Archive for month: May, 2024

Ahmedabad: Zydus, a discovery-based, global pharmaceutical company, has announced that it has
completed enrolment of its Phase II clinical study of NLRP3 inhibitor ‘Usnoflast (ZYIL1)’ in patients
with Amyotrophic Lateral Sclerosis (ALS).

ALS patients experience neuroinflammation and rapid neurodegeneration leading to steady loss of the
ability to move, speak, eat and eventually breathe. ALS results in loss of motor neurons in the brain and
spinal cord which controls voluntary muscle movement.

ALS affects approximately 31,000 people in
the U.S.A and on an average 5,000 new patients are diagnosed every year with this disease in USA as
per statistics from Centers for Disease Control and Prevention (CDC). More than 30,000 people are
estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an
estimated 75,000 people living with ALS. People living with ALS have a median survival of
approximately two years from diagnosis.

The Phase II clinical trial has recruited 24 ALS patients across 7 clinical trial sites in India and will
study safety, tolerability, pharmacokinetics and pharmacodynamics of Usnoflast. The change from
baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score will
be measured at week 4, week 8 and week 12, as the trial’s primary endpoint is the placebo-controlled,
randomised, double-blind Phase 2 clinical trial.

The trial will also evaluate Key Secondary Endpoints
including Slow Vital Capacity (SVC), a predictor of functional loss in ALS and neurofilament levels at
week 4 and week 12.

Usnoflast (ZYIL1) is a novel, oral small molecule NLRP3 inhibitor. Studies have demonstrated that
ZYIL1 is highly potent in human whole blood assay and can suppress inflammation caused by the
NLRP3 inflammasome. Usnoflast was found distributed in the brain and CSF of various nonclinical
species including mice, rats and non-human primates. The efficacy of Usnoflast has been established in
several validated pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel
Disease (IBD) and Multiple Sclerosis (MS).

The candidate, Usnoflast, has an acceptable ADME profile,
with a good safety margin. In Phase I studies, Usnoflast was found to be safe and well-tolerated [NCT04731324, NCT04972188]. Zydus has initiated a Phase 2 clinical study of Usnoflast in Ulcerative
Colitis [ClinicalTrials.gov ID NCT06398808]. Zydus has established the Phase 2 proof-of-concept in
CAPS patients [NCT05186051] and has now published the data in Clinical Pharmacology in Drug
Development.

The USFDA has granted Zydus an ‘Orphan Drug Designation’ for Usnoflast to treat
patients with Cryopyrin Associated Periodic Syndrome (CAPS), a rare auto-inflammatory disease.

Read also: Zydus Lifesciences gets USFDA nod for asthma drug Theophylline ER

Nagpur: Patients falling under the Below Poverty Line (BPL) category as well as senior citizens will get free cataract surgery at the All India Institute of Medical Sciences (AIIMS) Nagpur has taken a remarkable initiative to conduct 1,000 cataract surgeries using advanced Intra-Ocular Lens (IOL) for free of cost.

The surgeries will be conducted as part of the National Programme for Control of Blindness and Visual Impairment, which aims to achieve a target of 1 crore 5 lakh cataract surgeries in the financial year 2024-25 and the institute has been assigned a target of 1000 surgeries to address the backlog of eligible cataract cases.

The institute has decided to cover the costs of the advanced high-quality lens expenses, and patients falling into the two specified categories will receive the surgery free of cost.

Also read- Botched Cataract Surgeries: Gujarat Medical Council Suspends 3 Doctors

Unlike other government hospitals that use older, rigid lenses provided by government agencies, AIIMS Nagpur will use advanced intra-ocular lenses (IOL) for free to provide patients with proper and natural vision post-surgery. These IOLs not only last longer but also help correct astigmatism and offer better vision quality.

This decision comes in response to the reluctance of many patients to undergo surgery with outdated lenses, which has resulted in missed surgical targets in previous years. 

As per the TOI news report, when people visiting the hospital find out that surgeries are being conducted under the National Programme for Control of Blindness and Visual Impairment, they often asked about the quality of the lenses. They are fully aware that the lenses are outdated and rigid.

Hence, the patients would prefer to pay for a high-quality lens instead of receiving a low-quality one, which resulted in AIIMS Nagpur failing to meet its target last year. Last year, AIIMS Nagpur only completed 22 out of its target of 350 surgeries due to patients’ preference for modern lenses not covered by the program.

Speaking to The Daily, AIIMS Nagpur Director Dr P P Joshi said, “While surgeries are conducted for free, the lenses provided by the government are of old type and rigid. We have decided to use advanced lenses at our own expense and ensure the target is achieved.”

Under the National Programme for 2024-25, GMCH Nagpur has been given a target of 3,600 surgeries, while IGGMCH has a target of 3,200 patients. Charity hospitals are expected to conduct 11,253 surgeries, and private hospitals are set to perform 22,508 surgeries this year.

Also read- Nagpur IIM, AIIMS Launch PG Certificate Programme In Advanced Healthcare Management

Kohima: The Nagaland Medical Council (NMC) constituted under the Nagaland Medical Council Act of 2014 has issued directives to promote and safeguard ethical and safe practices among medical practitioners.  

Through a press release, the council has emphasized the significance of enforcing the Nagaland Health Care Establishment (NHCE) Act, 1997, an act to regulate the setting up of private hospitals, nursing homes, clinics and other such centres run by voluntary organisations catering to diagnostic, investigative, operative and other health care services.

It stands for rendering service to society with full respect for the dignity of the medical profession and that of every citizen. The council also promotes continued medical education (CME), and ethical and safe practice of allopathic medical practitioners.

Also read- Nagaland Directs Govt Doctors To Stop Private Practice Within One Month

“In adherence to guidelines set by the National Medical Commission/MCI (Medical Council of India), the NMC meticulously verifies relevant documents before issuing registration certificates to all allopathic (MBBS) doctors and regulates CME activities, awarding credit hours/points in line with established norms,” reads the press release.

Further, the council highlighted several key points which include: 

Mandatory Registration for Doctors

All MBBS doctors, whether they intend to work in the government or private sector in Nagaland, must be registered with the council as mandated in the ‘Nagaland Medical Council Act 2014’, chapter III, section 16(6). This includes Foreign Medical Graduates (FMGs), who must clear the NMC/MCI exam for FMGs before registration.

Health Centre Registration

All healthcare facilities, including hospitals, nursing homes, and clinics, must be registered in Nagaland with the Department of Health and Family Welfare under the NHCE Act, 1997 to operate legally. Treating patients at centres registered only with a pharmacy license or any other trade license will be illegal.

Inclusion of Various Clinics

All health centres including dental clinics, AYUSH clinics and clinical laboratories come under the NHCE Act, 1997, and pharmacy licensing comes under the drug control which is under the Department of Health and Family Welfare.

Prohibition of Private Practice by Government Doctors

“It is wrong and unethical for any in-service doctor in government service, after availing (and opting) for NPA (non-practising allowance) to indulge in private practice, because it is definitely a violation of government service rules. Despite being a longstanding concern, no concrete actions have been taken despite an investigation report by the Vigilance Department and subsequent directives from the Medical Department,” it added.

Reminding that the NHCE Act, 1997, Clause 8.1.C explicitly states that state-employed doctors, nurses, and paramedics cannot work in private healthcare establishments, allowing only home-based consultations, the council stated  “That no doctor, nurse or any paramedic or any other employee in the employment of the state government shall be employed in such health care establishment. This clearly implies that no government doctors can own a clinic or work in private hospitals and allows apparently only for consultation in a home-based office room.”

Accordingly, the council requested various associations to educate their members and disseminate correct information to prevent a few erring members from tarnishing the image of the entire fraternity. 

Ethical Practice and Verification

The NMC expressed concern over allopathic doctors from outside coming to Nagaland to practice without proper verification and registration for health camps or as visiting consultants, FMGs practising without passing the required exams, and pharmacies operating without qualified pharmacists or with government doctors and mushrooming of unregistered health centres promoting quackery under the guise of alternative medicines, etc. As a result, the council urged for stringent monitoring and enforcement of the NHCE Act to prevent such practices and maintain ethical standards.

“Therefore, it is very important and relevant to strengthen the NHCE authority and activate its ‘District Inspection Team’- the district inspection team which includes members from the district administration and the district health authority, to strictly monitor and implement the NHCE Act, 1997, on yearly time bound manner. Further for any other complaints pertaining to alleged professional misconduct, the matter may be addressed to appropriate authority,” it added. 

Also read- MoS Health Counts 13 Lakh Allopathic Doctors, 36.14 Lakh Nursing Personnel In India, Check Details