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This move came in line with the draft notification published by the Ministry on September 25, 2023, suggesting the insertion of Oseltamivir (serial number 49) and Zanamivir (serial number 50) into the list of medications listed as Schedule H1.

In view of the above, the draft notification invited objections and suggestions from stakeholders within thirty days.

Following this, the Central Government came up with the amendment to add Oseltamivir (serial number 49) and Zanamivir (serial number 50) to the list of drugs referred to as Schedule H1 after receiving and taking into consideration the public suggestions and consulting with the Drugs Technical Advisory Board.

The Drugs and Cosmetic Rules of 1945 allocated provisions for the classification of the drugs under various given schedules including details regarding the storage, display, sale, and prescription of an individual schedule. The prominent schedules included Schedule G, H, X, and J.

Schedule H1 has been introduced through Gazette notification GSR 588 (E) dated 30-08-2013 to check the indiscriminate use of antibiotics, anti-TB, and some other drugs in the country. The schedule contains certain 3rd and 4th generation antibiotics, certain habit-forming drugs, and anti-TB drugs.

Schedule H contains a list of drugs that can be sold only against the prescription of a registered medical practitioner. Another provision that needs to be followed is that only the required amount of medications mentioned in the prescription can be dispensed. These drugs can be supplied only to licensed parties.

The drug label must exhibit the text “Rx” and Schedule H drug warning: To be sold by retailers on the prescription of a Registered Medical Practioner only. As per the notification on 16th March 2006 released by the Department of Health under the Ministry of Health and Family Welfare, there are 536 Schedule H drugs. The original list contained 510 drugs but this has been revised by the Drugs Technical Advisory Board (DTAB) and the present list includes about 536 drugs.

The drug supplied under the schedule H1 specification should be recorded in a separate register at the time of supply, mentioning the name and address of the prescriber, the name of the patient, and the name of the drug along with the quantity supplied. This register has to be maintained confidentially for up to three years and should be open for inspection.

The schedule H1 drugs should be labeled with the symbol Rx in red, clearly displayed on the left top corner of the drug label. The label should also bear the following words in a box with a red border.

“Schedule H1 Drug-Warning:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner.”

In exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:

(1) These rules may be called the Drugs (Amendment) Rules, 2024.

(2) They shall come into force on the date of their final publication in the Official Gazette.

In the Drugs Rules, 1945, in Schedule H1, after serial number 48 and entries relating thereto, the following serial number and entry shall be inserted, namely:-

“49. Oseltamivir 50. Zanamivir”.

Also Read:PM Modi lays down foundation stone for AIIMS in Rewari

Online petitions have already been launched by the candidates highlighting the fact that the commencement of the NEET MDS 2024 in March is causing extreme emotional distress as they don’t have enough time to prepare for the exam. The aspirants filed several online petitions seeking the postponement of the exam on change.org a few days ago and it had been already signed by around 8000 aspirants in total.

In one of the recent copies of several online petitions circulating on social media, over 2,760 candidates have signed it as they pointed out that they are facing immense mental stress and pressure because of the NEET MDS schedule in March.

Also Read: #PostponeNEETMDS2024toJULY: Over 8000 dentists sign online petition demanding postponement of exam to July 2024

The hospital claimed in the release that no negligence was found on its part or the part of its doctors by the Delhi Medical Council and the erstwhile Medical Council of India. Therefore, referring to the State Commission order dated 09.02.2024, the Council termed it to be “surprising” and mentioned that the order is being studied in detail for further course of action.

For the full story, check out the link given below:

No Negligence Was Found In Medical Council Order, Sir Ganga Ram Hospital Calls Delhi Consumer Court Compensation Order “Surprising”

MP Doctor’s outburst towards guard in Chhatarpur caught on video

In Chhatarpur, Madhya Pradesh, a heated altercation between a doctor and a home guard, who was assisting an accident victim, escalated quickly and was captured on video, sparking widespread outrage on social media. The incident occurred when the home guard, in his duty to ensure proper care for the injured, requested a CT scan and X-ray for the patient from Dr.Arunendra Shukla.

The situation took a turn for the worse when the doctor reacted negatively after the home guard mentioned the district collector’s name, leading Dr. Shukla to angrily toss aside the documents and refuse to continue his work.

Pharmacist gets life sentence for Triple Murder in 2014

In a significant legal decision nearly a decade after a tragic incident, Sneha Swakhyar Samal, a 52-year-old pharmacist, has been sentenced to life imprisonment for the murder of three individuals. This verdict was delivered by Justice Debasis Rout of the first additional sessions court in Bhubaneswar.

The victims of this heinous crime were orthopaedic surgeon Atulya Chandra Meher, aged 55, his caretaker Prasant Behera, aged 42, and Behera’s son Minu, aged 14. The attack, which occurred on October 14, 2014, at Dr. Meher’s residence in Khandagiri, also left Prasant’s wife, Runu, aged 35, and their other 6-year-old son severely injured.

New Utah research suggests menopause might be postponed forever

At birth, ovaries in girls can contain about a million tiny structures called primordial follicles, each of which contains an egg cell. As girls grow and experience adulthood, most of these follicles will die while only one follicle will survive each month to ovulate a mature egg. When the loss of primordial follicles is nearly complete, and only hundreds remain, women experience menopause, a time when menstrual cycles have ceased for 12 months.

Johnson J, Lawley SD, Emerson JW, Oktay KH. Modeling delay of age at natural menopause with planned tissue cryopreservation and autologous transplantation. Am J Obstet Gynecol. 2024 Jan 4:S0002-9378(24)00003-6. doi: 10.1016/j.ajog.2023.12.037. Epub ahead of print. PMID: 38184290.

“Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

The FDA approval is based on positive data from the Phase III OUtMATCH study, which evaluated Xolair in patients aged 1 to 55 years allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut. The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is being conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10 clinical sites across the U.S. led by Johns Hopkins Children’s Center and co-led by Stanford School of Medicine. Detailed results from the study will be featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Sunday, 25 February.

“As more and more people are affected by food allergies, the need for a new approach to help prevent serious and often life-threatening allergic reactions and emergencies is critical,” said Sung Poblete, R.N., Ph.D., CEO of FARE (Food Allergy Research and Education). “As someone with food allergies, I know firsthand the significant impact they can have on people and their loved ones, and I share in the community’s excitement for this approval.”

“The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches, and holiday dinners with friends and family,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA). “Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”

Patients entered the OUtMATCH study unable to tolerate up to 100 mg of peanut protein (equivalent to about one third of a peanut), and up to 300 mg each of milk, egg and cashew protein. After 16 to 20 weeks of treatment with Xolair or placebo, each participant completed four food challenges, receiving gradually increasing amounts of foods they are allergic to (and a placebo ingredient), in order to assess their ability to consume a single dose of at least 600 mg of peanut protein (primary endpoint), and a single dose of at least 1,000 mg of milk, egg or cashew protein (secondary endpoints) without experiencing moderate to severe allergic symptoms.

Study results showed a statistically significant higher proportion of patients (68%) treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo (p<0.0001). This amount is equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter.

In addition, a statistically significant higher proportion of patients treated with Xolair compared to placebo tolerated at least 1,000 mg of protein from milk (66% vs. 11%; p<0.0001), egg (67% vs. 0%; p<0.0001) or cashew (42% vs. 3%; p<0.0001) without moderate to severe allergic symptoms. This amount is equivalent to approximately two tablespoons of 1% milk, one-quarter of an egg or three and a half cashews. While patients in the study tolerated these amounts of food, treatment with Xolair should be used with continued food allergen avoidance.

Safety findings were consistent with the known safety profile of Xolair across its additional indications and in previous clinical trials. The most common adverse events (≥3% of patients) in Xolair-treated patients in the study were injection site reaction (15.5% vs. 10.9% with placebo) and fever (6.4% vs. 3.6% with placebo).

About 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies, based on estimates for 2024. Food allergy prevalence has been on the rise for the past 20 years. There are 160 different foods that cause IgE-mediated food allergy. Allergic reactions can range from mild to moderate, including hives and swelling, to severe and life-threatening, such as anaphylaxis. More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year.

This marks the fourth FDA-approved indication for Xolair across allergic and inflammatory conditions, including moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). Since its initial approval in 2003, more than 700,000 patients have been treated with Xolair in the U.S.

Xolair is a prescription biologic medicine that is given as an injection under the skin (subcutaneous). It is the only FDA-approved antibody designed to target and block IgE — an underlying driver of food allergy reactions. The recommended Xolair dosage for treatment of food allergy is 75 mg to 600 mg once every 2 or 4 weeks. Xolair dose and dosing frequency is determined by total serum IgE level and body weight. Injections can be given by a healthcare provider in a healthcare setting or at home through self-injection after initiating in a healthcare setting. Healthcare providers will determine appropriate candidates for self-injection.

In the U.S., Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.