Lack of Basic Infrastructure: Doctor flags Plight of AIIMS Madurai Medicos, says Institute’s reputation doesn’t match reality

New Delhi: In a shocking post, a Delhi-based doctor and Health Activist has highlighted the plights of medical students at All India Institute of Medical Sciences (AIIMS), Madurai as he claimed that the institute lacks even the basic infrastructure required to run a medical college.

Unveiling the ‘real’ condition of the institute, Dr. Dhruv Chauhan, a Med-Influencer and also the National Committee Co-ordinator of the Indian Medical Association Junior Doctors’ Network (IMA-JDN) has expressed his disappointment over the fact that the reputation of AIIMS, a premier medical institute, does not match the current scenario of AIIMS Madurai.

Taking to X (formerly Twitter), Dr. Chauhan highlighted the condition of the institute and claimed that the students are pleading with the authorities to shift them to other medical colleges. According to Dr. Chauhan, this situation is a result of opening so many medical colleges without any basic facilities.

As per the X post, there are no patients in wards at the institute for clinical examination and there is a prohibition in visiting the OPD and OT as well. He also claimed that the institute lacks proper facilities to accommodate the medical students and as a result, 5 students are staying in a single room.

He also alleged that the libraries at the institute are so poor that there are no books for anyone except the 1st year medical students. In another post, he shared a picture of a library showing only one of the two almirahs in the picture filled with books.

Sharing the picture, Dr Chauhan wrote, “AIIMS madurai Library , even local street libraries have more books than this , here they don’t have anything for 2nd and 3rd year MBBS students !”

Also Read: AIIMS Madurai construction likely to start in December 2023: Health Minister Ma Subramanian

“AIIMS” the institution name sounds a big thing no ? But not anymore !” he mentioned in a post. On the one hand, he highlighted the problems faced by the medicos due to lack of facilities, and on the other, he mentioned in the post, “On asking the administration the reply is “who asked you to join AIIMS Madurai” ? This is the result of opening so many Medical colleges without any basic facilities !”

Responding to the post, some of the users questioned how there are students at the institute when AIIMS Madurai has not been even constructed yet. Explaining the situation, the doctor mentioned in another X post, “The answer is AIIMS Madurai has a temporary campus where 3 MBBS batches reside And their students go to GMC ramanathpuram college where they are studying in the “name of Aiims Madurai” and they don’t get any facilities because the GMC students are already there and occupancy is not sufficient .”

“So the question is it has been 4 years and in the name of admission of Aiims Madurai people have to study in state college while the tag is still of Aiims ! Isn’t it strange in itself ? Does that mean Aiims = GMC ?” he questioned, adding “Not just study they will graduate in the name of Aiims Madurai while their college will remain GMC ramanathpuram.”

Speaking to Medical Dialogues in this regard, Dr. Dhruv Chauhan informed that many students had approached him raising the issue. “AIIMS Madurai has 3 batches and are running in the name of temporary campus with their college and hospital as GMC Ramanathapuram. The AIIMS Madurai batches will pass even before seeing the building which is not even constructed yet and running in GMC which itself doesn’t provide them sufficient facilities,” he said.

Medical Dialogues team had earlier reported that the institute was finally expected to be completed by 2028, with its construction to begin by December 2023 and the tender for the construction was also floated.

However, earlier this year a Public Interest Litigation (PIL) was filed before the Madras High Court highlighting the prolonged delay in the construction of AIIMS Madurai and taking note of the issue, the HC bench of Justices D. Krishnakumar and Vijayakumar had earlier issued notices into the matter.

Also Read: Madras HC issues notice to Centre on PIL to expedite construction of AIIMS Madurai

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Sakra World Hospital completes 100 Robotic GI Surgeries

Bengaluru: Sakra World Hospital, a pioneering healthcare facility in India funded entirely by foreign direct investment (FDI), has successfully completed 100 robotic gastrointestinal (GI) surgeries.

In the medical field, robotic-assisted surgical procedures are steadily on the rise. The increasing acceptance of robotic surgeries can be attributed to their accuracy, minimally invasive techniques, and capacity to improve surgical outcomes. With a group of skilled surgeons and cutting-edge facilities, Sakra World Hospital has become a pioneer in leveraging this technology to help patients suffering from gastrointestinal surgical issues.

Also Read:Bengaluru Orthopaedician Dr Banarji B H gets patent for Arthroscopic Carpal Tunnel Release

Robotic-assisted surgery enables the performance of intricate procedures across a wide spectrum, including colorectal cancers, benign and malignant conditions of liver, biliary system, and pancreas, apart from complex hernia repairs, gallbladder removals, and abdominal wall reconstruction. With a focus on less trauma and greater precision in these surgical interventions, Sakra tremendously benefits patients specializing in upper gastrointestinal surgeries, such as giant hiatal hernias, gastroesophageal reflux disease (GERD), Heller’s myotomy, and even uncommon conditions like median arcuate ligament syndrome.

“We take immense pride in reaching a significant milestone in robotic GI surgeries, underscoring the skill and commitment of our proficient surgical team,” lauded Lovekesh Phasu, Chief Operating Officer, Sakra World Hospital, Bengaluru, adding, “At Sakra, we’re committed to setting high standards and achieving them, to benefit our patients and provide quality healthcare for all.”

The application of robot-assisted technologies has greatly improved surgical capabilities in GI surgeries. These systems are operated directly by surgeons, in contrast to autonomous systems, which enable careful dissection around target organs. Although laparoscopic surgery provides benefits such as accurate dissection under high-resolution imaging and minimally invasive procedures, it has limitations due to the limited dexterity of the instruments. These limitations are overcome by the existing robotic system’s articulated instruments, vibration filtering, and motion scaling functions. These capabilities allow surgeons to perform more versatile surgeries than they could with the standard laparoscopic equipment.

Moreover, the robotic system’s instruments with wrist-like movements and dexterity assures delicate tissue handling and precision surgery with minimal bleeding. This capability, coupled with three-dimensional magnified, enhanced imaging, provides a platform wherein complex procedures in critical places and organs can be safely performed. Through these innovations, robotics surgery in the gastrointestinal realm continues to push boundaries, enhancing surgical precision and expanding treatment options for patients.

Robotic GI surgery has emerged as a reassuring alternative to traditional methods, dispelling common fears. The robotic system not only provides surgeons with better visualization and precision, but the patient also benefits from smaller incisions, less blood loss, quicker recovery, and reduced post-operative pain.

“The completion of 100 robotic GI surgeries at Sakra World Hospital not only marks a numerical achievement, but also serves as evidence of the hospital’s steadfast dedication to delivering top-notch care to its patients,” remarked Dr Sadiq Saleem Sikora, Director of Gastrointestinal Surgery and Liver Transplantation at Sakra World Hospital, Bengaluru.

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From this year, MUHS to conduct online Evaluation of Answer Sheets

Maharashtra- After last year’s successful trials on the online evaluation of answer sheets, Maharashtra University of Health Sciences (MUHS) has decided to conduct an online evaluation of answer sheets instead of a manual evaluation for all courses from this academic year.

Following the fewer errors and declaring the results on time last year, the plan has been now officially firmed up as it will significantly help in reducing the errors and expediting the declaration of results within two weeks.

This online evaluation of answer sheets will significantly help MUHS to declare the results within two weeks as compared to the standard 1.5 months. To start this process, a digital evaluation centre is being set up in each medical college with an examination coordinator who will scan the answer sheets.

According to HT Media News report, the MUHS official said “These centres are under CCTV surveillance. Once the professor starts assessing answer sheets after logging in, they will get an OTP on their phone that will record all steps involved with the assessments”.

Thousands of exams are conducted every year. The benefit of having an online assessment is be the results won’t get delayed. Also, the software sends alerts if the assessor has missed checking an answer” the official further added.

MUHS officials said the new pattern of evaluation of answer sheets is on the lines of Rajiv Gandhi University of Health Sciences in Karnataka. They had visited the university before conducting the pilot run.

The Pilot project was implemented during the Bachelor of Dental Surgery (BDS), MBBS and PG examinations between December 2022 and June this year. During this pilot project, MUHS evaluated more than 28,300 answer sheets and the results were declared in two days.

On this, the vice-chancellor Lt Gen Dr Madhuri Kanitkar (retd) also said “Last year, on a pilot basis, we conducted an online assessment of certain answer sheets and it was observed that it was a more viable option. We have now decided to implement online assessment in all the courses from this academic year“.

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Arvinas, Novartis collaborate for development, commercialization of ARV-766 for prostate cancer

New Haven: Arvinas, Inc., a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, has announced it has entered into an exclusive strategic license agreement with Novartis for the worldwide development and commercialization of ARV-766, Arvinas’ second generation PROTAC androgen receptor (AR) degrader for patients with prostate cancer. The transaction also includes an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis.

“We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need,” said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. “We believe the expertise and scale of Novartis will broaden the development of ARV-766 and its potential to be a first- and best-in-class treatment for patients with prostate cancer. This strategic transaction also further validates our innovative PROTAC protein degrader platform and its potential to deliver new treatments.”

Under the terms of the transaction agreements, Novartis will be responsible for worldwide clinical development and commercialization of ARV-766 and will have all research, development, manufacturing, and commercialization rights with respect to the preclinical AR-V7 program. Arvinas will receive an upfront payment in the aggregate amount of $150.0 million. Under the License Agreement, Arvinas is eligible to receive additional development, regulatory, and commercial milestones of up to $1.01 billion, as well as tiered royalties for ARV-766.

Closing of the transaction is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.

ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Preclinically, ARV-766 has demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with AR mutations or amplification, both common potential mechanisms of resistance to currently available AR-targeted therapies.

Arvinas is a clinical-stage biotechnology company. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has four investigational clinical-stage programs: vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-766 and bavdegalutamide for the treatment of patients with metastatic castration-resistant prostate cancer; and ARV-102 for the treatment of patients with neurodegenerative disorders.

Read also: Novartis tender offer for MorphoSys AG commences

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

Dwarka: Contrary to the common misconception that ‘Stage IV cancer patients cannot be treated’, doctors at Manipal Hospital, Dwarka have successfully saved life of a 47-year-old male from Basra, Iraq, who was diagnosed with stage 4 rectal cancer. 

The patient had initially been diagnosed with piles and was undergoing treatment for the same in his country. However, it was later discovered that he was suffering from rectal cancer that had been misdiagnosed earlier. The patient underwent multiple chemotherapy and radiation sessions, post which he was referred to Dr Sanjeev Kumar, Surgical Oncologist, Manipal Hospital in Dwarka.

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

After evaluation, he was found to have Peritoneal disease in addition to the Rectal Cancer (Stage IV). Given the complexity of the case, Dr Sanjeev Kumar and his team decided to undertake a major surgery, performing CRS (Cytoreductive Surgery) and HIPEC (Hyperthermic Intraperitoneal Chemotherapy Surgery). These procedures were combined with the surgical removal of the cancerous tumour and the administration of heated chemotherapy to the abdomen, to maximize the effectiveness of the treatment.

Usually, stage IV cancers are incurable. But, peritoneal cancers, disease which spread to abdominal wall lining and surface, can be treated. CRS and HIPEC is a highly complex and challenging procedure. In HIPEC, heated mixture of chemotherapy is added in the operation field.

Commenting on the case, Dr Sanjeev Kumar, Consultant- Surgical Oncology, Manipal Hospital, Dwarka said, “This was challenging case as the patient had previously been misdiagnosed, and the fact that he weighed 122 kg added an additional level of complexity to the treatment. However, after thorough evaluation, we opted for a comprehensive treatment approach that combined advanced techniques (HIPEC).

Despite an unfavorable initial prognosis, the patient was successfully treated under the guidance of our team and returned home with a better quality of life. The success of his treatment highlights the importance of advanced medical solutions to complex problems like cancer.”

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Appoint only MBBS Degree Holders As Duty Medical Officers: Telangana Medical Council directs all hospitals

Hyderabad: The Telangana State Medical Council (TSMC) has issued directions to all the Super Speciality Hospitals, Nursing Homes, Clinics, Private Hospitals and Registered Medical Practitioners in the State to only appoint MBBS degree holders as Duty Medical Officers (DMOs). 

Issuing a Circular in this regard on 10.04.2024, the council has also issued strict instructions not to appoint other degree holders such as Pharm D, BAMS, BHMS, BUMS, etc as DMOs. The Council has also asked all the consultants practising in the State to get registered with TSMC and renew their registration in time.

Such directions were issued by the Council after it inspected various hospitals and clinics in the Greater Hyderabad Municipal Corporation (GHMC) area and found several lapses and violations of rules.

The Council noted that most of the hospitals were not displaying the registration numbers issued by medical council against the names of the consultant doctors in the hospital display board.

Further, it found that some of the hospitals were appointing Pharm D degree holders as Duty Medical Officers, and such officers were also tasked to write the case sheets of the patients.

Apart from this, the Council also came to know that many hospitals were appointing AYUSH doctors as DMOs, and few of the consultants from other States were practicing in Telangana without registering in TSMC. Some of the Consultants were found to be practicing without the renewal of registration with TSMC.

Also Read: Telangana Medical Council Continues Battle Against Quackery: 2 more FIRs Filed Against Unqualified Practitioners

Taking note of the situation, TSMC ordered in its latest circular, “In this connection, the Telangana State Medical Council is directing all the Super Speciality Hospitals, Nursing Homes, Clinics, Private Hospitals and also the Registered Medical Practitioners in the State to appoint only MBBS degree holders as DMO’s. The TSMC strictly instruct not to appoint other degree holders like Pharm D, BAMS, BHMS, BUMS etc., as Duty Medical Officers and also see that all consultants who are practicing in Telangana State should get registered/renewed in TSMC.”

Meanwhile, the Council has also advised the patients to verify the genuineness of the doctors online by using the Doctor Search option.

“It is further instructed that while appointing the doctors, the appointing authority may verify the genuinity of the doctors with the consultation of TSMC, you can also verify through online by using Doctor Search option,” the Circular stated.

“If any violations occurred, the TSMC will take appropriate action as per TSMRP Act and NMC Act 2019,” the Council further clarified.

Earlier this year, Telangana Government authorities issued an ultimatum to the medical establishments in the State and asked them to ensure that they have proper registration. The authorities asked them to register or renew their registration at the earliest in case they lacked the requirement. The health facilities were warned of action under the Clinical Establishments Act if they failed to adhere to these instructions.

Meanwhile, aiming to eradicate quackery in the State, TSMC has been filing several FIRs against quacks engaging in the practice of modern medicine and prescribing scheduled drugs.

Earlier, the Council had also complained to the Ayush Board to take necessary action against the following doctors who possess only BAMS, BHMS & BUMS degrees but are illegally practicing Allopathic Medicine without MBBS Qualification.

Also Read: Register or face action: Medical Establishments in Telangana Get Ultimatum

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INI CET July 2024 At NIMHANS, SCTIMST: Check seat matrix, fee details here

New Delhi- On its website, the AIIMS has released prospectus for INI CET July 2024 admissions at National Institute of Mental Health and Neuro Sciences (NIMHANS) and Shree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST).

In the 2  prospectus, the institutes have provided details on the fees, eligibility criteria, seat matrix and much more. The candidates can check out the same as mentioned below.

NIMHANS

ELIGIBILITY CRITERIA OF (NIMHANS) FOR MD, DM (3 & 6 YEARS), MCh (3 & 6 YEARS) COURSES

1 MBBS degree from a recognised University or from any other University recognised as equivalent thereto by NIMHANS and by the Medical Council of India/ National Medical Commission (NMC).

2 The candidate should have completed a compulsory rotation internship of one year after MBBS or its equivalent as recognized by NMC on or before 31st July 2024. A certificate to that effect has to be produced. The candidate should have permanent/provisional registration with the State Medical Council. Candidates who do not submit the Internship certificate on the day of admission to the course will not be admitted under any circumstance.

FEES STRUCTURE

S.NO

DETAILS

AMOUNT PER YEAR

COURSE WITH DURATION IN YEARS

MD Course

DM/M.Ch Courses

3 Years

6 Years

1

Eligibility fee

5,000

500

500

500

100

2

Registration fee

1,000

1,000

1,000

3

Tuition Fee

50,000

50,000

50,000

4

Laboratory fee

500

1,500

3,000

5

Gymkhana & Recreation Fee

250

750

1,500

6

Library fee

1,000

3,000

6,000

7

Caution Money & Hostel Deposit

5,000

5,000

5,000

8

Identification card fee

100

100

100

9

NHS card fee

100

100

100

10

Examination fee: Part I

4,500

4,500

4,500

11

Part II

6,500

6,500

6,500

12

Part III

12,500

12,500

13

Exit Examination Application fee

50

100

150

14

Marks Card fee

100

200

100

15

Total

73,250

90,950

FOREIGN NATIONALS (EXCEPT FROM SAARC COUNTRIES)

S.NO

NAME OF THE COURSE

TUITION FEE

REGISTRATION FEE

1

DM/M.Ch. ( 6 years duration) Courses

60,000

1,000

2

MD ( 3 years duration) Courses

50,000

1,000

SEAT MATRIX

The following seats are reserved for various ‘Domicile Categories’ in various courses:

Domicile reservation category

Karnataka Domicile

North Eastern States Domicile

MD in Psychiatry Course:

Session 1

04 seats under ‘Institute Stipendiary’ and 01 seat under ‘Sponsored Category’

03 Seats under ‘Institute Stipendiary Category’

SCTIMST

IMPORTANT DATES FOR ADMISSION IN (SCTIMST)

Admission Notification

As per schedule/important dates available in the Prospectus Part-A of the INIs for July 2024 session

Availability of online Application

Hall ticket download

Commencement of courses

1st July 2024

Director’s welcome address

06th July 2024

ELIGIBILITY CRITERIA OF (SCTIMST) FOR MD, MS, DM (6 YEARS), MCh (6 YEARS) & MDS COURSES

MBBS or equivalent degree from a recognised university. They should complete one year of compulsory internship from a medical college/institute on or before 31st July 2024. The candidate should have applied for and obtained registration with the State Medical Council before admission.

FEES STRUCTURE

S.NO

PARTICULARS

AMOUNT (INR)

1

Admission fee

2,000

2

Tuition Fee

63,000 (per year)

3

Caution Deposit (Refundable)

10,000

4

Examination Fee

10,000

5

Thesis Evaluation Fee

1500

6

Identity Card

220

7

Library

1,000

8

Student Welfare Fund

1,000

9

Certificates

1,000

10

Miscellaneous Fee

10,000

SEAT MATRIX

Program

Number of Seats

Duration (Years)

Qualifications required

General quota

Sponsored seats

MD in Transfusion Medicine

NIL

1

3

MBBS or equivalent degree from a recognised University

To view the (SCTIMST) prospectus, click the link below

To view the (NIMHANS) prospectus, click the link below

https://medicaldialogues.in/pdf_upload/nimhans-prospectus-236014.pdf

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Choosing sugary drinks over fruit juice for toddlers may increase risk of adult obesity: Study

Consuming sugar-sweetened drinks in the first few years of childhood can be linked to poor diet patterns that increase the risk of obesity in later life, according to a new study by the School of Psychology at Swansea University.

Published in the European Journal of Clinical Nutrition, the study tracked the influence of diet on 14,000 British children from birth to adulthood and is believed to be the longest of its kind ever reported.

Using the Avon Longitudinal Study of Parents and Children, the research team found:

Children who drank fizzy drinks such as cola or sugar-sweetened fruit cordials before the age of two gained more weight when they were 24 years old. Girls who had pure fruit juice gained less weight, while the weight of boys remained the same.

At three years of age, toddlers who drank cola consumed more calories, fat, protein, and sugar but less fibre. In contrast, those given pure apple juice consumed less fat and sugar but higher amounts of fibre.

The study also highlighted corresponding differences in food choices. Children who consumed pure apple juice often followed a diet with more fish, fruit, green vegetables, and salad, whereas those drinking cola ate more burgers, sausages, pizza, french fries, meat, chocolate, and sweets.

Additionally, the team discovered a link between sugar-sweetened drinks and social deprivation, with children from affluent backgrounds more likely to have access to pure fruit juice.

Lead researcher Professor David Benton said: “The early diet establishes a food pattern that influences, throughout life, whether weight increases. The important challenge is to ensure that a child develops a good dietary habit: one that offers less fat and sugar, although pure fruit juice, one of your five a day, adds vitamin C, potassium, folate, and plant polyphenols.”

Dr Hayley Young added: “Obesity is a serious health concern, one that increases the risk of many other conditions. Our study shows that the dietary causes of adult obesity begin in early childhood and that if we are to control it, more attention needs to be given to our diet in the first years of life.”

References: Benton, D., Young, H.A. Early exposure to sugar sweetened beverages or fruit juice differentially influences adult adiposity. Eur J Clin Nutr (2024). https://doi.org/10.1038/s41430-024-01430-y

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Submit analysis of clinical data of Asian, Indian Population: CDSCO Panel Tells AstraZeneca on Durvalumab

New Delhi: In response to the drug major AstraZeneca’s proposal for the approval of additional indication of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the subset analysis of the clinical data of Asian population and Indian population of Global clinical study(AEGEAN) conducted in the proposed indication.

In addition to the above, the expert panel stated to submit the results of the ongoing Phase IV clinical study and the status of regulatory approval of the proposed indication of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution.

This came after the drug major AstraZeneca presented the proposal for approval of additional indication i.e.,“Durvalumab (IMFINZI) in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours ≥ 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements” based on the global clinical trial conducted including subjects from India.

Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the growth of cancer cells. Durvalumab is an anticancer antibody that works to promote the antitumor responses mediated by immune cells. By blocking the action of PD-L1, durvalumab exerts its anticancer effects by increasing T-cell activation and enhancing the detection and ablation of tumor cells.

Durvalumab is used alone or with other drugs to treat adults with certain types of biliary tract cancer (including bile duct cancer and gallbladder cancer), hepatocellular carcinoma (a type of liver cancer), non-small cell lung cancer, and small cell lung cancer.

At the recent SEC meeting for Oncology held on 19th and 20th March 2024, the expert panel reviewed the proposal presented by the drug major AstraZeneca for the approval of the additional indication of Durvalumab (IMFINZI) based on the global clinical trial conducted including subjects from India.

The committee noted that the proposed indication is not yet approved by any regulatory authorities. Furthermore, the expert panel found that phase IV study of the drug is ongoing in India for the approved indication i.e., locally advanced, unresectable non-small cell lung cancer (NSCLC) and urothelial cancer.

After detailed deliberation, the committee recommended the firm to submit

1)subset analysis of clinical data of the Asian population and Indian population of Global clinical study(AEGEAN) conducted in the proposed indication.

2) Results of ongoing Phase IV clinical study

3) Status of regulatory approval of the proposed indication for further evaluation.

Also Read:Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

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

New Delhi: Reviewing the Phase IV clinical trial protocol of Lupin’s pulmonary FDC (Fixed Dose Combination) Glycopyrronium Bromide plus Vilanterol Trifenatate powder for inhalation in capsule, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has approved the firm conduct the Phase IV clinical trial of the said combination.

This decision came after the firm presented the Phase IV clinical trial protocol before the committee.

Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, as well as in combination with other medications for ulcer treatment and anesthesia.

Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD.

During the recent SEC meeting for Pulmonary held on March 5th, 2024, the expert panel reviewed the Phase IV clinical trial protocol of the pulmonary FDC Glycopyrronium Bromide eq. to 50mcg Glycopyrronium 63mcg + Vilanterol Trifenatate eq. to 25mcg Vilanterol 40mcg powder for inhalation in capsule.

After detailed deliberation, the committee recommended the conduct of the Phase IV clinical trial. Furthermore, the expert panel suggested that the firm is required to submit the Phase IV clinical trial report to CDSCO for further review by the committee.”

Also Read: CT waiver not considered, Conduct BA study: CDSCO Panel Tells Sun Pharma on Pulmonary FDC

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