April 2024 - Page 24 of 89

CENTAC issues notice on Common Entrance Test for BSc Nursing Admissions from this year, details

Puducherry- The CENTAC has recently issued a notice on its website regarding the conduct of a common entrance test for admission to the BSc Nursing course in the UT of Puducherry.

In its notice, the CENTAC notified about the government order referring to the Indian Nursing Council notification.

“The Indian Nursing Council has intimated that the admission to B Sc. (Nursing) from the academic year 2024-25 shall be made through the Common Entrance Examination by the State Government Common Entrance Cell / Universities in compliance with the Indian Nursing Council (Revised Regulations and Curriculum for B.Sc. (Nursing) Programme), Regulations, 2020”, the official notice stated.

As per the notice, approval to conduct common entrance examination for the BSc (Nursing) course by the Board of Examination for Nurses (BoEN), Directorate of Health & Family Welfare Services of Puducherry for the admission to the Pondicherry University affiliated colleges from the academic year 2024-25 in the state has been granted by the Honorable Lieutenant Governor, Puducherry.

It further stated that the Entire Entrance Examination process should be done by the Board of Examination of Nurses, Puducherry under the directions of the Indian Nursing Council from time to time.

Also Read: JnK Board invites online applications for Bsc Nursing, Paramedical, Technology courses, details

Further, the Deemed Universities in the Union Territory of Puducherry have also been directed to conduct the said entrance examination at their level as per the instructions of the Indian Nursing Council, New Delhi.

Meanwhile, other terms and conditions for admission, scheme of examination etc. will be notified separately and the schedule of the Common Entrance Examination will be notified with the concurrence of the EC1 on account of the Model Code of Conduct being in force.

Indian Nursing Council is a statutory body under the Ministry of Health & Family Welfare, Government of India, New Delhi. It was constituted by the Central Government under Section 3(1) of the Indian Nursing Council Act, 1947 of Parliament to establish a uniform standard of training for nurses, midwives and health visitors.

To view the notice, click the link below

https://medicaldialogues.in/pdf_upload/bscnursing-course-entrance-test-236377.pdf

Manipal Hospital unveils Advanced Robotic Technology for Orthopedics Surgeries

Pune: Manipal Hospital, Kharadi welcomes the legendary Indian cricket team captain, fitness enthusiast and recipient of Padma Bhushan Shri Kapil Dev to introduce a cutting-edge robotic technology for advanced orthopedic surgeries. This technology aims to improve knee replacement and joint treatment with robotic-assisted surgeries in Pune and nearby cities.

Over the last five years, there has been a significant increase in the number of joint replacement surgeries in India. Surgeons across the country have witnessed more than 2.5 lakh patients undergo knee replacement surgeries every year, and the number has increased manifold in recent years.

Also Read:Manipal Hospital Doctors give new lease of life to 47-Year-old Iraqi Patient with HIPEC surgery

Since few years, Manipal Hospital Kharadi has observed an increase in knee replacement surgeries. With newer and more advanced technology in India, people with total knee replacement can start to walk as early as six hours after the surgery. The evolution in orthopedic treatment and the introduction of robotic-assisted orthopedic surgeries have minimized the risks associated with knee replacement.

Robotic-assisted surgeries are advanced medical procedures performed using robotic devices guided by a surgeon. These procedures help surgeons perform complex surgeries with precision instruments and advanced systems, less bleeding reduced recovery time.

Unveiling the advanced robotic technology, veteran Indian cricketer Mr Kapil Dev said, “I would like to congratulate Manipal Hospital Kharadi for introducing the new and advanced robotic technology for joint replacement. In cricket, we constantly strive to improve our equipment’s and techniques for better performance. Similarly, the advancement in healthcare, one of which is robotic-assisted surgery, has improved the treatment option for people suffering with orthopedic problems.

As a sportsman, I understand the impact of joint injuries and the importance of faster recovery and this new robotic technology at Manipal Hospital is a game-changer in orthopedic treatment options available in the city. It offers faster recovery, less pain, and a quicker return to an active lifestyle.”

Emphasizing the need of robotic surgery, Dr Sinukumar Bhaskaran, Adult Joint Replacement & Reconstruction and Robotic Arthroplasty (Hip & Knee), Manipal Hospital, Kharadi, Pune said, “Our focus is on improving patient outcomes, and this robotic technology is a step towards offering quality orthopedic treatment. Robotic-assisted surgery is not only beneficial for the doctors performing complex surgeries but also for the patient by offering faster recoveries and reduced pain improving the quality-of-life post-surgery.

The new system allows personalized 3D CT scans, delivering sub-millimeter accuracy and enhanced safety with real-time bone movement monitoring for more precise implant surgery and reduced risk of infection. With a success rate of 98%, this meticulous precision results in longer-lasting joint replacements, reducing the need for costly and invasive revision surgeries. Using this technology and our unique clinical pathways, our hospital can offer patients fast-track knee surgery where the patients can go home within 24 hours.

Speaking on the event Parmeswar Das, Director, Manipal Hospital, Kharadi said, “Clinical Excellence and patient centricity is at the heart of all we do at Manipal Hospital, Kharadi. We are committed to providing our patients with access to the latest advancements in healthcare technology. The addition of this advanced robotic technology has ushered in a new era of orthopedic surgery that places a premium on accuracy, safety, and better patient results. This innovative technology allows us to offer our patients a minimally invasive procedure with the potential for faster recovery times, improved precision, and ultimately, a better quality of life.”

As a leader in patient-centric care, Manipal Hospital, Kharadi constantly thrives to offer the patients with access to the latest advancements in healthcare technology and the addition of this advanced robotic technology is yet another step towards it. With its ultra-modern, Hi-tech robotic equipment and facilities, along with an experienced medical team, the hospital will continue to ensure patient satisfaction and provide the best possible care.

Also Read:Manipal Hospital doctors give new lease of life to 17-year-old tiger attack survivor after multiple reconstructive surgeries

Doctors laud NMC move seeking stipend details from medical colleges

New Delhi: Doctors are hopeful about the recent move by the National Medical Commission (NMC), asking medical colleges across the country to submit the details of stipends paid to the MBBS interns and resident doctors. Hailing the move, the members of the medical fraternity have expressed their hope that this move will bring transparency as the medical colleges will now have to reveal the status of the stipend paid to the doctors.

Medical Dialogues had been reporting about the complaints from MBBS interns and resident doctors alleging that they were not receiving stipend or receiving a meagre amount despite working in the hospitals round the clock. These complaints mainly come from medical students belonging to the private medical colleges.

Recently, the National Medical Commission (NMC) asked the medical colleges to submit the details of the stipend paid to their UG Interns, Post-Graduate Residents, and Senior Residents or PGs in Super Specialty for the financial year 2023-24 by 23rd April 2024.

The medical colleges will have to submit the details of their name and address, the amount of stipend paid by the State Government, and the month-wise details of the stipend paid to the MBBS interns, 1st/2nd/3rd-year Post-Graduate Residents, and 1st/2nd/3rd-year Senior Residents or PGs in Super Specialty for the academic year 2023-2024.

Also Read: NMC gives deadline to all Medical Colleges to Submit Details of stipend paid to MBBS Interns, Resident Doctors

“Hon’ble Supreme Court of India in the WP (Civil) No. 730/2022 & other cases vide their orders dt. 16.09.2023 and 01.04.2024 has directed NMC to submit the details of stipends paid to the Medical interns and residents and accordingly, all the Health Institutions / Medical colleges are hereby directed to submit to NMC the details of stipend paid to their UG Interns, Post-Graduate Residents and Senior Residents or PGs in Super Specialty for the financial year 2023-24 as per Annexure 1 on E-mail ID:- stipend23- 24@nmc.org.in by 23.04.2024 positively,” NMC mentioned in the notice dated 16.04.2024.

NMC has provided a similar annexure for the details of the stipend paid to medical students for the academic year 2024-2025. However, in this regard, NMC directed the colleges concerned to update these details on the website of the institute every month (by 5th of every month). The colleges have been asked to submit the complete statement to NMC at the end of each financial year.

The NMC directions come after the Supreme Court order in this matter. The Apex Court was considering the issue of non-payment of stipends to the MBBS interns across the country and directed NMC to submit the details of the stipend paid to MBBS interns in all the medical colleges across all the States within four weeks.

Also Read: Submit Details of Stipend paid to MBBS Interns by Medical Colleges in All States: SC Directs NMC

Reaction from the Medical Fraternity:

Addressing the NMC decision, the Federation of All India Medical Association (FAIMA) lauded the move and thanked the Chairman and Secretary of the Commission for taking this step. In an X (formerly Twitter) post, FAIMA opined it to be a “Great decision to maintain the transparency.”

The NMC decision was also praised by the President of the United Doctors Front Association (UDFA), Dr. Lakshya Mittal who opined in an X post that NMC has “taken steps to ensure transparent stipend disbursal.”

Speaking to Medical Dialogues regarding the NMC direction to the medical colleges, Dr. Aviral Mathur, the president of FORDA said, “We want NMC to act at the grassroot level, talking and interacting with the residents and interns regarding their actual salaries. Many residents have come forward after the media coverage and the modus operandi across many colleges falls within those 4-5 examples.”

“So even though NMC has launched an initiative and we commend that, merely the college’s undertaking should not be taken on face value. They can still submit erroneous/ fake details and get away with it. Leading to very little trickle down effect of this exercise,” he further added.

The Federation of Resident Doctors Association (FORDA) had earlier raised the issue of ‘stipend scam’. Expressing its hope that the new NMC move will offer a solution, the association mentioned on X, “When we first raised the issue of ‘fake’ stipends to some residents across the country, we were surprised by the number of #doctors who came forward and were a victim of this atrocity. Finally @NMC_IND intervenes and we are grateful to them & @MoHFW_INDIA for this constructive intervention.”

FORDA also expressed its hope that this move will ultimately offer some justice to the Foreign Medical Graduates (FMG) who are doing internship as well. “Hope it sets parity. And hope it lends some justice to #FMG candidates too,” the post by FORDA stated.

Also Read: Supreme Court relief: FMGs to now get stipend during internship as Indian MBBS interns

Earlier, the Supreme Court while considering the issue of non-payment of stipend to the FMGs during the compulsory internship noted that the FMGs could not be treated differently and should be paid stipends during their internship like their counterparts who have done MBBS from the Indian medical colleges. Such observations were made by the top court bench comprising Justices Sudhanshu Dhulia and Prasanna Bhalachandra after taking note of the submissions of lawyer Tanvi Dubey, appearing for a group of doctors, that foreign medical graduates in certain medical colleges were not being paid stipends during their internships.

Addressing the issue and the recent move by NMC seeking the stipend details from the colleges, the FMG Wing of the All India Medical Students Association (AIMSA) wrote on X, “After the statement & direction from Hon.Supreme Court, all Medical Colleges & Institutions are asked to submit details of stipend paid to ‘UG Interns,’ ‘PG Residents’ & ‘Senior Residents of Superspeciality Branch’ by @NMC_IND. We hope FMGs will also get equal stipend state wise.”

Meanwhile, addressing the matter, the President-Elect of Delhi Medical Association, Dr. Ashwini Dalmiya also opined that all the FMGs should get an equal stipend. “All the FMGs should get equal stipend ( Arrears with interest to those who didn’t get last year ). All state Councils & NMC to ensure,” he wrote on X.

Similar opinions were expressed by Jammu and Kashmir Medical Student’s Association as well. The association wrote, “All Foreign Medical Graduates (FMGs) should receive an equal stipend, including arrears with interest for those who didn’t receive it last year. All state councils and the National Medical Commission (NMC) to ensure this.”

Also Read: PG Medicos not Getting Full Stipend by Mahadevappa Rampure Medical College: RTI Activist demands police investigation

Stipend issue:

The issue of non-payment of stipend does not only haunt the MBBS interns as the PG residents belonging to private medical colleges also complain of ongoing stipend scam. Despite the guidelines issued by the National Medical Commission (NMC) asking medical colleges to pay stipends to postgraduate medical students from private medical colleges, the complaints regarding non-payment of stipends remain unsolved.

Recently around 100 PG students at a private medical college in Sullia, Karnataka complained of non-payment of their monthly stipend by the college authorities. Even though the guidelines state that the PG doctors are entitled to receive Rs 45,000, Rs 50,000, and Rs 55,000 for their first, second, and third years, respectively. However, students revealed that they are only receiving Rs 10,000, Rs 12,500, and Rs 15,000 for the corresponding years.

Such stipend issues were earlier highlighted by the Right to Information (RTI) activist Sharanabasappa Ambesinghe as well who had previously demanded a police investigation of a similar alleged scam at Mahadevappa Rampure Medical College.

Also Read : 2110 PG medicos not receiving stipend: NMC issues stern warning to Private medical colleges

Medical Dialogues had last year reported about the glaring disparities in the amount of stipend paid to the Undergraduate and Postgraduate medical students across the country. As per the data regarding the students admitted through the National Eligibility-cum-Entrance Test Postgraduate (NEET-PG) examination 2022, which is available on the official website of the Commission, there were glaring disparities in the stipend paid to the Junior Resident doctors across the institutes in a state and also across the country.

The data revealed that the minimum amount of stipend (Rs 20,000 or less than Rs 20,000 per month) is paid to the resident doctors pursuing their postgraduate medical education in medical colleges located in States like Karnataka, Punjab, Rajasthan, and Uttar Pradesh.

Meanwhile recently releasing the final Post-Graduate Medical Education Regulations, 2023 (PGMER 2023), which were published in the official Gazette on 29.12.2023, the National Medical Commission (NMC) introduced uniformity in the amount of stipend paid to the PG medicos in a particular State/UT.

The Commission specified that the PG medicos who are pursuing degree, diploma or super-speciality courses should be paid a stipend at par with the stipend being paid to the PG students of Government institutes, in that particular State/UT.

Also Read: Uniform Stipend for all PG Medicos in a particular State, UT: NMC

Monitoring lapse post Septoplasty leads to patient’s death: ENT surgeon, Anaesthesiologist, Hospital slapped Rs 30 lakh compensation

Thiruvananthapuram: The State Consumer Disputes Redressal Commission, Kerala recently held a Marikkunnu-based hospital, an ENT surgeon and an Anaesthesiologist associated with the hospital liable for lapse on their part in monitoring a patient, who underwent a Septoplasty procedure.

Due to complications, the patient became cyanosed and ultimately lost consciousness. After being treated for several months in a vegetative state, he expired in 2003. “Therefore, we have no hesitation in concluding that the vegetative condition of the 1 st complainant was caused as a direct result of the monitoring lapse on the part of the opposite parties after the surgical procedure was completed,” the State Consumer Court noted and directed the hospital and doctors to pay Rs 30 lakh to the family of the deceased as compensation towards the loss, mental agony and hardships suffered and another Rs 25,000 as costs of the litigation within one month.

“All the amounts shall be paid by the opposite parties 1 to 3 with interest thereon @ 8% per annum from 08.02.2002, the date of filing of this complaint till the date of payment,” the Commission ordered.

The history of the case goes back to 2001 when the patient consulted the treating doctor, an ENT surgeon, for a minor deformity of his nose. After examining the patient, the doctor opined that the deformity could be easily corrected by a minor surgery for which, he advised the complainant to get admitted to the treating hospital at Marikkunnu.

It was alleged that the ENT surgeon and the Anaesthesiologist had informed the patient that the concerned procedure called Septoplasty was usually done under general anaesthesia. Accordingly, the patient was admitted and after the pre-operative check-up, the operation was conducted on 04.04.2001.

Although initially the doctor had assured that there was nothing wrong with the patient, after some time, the family of the patient was informed that the patient had not recovered from the surgery and was being shifted to the Intensive Care Unit (ICU). The doctors had allegedly ensured that the patient was alright and it was only a minor anesthetic complication.

However, the patient’s condition soon turned serious and he was put on ventilator support. He remained in the hospital till 16.04.2001 but his condition allegedly worsened. It was submitted that despite repeated requests to shift the patient to hospitals with better facilities, the treating doctors and hospital declined to issue a discharge summary or the details of the treatment, or a copy of the case sheet without which it was not possible to take the patient to any other hospital for better management or treatment.

Finally, after much persuasion, the patient was shifted to Kasturba Hospital, Manipal in the Ambulance of the National Hospital, Kozhikode accompanied by the treating ENT surgeon and another doctor.

Accordingly, the patient was treated as an inpatient in the Department of Neurology from 17.04.2001 till 12.05.2001. He remained deeply in comatose condition and there was no improvement. Finally, the doctors of the Kasturba Hospital decided that nothing more could be done and treatment continued from the local hospital.

The final diagnosis was hypoxic, hypoxemic, encephalopathy and persistent vegetative state. The patient was discharged, admitted to another hospital and was treated there for three months. He was discharged thereafter because his neurological status continued to remain status-quo without any improvement. It was advised that his treatment could be continued with the assistance of two trained nurses at home and periodic check up by doctors. Accordingly, he remained at home. He was given food through a tube and a catheter was inserted for urination. Since the filing of the complaint, he had not shown any improvement.

The wife and children of the patient filed the consumer complaint and alleged that all their loss, injury and hardships were consequences of the negligence, carelessness, deficiency in service and unfair trade practice on the part of the treating doctors and hospital. Had they bestowed reasonable care, caution and attention while treating the complainant during the surgery and thereafter, all the complications that ensued could have been avoided, they argued.

Further, the complainants contended that the surgery conducted by the ENT surgeon was an elective one and was akin to cosmetic surgery. Therefore, if there was any doubt regarding the complete fitness of the complainant to undergo the same under general anaesthesia, the surgery could have been postponed or avoided.

The complainants further alleged that initially the hospital and doctors failed to provide the discharge summary and only after being threatened with legal action, they provided the records. They also claimed that the case sheet had been tampered with and manipulated.

It was alleged by the complainants that improper administering of anaesthesia and conduct of surgery could be attributed to the cardiorespiratory arrest caused to the patient. Filing the consumer complaint, they claimed Rs 50 lakh as compensation, apart from the costs of the proceedings.

On the other hand, the hospital and doctors submitted that the surgery was conducted observing all established precautions and with utmost care and caution. The patient was extubated and was fully awake. He showed stable vital signs with full consciousness. They claimed that the patient had fully recovered from anaesthesia and was talking with all protective reflexes intact.

Therefore, the patient was shifted to the recovery room. In the recovery room, the patient developed cardiorespiratory arrest which was detected immediately and resuscitated. The patient was put on ventilator support and shifted to the Intensive Care Unit. Consequently, the patient developed seizures and was treated conservatively with anti-oedema measures, antiepileptics, antibiotics and all other possible supportive measures, in consultation with the Neurologist. Seizures were controlled and the patient showed marginal improvement. Later on, the patient was shifted to the KMC, Manipal, as requested by the relatives of the patient, for further management.

They also argued that Septoplasty under general anaesthesia is not a minor surgery. Denying all the allegations of negligence, they submitted that what had happened was an established known complication of any procedure under general anesthesia and the situation was tackled sincerely and wholeheartedly to the best of their abilities. They also denied the allegations of manipulation or tampering with the records.

While considering the matter, the Consumer Court noted that after the death of the patient on 31.08.2003, a Medical Board was constituted on the basis of the Police complaint filed by the complainants. The Medical Board evaluated the medical treatment that was provided by the hospital and concluded that there was no negligence on the part of the hospital and doctors. Based on the said report, the Police referred the case reporting that there was no negligent act warranting criminal action against the hospital and doctors. Therefore it was contended that the complaint was only to be dismissed accepting the said opinion of the Medical Board.

The Commission noted that as per the certificate issued by the Medical Board, it could not identify any professional negligence on the part of the doctors who treated the patient.

After considering an expert opinion, the Commission observed that the events that took place during the period from 10.30 am to 11 am on 04.04.2001 caused the deterioration of the condition of the patient.

The Consumer Court considered the evidence by the expert doctors by the treating hospital and doctors and noted that “It is clear from the evidence of DW2 and DW3 that there was no recording of the vital parameters of the patient during the crucial period. It is claimed that there was close monitoring of the condition of the patient. But, there is no evidence to support the said contention. Going by the notings in the case sheet, what emerges is that, no monitoring of the patient was done from 10.30 am to 10.55 am. There is no recording of monitoring in Ext. B1(a) regarding the vital parameters of the patient during that time.”

“In the absence of any such evidence, the only conclusion possible is that there was no monitoring of the condition of the patient during the crucial period that changed his entire life. Though it is seen recorded at page 31of Ext. B1(a) that the patient was conscious till 10.55 am that can even be a deceptive impression and cannot support the conclusion that the vitals of the patient were normal. It is for the said reason that five minutes thereafter the patient had become cyanosed,” the Commission further observed.

It also considered the evidence produced by an expert on behalf of the complainants and noted,

“It is also a fact that cardiac monitor was not used immediately after the surgery during the post surgical period. It was connected only at 11.08 am (page 31 of Ext. A17 case sheet) after the complication had occurred. According to PW3 a normal patient to become cyanosed would require definitely more than 3-4 minutes. It is a gradual process which could be easily identified, if there is constant monitoring. PW3 has further contended that complication of irreversible brain damage is not a surgical issue, but a possible delay in identifying the complication. It is a monitoring issue.”

Noting that the opinions formed by the complainant’s expert after examining the case sheet had not been seriously challenged or disproved by the hospital and doctors in the case, the Commission opined that the patient’s condition worsened due to the monitoring lapse.

“Therefore, we have no hesitation in concluding that the vegetative condition of the 1 st complainant was caused as a direct result of the monitoring lapse on the part of the opposite parties after the surgical procedure was completed. The omission on their part to follow the standard medical protocol in this case is therefore proved beyond any doubt. In view of the above, we are satisfied that the complainants are entitled to succeed in their claim for compensation against the opposite parties,” the consumer court opined.

Noting that the loss suffered by the complainants could not be compensated in terms of money, and also taking into account that the deceased patient was young, healthy and well-employed, the Commission ordered the hospital and doctors to pay Rs 30 lakh as compensation to the family of the deceased.

“He lost a career that would have been fruitful and profitable. Therefore, we consider that an amount of Rs. 30,00,000/- shall be a reasonable compensation for the loss of the 1 st complainant in this case. The 1 st opposite party (ENT surgeon) who conducted the surgery, the 2 nd opposite party, the anesthetist as well as the 3 rd opposite party hospital are equally responsible for the death of the 1 st complainant. As the surgeon, the 1 st opposite party ought to have taken care to avert the complication created by the lack of monitoring after the surgery. The 2 nd opposite party, Anesthetist, who was responsible for weaning off the patient from anesthesia failed to anticipate the cardio respiratory arrest that followed the surgery. In view of their contention that it was a known complication associated with any surgery under general anesthesia it was necessary for them to have been more alert and to have taken precautionary measures to handle such eventuality, which they sadly did not do. For the above reasons, all the opposite parties shall be liable to compensate the complainants,” it ordered.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/kerala-rs-30-lakh-compensation-236564.pdf

Also Read: Patient succumbs to hospital-associated infections Post CABG surgery, NCDRC slaps Rs 10 lakh compensation

Dr Reddy’s Laboratories gets CDSCO Panel Nod To Import and Market Toripalimab 240mg solution for infusion

New Delhi: Noting an unmet medical need for recurrent locally advanced/metastatic nasopharyngeal carcinoma (RM-NPC) in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Dr Reddy’s Laboratories to import and market Toripalimab 240mg solution for infusion with a waiver of local Phase III clinical trial with the condition to conduct Phase IV clinical trial in India.

This came after Dr. Reddy’s Laboratories presented the proposal for a grant of permission to import and market Toripalimab 240mg solution for infusion for the following indications:

1. In combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC).

2. As a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy with local Phase III clinical trial waiver.

The committee noted that the proposed drug Toripalimab was granted an orphan drug designation for the treatment of nasopharyngeal cancer by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) and approved in China and USA for the proposed indications based on Phase II and Phase III trials conducted.

The expert panel noted that there is an unmet medical need for recurrent locally advanced/metastatic nasopharyngeal carcinoma (RM-NPC) in India.

Toripalimab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Toripalimab is a type of immunotherapy called an immune checkpoint inhibitor. It targets a protein called PD-1 on certain immune cells, allowing them to better attack and kill cancer cells.

At the recent SEC meeting for Oncology on 3rd and 4th April 2024, the expert panel reviewed the proposal for grant of permission to import and market Toripalimab 240mg solution for infusion presented by drug major Dr Reddy’s Laboratories.

After detailed deliberation, the committee recommended a grant of permission to import and market Toripalimab 240mg solution for infusion with a waiver of local Phase III clinical trial with the condition of conducting Phase IV clinical trial in India.

Accordingly, the committee suggested that the Phase IV clinical trial protocol should be submitted by the firm within 3 months from the grant of marketing authorization.

Also Read: Lupin Gets CDSCO Panel Nod to Study Glycopyrronium Bromide, Vilanterol Trifenatate powder for inhalation in capsule

CDSCO approves Abbott’s proposal for Protocol Amendment of Triamcinolone Hexacetonide study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal for the inclusion of 40 mg dose of Triamcinolone Hexatonide injectable suspension USP presented by the drug major Abbott for the synthetic glucocorticoid corticosteroid Triamcinolone hexacetonide.

This came after Abbott presented the amendment in Phase-IV clinical trial protocol for the inclusion of a 40 mg dose of Triamcinolone Hexatonide injectable suspension USP.

Triamcinolone hexacetonide also known as triamcinolone acetonide 21-tebutate is a synthetic glucocorticoid corticosteroid.

Triamcinolone is a medication used to manage and treat various conditions such as atopic dermatitis, contact dermatitis (e.g., poison ivy), eczema, bullous dermatitis, herpetiform psoriasis, lichen planus, lichen sclerosis, subacute cutaneous lupus erythematosus, dermatomyositis, and seasonal or allergic rhinitis.

Triamcinolone hexacetonide binds to specific cytosolic glucocorticoid receptors and subsequently interacts with glucocorticoid receptor response elements on DNA and alters gene expression.

At the recent SEC meeting for Analgesic and Rheumatology held on 3rd April 2024, the expert panel reviewed the proposal presented by the drug major Abbott for the Phase IV protocol amendment for the inclusion of a 40 mg dose of Triamcinolone Hexatonide injectable suspension USP.

After detailed deliberation, the committee recommended a grant of permission to amend the Phase IV clinical trial protocol from protocol No. TRIA-422-0200, version 3.0 dated 08.11.2022 to protocol No. TRIA-422- 0200, version 4.0 dated 14.12.2023.

Also Read: CDSCO Panel Approves Roche’s Protocol Amendment Proposal For Anti-cancer Drug Atezolizumab, Lenvatinib, and Sorafenib Study

Conduct Phase III clinical trial: CDSCO Panel Tells BDR Pharmaceutical on Anti-cancer Drug Abiraterone Acetate

New Delhi: Reviewing the justification for waiver of the Phase III clinical trial of the anti-cancer drug Abiraterone Acetate presented by BDR Pharmaceutical Int, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has reiterated earlier recommendations to conduct Phase III clinical trial.

This came after BDR Pharmaceutical Int presented justification for waiver of the Phase III clinical trial before the committee.

The firm informed that the proposed drug formulation Abiraterone Acetate Oral Suspension 1000mg/5ml has not yet been approved anywhere.

The committee opined that the proposed formulation does not come under clinical trial waiver criteria i.e. unmet medical need, orphan drug status, or indicated serious life-threatening disease.

Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumor tissues, to regulate androgen biosynthesis.

At the recent SEC meeting for Oncology on 19th and 20th March 2024, the expert panel reviewed the justification for waiver of the Phase III clinical trial of the anti-cancer drug Abiraterone Acetate.

After detailed deliberation, the Committee reiterated their earlier recommendations to conduct a Phase III clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase III clinical trial protocol to CDSCO for further review by the committee.

Also Read: Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study FDC of Relugolix, Estradiol, Norethindrone Acetate

Health Bulletin 20/ April/ 2024

Here are the top health news for the day:

IRDAI removes age cap, mandates health insurance coverage for all age groups

In a major decision, the Insurance Regulatory and Development Authority of India (IRDAI) has removed the age cap for buying health insurance policies.

Releasing the new Insurance Regulatory and Development Authority of India (Insurance Products) Regulations, 2024, which was notified in the official Gazette on 20th March 2024, IRDAI has specified its directions for the health insurance companies regarding their product designs i.e. the type of their health insurance policies.

For more information click on the link below:

No Age Cap: IRDAI Directs Insurers To Offer Health Insurance To All Age Groups

H5N1 bird flu strain detected in milk: WHO

The detection of the H5N1 bird flu virus strain in raw milk from infected animals, as announced by the World Health Organization (WHO), has escalated concerns surrounding avian influenza outbreaks. Since its emergence in 1996, the Avian influenza A(H5N1) has witnessed a surge in bird outbreaks, with a notable increase in mammalian infections since 2020.

The unexpected susceptibility of cows and goats to this strain has resulted in outbreaks across six states, affecting at least 13 herds. Of particular concern is the first reported case of human infection from a cow in Texas, underscoring the gravity of the situation.

ICMR study finds anomalies in prescriptions at major central run hospitals

An Indian Council of Medical Research (ICMR) investigation revealed deviations from established medication guidelines in prescriptions at top government-run hospitals. Nearly 10% of prescriptions showed unacceptable deviations, with 45% departing from normal treatment standards. The study, part of the ICMR’s Rational Use of Medicines (ICMR-RUM) project, analyzed 4,838 prescriptions from 13 tertiary care hospitals, including AIIMS and PGIMER. Dr. Rima Dada from AIIMS Delhi stressed the hospital’s emphasis on comprehensive, generic prescriptions. However, significant deviations were observed, particularly in community medicine, ENT, and paediatrics OPDs. These deviations ranged from non-specific therapies to inappropriate medication use, raising concerns about antimicrobial resistance. The study highlighted the need to reinforce rational prescribing principles among medical professionals. Despite attempts to seek comments from relevant authorities, responses were not received. Addressing these issues is crucial to mitigate adverse drug reactions, hospitalizations, and rising treatment costs associated with inappropriate prescribing practices.

Scientists identify how sugary, fatty foods may trigger cancer in young people

Researchers from the National University of Singapore have unveiled a potential link between junk food consumption and increased cancer risk, particularly among young individuals. The study sheds light on methylglyoxal, a compound produced in higher amounts during the digestion of sugary and fatty foods.

The research team found that methylglyoxal can temporarily disable the BRCA2 gene, crucial for the body’s cancer defense mechanism. Dr. Ashok Venkitaraman, the lead author, explained, “Methylglyoxal triggers the destruction of BRCA2 protein, reducing its levels in cells. This effect is temporary but can last long enough to inhibit the tumor-preventing function of BRCA2.”

Yamunanagar Doctor selling medicines guaranteeing male child arrested

Yamunanagar: In a raid at a private clinic in the city, a team of the state health department caught a doctor who was allegedly selling allopathic medicine that guaranteed the birth of a baby boy.

After nabbing the accused red-handed, the health authorities handed him to the police following which he was arrested under Section 420 (cheating) of the Indian Penal Code (IPC); 12 and 21 of the NDPS Act; 15 (2) and 15 (3) of the Indian Medical Council Act; 34 (1) and 34 (2) of the National Medical Commission Act and relevant Sections of the PC PNDT Act.

Around 13 different types of allopathic medications were discovered to be expired and stored within the clinic’s premises. The clinic was located in Shastri Colony near Fountain Chowk in Yamunanagar City.

Also read- Amritsar Doctor Arrested In Case Of Cheating, Forgery For Death Of Patient In 2018

According to the health department officials, the medicines were unfit for human consumption. It was alleged that the accused sold the medicine to the woman who is reportedly a decoy promising that she will give birth to a male child after the course of this medication.

The incident came to light after a team of the health department including Dr Vipin Gondwal, deputy civil surgeon (PNDT) and Dr Shalini Saini, medical officer of Mukand Lal District Civil Hospital, Yamunanagar carried out a plan to nab the doctor acting on a tip-off.

They sent a decoy woman to the doctor under the pretext that she required medicine to give birth to a boy. When the woman met with the doctor, she gave him Rs 1000 for the medicines.

“The doctor took two notes of Rs 500 from the decoy after giving her medicines. During the raid, many types of allopathic drugs were also found stocked in clinic premises. The doctor was asked to produce a valid drug license or degree which allowed him to stock medicines and practice medicine using allopathic drugs. The doctor also failed to produce any purchase bills of allopathic drugs and other drugs possessed by him. No entry of decoy was made in the OPD register”, said Dr Vipin Gondwal in his complaint.

Yamunanagar City SHO inspector Jagdish Chander told TOI, “The doctor was produced before a duty magistrate on Wednesday, which sent him on a four-day police remand. A police team took the doctor to Chamba in Himachal Pradesh and Moga in Punjab for recovery of some items, which cannot be disclosed yet due to ongoing investigation.”

Further investigation is underway.

Also read- Illegal Sex Determination Racket Busted In Gujarat, Doctor Arrested

Medical Bulletin 20/ April/ 2024

Here are the top medical news for the day:

Does yoghurt help in prevention of diabetes and obesity?

A recent study published in Frontiers in Nutrition discussed the role of yoghurt as a nutritious food in preventing and managing diabetes and obesity.

Yoghurt, a low-calorie fermented dairy product, offers a balanced mix of proteins, essential nutrients, and beneficial bacteria. Studies have linked yoghurt consumption to lower risks of obesity, diabetes, osteoporosis, and heart disease while improving gut health and boosting immune function. According to an economic model for yoghurt use in diabetes risk reduction, the consumption of 100 grams of yogurt each day by adults can lead to 388,000 fewer people developing diabetes in the next 25 years.

In the study, researchers analyzed yogurt consumption data in the Argentine population, revealing an average annual intake of four kilograms per person. Over the past decade, both full-fat and skim yogurt consumption has declined by 44%. In 2019, diabetes prevalence was estimated at 13%.

Low-fat yogurt’s anti-diabetic properties stem from its low glycemic load and nutrient content, including proteins, calcium, magnesium, and vitamin D. Certain saturated fatty acids in yogurt are linked to reduced diabetes risk, with daily consumption of 50 grams associated with a 7% lower risk.Yogurt’s beneficial bacteria improve blood lipid profiles, lower cholesterol, and boost antioxidant status in diabetic patients. Additionally, yogurt’s organic acids, like lactic acid, reduce postprandial blood glucose and insulin levels.

Gut microbiota imbalance is a key factor in obesity, causing changes like increased fat deposition and metabolic dysfunction. Yoghurt, with its nutritious elements and beneficial bacteria, can mitigate obesity risk by replacing unhealthy foods. It also influences appetite regulation, energy balance, and body mass index (BMI).

The findings of the study indicated that yogurt consumption could be beneficial for the prevention and management of both diabetes and obesity. The rising prevalence of these chronic diseases throughout the world emphasizes the importance of encouraging people to incorporate yogurt as part of their healthy diet to improve public health.

Reference: Britos, S., Gonzalez, A. F., Marco, F. F., et al. (2024). Yogurt, in the context of a healthy diet, for the prevention and management of diabetes and obesity: a perspective from Argentina. Frontiers in Nutrition. doi:10.3389/fnut.2024.1373551.

Study finds new urine-based test to detect prostrate cancer

Researchers at the University of Michigan Rogel Cancer Center have developed a new urine-based test that addresses a major problem in prostate cancer.

The study was published in the journal JAMA Oncology.

Prostate cancer is a prevalent and deadly malignancy globally. Screening trials like the European Randomized Study of Screening for Prostate cancer and Göteborg Randomized Prostate Cancer Screening trial have demonstrated reduced cancer mortality with PSA-based screening. Current guidelines suggest men with high PSA levels undergo risk stratification via multiparametric magnetic resonance imaging or biomarker testing before biopsy.

The test, called MyProstateScore2.0, or MPS2, looks at 18 different genes linked to high-grade prostate cancer. In multiple tests using urine and tissue samples from men with prostate cancer, it successfully identified cancers classified as Grade Group 2, or higher. These cancers are more likely to grow and spread compared to Grade Group 1 prostate cancers, which are unlikely to spread or cause other impact.

In the study, multiple biomarker tests were assessed, including serum PSA alone, the Prostate Cancer Prevention Trial risk calculator, and the Prostate Health Index (PHI) and the 18-gene MPS2 models. Under a testing approach with 95% sensitivity for Prostate cancer of Grade group 2 or greater, measures of diagnostic accuracy and clinical consequences of testing were calculated. Cancers of GG 3 or greater were assessed secondarily.

Of 761 men included in the study, 151 had high-grade Prostate cancer on biopsy. Area under the graph showed 0.74 using the original MPS model compared with 0.81 using the MPS2 model and 0.82 using the MPS2+ model. Across pertinent subgroups, the MPS2 models had negative predictive values of 95% to 99% for cancers of Grade group 2 or greater and of 99% for cancers of Grade group 3 or greater.

The findings suggested that the use of this test would meaningfully reduce unnecessary biopsies performed while maintaining highly sensitive detection of high-grade cancers. The data supported use of this new Prostate cancer biomarker test in patients with elevated PSA levels to reduce the potential harms of prostate cancer screening while preserving its long-term benefits.

Reference: Jeffrey J. Tosoian, MD, MPH; Yuping Zhang, PhD; Lanbo Xiao, PhD; et al; Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer; Journal: JAMA Oncology; doi:10.1001/jamaoncol.2024.0455

Are dietary treatments more effective for IBS?

According to a study conducted at the University of Gothenburg, dietary treatment is more effective than medications in irritable bowel syndrome (IBS). With dietary adjustments, more than seven out of ten patients had significantly reduced symptoms.

The study, published in The Lancet Gastroenterology & Hepatology, compared three treatments: two dietary and one based on use of medications.

Irritable bowel syndrome (IBS) is a common condition characterized by abdominal pain, gas, bloating, diarrhea, and constipation. Treatment typically involves dietary changes like eating small, frequent meals and avoiding triggers such as coffee and alcohol. Medications may also be prescribed to alleviate symptoms like gas, constipation, diarrhea, and bloating. In some cases, antidepressants are used to manage IBS symptoms.

In the study, participants with severe or moderate IBS symptoms at Sahlgrenska University Hospital in Gothenburg were divided into three treatment groups. One group received traditional dietary advice focusing on low-FODMAP foods, another received a low-carbohydrate, high-protein and high-fat diet, and the third group was treated with medication tailored to their specific symptoms. Treatment lasted for four weeks, and the participants’ responses were assessed using an IBS symptom scoring scale.

The results showed that of those who received traditional IBS dietary advice and low content of FODMAPs, 76% had significantly reduced symptoms. In the group receiving low carbohydrates and high protein and fat, the proportion was 71%, and in the medication group 58%. All groups reported significantly better quality of life, less physical symptoms and less symptoms of anxiety and depression.

“With this study, we can show that diet plays a central role in the treatment of IBS, but that there are several alternative treatments that are effective. We need more knowledge about how to best personalize the treatment of IBS in the future and we will further investigate whether there are certain factors that can predict whether individuals will respond better to different treatment options,” said Sanna Nybacka, lead author of the study.

Reference: Sanna Nybacka, PhD, et al; A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARBIS): a single-centre, single-blind, randomised controlled trial; Journal: The Lancet Gastroenterology & Hepatology; DOI:https://doi.org/10.1016/S2468-1253(24)00045-1