Pfizer Gets CDSCO Panel nod to Import Abrocitinib tablets for moderate to severe atopic dermatitis

New Delhi: Pharmaceutical major Pfizer Products India has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import Abrocitinib tablets 50 mg, 100 mg, and 200 mg for sale or for distribution for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

However, this nod is subject to the condition that the firm should conduct a Phase IV clinical trial study.

This came after Pfizer Products India presented its application for grant of permission to import Abrocitinib tablets 50mg, 100mg, and 200mg for sale or for distribution along with Phase III clinical study data to the committee.

The committee noted that the proposed additional indication of Abrocitinib tablets 50 mg, 100 mg, and 200 mg is approved in the USA, Europe, and other countries.

Abrocitinib is an oral small-molecule inhibitor of Janus kinase 1 (JAK1). Janus kinases are intracellular enzymes involved in transduction pathways that regulate hematopoiesis and immune cell function. The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) signalling pathway plays a central role in the pathogenesis of a variety of autoimmune and inflammatory diseases, including atopic dermatitis, a chronic inflammatory skin disease with complex pathogenesis. Atopic dermatitis is characterized by epidermal hyperplasia, skin barrier dysfunction, and the aberrant activation of immune cells.

At the recent SEC meeting for dermatology and allergy held on 5th and 6th December 2024, the expert panel reviewed the application presented by Phizer Product India to import Abrocitinib tablets 50mg, 100mg, and 200mg for sale or distribution along with Phase III clinical study data.

After detailed deliberation, the committee recommended the grant of import permission for the sale or distribution of Abrocitinib tablets 50 mg, 100 mg, and 200 mg indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy, subject to the condition that the firm should conduct a Phase IV clinical trial study.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months from the date of approval of the drug product for review by the committee.

Also Read:MSD Pharmaceutical Gets CDSCO Panel Nod To study MK-1084

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Medgenome labs faces Rs 7 crore lawsuit for alleged negligence in genetic testing

In a case of alleged medical negligence, the wife of a serving soldier, has filed a Rs 7 crore lawsuit in a consumer court against MedGenome Labs Limited, Bengaluru, and M/S College of American Pathologists. The lawsuit claims that errors in genetic testing resulted in severe consequences for her family.

According to Hatkar, her son, born on December 12, 2017, was later diagnosed with two rare conditions: Ichthyosis and Penoscrotal Hypospadias. In October 2020, a genetic test conducted at a hospital in Pune revealed a NIPAL4 mutation, confirming a diagnosis of autosomal recessive congenital ichthyosis, a severe genetic disorder.

For more information, click on the link below:

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Are we moral blank slates at birth? A new study offers some clues

What does a baby know about right and wrong? A foundational finding in moral psychology suggested that even infants have a moral sense, preferring “helpers” over “hinderers” before uttering their first word. Now, nearly 20 years later, a study that tried to replicate these findings calls this result into question.

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The ‘choking game’ and other challenges amplified by social media can come with deadly consequences

The “choking game” has potentially deadly consequences, as players are challenged to temporarily strangle themselves by restricting oxygen to the brain. It sounds terrifying, but rough estimates suggest that about 10% of U.S. teenagers may have played this type of game at least once.

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Why there is no such thing as normal in child development

For parents, caregivers and teachers, it’s often tempting to base our thinking on a child’s development around what we understand as “normal.” Much of the time we do this without thinking, describing a child as “doing well” in one subject and “behind” in another.

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Women having surgery to treat pelvic organ prolapse don’t always need a hysterectomy

Pelvic organ prolapse (POP) affects up to half of all women during their lifetime, and one in eight will have surgery to treat it by the age of 85. Yet, despite how common POP is, the public’s awareness and understanding of this condition remains limited.

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Nurses need care, too—how curbing self-sacrifice can prevent burnouts

Reflecting on my mother’s decade-long nursing career, I often wonder why so many nurses leave the profession after just a few years.

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Agartala Medical College GBP Hospital workers stage protest over unpaid wages

Agartala: Outsourcing workers at Agartala Government Medical College (AGMC) and GBP Hospital staged a protest over delayed payments and inadequate wages. The march, led by the Akhil Safai Mazdoor Sangh, ended with a mass sit-in demonstration at the GBP Hospital premises.

According to the protesting workers, a total of 509 salaried employees are currently employed under outsourcing contractors at both Agartala Medical College and GBP Hospital. These workers, who carry out essential tasks such as sanitation, support services, and maintenance, have been receiving a modest salary of Rs 9,000 per month. The workers alleged that their salaries have not been paid for the past three months, which has led to the protest.

Also Read: 25 percent salary hike likely for Doctors under contract with Maharashtra BMC

Speaking to Tripura Chronicle, the worker stated, “We have been working at Agartala Medical College and GBP Hospital for a long time, but the contractors are making excuses when it comes to salary payment. We are not being paid on a specific date every month, which is causing various problems for us”.

The delay in salary payments has had a severe impact on the workers’ livelihoods. Providing essential services in sanitation, security, and support roles at the hospitals, the workers have expressed their frustration over the ongoing non-payment of wages. They have raised their concerns and are demanding immediate action to resolve the issue. However, both the contractors and the hospital management have yet to respond to the workers’ demands.  

Also Read: Salary Delay: GMC Sringar’s resident doctors threaten protest

Medical Dialogues had earlier reported that in a concerning development, resident doctors at Government Medical College (GMC), Srinagar, have issued a stern warning of protest due to persistent delays in salary payments. The Resident Doctors Association (RDA) released a statement highlighting the distressing situation faced by resident doctors at GMC Srinagar, citing prolonged delays in salary payments, exceeding five months in some instances, over the past year.

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J&K: Dialysis Centres to be set up at 11 SDHs, CHCs

Ganderbal: In a move to address the healthcare challenges faced by kidney patients, the Health Department of Jammu and Kashmir is set to establish a dialysis centre at the Sub-District Hospital (SDH) Kangan, located in the central Kashmir’s Ganderbal district.

According to officials, SDH Kangan is one of 11 health facilities across Kashmir where the Directorate of Health Services Kashmir (DHSK) has planned to establish dialysis centres. The project aims to provide convenience to the kidney patients. Following this, the Directorate has already written to the Chief Engineer of the Mechanical Engineering Department Kashmir to prepare detailed estimates for the installation of the dialysis centres. This includes the installation of essential infrastructure like water loops, storage systems, transfer pumps, electrical backups with stabilizers, and other allied works.

Also Read: Safdarjung hospital launches new haemodialysis centre for better dialysis

The Chief Engineer has been asked to submit the estimates within seven days in consultation with the respective Block Medical Officers to expedite the approval process. This move is expected to speed up the setup of the dialysis unit. In addition to SDH Kangan, the 11 health facilities identified for the establishment of dialysis centres include SDH Dooru in Anantnag; CHC Pattan and CHC Chandoosa in Baramulla; CHC Chaar-e-Shareef, CHC Nagam, and CHC Pakherpora in Budgam; SDH Kralpora in Kupwara; SDH DH Pora in Kulgam; SDH Zainapora in Shopian; and SDH Tral in Pulwama. 

Also Read: Fortis Vasant Kunj opens 16 bedded dialysis center in association with Fresenius Medical Care

As per the recent media report in Greater Kashmir, member of the Legislative Assembly Kangan Mian Mehar Ali has expressed gratitude to the Secretary of Health and Medical Education department and Director of Health Services Kashmir for starting the process of establishing a dialysis center in SDH Kangan. He said this will enable the patients to receive required treatment without any hardship.

Currently, patients requiring dialysis face immense hardships due to the unavailability of such centres in many parts of the region. As a result, most patients often have to travel for hours, incur travel costs, and lose wages, which has led to financial strain for their families.

Moreover, a patient from Kangan mentioned that, in the absence of a government-run facility in such areas, patients are forced to seek treatment at private dialysis centres, which involve high costs, adding significant financial strain to their already challenging medical conditions. This decentralization of dialysis services will not only improve access to care but also help reduce the patient load in tertiary hospitals in larger cities.

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Fact Check: Can papaya, oats and banana drink eliminate constipation in just 3 days?

An Instagram post claims that papaya, oats and banana drink can eliminate constipation in just 3 days. The claim by the user is Misleading.

Claim

An Instagram post claims that papaya, oats and banana drink can eliminate constipation in just 3 days. In the reel the user plan.cures says to take a papaya peel and cut it into pieces and then mix it with banana and oats and you can create a natural drink capable of cleansing, your intestines and eliminating constipation in just three days. The user talks about the recipe of the drink and says, “Let’s take a cup of oats soaked in water for 10 minutes. Oats are rich in soluble fiber which will increase the size of your stool making it easier to pass. Now cut half a papaya into pieces, the enzyme and fiber combination in papaya gives it a mild natural laxative effect Promoting regular bowel movements without being harsh on the digestive system. Now will also add a banana. Not only will it improve the flavor of our drink but also contain fructooligosaccharides,  a type of fiber that feeds, the good bacteria in your gut. Keeping these bacteria, healthy helps improve digestion, and keeps your bowel movements regular. After 10 minutes, strain the oats place all the ingredients in a blender along with a litre or 33 oz of skim milk blend for a few minutes and our drink will be ready.” The user further talks about the consumption of the drink and adds, “Drink one, glass, a day before breakfast.” As per the user doing this for three consecutive days and your intestines will be cleansed and healthy. 

The claim can be accessed here.

Fact Check

The user claims that papaya, oats and banana drink can eliminate constipation in just 3 days is Misleading.The drink may help alleviate mild constipation due to its fiber and nutrient content, but it is not a guaranteed cure for constipation that too in just three days 

What is Constipation?

As per Johns Hopkins Medicine, “Constipation is a condition in which a person has uncomfortable or infrequent bowel movements. Generally, a person is considered to be constipated when bowel movements result in passage of small amounts of hard, dry stool, usually fewer than three times a week.”

Constipation can be caused by medications, lack of exercise, insufficient liquids or fiber, IBS, ignoring bowel urges, lifestyle changes (like travel, pregnancy, and aging), intestinal function issues, and laxative abuse.

Dr. Amit Yelsangikar, Consultant – Medical Gastroenterology, Aster CMI Hospital, Bangalore explained, ” Constipation is a common gastrointestinal condition characterized by infrequent bowel movements or difficulty in passing stools. It is typically defined as having fewer than three bowel movements per week, and it may be accompanied by symptoms such as straining during defecation, hard or lumpy stools, and a sensation of incomplete evacuation. Various factors can contribute to constipation, including dietary habits, lack of physical activity, dehydration, and certain medical conditions or medications. Understanding the underlying causes and symptoms of constipation is essential for effective management and treatment of this condition.”

What are the types of Constipation?

Constipation can be categorized as acute or chronic. Acute constipation is usually short-term and may result from dietary changes, dehydration, or temporary illness. It often resolves with lifestyle modifications and over-the-counter remedies. Chronic constipation, however, persists for more than three months and is a more serious condition. It cannot be effectively treated with natural remedies alone and requires medical attention to identify and manage underlying causes for long-term relief.

Can Constipation Be Cured?

Constipation can often be effectively managed and, in many cases, cured by addressing its underlying causes through lifestyle changes, dietary adjustments, and, if necessary, medical interventions. Increasing fiber intake, staying hydrated, and engaging in regular physical activity can help regulate bowel movements and alleviate symptoms. Establishing a routine for bowel movements, known as bowel training, can also improve regularity. Over-the-counter treatments, such as fiber supplements, stool softeners, or laxatives, may provide temporary relief, while prescription medications like lubiprostone, linaclotide, or prucalopride are options for chronic cases. For muscle-related issues, biofeedback therapy may retrain bowel movement control. In severe cases, surgery might be required. With the right combination of these approaches, constipation can often be resolved or significantly improved.

Dr. Anupama N K, Consultant – Medical Gastroenterology, Aster CMI Hospital, Bangalore said, “Constipation, characterized by infrequent bowel movements or difficulty in passing stools, can often be alleviated through various interventions. These may include dietary modifications, such as increasing fiber intake, ensuring adequate hydration, and incorporating regular physical activity into one’s routine. Additionally, over-the-counter laxatives and other medications may provide relief for some patients. In more persistent cases, it is advisable to consult a healthcare professional who can offer tailored treatment options and investigate any underlying causes that may be contributing to the issue. Ultimately, while constipation can often be managed and improved, the approach to treatment may vary based on individual circumstances and health conditions.”

What are the nutritional benefits of papaya, oats and bananas?

Papaya (Carica papaya L.) is a tropical fruit is a popular fruit in India, known for its abundance of bioactive compounds such as carpaines, benzyl isothiocyanate (BITC), benzyl glucosinolates, latex, papain, zeaxanthin, and choline. Its seeds, leaves, and fruit offer numerous health benefits, including antioxidant properties, digestive support, and potential nutraceutical applications. Papayas are an excellent source of vitamins A, B, C, E, and K, along with folate, pantothenic acid, magnesium, copper, calcium, and potassium. They are also rich in fiber, antioxidants, and vitamin C. Papaya contains the enzyme papain, which aids in improving intestinal motility and reducing transit time. It is also beneficial in treating traumas, allergies, and sports injuries, with its healing effects largely due to papain’s enzymatic action. 

Oats are a highly nutritious cereal crop, celebrated for their rich composition of bioactive compounds that promote health. A primary benefit comes from beta-glucan, a soluble fiber known for its cholesterol-lowering and antidiabetic properties, making oats a valuable dietary choice for heart and metabolic health. Additionally, oats are packed with phenolic acids, tocols, sterols, and exhibit anti-inflammatory and antioxidant effects. Regular oat consumption supports gut health by improving microbiota and strengthens the immune system through immunomodulatory effects. 

Banana (Musa paradisiaca Linn) is low calorie (1 banana- approx. 116 kcal), low fat and rich in vitamins and minerals. It also has certain antifungal, antibiotic, antimicrobial, antidiabetic, antioxidant, and anti-inflammatory properties. Bananas are also a good source of potassium as well an excellent source of vitamins A, B-6, C, and D.

Can papaya, oats and banana drink eliminate constipation in just 3 days?

While papaya, oats, and bananas may help relieve constipation due to their high fiber and water content, claiming a drink made of these ingredients will eliminate constipation in just 3 days is not supported by any scientific evidence or medical consensus. While these ingredients may provide relief from constipation, they are unlikely to eliminate chronic constipation in 3 days. Hence, the claim is Misleading.

Papaya, known for its rich nutrient profile and digestive benefits, has been increasingly studied for its potential role in alleviating gastrointestinal issues, especially constipation. Nilawati Soputri et. al. concluded in their study that papaya has the potential to act as a natural remedy or an alternative treatment for effectively managing constipation.

Similarly, a study conducted by Sheed Iseal et. al. found that papaya, rich in enzymes like papain, aids in protein digestion, thereby improving overall digestive health and reducing symptoms like bloating and constipation. Additionally, its high fiber content promotes regular bowel movements, supporting optimal gastrointestinal function.

Oats, a nutrient-dense whole grain, are well-known for their high fiber content and numerous health benefits, particularly in supporting digestive health. In a systematic review, Thies et. al. found that oats or oat bran can significantly increase stool weight and reduce constipation in humans because of the high fiber levels in oats.

Bananas have gained attention for their role in supporting intestinal health and addressing digestive issues like constipation. The study published in the Journal of Medicinal Foods concluded that Baana Resistant Starch effectively enhances intestinal motility by accelerating small intestine movement and reducing defecation onset time, without affecting body weight or food intake. This suggests its potential utility in managing constipation.

While scientific evidence supports that papaya, oats, and bananas may aid in managing constipation, there is no medical consensus or scientific evidence to back the claim that a combination of these ingredients for a drink can eliminate constipation in 3 days. Also, these ingredients could be beneficial in managing constipation, but chronic constipation requires more comprehensive treatment.

Responding to the claim Dr. Amit Yelsangikar, Consultant – Medical Gastroenterology, Aster CMI Hospital, Bangalore said, “This blend of ingredients is noted for its high fiber content, which can aid in promoting regular bowel movements. Papaya contains enzymes that may facilitate digestion, while oats are renowned for their soluble fiber that helps to soften stools. Additionally, bananas contribute both fiber and potassium, which are essential for maintaining healthy digestive function. Therefore, incorporating this specific drink into one’s diet could prove to be an effective natural remedy for individuals struggling with constipation over a short timeframe.”

Dr. Anupama N K, Consultant – Medical Gastroenterology, Aster CMI Hospital, Bangalore further said, “This mixture of ingredients is recognized for its abundant fiber content, which can assist in encouraging regular bowel movements. Papaya is rich in enzymes that may support digestion, while oats are well-known for their soluble fiber, which helps in softening stools. Moreover, bananas provide a combination of fiber both of which play a crucial role in maintaining healthy digestive function. Consequently, adding this particular drink to one’s diet could serve as a natural and effective remedy for individuals experiencing constipation.”

Medical Dialogues Final Take

The ingredients papaya oats, and banana may aid digestion and alleviate mild constipation due to their fiber and nutrient content. It is also important to note that these ingredients may relieve constipation temporarily but are not effective in addressing chronic constipation permanently. Further, there is no scientific evidence or medical consensus to support the claim that the combination of these ingredients for a drink will eliminate constipation in just 3 days.

Hence, the claim by the user is Misleading.

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