Gujarat flag bearer of India’s pharma industry, says State govt

Gujarat: Gujarat has been the flag bearer of India’s pharma industry and a hub for pharmaceutical manufacturing and exports for years, the state government has said as it gears up to host the Vibrant Gujarat Global Investor Summit. Gujarat provides employment to about 50,000 persons in over 4,000 manufacturing units producing allopathic, homoeopathic, ayurvedic and cosmetic drugs, according to a release by the state government.

As per official numbers, the state accounts for 53 per cent of India’s medical devices manufacturing and 78 per cent of the country’s cardiac stents manufacturing. About 40 per cent of the nation’s contract research organisations are based in Gujarat.
Ahead of the upcoming Vibrant Gujarat Global Investor Summit, Chief Minister Bhupendra Patel had earlier sought to highlight the state’s dominant role in the pharma sector. “Gujarat contributes 30 per cent of India’s pharmaceutical production and 28 per cent of total pharma export,” Patel had said.
The 10th edition of the Vibrant Gujarat event, which aims to pitch the state as the most favourable investment destination, will be held in January next year in Gandhinagar.
With over 700 pharma manufacturing licenses issued from 2020 to 2022, experts believe Gujarat’s share in the global pharmaceutical vertical is bound to skyrocket.
While 130 Gujarat registered pharma companies are United States Food and Drug Administration (USFDA) approved, 753 units are WHO Good Manufacturing Practices (GMP) approved.
“This vibrant Gujarat has been started by Narendra Modi. Since then, we have seen that everything is vibrant and huge investments are being made (in pharma sector). We are all connected to vibrant Gujarat, and our business has grown due to it,” said Sharad Patel, chairman of Sotac Pharmaceutical Limited.
Gujarat’s pharmaceutical sector is also noteworthy for its innovation and has expanded its business horizons to include the production of generics, research and development (R&D), contract research and manufacturing organisations (CRAMS), bulk drug productions, and new chemical entities (NCE), according to the state government.

Read also: Seizure drug: Zydus Lifesciences gets USFDA approval for Lacosamide tablets

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Medical Bulletin 16/December/2023

Here are the top medical news of the day:

Eating meals early could reduce cardiovascular risk

Cardiovascular diseases are the leading cause of death in the world according to the Global Burden of Disease study, with 18.6 million annual deaths in 2019, of which around 7.9 are attributable to diet. This means that diet plays a major role in the development and progression of these diseases. The modern lifestyle of Western societies has led to specific eating habits such as eating dinner late or skipping breakfast.

In addition to light, the daily cycle of food intake (meals, snacks, etc.) alternating with periods of fasting synchronizes the peripheral clocks, or circadian rhythms, of the body’s various organs, thus influencing cardiometabolic functions such as blood pressure regulation. Chrononutrition is emerging as an important new field for understanding the relationship between the timing of food intake, circadian rhythms and health.

To reduce the risk of possible bias, the researchers accounted for a large number of confounding factors, especially sociodemographic factors (age, sex, family situation, etc.), diet nutritional quality, lifestyle and sleep cycle. The study is published in Nature Communications.

The results show that having a first meal later in the day (such as when skipping breakfast), is associated with a higher risk of cardiovascular disease, with a 6% increase in risk per hour delay. For example, a person who eats for the first time at 9 a.m. is 6% more likely to develop cardiovascular disease than someone who eats at 8 a.m.

When it comes to the last meal of the day, eating late (after 9 p.m.) is associated with a 28% increase in the risk of cerebrovascular disease such as stroke compared with eating before 8 p.m., particularly in women. Finally, a longer duration of night-time fasting – the time between the last meal of the day and the first meal of the following day – is associated with a reduced risk of cerebrovascular disease, supporting the idea of eating one’s first and last meals earlier in the day.

Reference: Eating meals early could reduce cardiovascular risk; Nature Communications DOI:10.1038/s41467-023-43444-

Spinal cord stimulation reduces pain, improves balance in people with lower limb amputation

Spinal cord stimulation can elicit sensation in the missing foot and alleviate phantom limb pain in people with lower limb amputations, University of Pittsburgh School of Medicine rehabilitation scientists report today.

Pressure sensors on the insole of a prosthetic foot triggered electrical pulses that were then delivered to a participants’ spinal cord. Researchers found that this sensory feedback also improved balance and gait stability. The proof-of-concept study was done in collaboration with Carnegie Mellon University and University of Chicago researchers and reported in Nature Biomedical Engineering.

Unlike the typical stimulation system that works by shutting down pain neurons by overriding them with another sensory signal — similar to how rubbing your sore elbow helps relieve the pain — Fisher’s group leveraged the existing spinal cord stimulation technology to restore sensory feedback by replacing the severed connections between sensory neurons in the missing foot and the central nervous system.

In addition to clinically meaningful improvement in balance control and gait even in the most challenging conditions, such as standing on a moving platform with eyes closed, participants reported an average 70% reduction in phantom limb pain — a highly meaningful outcome given the lack of clinically available treatment options.

The beauty of this technology lies in its versatility: the pilot study showed that it can work in people with extensive peripheral nerve damage due to chronic conditions, such as diabetes, or in people with traumatic amputations. It also doesn’t require costly custom-made electrodes or uncommon surgical procedures, making it easier to scale up on a national level.

Reference: Spinal cord stimulation reduces pain, improves balance in people with lower limb amputation; Nature Biomedical Engineering; DOI: 10.1038/s41551-023-01153-8

Children who are sedentary may have a higher risk of heart attack or stroke later in life

Children who are physically inactive may have high cholesterol in early adulthood and subsequent heart health issues in their mid-forties, according to new research published in The Journal of Clinical Endocrinology & Metabolism.

High cholesterol during childhood has been associated with early signs of heart disease when individuals reach their mid-twenties and an increased risk of premature cardiovascular death in their mid-forties. Several clinical trials aimed at lowering cholesterol levels in the youth population have had minimal or no effect.

“Our study shows increased sedentary time in childhood may contribute to two-thirds of the total increase in a person’s cholesterol levels before their mid-twenties. This suggests childhood sedentariness may be a major risk factor for elevated cholesterol and subsequent premature heart attack or stroke when individuals reach their mid-forties,” said study author Andrew O. Agbaje, M.D., M.P.H., of the University of Eastern Finland in Kuopio, Finland. “We also discovered light-intensity physical activity from childhood may be 5-8 times more effective than moderate-to-vigorous physical activity at reversing the adverse effect of sedentary time on high cholesterol.”

They also determined light physical activity decreased from 6 hours/day in childhood to 3 hours/day in young adulthood but was cumulatively associated with reduced total cholesterol. Increased total body fat slightly reduced the effect of light physical activity on total cholesterol.

Moderate-to-vigorous physical activity was relatively stable around 50 mins/day from childhood until young adulthood and was only associated with reduced total cholesterol, but increased total body fat seriously diminished the effect of moderate-to-vigorous physical activity on total cholesterol.

Reference: Children who are sedentary may have a higher risk of heart attack or stroke later in life; The Journal of Clinical Endocrinology & Metabolism

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After WHO ban, NMC directs doctors not to participate in e cigarettes related research without permission

New Delhi: After the World Health Organization’s (WHO) call for a ban on e-cigarettes, the National Medical Commission (NMC) has now directed doctors to refrain from initiating or participating in any research activities related to e-cigarettes and HTPs without obtaining the necessary approval from the Directorate General of Health Services (DGHS) and the Ministry of Health and Family Welfare (MoHFW).

This comes after the Director General of Health Services, Dr. Atul Goel wrote to the Commission raising the issue and asked it to issue necessary instructions to all healthcare professionals affiliated with NMC and the Indian Medical Association (IMA).

In the letter dated 08.12.2023, the DGHS mentioned in the letter, “I am writing to address a matter of utmost importance concerning healthcare professional’s engagement in research related to electronic cigarettes (e-cigarettes) and heated tobacco products (HTPs).”

“As you are aware, the Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage, and Advertisement) Act,20l9 (PECA 2019), has unequivocally banned the use of e-cigarettes, HTPs and like devices in India. In light of this, it is imperative that all healthcare professionals affiliated with the National Medical Commission (NMC) and the Indian Medical Association (lMA) refrain from initiating or participating in any research activities related to e-cigarettes and HTPs without obtaining the necessary approvals from the Dte.GHS and MoHFW. In this regard, I would request that necessary instructions please be issued to all healthcare professionals affiliated with the National Medical Commission (NMC) and the lndian Medical Association (lMA),” mentioned the letter.

“I trust that the NMC and IMA can play a pivotal role in disseminating this directive among their members, emphasizing the gravity of adherence to the ban on e-cigarettes and HTPs, and promoting responsible research within the healthcare community,” it added.

Following the DGHS directive, the NMC Policy and Coordination Division also issued a notice on 15.12.2023 and pointed out that the Union Government unequivocally banned the use of e-cigarettes, HTPs, and like devices in India.

Also Read: Health Ministry Highlights 2019: 15,700 more MBBS seats, NMC, E Cigarette Ban, Modicare

Referring to this, NMC mentioned in the notice, “The Government have vide the Prohibition of Electronic Cigarettes (Production, manufacture, import, export, transport, sale, distribution, storage and advertisement) Act, 2019 (PECA, 2019) unequivocally banned the use of e-cigarettes, HTPs and like devices in India. In light of the same, it is imperative that all healthcare professionals affiliated with the NMC refrain from initiating or participating in any research activities related to e-cigarettes and HTPs without obtaining the necessary approvals from the Dte.GHS and MoHFW.”

Along with the notice, NMC also referred to a copy of the D.O letter No. H.11013/03/2021-TC dated 08 December 2023 for information and compliance by all healthcare professionals affiliated with the NMC.

Medical Dialogues had earlier reported that the Prohibition of Electronic Cigarettes Act, 2019 was notified on December 6 making the production, import, export, transport, sale or advertisements of such “alternative” smoking devices a cognisable offence attracting jail term and fine.

WHO Directive: 

Meanwhile, WHO on Thursday urged governments to treat e-cigarettes similarly to tobacco and ban all flavours, threatening cigarette companies’ bets on smoking alternatives.

Some researchers, campaigners and governments see e-cigarettes, or vapes, as a key tool in reducing the death and disease caused by smoking. But the U.N. agency said “urgent measures” were needed to control them.

Citing studies, it said there was insufficient evidence that vapes helped smokers quit, that they were harmful to health and that they could drive nicotine addiction among non-smokers, especially children and young people.

“Kids are being recruited and trapped at an early age to use e-cigarettes and may get hooked to nicotine,” said Tedros Adhanom Ghebreyesus, WHO Director-General, urging countries to implement strict measures.

To view the NMC notice, click on the link below:

https://medicaldialogues.in/pdf_upload/nmc-notice-e-cigarettes-228004.pdf

Also Read: WHO calls for ban on flavoured vapes, treating e-cigarettes the same as tobacco

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33 Seats Vacant For Final Mop-Up Round Of Sponsored DNB Post MBBS admissions: NBE

Delhi: The National
Board of Examinations (NBE) has released the indicative seat matrix for the final
mop-up round of counseling admission to Sponsored DNB (Post MBBS) courses – 2023
admission session.

A total of 33
seats are available for the final mop-up round of counseling admission to
Sponsored DNB (Post MBBS) courses. General Medicine has the highest number of
seats (7) vacant, followed by Anaesthesiology and General Surgery. The seats
are vacant in the state of Karnataka, Maharashtra, Pondicherry, Tamil Nadu,
Telangana, Kerala, Delhi, Jammu and Kashmir, Jharkhand, West Bengal, and Andhra
Pradesh.

Detailed
seat matrix –

Course

Seat

Anaesthesiology

6

Emergency Medicine

1

Family Medicine

5

General Medicine

7

General Surgery

6

Ophthalmology

4

Orthopaedics

1

Pediatrics

1

Pharmacology

1

Psychiatry

1

Candidates are advised to visit the website of the respective
Hospital/ Institution to check the information regarding applicable Bond
policy before choosing preferences of seat (s). They may contact the Hospital/
institution for any other additional information. The Seat Matrix is purely
provisional.

The detailed counseling schedule –

1. Login by candidates and Payment of 1st Year Course Fee to participate in the Final Mop-up Round – 15th – 19th December 2023 (Up to 05:00 PM)

2. Filling of Choices/options for the Final (Mop-up) Round of counseling – 15th – 19th December 2023 (Up to 05:00 PM)

3. Processing of the Allotment – 20th December, 2023

4. Result of the Allotment – 21st December, 2023

5. Physical joining at the allotted hospital – 21st to 29th December 20

As per the handbook of counseling for Post MBBS Sponsored seats of the 2023 admission session, all such candidates who have not been offered any seat during the First or Second round of counseling are eligible for the final round (mop-up) of counselling.

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/natboard-datapublicnoticenotice202312157142-227986.pdf

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Female fetus found inside dustbin : Hospital sealed, doctor absconding

Bengaluru: A distressing incident causing widespread shock and concern among the public has unfolded at a private hospital at Tirumalashettyhalli in Hoskote on Bengaluru’s outskirts where a 22-week-old female fetus was discovered in a dustbin in the operation theatre of the hospital. 

In response to the shocking discovery, the police registered a case against Dr Srinivas, the owner of the private hospital and four hospital staff in connection with the case. 

Acting on the FIR, four hospital staff including two women nurses, a lab technician and a lab assistant have been arrested by the police for questioning. However, the doctor is currently absconding and a police team have been forced to trace him.  

Also read- Medical Rape: Lawsuit Filed Against Boston Retired IVF Doctor For Allegedly Secretly Impregnating Patient With Own Sperm In 1980

According to DH reports, the doctor is reported to be an unregistered radiologist who was running the private hospital and the fetus discovered in the dustbin is alleged to be illegally aborted. 

“During a regular inspection, the District Family Welfare Officer found an unregistered ultrasound machine at the SPG Hospital and Diagnostic Centre,” Dr Vivek Dorai, Deputy Director (Medical Acts), told the daily.

Talking about the woman patient who allegedly aborted the fetus illegally at the hospital, a health official said “She is yet to be traced. It appears that the hospital owner himself conducted the abortion.”

A senior police officer informed PTI that a team of health officials visited the hospital on Wednesday as part of their routine inspection and found the female fetus wrapped in a black polythene cover and dumbed in the dustbin. 

During inspection, they also found a woman lying in the operation theater and they suspected that the fetus thrown in the dustbin was hers. However, the officer said, “Investigation is ongoing and it has not yet been confirmed whether the fetus thrown was hers or someone else’s.”

He said that health officials informed the police, after which the police sealed the hospital. Before sealing the hospital, the health officials found about 20 patients in the hospital and all of them have been shifted to other hospitals.

While the hospital had the licence under the Karnataka Private Medical Establishment Act, it did not have permission to use the portable ultrasound scanning machine nor was it licensed under the Medical Termination of Pregnancy Act to conduct abortions, the FIR noted.

“A few days ago, a report on the illegal ultrasound scanning machine at the hospital had reached the district health officer, following which Dr Srinivas was asked to respond. Dr Srinivas did not reply to the DHO’s queries and continued to run the machine. When health officials raided the hospital Wednesday evening, the machine was under use. Also, the foetus found in the dustbin was fresh and appeared to have been eliminated after a procedure conducted on Wednesday,” a police officer told TOI.

“There were no records related to this particular foetus. It did not show any abnormality. It doesn’t look like an abnormal baby that was aborted. Everything points to illegal sex determination and female foeticide. We will ensure that the guilty are punished,” D Randeep, health commissioner, Karnataka, said, adding the centre was always on the radar.

State Health Commissioner Randeep D said this was the first case of female feticide through illegal abortion recorded in Karnataka. He told PTI that the hospital was sealed due to lack of inspection by health officials, evidence obtained and proper records.

The official said that based on the statement and complaint of the concerned health authorities, we have registered a case against the owner and staff of the hospital under the Prohibition of Sex Selection Act, Medical Abortion Act and sections 312, 314 and 315 of the Indian Penal Code.

Dr Dorai said “No official records of the hospital owner being a radiologist were found so far. Prescription pads with the letterhead claiming that he was a radiologist were found in the hospital.”

“He, however, hasn’t been empanelled. If he was the radiologist, the ultrasound machine should have been empanelled in his name. We have found that the ultrasound machine was empanelled in the name of one Deepika, a gynaecologist, who doesn’t even visit the hospital,” he added.

Govt to formulate new policy to prevent female foeticides

The Karnataka government is taking measures to prevent female foeticides, including amending the concerned legislations, formulating a new policy and setting up a State-level task force, Health Minister Dinesh Gundu Rao told the Legislative Assembly on Thursday. Along with creating awareness in society, the government also wants to create a fear of law among people, against indulging in such heinous acts, he said.

A CID probe has already been ordered to probe such incidents, Rao informed PTI.

Health Department officials have been directed to regularly conduct spot inspections, the Minister said but acknowledged that ineffective implementation of the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act is coming in the way of fully stopping cases of female foeticides and arresting the declining sex ratio in India.

The declining gender ratio indicates female foeticides are happening, he further said. “If you look at civil registration data, last year it was 947 females for 1,000 men, this year it is 929. It has come down.” He was replying to issues raised by a few MLAs including Leader of Opposition R Ashoka, expressing concern over the increasing cases of female foeticide in the state.

Highlighting the need for a joint operation by the health and police departments to prevent female foeticides, Rao said the proposed State-level task force would help in swiftly acting against any illegal activities. In addition, there are plans for setting up sub-division level monitoring committees, besides deploying an ACP-level officer for proper coordination to deal exclusively with female foeticide cases.

He said the call centre of the health department, which is currently non-functional, would be activated from next month. A tender will be called for this, and this would also cater to instances of female foeticides, among other health-related concerns.

The Minister said the government is also planning to come out with a policy to prevent female foeticides.

He said amendments to the legislation concerned would be effected in consultation with the Health, Home and Law Departments, to make it more effective.

“Nothing will come out of normal inspection or spot visits. Collecting intelligence by involving ASHA and Anganwadi workers and local leaders is important,” the Minister said adding that the District Health Officers (DHOs) and Family Welfare Officers have been told to conduct decoy operations once in three months, in their jurisdictions, to identify hospitals involved in female foeticides.

Also read- Karnataka Doctor Who Allegedly Performed Around 900 Illegal Abortions Arrested

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AIIMS Kalyani Invites Online Application For 7 Post-Doctoral Certificate Courses

West Bengal: All India Institute of Medical Sciences (AIIMS Kalyani) has invited online applications for Post-Doctoral Certificate Courses (PDCC) courses.

The online application form and fees must be submitted by 21st December 2023. The link to the application form is enclosed in the notice below.

Application fee –

For Unreserved/OBC candidates is Rs.1000/-. The candidates have to pay the prescribed application fee. NEFT in favour of “AIIMS KALYANI INTERNAL RESOURCES ACCOUNT” as per the bank details enclosed in the notice below. The application fee, once remitted, shall not be refunded under any circumstances. No fee for SC/ST Candidates of any community. Applications without the prescribed fee will not be considered and summarily rejected.

The following modalities are for the Post-Doctoral Certificate Courses (PDCC) –

1. Post-Doctoral Certificate Course (PDCC) in Neuroanaesthesia

2. Post-Doctoral Certificate Course (PDCC) in Glaucoma

3. Post-Doctoral Certificate Course (PDCC) in Pediatric Allergy

4. Post-Doctoral Certificate Course (PDCC) in Molecular and Biochemical Genetics

5. Post-Doctoral Certificate Course (PDCC) in Head and Neck Surgery

6. Post-Doctoral Certificate Course (PDCC) in Addiction Psychiatry

This course will be of 12 months’ duration in the January 2024 session (1st January to 31st December 2024).

a) Name of the course

with Department

PDCC in Neuroanaesthesia by the Department of Anesthesiology

Essential qualifications

MD/DNB in Anesthesiology from an institute or Medical
College recognized by the Medical Council of India.

The essential qualification must be completed in all
respects

before the last date of receipt of the application

Number of seats

One (Government Sponsored)

b) Name of the course

PDCC in Glaucoma by the Department of Ophthalmology


Essential qualifications

MS/ DNB in Ophthalmology from an institute or Medical College recognized by the Medical Council of India.

The essential qualification must be completed in all
respects before the last date of receipt of the application

Number of seats

One (Government Sponsored)

c) Name of the course

PDCC Pediatric Allergy by Department of Pediatrics

Essential qualifications

MD/DNB in Pediatrics from an institute or Medical College
recognized by the Medical Council of India. The essential qualification must be
completed in all respects before the last date of receipt of the application

Number of seats

One (Government Sponsored)

d) Name of the course

PDCC in Molecular and Biochemical Genetics by Department of Biochemistry

Essential qualifications

MD/DNB in Biochemistry from an institute or Medical
College recognized by the Medical Council of India.

The essential qualification must be completed in all
respects before the last date of receipt of the application

Number of seats

One (Government Sponsored)

e) Name of the course

PDCC in Head and Neck Surgery by the Department of ENT

Essential qualifications

MS/DNB in ENT from an institute or Medical College recognized by the Medical Council of India.

The essential qualification must be completed in all
respects before the last date of receipt of the application

Number of seats

One (Government Sponsored)

f) Name of the course

PDCC in Addiction Psychiatry by the Department of Psychiatry

Essential qualifications

MD/DNB in Psychiatry from an institute or Medical College

Recognized by the Medical Council of India.

The essential qualification must be completed in all respects before the last date of receipt of the application

Number of seats

One (Government Sponsored)

Applicable for the above courses

Age limit

45 years (as for Senior Resident) and relaxations as per
GoI norms

Emoluments

As applicable to first-year senior residents under the residency
scheme of Govt. of India

Leaves

As per the residency scheme (2.5 EL/Month=30EL/Year)

Seats –

A total of 6 seats are vacant for PDCC courses. The detailed seat matrix is mentioned above. 

Final Selection by interview –

All Government sponsored candidates found eligible will be called for an interview to be conducted on Hybrid mode on 27.12.2023 on the Ground Floor of Administrative Block AIIMS Kalyani from 9 am onwards. The composition of the interview panel will be the same as that for a Senior Resident / Tutor in the concerned speciality. Selected candidates must join within 15 days of the commencement of the session, and in case of non-response, the seat will be offered to the next candidate on the waiting list. If the seats are unfilled by 31st January in the January session, the seat will be lapsed.

Provision for penalty –

Original certificates of any candidate who opts for a confirmed seat will be retained in the Academic Session. The same will not be returned to the candidate before completion of the course unless he/she deposits a sum of Rs. 200000 once a seat has been confirmed by joining the course as compensation for losses incurred by AIIMS Kalyani due to such midterm departure. The stipend/salary for the month in which his /her resignation from the program becomes effective shall also stand forfeited.

Fee Structure –

The candidates will have to pay a fee of Rs 3375/-.

Registration Fee – 25/-

Tuition fee – 1050/-

Lab – 120/-

Pot money – 720/-

Electricity – 240/-

Gymkhana – 120/-

Caution – 100/-

Hostel Security – 1000/-

Hostel Accommodation – Subject to availability

Eligibility for appearing in PDCC exit exam – 75% Attendance is compulsory for appearing in the exit exam. If the candidate is short of attendance, will appear for the exam in the next session (January).

Method of evaluation –

The selected candidates will have a three-monthly formative evaluation (at 3, 6 and 9 months), which will consist of both the practical and theoretical components. The total formative assessment will be of 200 marks (100 for theory and 100 for practical)

Each course will have a summative practical and theory assessment. This assessment will be performed by at least two internal and two external examiners. The total summative assessment will be of 200 marks (100 for theory and 100 for practical)

The final assessment will be made on the basis of combined scores of formative and summative assessments in theory and practical. Candidates will be declared successful in the course only after securing at least 50% marks. Theory and practical need to be separately passed.

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/81223pdcc-advertisementfinal-227473.pdf

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USFDA gives tentative nod for Lupin diabetes drug Sitagliptin

Mumbai: Global pharma major Lupin Limited has announced
that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA)
for its Abbreviated New Drug Application (ANDA), Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg
to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and
Dohme Corp.

This product will be manufactured at Lupin’s Pithampur facility in India.


Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to
improve glycemic control in patients with type 2 diabetes mellitus.

Sitagliptin Tablets (RLD Januvia) had estimated annual sales of USD 5789.3 million in the U.S. (IQVIA
MAT October 2023). 

Read also: Include Ankle Brachial Index test to exclude peripheral artery disease: CDSCO Panel Tells Lupin on Denosumab PK/PD study

Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB.

Read also: Lupin Dapagliflozin Tablets gets tentative USFDA okay

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin Diagnostics unveils Regional Reference Laboratory in Chennai

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New gene therapy promising for reducing seizures in children with focal cortical dysplasia

UK: A recent study, published in Brain, sought to find an alternative to surgery for children with focal cortical dysplasia.

UCL researchers developed a new gene therapy to cure a devastating form of childhood epilepsy, which the study shows can significantly reduce seizures in mice.

Focal cortical dysplasia is caused by areas of the brain that have developed abnormally and is among the most common causes of drug-resistant epilepsy in children. It frequently occurs in the frontal lobes, which are important for planning and decision-making. Epilepsy in focal cortical dysplasia is associated with comorbidities, including learning disabilities.

Although surgery to remove the affected brain malformation is effective, its use is severely limited by the risk of permanent neurological deficit and does not always result in seizure freedom.

Consequently, researchers at the UCL Queen Square Institute of Neurology evaluated a gene therapy based on the overexpression of a potassium channel which regulates neuronal excitability in a mouse model of focal cortical dysplasia in the frontal lobe.

Potassium channels control the movement of potassium ions in and out of cells. When there is an overexpression of a potassium channel, it means that there is greater regulation, resulting in the decrease of the activity of cells and, in turn, stopping seizures.

Co-corresponding author, Professor Gabriele Lignani (UCL Queen Square Institute of Neurology), said: “It is very exciting to see that this new gene therapy could potentially be used as an effective alternative to surgery in patients with focal cortical dysplasia.”

Gene therapies have previously been shown to work in another form of epilepsy where seizures arise in the temporal lobes, but have not been tested in focal cortical dysplasia.

In this case, the researchers introduced an engineered potassium channel gene called EKC into the affected frontal lobe of the epileptic mice. For added safety, they used a virus that is unable to replicate in order to carry the potassium channel gene.

Before giving the treatment, researchers monitored the mice’s brain activity for 15 days. They then injected either the virus carrying the EKC gene or a control virus into the affected brain area. The team then monitored the mice’s brain activity for another 15 days.

The researchers found that the gene therapy reduced seizures by an average of 87% when compared with the control group, without affecting the mouse’s memory or behaviour.

Lead author Dr Vincent Magloire (UCL Queen Square Institute of Neurology) said: “Following the successful study in mice, we believe the treatment is suitable for clinical translation, and, taking into account the size of the unmet need, it could be deployed to thousands of children who are currently severely affected by uncontrolled seizures.”

Co-corresponding author, Professor Dimitri Kullmann (UCL Queen Square Institute of Neurology) added: “Plans for a first in human clinical trial are underway and are planned in the next five years.”

Reference:

Amanda Almacellas-Barbanoj, Robert T. Graham, Jenna Carpenter, Marco Leite, Justin Hoke, Felisia Hardjo, James Scott-Solache, Christos Chimonides, : Anti-seizure Gene Therapy for Focal Cortical Dysplasia, https://doi.org/10.1093/brain/awad387.

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Post-meal insulin surge not a villain, says new research

Researchers at Sinai Health have unearthed vital information about the relationship between insulin levels after eating and long-term heart and metabolic health. The research upends the notion that insulin surge following food intake is a bad thing.

On the contrary-it could be an indicator of good health to come.

Led by Dr. Ravi Retnakaran, Clinician-Scientist at the Lunenfeld-Tanenbaum Research Institute, part of Sinai Health, the study set out to explore how insulin levels after meals impact cardiometabolic health. While past research has yielded conflicting results, suggesting both harmful and beneficial effects, this new study aimed to provide a clearer picture over an extended period of time.

The team reported their findings in the online journal eClinicalMedicine, published by the Lancet group.

Normally, insulin levels rise after eating to help manage blood sugar. However, the concern is whether a rapid increase in insulin after a meal could spell bad health. Some believe the insulin surge, especially after eating carbs, promotes weight gain and contributes to insulin resistance. This occurs when the body’s cells don’t respond well to insulin, making it harder to control blood sugar levels and increasing the risk of type 2 diabetes.

“The suggestion has been made by some people that those insulin peaks have deleterious effects by promoting weight gain,” said Dr. Retnakaran, who is also Endocrinologist at the Leadership Sinai Centre for Diabetes at Mount Sinai Hospital where he holds the Boehringer Ingelheim Chair in Beta-cell Preservation, Function and Regeneration. He is also a Professor at the University of Toronto’s Temerty Faculty of Medicine.

“Sometimes I see patients in the clinic who have adopted this notion, maybe from the internet or what they’re reading, that they can’t have their insulin level go too high,” he said.

The science is just not conclusive enough to support this notion. Most studies on this topic were either conducted over a short period of time or were based on insulin measurements in isolation that are inadequate and can be misleading, said Dr. Retnakaran.

His team sought to address this problem by looking at cardiometabolic implications of insulin response over the long term, and in a way that accounts for baseline blood sugar levels. The latter point is key because each person has an individual insulin response that varies depending on how much sugar is in the blood.

The study followed new mothers because the insulin resistance that occurs during pregnancy makes it possible to determine their future risk of type 2 diabetes. 306 participants were recruited during pregnancy, between 2003 and 2014, and underwent comprehensive cardiometabolic testing, including glucose challenge tests, at one, three, and five years after giving birth. The glucose challenge test measures glucose and insulin levels at varying time points after a person has had a sugary drink containing 75 grams of glucose and following a period of fasting.

While commonly used in medical practice, the interpretation of insulin levels from the test can be misleading if one does not account for baseline blood sugar. “It’s not just about insulin levels; it’s about understanding them in relation to glucose,” Dr. Retnakaran said, pointing out that this is where many past interpretations fell short. A better measurement is the corrected insulin response (CIR) that accounts for baseline blood glucose levels, and which is slowly gaining prominence in the field, he said.

The study revealed some surprising trends. As the corrected insulin response increased, there was a noticeable worsening in waist circumference, HDL (good cholesterol) levels, inflammation, and insulin resistance, if one did not consider accompanying factors. However, these seemingly negative trends were accompanied by better beta-cell function. Beta cells produce insulin, and their ability to do so is closely associated with diabetes risk – the better the beta cell function, the lower the risk.

“Our findings do not support the carbohydrate-insulin model of obesity,” said Dr. Retnakaran. “We observed that a robust post-challenge insulin secretory response-once adjusted for glucose levels-is only associated with the beneficial metabolic effects”.

“Not only does a robust post-challenge insulin secretory response not indicate adverse cardiometabolic health, but rather it predicts favorable metabolic function in the years to come.”

There are practitioners who subscribe to this notion of higher insulin levels being a bad thing, and sometimes are making recommendations to patients to limit their insulin fluctuations after the meal. But it’s not that simple

In the long run, higher corrected insulin response levels were linked with better beta-cell function and lower glucose levels, without correlating with BMI, waist size, lipids, inflammation, or insulin sensitivity or resistance. Most importantly, women who had the highest CIR had a significantly reduced risk of developing pre-diabetes or diabetes in the future.

“This research challenges the notion that high post-meal insulin levels are inherently bad and is an important step forward in our understanding of the complex roles insulin plays in regulation of metabolism,” said Anne-Claude Gingras, Director of LTRI and Vice-President of Research at Sinai Health.

Dr. Retnakaran hopes their findings will reshape how medical professionals and the public view insulin’s role in metabolism and weight management.

“There are practitioners who subscribe to this notion of higher insulin levels being a bad thing, and sometimes are making recommendations to patients to limit their insulin fluctuations after the meal. But it’s not that simple,” he said.

Reference:

Ravi Retnakaran, Jiajie Pu, Anthony J. Hanley, Philip W. Connelly, Mathew Sermer, Bernard Zinman, Future cardiometabolic implications of insulin hypersecretion in response to oral glucose: a prospective cohort study, DOI:https://doi.org/10.1016/j.eclinm.2023.102363.

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Mannose supplementation reduces ageing-induced changes in urinary tract that increase susceptibility to UTIs: Study

USA: A recent study revealed that mannose supplementation can reduce the severity of aging-associated decline in urinary tract functionality, suggesting that this common, over-the-counter supplement could improve the age-associated dysfunction and help reduce urinary tract infections (UTIs).

“Mannose supplementation could counter age-associated urothelial dysfunction in addition to limiting recurring UTIs,” the resarchers wrote in their study published in Developmental Cell. 

Aging poses a number of challenges to the body’s well-being, one of the most important being an increased susceptibility to multiple diseases, including UTIs. The connection between aging and more prevalent UTIs is not well understood, but now researchers at Baylor College of Medicine have found an explanation.

The researchers show that compared to the younger counterpart, the aging urinary tract in animal models changes how it functions at the cellular level in ways that seem to favor the establishment and recurrence of UTIs. Furthermore, the researchers also found that the sugar D-mannose reduces the severity of aging-associated decline in urinary tract functionality, suggesting that this common, over-the-counter supplement could improve this age-associated dysfunction and help reduce UTIs.

“We began this study by comparing the functions of naturally aging cells in mouse bladders with those of younger animals, in the absence of a bacterial infection. Specifically, we studied urothelial cells, the cells that line the inside of the bladder where urine is stored,” said corresponding author Dr. Indira Mysorekar, professor of medicine – infectious diseases and E.L. Wagner, M.D., Chair of Internal Medicine at Baylor.

The researchers investigated a process called autophagy that all cells naturally use to clean up old or defective cellular materials by digesting and recycling them in structures called lysosomes. “We found that the recycling process naturally slows down as urothelial cells age,” said Mysorekar, a professor in the Huffington Center on Aging. “Older cells accumulate larger lysosomes that are less effective at degrading cellular materials, which leads to their toxic accumulation inside the cell.”

Aged urothelial cells also accumulate more damaging reactive oxygen species (ROS) than younger tissues. “ROS are molecules that can harm tissues, and the redox response that normally neutralizes ROS in younger cells is dampened in aging urothelial cells,” said co-first author Dr. Arnold M. Salazar, senior staff scientist in the Mysorekar lab. “Consequently, an inflammatory process builds up, leading to cell death. Dead urothelial cells leave their location, exfoliating the bladder and disrupting its integrity, which further exacerbates age-related dysfunction.”

Importantly, they also discovered that treating aged mice with D-Mannose, a natural sugar, restores autophagy and mitigates ROS and urothelial cell shedding, suggesting that mannose supplementation could counter age-associated human urothelial dysfunction.

Mysorekar, Salazar and their colleagues then compared bacterial UTIs in older animals versus younger animals. “We found that aged mice have more bacterial reservoirs in the urinary tract and are more prone to spontaneous recurrent UTI than younger mice, suggesting that the age-related dysfunction of the tissue could explain the higher recurrence of UTIs observed in older age,” Salazar said.

“Collectively, our results demonstrate that normal aging affects bladder physiology, with aging alone increasing baseline cellular stress and susceptibility to infection,” said Mysorekar, also a professor of molecular virology and microbiology. “We suggest that mannose supplementation could counter age-associated urothelial dysfunction in addition to limiting recurring UTIs.”

Reference:

Chetanchandra S. Joshi, Arnold M. Salazar, Caihong Wang, Marianne M. Ligon, Rayvanth R. Chappidi, Bisiayo E. Fashemi, Paul A. Felder, Amy Mora, Sandra L. Grimm, Cristian Coarfa, Indira U. Mysorekar, D-Mannose reduces cellular senescence and NLRP3/GasderminD/IL-1β-driven pyroptotic uroepithelial cell shedding in the murine bladder, Developmental Cell, 2023, https://doi.org/10.1016/j.devcel.2023.11.017.

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