Juvederm).

For more information, click on the link below:

Yet to Receive DoP Intimation to Take Action Against 30 Doctors Accepting Pharma Freebies: NMC

UP Medical College Principal Removed Over Corruption, Harassment Charges

Lucknow: Accused of corruption and harassment of staff, the principal of Rajarshi Dashrath Autonomous State Medical College of Ayodhya has now been removed from the post. Deputy Chief Minister of the State, Brajesh Pathak took this decision to ensure a zero-tolerance policy against corruption, Amar Ujala has reported.

Confirming the action against the principal, the Deputy CM informed that the college’s principal Dr. Gyanendra Kumar has been removed from the post. Dr. Kumar has also been attached to the office of the Director General of Medical Education and Training.

For more information, click on the link below:

Accused of Corruption, Harassment! UP’s Medical College Principal Removed


Will the NEET MDS 2025 Exam Get Postponed? Aspirants ask Amid Delay in application Form Release

New Delhi: Even though the National Eligibility-Entrance Test for Masters of Dental Surgery (NEET-MDS) 2025 is scheduled to take place on 31.01.2025, the application form for the entrance exam has not been released yet.

Amid this, the dentists willing to appear in the NEET MDS 2025 examination have expressed their doubts about whether the entrance test would be postponed.

For more information, click on the link below:

Will the NEET MDS 2025 Exam Get Postponed? Aspirants ask Amid Delay in application Form Release

Doctor held for trafficking of Newborns

Lucknow: The Gudamba police recently uncovered a child trafficking racket in the city, arresting a doctor who owns a private clinic and is believed to be the mastermind behind the operation. Along with the doctor, several other gang members were arrested. The group allegedly targeted impoverished families, lured them with money, and sold their newborns to childless couples for large sums of money.

The group allegedly used manipulation, coercion, and abduction to maintain their illicit operations. Initially, the gang lured impoverished families into handing over their children for money and in case they refused, the children were kidnapped.

For more information, click on the link below:

Lucknow doctor arrested for trafficking of Newborns

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Alcium-D3 tablets worth Rs 1.5 lakhs seized in Uppal

Telangana: Drugs Control Administration, Telangana has seized Alcium-D3 Tablets (Calcium with Vitamin D3 Tablets) worth Rs. 1.5 lakhs in Kothapet Village, Uppal Mandal, Medchal-Malkajgiri District, which were falsely manufactured and sold under the guise of ‘food products/nutraceuticals’.

The product was found to be  manufactured by Hindustan Nutraceuticals Inc., Plot No. 1, Sy. No. 581/1, Industrial Park, Uppal, Medchal-Malkajgiri District.

The said product was falsely manufactured under a ‘food license (FSSAI license)’ (FSSAI. Lic. No. 10017047000796) and falsely claimed to be a food product/nutraceutical. According to the label composition of the product, it is classified as a drug under the Drugs and Cosmetics Act, 1940.

The product must be manufactured only under a ‘drug licence’ issued under the Drugs and Cosmetics Act, adhering strictly to the ‘Good Manufacturing Practices’ (GMP) outlined in Schedule-M of the Drugs Rules.

Additionally, it must meet the quality standards prescribed in the ‘Indian Pharmacopoeia’ (IP) as mandated.

 Dr. B. Lakshmi Narayana, Drugs Inspector, Uppal and Smt. G. IndiraPriyadarshini, Drugs Inspector, Habsiguda carried out the raid under the supervision of Sri. G. Sreenivas, Assistant Director, Shameepet (i/c). 

The drugs that are falsely manufactured and sold under a food license are not produced in accordance with ‘Good Manufacturing Practices’ (GMPs)and often fail to meet the quality standards prescribed in the Indian Pharmacopoeia (IP). Such products pose serious risks to patients’ health and may have severe implications.

Manufacturing and selling ‘drugs’ without a valid ‘drug license’ is punishable under the Drugs and Cosmetics Act, with imprisonment for up to five years.

Read also: Telangana: Medicines worth Rs 2 crore seized

Medical Dialogues team has recently reported that Drugs Control Administration, Telangana officials, has also seized certain medicines circulating in the market with misleading claims on their labels, stating that they treat, ‘Kidney Stones’, and ‘For Prophylaxis and Treatment of Eye Infections’.

Read also: Telangana DCA seizes certain medicines for misleading advertisements

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Medical Specialists in Karnataka to now get hired on per day, per case basis

Bengaluru: Medical specialists in Karnataka will now be recruited on a per-day and per-case basis and their incentives will be calculated proportionally based on the days worked. This initiative by the Karnataka government has been introduced to tackle the severe shortage of specialists in the state.

According to the new alternative hiring model that will remain in effect till June 30, specialists in obstetrics, gynaecology, anaesthesiology, and surgery hired on a per-day basis will be required to work a minimum of two days per week. They will be paid as per Ayushman Bharat- Arogya Karnataka scheme rates. The current per-day rate is Rs 3,930.

Also read- NHM offers Incentives, Honorariums to encourage doctors to practice in Rural Areas: MoS Health

Therefore, the specialist will receive Rs 3,930 a day calculated by dividing the monthly salary of a contract specialist by the total number of working days in that month. This will allow them to work on days of their choice and receive a percentage of the total cost of duties or procedures they perform. The new contract will be valid for one year.

This initiative seeks to establish a more flexible hiring and working environment for specialists in diverse medical fields. It will address the shortage of specialists in hospitals in the state as the model is expected to attract more professionals to the public healthcare sector.

An order was issued in this regard on January 1 as reported by Deccan Herald mentioned, “Specialists hired on a per-day basis must work at least two days a week. Their pay will be calculated by dividing the monthly salary of a contract specialist by the number of days worked.”

Specialists can be hired for a period of one year with the possibility of extending the hiring for an additional six months, subject to a review of the implementation process and challenges faced, the order adds. The ABArK scheme offers incentive-based pay for specialists in fields like OBG, anaesthesia and surgery.

On the other hand, the pay-per-case model enables specialists to focus on individual cases as needed. For radiologists, this approach involves hiring on a per-case basis, where they will be paid for services such as radiographs, CT scans, and MRIs. They can certify these scans either in person or via a teleradiology system.  

Further, the health commissioner will issue guidelines to ensure that unnecessary procedures are not conducted to increase incentives, as per a TNIE news report. Rates will be finalised via local tenders after ceiling rates are certified by the commissioner of the State Health Department.

Also read- CAG Flags 64 per cent shortage of Hospital Beds in Odisha Government Hospitals

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NEET PG 2024 counselling cutoff percentile reduced, Check all details

New Delhi: The Medical Counselling Committee (MCC), operative under the Directorate General of Health Services (DGHS) has reduced the cut-off for National Eligibility-Entrance Test Postgraduate (NEET-PG) 2024 admissions making General/EWS candidates securing 15 percentile and above and SC/ST/OBC/PwD candidates securing 10 percentile and above eligible to participate in the counselling process. 

Issuing an urgent notification in this regard to the medical colleges today, the MCC mentioned that “as per decision taken by MoHFW in consultation with NMC, the percentile for NEET PG counselling 2024 has been lowered.”

The reduced percentile for the NEET PG 2024 is as follows:

 General Category/EWS- 15 percentile and above will be eligible to participate
in counselling

 SC/ST/OBC/ PwD category- 10 percentile and above will be eligible
to participate in counselling.

Previously, the qualifying the cutoff for the General category was 50th percentile. The cut-off was 45th percentile for General-PwBD category candidates, and 40th percentile for SC/ST/OBC (including PwBD of SC/ST/OBC) category students.

Also Read: NBE Releases NEET PG 2024 Results scorecard for 50 percent All India Quota Seats, details

The MCC notice comes after yesterday i.e. on 03.01.2025, the Delhi High Court bench approved the reduction in the percentile in the National Eligibility-Entrance Test Postgraduate (NEET-PG) 2024 examination for the subsequent rounds of counseling for admission to the Doctor of Medicine (MD), Master of Surgery (MS), and Diplomate of National Board (DNB) courses for the year 2024.

“Pursuant to the previous order dated 30th December 2024, counsel for respondents states that a decision for relaxation of existing percentile has been taken by the Competent Authority and has been approved…The percentile having been reduced for issues of admission to the concerned MS/MD/DNB courses for NEET PG Counselling 2024, counsel for petitioner states that their grievance stands addressed for the time being…Accordingly, petition is disposed of taking note of the statement made by counsel for respondents,” the HC bench comprising Justice Anish Dayal mentioned in the order dated 03.01.2025.

This order has been issued by the HC bench while considering the pleas filed by physically disabled PG medical aspirants, who had challenged the conversion of the vacant postgraduate medical seats reserved for physically disabled candidates to general candidates in the third round of NEET PG counselling 2024.

Also Read: Plea Seeks to Halt Conversion of PwD Quota Seats to General in NEET PG Counselling, HC asks MCC to respond

Medical Dialogues had earlier reported that the petitioners had earlier sought the intervention of the Court to preserve the seats for the PwD candidates in the NEET PG Counselling till the stray vacancy round. They had pointed out that the majority of the seats reserved for the PwD candidates were still lying vacant due to the non-availability of qualified PwD candidates even after two rounds of counselling.

Earlier, during the proceedings of the case on 30.12.2024, the counsel for the Government authorities had informed the bench that the file for relaxing the existing percentile was under submission before the competent authority and the decision in this regard was awaited.

Further, the counsel had submitted that subject to the decision of the authorities regarding the reduction in the cut-off percentile, they would also seek an appropriate extension for the third round of counseling.

In this regard, the Union Government counsel confirmed before the HC bench on 03.01.2025 regarding its decision to reduce the cut-off for admission to MD/MS/DNB courses. Taking note of the same, the HC bench disposed of the plea.

However, the authorities including the Medical Counselling Committee (MCC), National Board of Examinations (NBE) or the National Medical Commission (NMC) has not notified any official decision regarding the reduction in the cut-off percentile and therefore the aspirants are waiting for the same.

Meanwhile, MCC recently extended the last date of resignation for students who have been allotted seats during the National Eligibility and Entrance Test-Postgraduate (NEET PG) Round 1 or Round 2 counselling process.

According to the official website of MCC, the last date for resignation with forfeiture of security deposit for NEET PG Round 1 or Round 2 seats is now extended to 4th January 2025 at 06:00 PM. With this, candidates are instructed not to wait for the last date and hence complete the process as soon as possible. Earlier the last date for resignation of Round 1 or Round-2 seat was fixed as 26 December 2024 at 06:00 PM.

To view the Delhi HC order, click on the link below:

https://medicaldialogues.in/pdf_upload/delhi-hc-order-neet-pg-percentile-267635.pdf

Also Read: MCC Extends NEET PG 2024 Round 1, 2 Seat Resignation Deadline

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Vice President Dhankhar inaugurates mobile medical clinics for Srinagar, Kalaburagi

New Delhi: The Vice-President of India, Shri Jagdeep Dhankhar recently flagged off two state-of-the-art Mobile Clinics with IoT-Integrated Tele-medicine Services by Aster DM Healthcare’s Corporate Social Responsibility (CSR) initiative for deployment in Srinagar (Jammu & Kashmir) and Kalaburagi (Karnataka).

Addressing the gathering before flagging off the Mobile Clinics in New Delhi yesterday, the Vice-President emphasized, “Quality healthcare, accessible healthcare, affordable healthcare has been a mission of Prime Minister Narendra Modi, and over the last decade, he has brought about a big change in this direction. He said, “Prime Minister Narendra Modi has committed himself and then successfully delivered last-mile delivery when it comes to healthcare.

The Ayushman Bharat program, one of the world’s largest programs, gives reprieve to the people from fiscal burden by making available to them up to 5 lakh rupees health care. Anyone who is a senior citizen, irrespective of fiscal power, will get this treatment free. The Swachh Bharat Abhiyan provides toilet in every house, potable water in every tap in every house with primary focus on good health”, he remarked.

Also Read:Vice President Jagdeep Dhankhar addresses 18th Foundation Day of ICMR, National Institute of Traditional Medicine

Shri Dhankhar mentioned that “The Government of India has also initiated telemedicine. It has been remarkably successful. Diagnostic tests, medical tests are all available through internet usage. Our digital penetration has gained global accolade. A country of 1.4 billion has accessibility to that extent. Every village is so well equipped on this front”, he remarked.

Highlighting the importance of Mobile clinics, the Vice-President said, “To be assured that there is a mobile clinic within your reach is a great assurance to the people in distress. Therefore, this has been a very soothing aspect of corporate social responsibility. It reflects even our civilization ethos. We must always work hard to give back to society”, he noted.

Shri Dhankhar said, “India’s economic growth, supported by exponential infrastructure development and deep digitization, has been globally acclaimed. Our platforms are gaining global recognition,” the Vice-President said, noting that India has transitioned from a nation of potential to a nation on the rise. He reiterated that achieving a developed Bharat by 2047 is not merely a dream but a destination, emphasizing that a Fit India is foundational to this vision. “To have Fit India,” he said, “we need facilities that ensure early detection, prompt treatment, and doorstep delivery of quality healthcare.”

The Vice-President provided examples of the quantum leaps India has made in healthcare. He said, “Over the past decade, Ayushman Bharat Yojana has already benefited around millions individuals, providing substantial financial relief to families.” He also expressed pride saying, “the doctor-to-population ratio of 1:836, a remarkable achievement for a nation of 1.4 billion people. Medical education has seen unprecedented growth, with the number of medical colleges doubling, paramedical services expanding, and diagnostic clinics now accessible even in remote areas.” These advancements, he said, “ensure that the nation is on the path to better health outcomes.

Reflecting on the transformation in healthcare infrastructure, the Vice-President stated, the number of AIIMS and medical seats have increased remarkably, strengthening the nation’s capacity to train healthcare professionals. “India is truly the pharmacy of the world,” he added, acknowledging the nation’s global leadership in pharmaceuticals and healthcare innovation.

Also Read:64th NAMS Convocation at AIIMS Jodhpur held, ‘Healthy society a need to make Viksit Bharat!’ says Vice President Dhankhar

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New guidelines for managing blood cancers in pregnancy

A new set of guidelines has been developed to assist with the diagnosis and expert management of serious blood cancers in pregnancy.

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Improving predictions about brain cancer outcomes with the right imaging criteria

A paper published in the Journal of Clinical Oncology, titled “Comparative Analysis of Intracranial Response Assessment Criteria in Patients With Melanoma Brain Metastases Treated With Combination Nivolumab + Ipilimumab in CheckMate 204,” examines how different imaging criteria can be used to assess brain tumor responses in patients with melanoma treated with immunotherapy drugs.

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FDA approves subcutaneous opdivo qvantig for most solid tumor indications

The U.S. Food and Drug Administration has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use for most previously approved adult, solid tumor Opdivo (nivolumab) indications.

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Scientists unveil surprising human vs. mouse differences in a major cancer immunotherapy target

Since its discovery in the 1990s, programmed cell death protein 1 (PD-1) has been regarded as a leading target in cancer treatments. A checkpoint receptor that often resides on the surface of immune system cells, the PD-1 molecule works as a type of “off” switch that keeps immune cells from attacking other cells.

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