Major setback for doctors, Still liable under Consumer Protection Act

In a landmark order, the Supreme Court has refused to reconsider the 1995 judgment in the case of Indian Medical Association v VP Shantha, which brought medical professionals under the ambit of the Consumer Protection Act, 1986 (as re-enacted in 2019).

Although earlier this year a two-judge bench of the Apex Court had observed that the 1995 judgment required reconsideration, the three-judge bench disposed of the reference made against the 1995 order, observing that it was unnecessary.

For more information, click on the link below:

Powered by WPeMatico

HC criticises govt doctors for choosing private practice over government duties

While considering a suo motu Public Interest Litigation (PIL) aimed to address the shortcomings in public health service across the State, the Chhattisgarh High Court recently expressed grave concern over the failure of the Government doctors in the State to adhere to the prescribed government guidelines.
The HC bench comprising Chief Justice Ramesh Sinha and Justice Bibhu Datta Guru took cognisance of the issue after a newspaper report alleged that more than half of the government-appointed doctors in Chhattisgarh were neglecting their duties in district hospitals as they were engaged in private practice of their own, Law Trend has reported.

For more information, click on the link below:

Powered by WPeMatico

Doctor, nurse booked for cannula insertion pricks, patient alleges they were intoxicated

A doctor and nurse have been booked for cannula injury in a strange medical negligence case. While the patient has claimed that the doctor was drunk and cannula was repeatedly inserted incorrectly causing pricks, the hospital has responded that it was a simple case where the staff could not find the vein.
In her complaint, the patient claimed that the doctor and nurse were in a drunken state and poked her multiple times with the needle in search of a vein for the saline drip which she said left her with injuries on her hand. She also claimed that the doctor and the nurse misbehaved with her during her treatment.

For more information, click on the link below:

Powered by WPeMatico

Pfizer Gets CDSCO Panel Nod To Conduct Phase III CT of Rimegepant

New Delhi: Pharmaceutical major Pfizer has received the go-ahead from the Subject Expert Committee (SEC), which is functional under the Central Drug Standard Control Organisation (CDSCO), to conduct the Phase III clinical study of the calcitonin gene-related peptide receptor antagonist Rimegepant.

This came after the firm presented Phase III clinical study protocol no. C4951013 amendment 1 dated 19.03.2024.

However, this approval is subjected to a condition that the firm should enrol the paediatric subjects of at least 40kg weight.

Rimegepant is a small molecule inhibitor of the calcitonin gene-related peptide (CGRP) receptor that blocks the action of CGRP, a potent vasodilator believed to play a role in migraine headaches.

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine with or without aura in adults and for the preventive treatment of episodic migraine in adults.

Rimegepant is an antagonist of the calcitonin gene-related peptide receptor 1 – it competes with CGRP for occupancy at these receptors, preventing the actions of CGRP and its ability to amplify and perpetuate migraine headache pain, ultimately terminating the headache.

Rimegepant belongs to a new generation of treatments for acute migraine headaches. The drug is awaiting approval from the U.S. Food and Drug Administration and give benefits over migraine medicines presently available.

Earlier, the Medical Dialogues Team had reported that the expert panel rejected the firm’s proposal for a local Phase III clinical trial waiver and recommended conducting the randomized controlled Phase III clinical trials of Rimegepant orally disintegrating tablet (ODT) 75 mg in Indian population.

At the recent SEC meeting for Neurology and Psychiatry, held on 29 October 2024, the expert panel reviewed the Phase III clinical study protocol no. C4951013 amendment 1, dated 19.03.2024.

After detailed deliberation, the committee recommended that permission to conduct the trial as presented by the firm be granted, with the condition that pediatric subjects of at least 40kg weight be enrolled.

Also Read: CDSCO Panel Approves Pfizer Protocol Amendment proposal to study anti-cancer drug Elranatamab

Powered by WPeMatico

18-year-old NEET aspirant dies by suicide in hostel, Family claims mental pressure from coaching institute

In an unfortunate incident, an 18-year-old medical aspirant preparing for the NEET entrance exam at a private coaching institute in Patia allegedly committed suicide by hanging herself from the ceiling fan in her hostel room
According to family members, the deceased girl from Salepur, Cuttack district, a Plus II science student was preparing for NEET at a private institute in Bhubaneswar over the last 18 months. They alleged that their daughter was unable to handle the pressure of her studies following which she fell into depression. They claimed that she suffered extreme mental pressure from the coaching centre.

For more information, click on the link below:

Powered by WPeMatico

CEE Kerala Invites Applications for DNB Post MBBS, DNB Post Diploma Admissions under State Quota, details

Kerala: Commissioner for Entrance Examinations (CEE) has invited applications for admission to the State quota seats in DNB Post MBBS and Post Diploma courses for the academic year 2024-25. As all the State quota seats are earmarked for In-Service (Medical Education Service/Health Service/Insurance Medical Service of the Govt. of Kerala) candidates, applicants should be In-Service candidates of Medical Education Service/Health Service/ Insurance Medical Service under Govt. of Kerala.

In-Service candidates qualified in NEET PG-2024/DNB PDCET-2024 Examination conducted by National Board of Examinations, as the case may be, only are eligible to apply and register their options for DNB (Post MBBS) and DNB Post Diploma courses.

All In-Service candidates seeking admission to the DNB (Post MBBS) and Post Diploma Courses 2024 can apply Online till 12.11.2024, 12.00 PM through the website of the Commissioner for Entrance Examinations and remit the required fee of Rs.1,000/- by way of online payment. After remitting the required application fee, the candidate should upload his/her photo and signature, and all necessary certificates as proof of eligibility and various claims. Documents can be uploaded till 13.11.2024, 12.00 PM.

Eligibility for Admission to DNB-Post MBBS

Applicant should be a service candidate who has qualified NEET PG 2024 and in possession of MBBS degree. The merit list of Kerala (service quota) NEET- PG 2024 shall be utilized by the Commissioner for Entrance Examinations (CEE), Kerala, for admissions to the state in-service quota seats of the various DNB (Post MBBS) courses in the state.

Candidates already pursuing a DNB/MD/MS course are not eligible for admission in DNB Course till such time they have completed the entire duration of the prescribed course or have been discharged from the course. Candidates who have joined DNB Broad Specialty course in or after January2023 admission session are not eligible for admission to 2024 session. This shall be irrespective of their resignation or discontinuation from the course due to any reason

Eligibility for admission to DNB-Post Diploma:

The eligibility criteria for admission to Post Diploma in DNB Courses of 2 year duration is as follows: Service Candidates must have qualified in DNB PDCET-2024. Candidates who have passed the final examination leading to the award of Post Graduate Diploma from Indian Universities which are duly recognized as per provisions of the NMC Act 2019 and the repealed Indian Medical Council Act 1956, can apply for the DNB-PDCET 2024 in the same Broad Specialty.

The result of final examination for the said Post Graduate Diploma qualification should have been declared on or before 31 May 2024. Candidates must note that it is mandatory for them to submit proof/documentary evidence clearly establishes that the result of the final examination for their Post Graduate Diploma qualification was declared on or before the cut-off date i.e. 31 May 2024.

Eligibility for admission to DNB-Post Diploma: The eligibility criteria for admission to Post Diploma in DNB Courses of 2 year duration is as follows:

Service Candidates must have qualified in DNB PDCET-2024.

Candidates who have passed the final examination leading to the award of Post Graduate Diploma from Indian Universities which are duly recognized as per provisions of the NMC Act 2019 and the repealed Indian Medical Council Act 1956, can apply for the DNB-PDCET 2024 in the same Broad Specialty. 

The result of final examination for the said Post Graduate Diploma qualification should have been declared on or before 31 May 2024.

Candidates must note that it is mandatory for them to submit proof/documentary evidence clearly establishes that the result of the final examination for their Post Graduate Diploma qualification was declared on or before the cut-off date i.e. 31 May 2024.

In the event that the proof/documentary evidence submitted by the candidate does not clearly establishes that the result of the final examination of his/her Post Graduate Diploma qualification was declared on or before 31 May 2024, the candidature shall be cancelled and the candidate shall be declared as ineligible. 

Candidates found to be ineligible at any stage of counseling and admissions will not be permitted to join the course.

Candidates already pursuing a MD/MS/DNB course are not eligible to appear for counseling for DNB Post Diploma till such time they have completed the duration of prescribed course or have been discharged from the course. This shall be irrespective of their resignation or discontinuation from the course due to any reason

Candidates possessing Diploma qualifications awarded by the College of Physicians and Surgeons (CPS), Mumbai other than DPB, DCH and DGO are NOT eligible to attend counseling or for admission in DNB Post Diploma in line with the clarification received from the Govt of India vide MoHFW letter No.C.18018/11/2021-MEP dated 30.04.2021.

Registration with the NMC/the erstwhile Medical Council of India or State Medical Council is necessary and its documentary proof should be furnished by the candidates at the time of counseling/admission. Nativity: Applicants have to be Indian Citizens of Kerala origin. One of the following documents is required to establish that the applicant is a Keralite.

i. Relevant page of the Secondary School Leaving Certificate/Indian Passport/Birth Certificate of the candidate or either of the parents showing place of birth in Kerala. In case certificate of parent is attached, corroborative certificate to establish the relationship between the parent and the candidate should also be uploaded.

OR

ii. Nativity Certificate for Kerala Origin, obtained from the Village Officer to show that he/she or his/her father/mother was born in Kerala. Candidates who are sons/daughters of Non-Keralite parents, who have obtained MBBS degree from any of the Medical Colleges in the State of Kerala. But they will not be eligible for Communal/Special/PD reservation benefits (Uploading of nativity proof at the time of the online application submission is mandatory for all categories of candidates). 

Age:

For the Medical Education Service Quota, the upper age limit is 49 years as on 31 December of the year of issue of Notification by CEE assuring minimum of 10 years of service after completion of the course as stipulated in the service quota rules (including the candidates of IIMS, Palakkad). For Health Service Quota and Insurance Medical Service Quota, the upper age limit is 47 years as on 31 December of the year of issue of Notification by CEE, assuring minimum of 10 years of service after completion of the course as stipulated in the service quota rules.

Submission of Application:

All In-Service candidates seeking admission to the DNB (Post MBBS) and Post Diploma Courses 2024 can apply Online till 12.11.2024, 12.00 PM through the website of the Commissioner for Entrance Examinations and remit the required fee of Rs.1,000/- by way of online payment. After remitting the required application fee, the candidate should upload his/her photo and signature, and all necessary certificates as proof of eligibility and various claims. Documents can be uploaded till 13.11.2024, 12.00 PM.

The printout of the Application Acknowledgement page along with all necessary service documents (including copies of uploaded documents) should be forwarded to the respective Heads of Departments (DME/DHS/IIMS). There is no need to send a printout of the Application Acknowledgement page or any documents to the Office of the Commissioner for Entrance Examinations.

Option Registration:

The selection and ordering of options (Specialty and Institution combinations which the candidate would like to join if allotted) should be done by the candidate as part of the Online Application Procedure. The facility for selection and ordering of the options shall be available at the link OPTION REGISTRATION, which will be available after uploading all necessary documents to the online application. The online application process will be completed only after registration of options.

Application Fee:

The application fee is Rs.1,000/- and is non-refundable. Payment is to be made in the payment section of the application by credit card/debit card or net banking. 

Last Date and Time for the submission of online application :

All candidates seeking admission to the course should submit the online application along with uploaded mandatory documents/ before 12.00 PM of 12.11.2024. Certificates mentioned in clause 15 of the Information Bulletin to DNB (Post Diploma) and clause 5 of the DNB (Post MBBS) can be uploaded till 13.11.2024, 12.00 PM. Defective and incomplete applications will be summarily rejected. No correspondence will be undertaken in this regard.

Candidates will not be allowed to include any information in the application form or submit any certificates/documents after the last date of submission of the online application. The allotment of seats to candidates will be made by the Commissioner for Entrance Examinations through the Centralized Allotment Process (CAP). Details of the Centralized Allotment Process (CAP) will be published in the official website  of the Commissioner for Entrance Examinations in due course.

Mode of selection:

The Commissioner for Entrance Examinations (CEE) will provide the list of applicants qualified in the NEET PG 2024/DNB PDCET 2024 to the respective controlling officers through the Director of Health Services, Kerala. The Controlling Officer/Head of Department (DME/DHS/IIMS) concerned, upon verification of applications and related documents will prepare a rank list according to the merit and service of the candidates in accordance with the conditions stipulated in the Information Bulletin. The finalized rank lists will be forwarded to the CEE through the Director of Health Services (Convenor of Selection Committee). The CEE will conduct the Centralized Allotment Process (CAP) based on the finalized rank lists obtained from the Director of Health Services and the Options selected and ordered by the candidates according to the relative preferences for various specialties and institutions.

Candidates may go through the various provisions of the Information bulletin of DNB Post MBBS Course and DNB Post Diploma Course, as the case may be, available on the official website of the Commissioner for Entrance Examinations before filling up the online application. Candidates should also frequently visit the website for authentic information with regard to application/allotments/admissions and related matters. No communication will be sent by post or any other mode in connection with the application/allotments/admissions of DNB Post MBBS Course and DNB Post Diploma Course.

To view the official Notice, Click here :  https://medicaldialogues.in/pdf_upload/upload1-1-260082.pdf

Powered by WPeMatico

Delhi HC upholds Bristol Myers’ patent for anti-cancer drug Dasatinib, imposes Rs 5L penalty on SP Labs

New Delhi: In relief to Bristol-Myers Squibb Holdings Ireland (BMS), the Delhi High Court has upheld its patent for the anti-cancer drug dasatinib and imposed a penalty of Rs 5 lakh on SP Labs for patent infringement.

BMS initially filed the case in 2015, asserting that SP Labs infringed on its patent by marketing a generic dasatinib product in India before the patent’s expiry in April 2020. Despite repeated notices, SP Labs failed to appear in court, leading to an ex-parte ruling and financial penalty in favor of BMS.

On August 27, 2024, the Delhi High Court delivered its ruling in the patent infringement case between Bristol-Myers Squibb Holdings Ireland (BMS) and multiple defendants, including SP Labs, over the drug dasatinib, used in cancer treatment.

BMS sought a permanent injunction against the defendants for infringing its Indian Patent No. IN 203937, which covered dasatinib and its pharmaceutically acceptable salts, solvates, isomers, and prodrugs. This patent was valid until April 12, 2020, yet BMS contended that unauthorized actions by SP Labs and other entities in India, such as advertising and attempting to distribute a generic version, constituted infringement before the expiration date.

In the initial proceedings, the High Court had issued an ex-parte injunction on September 4, 2015, restraining the defendants from manufacturing or selling dasatinib-based products. This order was later made permanent until the patent’s expiry in 2020. Despite the injunction, BMS discovered in November 2016 that a product branded “DASA SPL,” which contained dasatinib, was being marketed at the distributor level in India. Investigations revealed that this product was manufactured by SP Labs, based in Bangladesh, which was connected to the Indian entity SP Labs Pvt. Ltd. According to BMS, SP Labs was attempting to bypass Indian patent laws by manufacturing in Bangladesh, where dasatinib was not under patent protection, and then importing the product to India.

The court documents highlighted that BMS had obtained evidence connecting SP Labs in Bangladesh to the Indian defendants, despite the defendants’ claims to the contrary. In previous rulings, including a December 2023 court order, the Delhi High Court had noted connections between SP Labs and Indian distributors, further supporting BMS’s argument that SP Labs was circumventing the injunction through its operations in Bangladesh.

In the present 2024 hearing, the court confirmed that SP Labs had been properly notified about the case but had not appeared in court or presented a defense. Given the lack of response from SP Labs and the evidence provided by BMS, the court ruled in BMS’s favor. It decreed a cost of Rs 5,00,000 against SP Labs, payable to the Delhi High Court Bar Association Employee Welfare Fund, as a penalty for its non-compliance and continued infringement actions.

The court also acknowledged the validity of BMS’s patent and noted that other defendants, who appeared in court, had not commercially launched any infringing products during the patent’s term and had respected the patent’s validity.

The court’s final ruling imposed several notable restrictions and penalties on SP Labs. First, due to SP Labs’ absence in court despite receiving proper notification, the court issued an ex-parte decree, holding SP Labs liable for patent infringement and ordering financial penalties.

Furthermore, the defendants who did appear in court acknowledged the validity of BMS’s patent and refrained from launching dasatinib-based products in India during the patent’s active period. It observed;

“The defendant nos. 1 to 3, 5 and 6, did not launch any dasatinib containing product till the expiry of the suit patent on 12 th April, 2024. II. There has been no commercial use by defendant nos. 1 to 3, 5 and 6, of any kind, whatsoever, in relation to dasatinib till date. III. The defendant nos. 1 to 3, 5 and 6, acknowledge the validity of the Patent No. IN 203937, during its term, till the expiry of such patent on 12th April, 2020.”

The court, however, confirmed that SP Labs, identified as Defendant No. 7, infringed upon BMS’s patent by marketing dasatinib under the brand name DASA SPL, thereby substantiating BMS’s infringement claim. Additionally, a significant fine of Rs 5,00,000 was levied against SP Labs.

Subsequently, the court noted;

“The defendant no. 7 has not entered appearance in the matter and had in fact launched the impugned product dasatinib, under the brand name DASA SPL. Considering the fact that the defendant no. 7 has not appeared before this Court despite valid service, and not raised any defence and has rather introduced the impugned product dasatinib under the brand name DASA SPL, and considering the fact that the present suit has been pending since the year 2015, cost of ₹ 5,00,000/- is imposed against defendant no. 7 in favour of DHCBA Employee Welfare Fund. ”

To view the original order, click on the link below:

https://indiankanoon.org/doc/111815577/

Powered by WPeMatico

TN Medical Council Files Complaint Against Doctor for Practicing with Cancelled License

Chennai: Taking action against a doctor for illegally practising in the Theni district after his license was cancelled for one year, the Tamil Nadu Medical Council (TMC) has lodged a complaint with the Directorate of Medical Services (DMS). 

It was found that the doctor was practising illegally, without a valid licence and without filing an appeal with the National Medical Commission, within a stipulated period of 60 days after the TMC cancelled his license and removed his name from the state medical register.  

The doctor’s license was cancelled due to alleged medical negligence after a cardiac surgery patient died at a private hospital in Chennai years ago as the doctor allegedly failed to provide adequate post-operative care. Also includes unethical financial conduct, professional misconduct and fraudulent activities among other reasons. 

Also read- Medical Officer stabs Junior Nursing Assistant, another at GMC Kathua; Suspended

It came to light that an inquiry was performed and the council cancelled his license for a year. Under the Clinical Establishment Act, only registered practitioners should be employed in hospitals and can practice medicine. However, the doctor violated the rules and regulations and engaged in illegal practice.  

While DMS has sent the complaint to the Joint Director of Medical Services who will notify any private hospitals employing the doctor of his disqualification, TMC has alerted the Theni superintendent of police, urging immediate legal action to prevent further illegal practice.  

Defining the illegal practice as equivalent to quackery, a member of TMC told TNIE, “After his licence was cancelled for one year following an inquiry, he moved to Theni district from Chennai and has been practising.”

Officials at the DMS said, “If the doctor is practising without the licence, then it’s equal to quackery. So, the private hospital in which he is practising will be informed about it.”

In its press release, TMC said, “We have taken disciplinary action in the case of Dr ***, who faced allegations of medical negligence, unethical financial conduct, professional misconduct and fraudulent activities. Following an inquiry, the charges were substantiated, and as a result, his name was officially removed from the State Medical Register for a period of one year, as per the council’s final order dated June 5,2024.”

“Dr Dhinesh received the order from the council on July 6,2024. Despite the clear order of removal of his name from the state medical register, it has been brought to the notice of the council that he continues practising medicine illegally, without valid licence and without filing an appeal with the National Medical Commission,within a stipulated period of 60 days. Such actions not only violate the TMC mandate but also endanger public health and undermine the integrity of the medical profession,” reads the PR. 

Also read- Rajasthan Medical Council Registrar suspended over Fake Registrations of Doctors

Powered by WPeMatico

Health Bulletin 09/ November/ 2024

Here are the top health news for the day:

Major setback for doctors, Still liable under Consumer Protection Act
In a landmark order, the Supreme Court has refused to reconsider the 1995 judgment in the case of Indian Medical Association v VP Shantha, which brought medical professionals under the ambit of the Consumer Protection Act, 1986 (as re-enacted in 2019).
Although earlier this year a two-judge bench of the Apex Court had observed that the 1995 judgment required reconsideration, the three-judge bench disposed of the reference made against the 1995 order, observing that it was unnecessary.

For more information, click on the link below:

Doctor, nurse booked for cannula insertion pricks, patient alleges they were intoxicated
A doctor and nurse have been booked for cannula injury in a strange medical negligence case. While the patient has claimed that the doctor was drunk and cannula was repeatedly inserted incorrectly causing pricks, the hospital has responded that it was a simple case where the staff could not find the vein.
In her complaint, the patient claimed that the doctor and nurse were in a drunken state and poked her multiple times with the needle in search of a vein for the saline drip which she said left her with injuries on her hand. She also claimed that the doctor and the nurse misbehaved with her during her treatment.

For more information, click on the link below:

HC criticises govt doctors for choosing private practice over government duties
While considering a suo motu Public Interest Litigation (PIL) aimed to address the shortcomings in public health service across the State, the Chhattisgarh High Court recently expressed grave concern over the failure of the Government doctors in the State to adhere to the prescribed government guidelines.
The HC bench comprising Chief Justice Ramesh Sinha and Justice Bibhu Datta Guru took cognisance of the issue after a newspaper report alleged that more than half of the government-appointed doctors in Chhattisgarh were neglecting their duties in district hospitals as they were engaged in private practice of their own, Law Trend has reported.

For more information, click on the link below:

18-year-old NEET aspirant dies by suicide in hostel, Family claims mental pressure from coaching institute
In an unfortunate incident, an 18-year-old medical aspirant preparing for the NEET entrance exam at a private coaching institute in Patia allegedly committed suicide by hanging herself from the ceiling fan in her hostel room
According to family members, the deceased girl from Salepur, Cuttack district, a Plus II science student was preparing for NEET at a private institute in Bhubaneswar over the last 18 months. They alleged that their daughter was unable to handle the pressure of her studies following which she fell into depression. They claimed that she suffered extreme mental pressure from the coaching centre.

For more information, click on the link below:

Powered by WPeMatico

Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study Ranibizumab Solution for Injection

New Delhi: The drug major Sun Pharmaceutical Industries has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase IV study of Ranibizumab Solution for Injection 10 mg/ml

This came after Sun Pharmaceutical Industries presented the proposal for conducting the phase IV study in the approved indications vide revised protocol ICR 23/004, Version No. 3.0dated 09.07.2024.

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration.

Ranibizumab is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration. It is used to treat eye conditions such as diabetic retinopathy and macular edema.

Ranibizumab binds to VEGF-A with high affinity as well as its biologically active forms, such as VEGF165, VEGF121, and VEGF110.4 Notably, VEGF165 is the most predominant isoform in the human eye that promotes ocular neovascularization. VEGF165 enhances vascular permeability, inhibits apoptosis, and causes endothelial-cell mobilization from the bone marrow and differentiation for angiogenesis. Ranibizumab binds to the receptor-binding site of VEGF-A, preventing it from binding to its receptors – VEGFR1 and VEGFR2 – that are expressed on the surface of endothelial cells. Ranibizumab thereby attenuates endothelial cell proliferation, vascular leakage, and new blood vessel formation.

At the recent SEC meeting for Ophthalmology held on 24th October 2024, the expert panel reviewed the proposal for the conduct of Phase IV study in the approved indications vide revised protocol ICR 23/004, Version No. 3.0 dated 09.07.2024.

After detailed deliberation, the committee granted the approval to conduct the study as per revised protocol presented by the firm.

Also Read: CDSCO Panel Approves Pfizer Protocol Amendment proposal to study anti-cancer drug Elranatamab

Powered by WPeMatico