Staccato Alprazolam Shows efficacy and Tolerability for rapid termination of seizures in Phase 1 Studies

Staccato® alprazolam is a novel drug-device combination designed to deliver alprazolam to the deep lung for the rapid termination of seizures. Two phase 1 studies evaluated its pharmacokinetics (PK) and safety profile in healthy adult participants. This article presents the findings from these studies. This study was published in the journal Epilepsia. The study was conducted by Yoshinobu H. and colleagues.

Alprazolam is commonly used to treat anxiety and panic disorders, but its rapid absorption and distribution via inhalation make it a potential candidate for seizure termination. The Staccato device delivers a single-use, inhaled dose of alprazolam, offering a promising approach for rapid seizure control.

The smoker study (EPK-002/NCT03516305) involved 36 participants aged 21–50 years, including smokers and nonsmokers, who received a single inhaled dose of 1 mg Staccato alprazolam. The ethnobridging study (UP0101/NCT04782388) included Japanese, Chinese, and Caucasian participants aged 18–55 years who were randomized to receive a single inhaled dose of Staccato alprazolam 2 mg or placebo.

The key findings of the study were as follows:

  • Rapid Absorption: Alprazolam was rapidly absorbed, with a median time to peak plasma concentration (Tmax) of 1.5–2 minutes post-dose in both studies.

  • This rapid absorption was consistent across smokers, nonsmokers, and participants of different ethnicities.

  • Similar Absorption in Smokers and Nonsmokers: Staccato alprazolam was absorbed to a similar extent in both smokers and nonsmokers, indicating consistent pharmacokinetics regardless of smoking status.

  • Tolerability: The most commonly reported treatment-emergent adverse events (TEAEs) were somnolence and dizziness, with no serious or severe TEAEs reported.

  • Staccato alprazolam demonstrated a safety profile consistent with other alprazolam formulations, with no new safety signals identified.

The phase 1 studies of Staccato alprazolam demonstrated rapid absorption, reaching therapeutic drug levels within 2 minutes post-dose. The drug was well tolerated across different populations, including smokers and individuals of various ethnicities. These findings support further investigation of Staccato alprazolam as a potential treatment for rapid seizure termination.

Reference:

Hayakawa, Y., Rospo, C., Bartmann, A. P., King, A., Roebling, R., & Chanteux, H. (2024). Pharmacokinetics of Staccato® alprazolam in healthy adult participants in two phase 1 studies: An open‐label smoker study and a randomized, placebo‐controlled ethnobridging study. Epilepsia. https://doi.org/10.1111/epi.17901

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SC rejects apology of Ramdev, MD Balkrishna in misleading ads case

New Delhi: Not convinced by the latest apology, the Supreme Court on Wednesday refused to accept the second affidavits filed by Ramdev and managing director of Patanjali Ayurved Balkrishna tendering unconditional apologies over publishing “misleading” advertisements, asserting they did so when “caught on the wrong foot”. 

Refusing to accept the latest affidavit, the apex court described the apology as “on paper” and questioned the intention of the apology as it asked if the apology was “even heartfelt”. Further, the court warned both Baba Ramdev and the company’s MD, Acharya Krishan, to brace themselves for potential repercussions.

The court also came down hard on the State Licensing Authority for its inaction on the issue and said it is not going to take it lightly. “We will rip you apart,” a bench of Justices Hima Kohli and Ahsanuddin Amanullah said in an unusually stern reprimand. 

Also read- Your Apology…More Of A Lip Service: SC Slams Baba Ramdev, Patanjali In Misleading Ads Case

Ramdev and Balkrishna have tendered an “unconditional and unqualified apology” before the apex court over advertisements issued by the firm making tall claims about the medicinal efficacy of its products. 

“Apology is on paper. Their back is against the wall. We decline to accept this, we consider it a deliberate violation of undertaking. Be ready for something next to rejection of affidavit,” Justice Kohli told Senior Advocate Mukul Rohatgi who represents Patanjali in this case.

When Rohatgi said, “People make mistakes”, to which Justice Kohli retorted, “Then they suffer. We don’t want to be so generous in this case.”

“Why should we not treat your apology with the same disdain as shown to court undertaking? We are not convinced. Now going to turn down this apology,” Justice Kohli further remarked.

As per NDTV news report, the bench while undergoing their affidavit noted that Ramdev and Balkrishna sent their apologies to the media first. 

In response to the action, Justice Kohli said, “Till the matter hit the court, the contemnors did not find it fit to send us the affidavits. They sent it to the media first, till 7.30 pm yesterday it was not uploaded for us. They believe in publicity clearly.”

Further, Justice Amanullah asked if the apology was “even heartfelt”. “What else needs to be said, my lords, we will. He is not (a) a professional litigant. People make mistakes in life,” Mr Rohatgi replied. 

“Even after our orders? Tendering an apology is not enough. You should suffer the consequences for violating the court’s order. We do not want to be generous in this case,” the court said.

The apex court observed that after notices to show cause were issued to them and they were directed to present themselves before it, Ramdev and Balkrishna “attempted to wriggle out” of the situation by making false claims of travel abroad where personal presence was warranted. It is “most unacceptable”, the court said.

“Having regard to the entire history of the matter and the past conduct of the contemnors…, we have expressed our reservations about accepting the latest affidavit filed by them,” the bench said while dictating the order in the courtroom as noted by PTI.

The court fixed the matter for a resumed hearing on April 16.

Reproaching the Authority, the top court said, “We are appalled to note that except for pushing the files, the State Licensing Authority did nothing and was in “deep slumber” over the issue for four to five years. It asked the state’s officer present on behalf of the Authority to explain the reasons for inaction.”

While declining to accept the apologies tendered by Ramdev and Balkrishna, the bench said, “We don’t want to be so generous in this case.” “The apologies that are on record are on paper. We think that having been caught on the wrong foot and noticing that their back is actually against the wall and having gone to town saying all kinds of things on the very next day of the order passed where your counsel had given undertaking, we don’t accept this affidavit,” it said. 

“We decline to accept or condone it. We consider it a wilful and deliberate violation of the order and the breach of the undertaking…,” the bench told senior advocate Mukul Rohatgi, who appeared for Ramdev and Balkrishna.

Coming down heavily on the government, the court said, “In 2021, the ministry wrote to the Uttarakhand licensing authority against a misleading advertisement. In response, the company gave a response to the licensing authority. However, the authority let off the company with a warning. The 1954 Act does not provide for warning and there is no provision for compounding the offence,”

“This has happened six times, back and forth back and forth, the licensing inspector remained quiet. There is no report by the officer. The person appointed subsequently acted the same way. All those three officers should be suspended right now,” it said, adding that the licensing authority was “in cahoots with the contemnors”.

“You are acting like a post office. Did you take legal advice? Shameful of you. Why don’t we agree that you are hand-in-glove with Patanjali,” the court asked the authority, adding, “you have being playing with people’s life”.

Following this, the licensing authority apologised to the court and assured that they would surely act on the matter.

On April 2, the top court came down hard on Ramdev and Balkrishna and rejected their previous apology as “lip service”.

It had also questioned the Centre’s alleged inaction over Patanjali’s claims about the efficacy of its products and for denigrating allopathy during the Covid peak and asked why the government chose to keep its “eyes shut”.

The apex court had strongly disapproved of Balkrishna’s statement that the Drugs and Cosmetics (Magic Remedies) Act was “archaic” and said Patanjali Ayurved’s advertisements were in the “teeth of the Act” and violated with impunity the undertaking given to the court.

Medical Dialogues had earlier reported that after issuing a contempt notice on the matter, during the previous hearing of the case on March 19, the Court had passed an order seeking the personal appearance of Acharya Balakrishna and the company’s co-founder Baba Ramdev.

The IMA filed a plea seeking to put a stop to the “smear campaign” and negative advertisements by Patanjali against modern medicines and especially the vaccination drive during the pandemic.

The plea specifically referred to an advertisement titled “MISCONCEPTIONS SPREAD BY ALLOPATHY: SAVE YOURSELF AND THE COUNTRY FROM THE MISCONCEPTIONS SPREAD BY PHARMA AND MEDICAL INDUSTRY,” published on July 10, 2022. The IMA alleged that Patanjali’s advertisements violated laws such as the Drugs & Other Magic Remedies Act, 1954, and the Consumer Protection Act, 2019, by making unverified claims.

Moreover, the petition highlighted Ramdev’s previous controversial remarks, including denigrating allopathy as a “stupid and bankrupt science” and spreading false information about deaths due to allopathic medicines during the COVID-19 second wave. Patanjali was also accused of contributing to vaccine hesitancy and belittling citizens seeking oxygen cylinders during the pandemic’s peak.

Despite a Memorandum of Understanding between the Ministry of AYUSH and the Advertising Standards Council of India (ASCI) aimed at monitoring misleading advertisements of AYUSH drugs, Patanjali continued allegedly violating laws with impunity, the petition added.

Patanjali Ayurved Ltd had assured the top court on November 21, 2023, that it will not violate any law, especially the laws relating to advertising or branding of products. Even though Patanjali had assured the top court bench that no such statements would be made, the practice continued.

On March 19, the apex court directed Ramdev and Balkrishna to appear before it after taking exception to the company’s failure to respond to the notice issued in the case relating to advertisements of the firm’s products and their medicinal efficacy.

The top court had said it deemed it appropriate to issue a show cause notice to Ramdev as the advertisements issued by Patanjali, which were in the teeth of the undertaking given to the court on November 21, 2023, reflect an endorsement by him.

Last month, Balkrishna had tendered an unqualified apology to the apex court for advertising the herbal products of the firm claiming their medicinal efficacy in treating several serious diseases and running down other systems of medicine. 

Also read- Misleading Ads Row: Patanjali MD Acharya Balkrishna Tenders Unqualified Apology

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Who is an Intensivist? DGHS defends broader definition of Intensivist, Critical Care Specialists see red

New Delhi: Although the Directorate General of Health Services (DGHS) under the Union Health Ministry recently defended its broader definition of an “Intensivist” citing the scarcity of physician staff with minimum standards of training for critical care delivery, the critical care specialists having NMC recognised degrees are not happy with the explanation.

Raising the issue, a newly formed Forum of Intensivists and Critical Care Specialists (FICCS) agreed that the need for critical care specialists in resource-limited settings is a matter of concern and “possibly DGHS have given a uniform all-inclusive definition of intensivists to match the demand.”

However, the doctors highlighted that the ICU guidelines by DGHS, which defined an “Intensivist”, nowhere mention that these non-recognized intensive care practitioners will only work in resource-limited settings. The guidelines do not also mention any steps to prevent them from working in resource-sufficient settings.

“Rather by keeping all the practitioners in one same bracket allows inadequately trained junior doctor to work as or present themselves as a superspecialist, even at best of the hospitals. This is obviously misinterpretation of qualification. This is surely unethical in terms of patient care and may give a false impression to patient of being in best care when he/she is actually not,” the Forum highlighted.

Speaking to Medical Dialogues in this regard, a member of the Forum and a specialist doctor working as a consultant in critical care said, “We respect this sentiment that we need more people. But at the same time, there are better ways of increasing the workforce by creating more Departments of Critical Care, and creating more jobs. So, there are better ways to deal with the situation rather than opting for shortcuts.”

“Giving this definition to everybody creates confusion in the minds of patients. People practicing critical care understand the core need to distinguish between physicians with proper NMC-recognised training and those who lack that training. True, it is an issue of self-identification. But at the same time, it is ethically important to inform the patients who are treating them and what credentials they have.”

“How can an MBBS with 3 years of experience be equivalent to a doctor, who pursues a Masters, Super Speciality training?” the doctor questioned. 

Medical Dialogues has been reporting the debate concerning the definition of the term “Intensivist” as provided in the recently released guidelines for Intensive Care Unit (ICU) Admission and Discharge Criteria.

Apart from recognizing doctors with NMC-recognised super speciality degrees, DGHS had mentioned in the guidelines that a few candidates of the Indian Society of Critical Care Medicine (ISCCM) Certificate Course- Certificate of Training in Critical Care Medicine (CTCCM) who have been certified with a 3-year training programme in the Intensive Care after MBBS are also recognised as Intensivists.

Also Read: New Govt Guidelines Define Who is an Intensivist

Who is an Intensivist as per DGHS?

The DGHS ICU guidelines, compiled by a total number of 24 experts, specified that to be called an “Intensivist”, a specialist needs to have specific training, certification, and experience in managing critically ill patients in an ICU.

As per the guidelines, the Intensivist should have a postgraduate qualification in Internal Medicine, Anaesthesia, Pulmonary Medicine, Emergency Medicine or General Surgery with either of the following:

a) An additional qualification in Intensive Care such as DM Critical Care/Pulmonary Critical Care, DNB/FNB Critical Care (National Board of Examinations), Certificate Courses in Critical Care of the ISCCM (IDCCM and IFCCM), Post-Doctoral Fellowship in critical Care (PDCC/Fellowship) from an NMC recognised University, or equivalent qualifications from abroad such as the American Board Certification, Australian or New Zealand Fellowship (FANZCA or FFICANZCA), UK (CCT dual recognition), or equivalent from Canada

b) At least one year of training in a reputed ICU abroad.

Apart from this, the guidelines clarified that a few candidates of the ISCCM Certificate Course (CTCCM) who have been certified with a 3-year training programme in Intensive Care after MBBS are also recognised as Intensivists. “In addition, persons so qualified or trained must have at least two years’ experience in ICU (at least 50% time spent in the ICU),” stated the Guidelines.

If a doctor does not have either of the above-mentioned qualifications or training, they are required to have extensive experience in Intensive Care in India after MBBS, quantified as at least three years’ experience in the ICU (at least 50% time spent in the ICU).

Doctors Express Concern: 

However, the definition of an “Intensivist”, provided by the DGHS, raised concern among the critical care specialists, who previously wrote to the National Medical Commission (NMC) and expressed their grievances and issues over the “misleading” definition of the term prescribed by the Union Health Ministry.

While the doctors expressed their appreciation for the efforts to establish standards for managing critically ill patients in the ICUs, they expressed their concern regarding the inclusion of doctors who completed a three-year training program in the ICU after MBBS without pursuing a recognized speciality course.

Also Read: Who is an intensivist? Doctors demand Apex Medical Regulator to re-evaluate the criteria

DGHS Defends its Guidelines: 

Recently, taking cognisance of the concerns among the critical care specialists over the issue, DGHS, in a letter, defended its broad definition of the term “Intensivists”.

Answering the point regarding the definition being different from the NMC nomenclature, DGHS mentioned, “The intention and purpose of the Ministry’s Advisory was to have a definition for ICU physician workforce applicable across the spectrum of settings in the country, not just in the metropolises. The guidelines were framed in compliance with this brief. A crucial resource in an ICU is the trained physician and nursing staff. This document also acknowledges the scarcity of physician staff with minimum standards of training for critical care delivery. The definition of an “intensivist” here is therefore a broad one, describing those who are eligible to work in an ICU.”

Mentioning that “Uniform” standards across both resource-sufficient and resource-limited settings are “scarcely possible”, DGHS offered a “feasible” solution of accommodating the latter settings, with specified minimum standards for the physician workforce in the ICU.

“This would go a long way in preventing ICUs being manned by physicians with no prior exposure in critical care or those having only AYUSH training with or without any “bridging courses” defined by the NMC. In fact, this is a progressive step forward as envisioned by the MoHFW and shared by the team of expert intensive care specialists of repute from both public and private sectors. Intensive care demands 24×7 team work. Its quality depends on having adequacy of trained physician, nursing and paramedical workforce,” DGHS mentioned in the letter.

“Although the superspecialist courses have been established recently, the need of a large body of trained physician workforce across the country cannot be met at present if we define the “intensivist” narrowly to include only those with superspecialty training. In fact, the initial workforce was through less formal courses conducted by the ISCCM since 2002. As such, a sizeable workforce with these certificate courses already exists whose value was evident during the COVID pandemic,” it further added.

DGHS, operative under the Union Health Ministry, referred to the rapid evolution of the speciality through the initiatives by intensivists themselves and added that “this is expected to grow as we continually improve critical care delivery.”

However, DGHS clarified that the super-speciality definition requiring postgraduate qualifications and experience remains as before and further added that the specialists of this description would lead the chain of command amongst the physician team in the ICU. Those not meeting those qualifications would function as non-specialist intensivists lower in the chain of command, clarified DGHS. It further added that this additional clarification may be added to the existing definition in the Advisory to allay the fears raised regarding possible dilution of the superspecialty qualifications.

“The new entrants would be encouraged by the clear guidelines from the MoHFW, the increasing access to superspecialty training and at the same time having sufficient physician workforce on the ground. Indeed, this is what is envisioned by the technical resource group that worked on the document,” stated the DGHS.

Clarifying that the purpose and value of the guidelines must not be misinterpreted, it further added that the brief by the MoHFW was clearly to “ensure that minimum standards are met in any location and resource utilisation is optimal. All this is in the best interests of the patients, their families and the society as a whole.”

Representation by FICCS: 

However, the critical care specialists are not happy with the explanation given by the DGHS, and recently they took up the matter with authorities including the DGHS, Union Health Secretary, and the National Medical Commission (NMC).

Although the Forum of Intensivists and Critical Care Specialists (FICCS) thanked the authorities for formulating the guidelines, it expressed its reservations regarding the definition of the Intensivist or Critical Care Specialists as provided in the guidelines.

The Forum opined that the document on ICU admission and discharge criteria should have been restricted to the sole purpose of ICU Admission and Discharge Criteria and the authorities should have left the job of defining an “Intensivist” to the National Medical Commission (NMC).

“…only doctors with NMC recognised degree can claim to be Specialist or Superspecialist. Issuing a new definition will lead to confusion regarding specialist among Care givers and society and it can be misused by nonrecognised practitioners,” FICCS mentioned.

The Forum on the one hand referred to the 2-year recognised Fellowship in National Board (FNB) Course since 2001 offered by the National Board of Examinations and also 400+ DrNB/DM seats every year in Critical Care Medicine; on the other, it also pointed out that there is now a trend of super speciality DM/DrNB seats not being picked up by candidates aspiring to practice critical care.

Highlighting that such candidates are opting for and preferring shorter duration courses (not recognized by NMC) offered by the various societies/universities, as they would equally be considered as a superspecialist by virtue of this new definition, the Forum added, “This is surely a threat to quality and standardization of protocol-based practice which is an essence is medical science.”

“It is equally important to register that critical care has been recognized as a super speciality branch with well-organized curriculum by NMC and no other training either at some private institution or under some private body can match the standards required to work as Intensivists and handle critically ill patients,” it added.

Referring to the stand of DGHS to offer an all-inclusive definition of intensivists to match the demand of critical care specialists in resource-limited settings, the Forum pointed out that the guidelines do not mention that these non-recognized intensive care practitioners will only work in resource-limited settings. Further, there is no mention in the guidelines about any steps to prevent them from working in resource-sufficient settings.

“Rather by keeping all the practitioners in one same bracket allows inadequately trained junior doctor to work as or present themselves as a superspecialist, even at best of the hospitals. This is obviously misinterpretation of qualification. This is surely unethical in terms of patient care and may give a false impression to patient of being in best care when he/she is actually not. In personal communications, DGHS have backed their step as a mean to stop AYUSH doctors from practicing Critical Care. We consider this as irrational explanation as AYUSH doctors are not allowed to practice any super-speciality branch in any ways. The authorities must take some stringent measure to stop this rather than create another bunch of inadequately trained physicians practicing any super-speciality branch including critical care,” added the Forum.

While the Forum acknowledged the contribution of doctors with ISCCM certificate courses in the ICUs during COVID pandemic, it opined that such efforts don’t warrant inadequacy in medical training during normal times.

Highlighting the importance of proper medical care, the Forum mentioned in its letter that Critical Care is one of the most crucial lifesaving medical specialities that handles the most critical patients. Therefore, finding shortcuts to such super specialities is not a step of intelligence in terms of medical science and patients as well, opined the Forum.

Supporting DGHS’s stand of keeping a well-defined stratification and differentiation between a Specialist and Non-Specialist on the basis of NMC-recognised degrees, the Forum highlighted that the NMC-recognized courses adhere to specific curriculum standards set by the regulator, covering essential topics and skills required. 

“In contrast, casually trained junior doctors may have received ad-hoc training without consistent adherence to standardized curriculum guidelines. Also, NMC recognized courses typically include structured clinical training components, ensuring that students gain hands-on experience under supervision in various healthcare settings. Casually trained junior doctors may have acquired clinical experience through less formal avenues, potentially leading to variations in the quality and breadth of their training. Thus, in no way a NMC recognized superspecialist can be kept at same platform as a physician with experience in respective field,” added the Forum.

“Even ISCCM Guidelines quoted by experts was published in 2020 which also recommended at least 10 years of experience after Post graduation to Be termed as a Critical Care Specialist but they selectively ignored this statement and quoted old document published in 2013 to justify this irrational definition,” it further mentioned.

The Forum further highlighted that such “shortcut courses” are no solutions to the rising need for critical care physicians and opined that such courses are just means of substandard and non-uniform medical practice.

Pointing out that critical care as a super speciality branch is recognized all across the world the Forum highlighted that globally the training duration of any recognized critical care specialist is no less than 5 years after completion of MBBS. “So by promoting these shortcut courses, we are not doing justice to our patients in any ways…” it added.

FICCS emphasized that it does not intend to question anyone practising critical care, but only to emphasize on the quality of patient care and an ethical medical practice. 

“Surely there is a need of physicians practising critical care at junior level or workforce but then there should be a strict measure to maintain the hierarchy and also a clear-cut difference in recognition of NMC recognized courses and other certificate courses. These two categories cannot be clubbed together and share same recognition in the general society,” it mentioned. 

The Forum urged the Health Ministry and DGHS authorities to consult with NMC regarding the matter, consider the facts and find an appropriate solution by rectifying the definition of “Intensivist” and assigning some other term to physicians (without NMC-recognized courses) practising critical care.

Also Read: Doctors upset with Intensivist defination provided by DGHS, urges NMC to intervene

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Conduct Phase-III clinical trial: CDSCO Panel tells Abbott on Ademetionine for Injection 400mg

New Delhi: Responding to the proposal of import and marketing of Ademetionine for injection 400mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Abbott Limited to conduct the Phase III clinical trial of the drug Ademetionine for Injection 400mg.

This came after Abbott Limited presented the proposal for grant of permission to import and marketing of Ademetionine for injection 400mg along with Phase-III clinical trial protocol before the committee.

Ademetionine occurs naturally in cells, tissue, and body fluids. It helps to treat depression, osteoarthritis, and liver illness. In liver disease, this drug controls liver glutathione levels to prevent liver damage and the buildup of cirrhosis-related lipids outside the liver.

Ademetionine is used in the treatment of liver disease. It is used in liver conditions associated with reduced bile formation (intrahepatic cholestasis). Ademetionine protects the liver cells from toxins and helps the liver to perform its normal functions.

In depression, it affects serotonin in the brain, which communicates between brain cells and regulates mood. In osteoarthritis, it stimulates cartilage production and reduces the inflammatory mediator.

At the recent SEC meeting for Gastroenterology and Hepatology held on 13th March 2024, the expert panel reviewed the proposal for the grant of permission to import and market the Ademetionine for injection 400mg along with Phase-III clinical trial protocol before the committee.

After detailed deliberation, the committee recommended conducting a Phase-III clinical trial as per protocol (protocol No. ADEM-323-0417, version No. 1.0, dated 18.12.2023) presented by the firm.

Also Read: CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal For COPD Drug Study

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World Homoeopathy Day 2024: Encouraging scientific rigor will increase people’s confidence in Homoeopathy

New Delhi: Inaugurating the Scientific Convention on World Homoeopathy Day 2024 today at Yashobhoomi Conventional Centre Dwarka New Delhi, President Smt Droupadi Murmu said, ”Many individuals who had become disillusioned with various methods of treatment have benefited from the miracles of Homeopathy.  

However, within the scientific community, such experiences can only be acknowledged when presented with a sufficient number of experiences backed by facts and analysis. Encouraging scientific rigor will increase confidence in this method of treatment among people.”

She added in her address “Scientific validity forms the basis of authenticity and both acceptance and popularity will increase with authenticity. Your efforts to empower research and enhance proficiency will be beneficial in promoting homeopathy. This will benefit everyone involved in Homeopathy, including doctors, patients, drug manufacturers, and researchers.”

Also Read:Union Ayush Minister inaugurates Panchakarma Block at Central Ayurveda Research Institute in North East

The President further said that the continuous improvement in the education system of homeopathy will make this method more attractive to young students. The involvement of a large number of young people is essential for the bright future of homeopathy. President congratulated the Ayush ministry for organising this mega event and promoting homeopathy along with other Ayush systems of medicine.

President graced this two-day Scientific Convention on the theme of “Empowering Research, Enhancing Proficiency” organized by Central Council for Research in Homoeopathy (CCRH), an autonomous apex research organization under Ministry of Ayush to celebrate the occasion of the World Homoeopathy Day today.

On this occasion, Secretary, Ministry of Ayush Vaidya Rajesh Kotecha said “In homeopathy, there are immense possibilities for integration between other medical systems and traditional medicine. Efforts to integrate these systems, where appropriate, will benefit patients who demand a comprehensive approach to healthcare. Strong research and clinical testing are crucial for establishing a robust scientific foundation for homeopathy. The government is committed to quality control and patient safety by working collaboratively with the homeopathic community.

To increase public access to homeopathy and expand its reach, we are actively promoting its integration into primary healthcare systems. We are actively encouraging research in homeopathy through facilities like the CCRH and other collaborators and allocating resources for clinical trials and evidence-based studies.”

Dr Subhash Kaushik, DG, CCRH, Ministry of Ayush, in his welcome address, emphasized on the need of evidence-based research in today’s era, for which it is important that the scientists of various fields and specialties come together. He thanked eminent scientists and doctors from various organisations like AIIMS, ICMR, Apollo Cancer Hospital, Chennai, Janakpuri Superspecialty Hospital, Delhi, etc. for showing their support for Homoeopathy by attending the symposium.

The inaugural ceremony was followed by a session on ‘Words of Wisdom’, chaired by the Padma Bhushan and Padma Shri Vaidya Devendra Triguna Ji and Padma Shri Dr. HR Nagendra Ji. In this session Padma Awardees Padma Awardees of Homoeopathy sector Padma Shri Dr. V.K. Gupta, Padma Shri Dr. Mukesh Batra, Padma Shri Dr. Kalyan Banerjee, and Padma Shri Dr. RS Pareek share their enriching experience with the gathering.

Dr Anil Khurana, Chairman, National Commission for Homoeopathy along with Ayush Scientist Chair, Dr. Sangeeta A. Duggal, Advisor (Homoeopathy), Ministry of Ayush, Dr Pinakin N Trivedi, President, Board of Ethics and Registration for Homoeopathy, NCH Dr. Janardanan Nair, President, Medical Assessment and Rating Board for Homoeopathy, NCH Dr. Tarkeshwar Jain, President, Homoeopathy Education Board, NCH, Dr Nandini Kumar Ayush distinguished chair were among the other dignitaries at the event. The event also saw participation of 8 delegates from Netherlands, Spain, Columbia, Canada and Bangladesh. During the event, 17 CCRH publications were released.

Subsequent sessions will include talks and panel discussion on topics like Empowering Homoeopathy and the Modern Perspectives, Clinicians Perspectives and Advancing practice. These sessions would witness inputs from Dr. V.K. Gupta, Chairman, SAB, CCRH, Sh. B.K Singh, Joint Secretary, Ministry of Ayush, Dr. Sangeeta A. Duggal, Advisor (Homoeopathy), Ministry of Ayush, Dr. Raj K. Manchanda, Chairperson, Homoeopathic Sectional Committee, Ayush Department, Bureau of Indian Standards (BIS) & Former DG, CCRH, Dr.Chintan Vaishnav, Mission Director, Atal Innovation Mission, NITI Ayog, Dr. LK Nanda, Chairperson, SCCR, CCRH and other renowned clinicians.

The Scientific Convention over the 2 days will also include sessions on Translational Research, Evidence Base: Research & Practice Experience, Epidemic and Public health, Homoeopathic Drug Standardisation and Basic Research, Interdisciplinary Research, Reforms and Research in Education, Global Perspectives., Challenges in Homoeopathy – Role of Homoeopathic Professional Associations, Veterinary Homoeopathy, Quality Assurance in Homoeopathic Medicinal Products and Services, etc.

This convention aims to promote evidence-based scientific treatment in clinical practice and health programs, to capacitate homoeopathic community in research-based therapeutics, to become a healthcare powerhouse meeting the population’s needs for personalized, safe, and credible healthcare, and to enrich homoeopathic medicine with quality diagnostics, therapeutics, and scientific tools for better patient outcomes.

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INI CET July 2024 at JIPMER: 146 seats available for MD, MS, MCh, MDS candidates

Puducherry- The registration of Institutes of National Importance Combined Entrance Test (INI-CET) for admission to Postgraduate (PG) courses (MD, MS, DM (6 years), MCh (6 years) and MDS) for July 2024 is soon going to end, therefore, candidates are advised to apply as soon as possible by 12.04.2024 (by 5:00 PM). These PG courses are offered at AIIMS, New Delhi as well as other AIIMS, JIPMER Puducherry, NIMHANS Bengaluru, PGIMER Chandigarh and SCTIMST Thiruvananthapuram for the July 2024 session.

INI-CET for the July 2024 session will be conducted in Computer Based Testing (CBT) mode on Sunday, May 19, 2024, across all cities in India and the result is likely to be declared on Saturday, May 25, 2024.  The last date for admission to the courses is August 31, 2024.

Meanwhile, the prospectus for Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry has been released detailing the vacant seat positions and eligibility criteria for the postgraduate (PG) courses.

ELIGIBILITY CRITERIA

1 The applicant must be an Indian National (IN) or Overseas Citizen of India (OCI) or Foreign National (FN) under the permitted categories.

2 The candidates must possess an MBBS degree from a University recognised by the National Medical Commission/Medical Council of India for admission to MD/MS/6-year MCh courses.

3 The candidates must possess a BDS degree from a University recognised by the Dental Council of India for admission to MDS courses.

4 A candidate must have completed the required period of 12 months’ compulsory rotatory internship/Practical training on or before 31st July 2024. No condonation of Compulsory Rotating Internship shall be accepted.

Minimum Qualifying Marks

i. For Unreserved (UR), Institute (INST), Economic Weaker Section (EWS) and OBC Category: 55% marks in aggregate.

ii. For candidates belonging to the SC/ST Categories: 50% marks in aggregate.

iii. For PwBD candidates, the minimum aggregate provided in (i) and (ii) for the category to which the candidate belongs shall apply.

iv. For Indian Nationals who graduated from foreign Universities, marks obtained in the Foreign Medical Graduate Examination (FMGE) conducted by the National Board of Examination (NBE) shall be considered in lieu of aggregate marks. The eligibility criteria for minimum marks shall remain as mentioned above in points (i), (ii), and (iii) as applicable.

SEAT MATRIX

There are a total of 146 vacant seat posts for all Indian Citizens, Indian candidates sponsored by the Government. (Central/State/Services) and Foreign Nationals including OCI candidates.

S.NO

SUBJECT

SEATS

1

MD Anaesthesiology

13

2

MD Anatomy

4

3

MD Biochemistry

3

4

MD Community Medicine

5

5

MD Dermatology, Venereology & Leprology

4

6

MD Emergency Medicine

7

7

MD Forensic Medicine

2

8

MD General Medicine

12

9

MD Immuno-Haematology & Blood Transfusion

3

10

MD Microbiology

4

11

MD Nuclear Medicine

2

12

MD Pathology

4

13

MD Paediatrics

11

14

MD Pharmacology

6

15

MD Physiology

5

16

MD Psychiatry

3

17

MD Pulmonary Medicine

3

18

MD Radio-diagnosis

7

19

MD Radiation Oncology

6

20

MS General Surgery

12

21

MS Obstetrics & Gynaecology

12

22

MS Ophthalmology

5

23

MS Orthopaedic Surgery

5

24

MS Oto-Rhino Laryngology (ENT)

4

25

MCh Neurosurgery

1

26

MCh Paediatric Surgery

1

27

MDS Orthodontics & Dentofacial orthopaedics

1

28

MDS Oral & Maxillofacial surgery

1

To view the prospectus, click the link below

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Health Bulletin 04/ April/ 2024

Here are the top health news for the day:

NTA reopens NEET 2024 registration window
Through a public notice, the National Testing Agency (NTA) has announced the reopening of the registration window for the National Eligibility-cum-Entrance Test for (Undergraduate) courses- NEET UG 2024.
As per the notice, the NTA, “received various representations from stakeholders with a request to re-open the registration window of NEET (UG)- 2024”.
For more information, click on the link below:
Hepatitis viruses kill 3,500 people a day: WHO

According to the World Health Organization (WHO) 2024 Global Hepatitis Report, the number of lives lost due to viral hepatitis is increasing. The disease is the second leading infectious cause of death globally — with 1.3 million deaths per year, the same as tuberculosis, a top infectious killer.

The report, released at the World Hepatitis Summit, highlights that despite better tools for diagnosis and treatment, and decreasing product prices, testing and treatment coverage rates have stalled. But, reaching the WHO elimination goal by 2030 should still be achievable, if swift actions are taken now.

Kerala PG medico suicide case: HC grants interim relief to accused doctor

Granting interim relief to the doctor accused of abetting his former fiance’s suicide, the Kerala High Court has allowed him to rejoin his post-graduate studies.

This order was passed by a single-judge bench consisting of Justice Ziyad Rahman AA after considering the ‘irreversible damage’ caused by preventing the accused doctor from attending classes, Live Law has reported.

For more information, click on the link below:


H5N1 bird flu vaccine available, no need to panic: Former AIIMS director Dr Randeep Guleria
Recently, H5N1 bird flu has been making headlines due to concerns about its potential to cause a pandemic. This virus, primarily affecting avian species, has sparked global attention amid fears of a potential outbreak that could be significantly more severe than Covid-19. Experts warn that if H5N1 were to mutate into a form capable of human-to-human transmission, it could result in a devastatingly high mortality rate, estimated at 60%.
Addressing these concerns, former AIIMS director Dr. Randeep Guleria has reassured the public that there is no need to panic. He emphasizes that while avian influenza has been present for over two decades, the virus has remained dormant for many years. Additionally, Guleria highlights the existence of a vaccine against H5N1, developed and stockpiled in anticipation of a potential outbreak. Despite the expiration of previous vaccine stockpiles, advancements in technology mean that pharmaceutical companies could swiftly produce new batches if needed. 

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Boehringer Ingelheim Biopharmaceuticals China receives nod for supply of EU, US markets

Boehringer Ingelheim Biopharmaceuticals China (BioChina), in collaboration with a customer, has successfully passed pre-approval inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). 

As a result, the customer is now approved for the supply of the biopharmaceutical to the EU and US markets from product manufactured by Boehringer Ingelheim Biopharmaceuticals China. The inspections validated compliance with ICH, GxP regulations, international manufacturing standards, and patient safety requirements at Boehringer Ingelheim’s OASIS manufacturing site in Shanghai.

“For us as a world-leading contract manufacturer of biopharmaceuticals, the official approvals for our site are a confirmation of our own aspiration to transform lives for generations,” explains Ulrike Falk, Head of Global Quality Biopharma Operations at Boehringer Ingelheim.

Boehringer Ingelheim’s contract manufacturing activities in China, began in 2013.

Through its collaboration and the provision of manufacturing services for this biopharmaceutical, Boehringer Ingelheim Biopharmaceuticals China was the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL). As a result, this customer product is the first innovative biologic commissioned under the new MAH model in China.

“With recent approvals of this biologic by renowned health authorities including EMA, MFDS, and now the FDA, BioChina continues on a transformative journey supplying our long-time partner in expanding global reach. By offering our partner top-tier quality products, BioChina is fully devoted to improving the lives of patients worldwide,” states Dr. Yuguo Zang, Head of BioChina at Boehringer Ingelheim.

Boehringer Ingelheim BioXcellence so far has supplied more than 40 commercial products through its global network.

Read also: Boehringer Ingelheim, Sosei Heptares collaborate to develop first-in-class treatments targeting all symptoms of schizophrenia

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Researchers find current evidence for puberty blockers and hormone treatment for gender transition is inadequate

The evidence on the use of puberty blockers and hormones for children and young people experiencing gender related distress is wholly inadequate, making it impossible to gauge their effectiveness or their impact on mental and physical health, find two systematic reviews of the available research, published in the Archives of Disease in Childhood.

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Xylazine has infiltrated the UK’s illicit drug market

Xylazine, a powerful animal tranquilizer linked to horrific side effects, is now widespread in the UK illicit drug market.

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