Modify Phase IV CT protocol: CDSCO Panel Tells Alkem on Amoxicillin, Clavulanate Oral Suspension

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Alkem Pharmaceutical to modify the Phase IV clinical trial protocol of the fixed-dose combination (FDC) drug Amoxicillin plus Clavulanate Potassium oral suspension in accordance with the Inclusion criteria, dose of the Potassium Clavulanate, sites of study.

This came after the firm presented the Phase IV clinical trial protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 10.09.2021.

In line with the inclusion criteria, the expert panel suggested that inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.

Furthermore, the committee stated that participants should be enrolled in thousands, and North Indian sites should be included to represent pan-Indian representation.

In addition, the committee noted that the dose of Potassium Clavulanate should be corrected.

Amoxicillin/clavulanic acid is a combination of penicillin-type antibiotics used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.
Amoxicillin belongs to the group of medicines known as penicillin antibiotics. Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin-binding proteins. Penicillin-binding proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin-binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.
It is used to treat bacterial infections, such as chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It’s often prescribed for children, to treat ear infections and chest infections.
Clavulanate potassium (the potassium salt of clavulanic acid) is a β-lactamase inhibitor that is added to amoxicillin to prevent inactivation by bacterial enzymes. β-Lactamase inhibitors (clavulanate, sulbactam, tazobactam) irreversibly bind to β-lactamase.
At the recent SEC meeting for Antimicrobial and Antiviral held on 29th November 2023, the expert panel reviewed the Phase IV clinical trial protocol of FDC Amoxicillin plus Clavulanate Potassium Oral Suspension.
After detailed deliberation, the committee recommended the following modification in the Phase IV clinical trial Protocol:
1. As it is presented as a phase IV clinical study, participants should be enrolled in thousands.
2. Inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.
3. Dose of the Potassium Clavulanate should be corrected.
4. North Indian sites should be included to represent pan-Indian representation.

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Submit Justification and Rational: CDSCO Panel tells Pfizer on protocol amendment proposal for Palbociclib

New Delhi: In response to the proposal presented by the drug major Pfizer for the protocol amendment, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit the justification and rationale for the proposed amendment of the anti-cancer drug Palbociclib.

This came after the firm presented Protocol Amendment 7.0 dated 31 May 2023, Protocol no. A5481092.
Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.
Palbociclib is an oral medicine that is used to treat specific types of breast cancer in adults. It is used in combination with other cancer treatments, either aromatase inhibitor or fulvestrant depending on clinical factors.
At the recent SEC meeting for Oncology and Hematology held on the 29th and 30th of November 2023, the expert panel reviewed the proposal presented by the drug major Pfizer for the protocol Amendment of the anti-cancer drug (Palbociclib).
After detailed deliberation, the committee recommended that the justification and rationale for the proposed amendment need to be submitted for further review by the committee.

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Sanofi India names Himanshu Bakshi as General Manager for Consumer Healthcare Business

Sanofi India Limited (SIL) has announced the appointment of Himanshu Bakshi as General Manager for its Consumer Healthcare (CHC) business, effective 15th January 2024.

SIL earlier this year had announced that the Company’s Consumer Healthcare business will be demerged into its wholly owned subsidiary, Sanofi Consumer Healthcare India Limited (SCHIL), subject to necessary approvals and sanction by the National Company Law Tribunal, Mumbai.

For more details, check out the link given below:

Sanofi India Ropes In Himanshu Bakshi As General Manager For Consumer Healthcare Business

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Breaking News: Home Minister Amit Shah Promises to Decriminalize Medical Negligence

New Delhi: In an unprecedented move, Union Home Minister Amit Shah has promised in the Parliament to decriminalise medical negligence by doctors, drawing a big cheer from the entire medical fraternity.

Addressing the Lok Sabha, the Home Minister stated, “Currently, if there is a death due to negligence of a doctor, it is also treated as criminal negligence, almost akin to murder. Hence, I will bring an official amendment now to free the doctors from this criminal negligence.”

“Indian Medical Association had asked us to look into the matter. And hence we have decided to free the doctors from the culpability of criminal negligence,” the Minister said while addressing the Lok Sabha.

Criminal Negligence is a very bothersome and painful point for the medical fraternity. Currently, criminal negligence is dealt under IPC 304 A, which is causing death due to negligence.

As per IPC 304 A, whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.

However, the problem for doctors in reality does not end there, as many of the doctors are tried in the IPC 304 rather than IPC 304 A. While 304 A deals with charges of causing death due to negligence, IPC 304 deals with charges of Culpable homicide not amounting to murder.

Accused, who are charged under IPC 304 are punished with life imprisonment or imprisonment for up to ten years, and they may also be fined, depending on whether the act was done with the intention of causing death or with the knowledge that is is likely to cause death.

There has been a long-standing demand from the medical fraternity, that death due to to negligence of doctors should not be treated as criminal negligence.

Medical Dialogues in 2022 reported the story and the unfortunate death of Dr. Archana Sharma, a gynecologist, who had committed suicide after being booked for alleged medical negligence. 

Also Read: Booked for murder after patient death, distressed Gynecologist Commits Suicide in Rajasthan

Her patient had died due to postpartum hemorrhage (PPH) post-delivery. However, the family of the patient created a ruckus at the hospital and lodged an FIR against the late gynecologist and her husband. Holding negligence against both of the doctors, the family of the patient demanded that the two should be booked under IPC section 302 (which prescribes the punishment to murder).

Based on the allegations of the family, the police registered an FIR under IPC section 302 (Murder). Unable to face the harassment, the doctor took the extreme step of ending her life.

Amidst this, Union Home Minister’s announcement to decriminalise medical negligence by doctors has been welcomed by the medical fraternity. The announcement by the Home Minister comes after the Indian Medical Association (IMA) wrote to him raising the issue.

In a letter dated 22.11.2023, IMA requested the Government of India and the Union Home Ministry to exempt professional medical practice from criminal prosecution and to consider medical negligence only under the Law of TORTS. “The prime component of a crime mens rea is absent between a doctor and the patient during any treatment. We trust that the above appeal of the medical profession of India is under your active consideration. We had also submitted to define medical accident in the new Bharatiya Nyaya Sanhita 2023,” the association had mentioned in the letter.

“However, we understand that the new Law has not taken cognition of the representation of the medical profession. Moreover, as the Bill stands today doctors will not only be prosecuted but will be sentenced up to 7 years instead of the current 2 years. We humbly put up to you that the medical profession is greatly disturbed on this count. If the Government is considering our appeal, we expect a good gesture of atleast not raising the punishable years,” the association had further mentioned.

In the letter, IMA had urged the Minister to treat doctors differently and the association had also placed reliance on the Supreme Court order in the case of Jacob Mathew Vs State of Punjab 2005, to highlight that the Apex Court “had reiterated that such a consideration for doctors and the medical profession is entirely justified.”

Also Read: Mens rea as intent not necessary in Medical negligence cases, Following Established procedure is: Supreme Court

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State hospitals to face complete shutdown of Health services from December 29, says Haryana doctor’s body

The Haryana Civil Medical Service (HCMS) association has issued a stark ultimatum, warning of a potential disruption in medical services if the state authorities fail to promptly address their concerns. Scheduled for December 27, doctors in the state are prepared to suspend Outpatient Department (OPD) services, with a complete shutdown of all services looming from December 29 onwards if their demands remain unmet.

In a display of discontent on Tuesday, doctors statewide donned black badges and submitted a memorandum outlining their grievances to MLAs, ministers, and deputy commissioners.

For more news & updates, check out the link given below:

https://medicaldialogues.in/

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NMC warns medical colleges to ensure 75 percent faculty attendance or lose recognition

Few days after issuing show-cause notices to over 350 medical colleges after finding a deficiency in attendance and failure to meet required faculty requirements (Minimum Standard Requirements 2020), the National Medical Commission (NMC) has now issued a warning for the institutions directing them to strictly follow UG-MSR 2023 and MSMER 2023 otherwise their applications will not be considered and they will lose on approvals/recognition.

For more details, check out the link given below:

Ensure 75 Percent Faculty Attendance Or Lose Recognition: NMC Warns Medical Colleges

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FDA approves birch triterpenes gel as topical medication for epidermolysis bullosa

The US Food and Drug Administration (FDA) has approved the new birch triterpenes topical gel (Filsuvez) for treating 2 variants of epidermolysis bullosa (EB).Birch triterpenes topical gel is designed for partial thickness wounds in seen in individuals aged 6 months and older with a diagnosis of Junctional Epidermolysis Bullosa (JEB) and with Dystrophic Epidermolysis Bullosa (DEB).

FILSUVEZ is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy. FILSUVEZ joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year.

EB is a debilitating inherited skin disease that causes a person’s skin to be so fragile it can be injured just from touch. This rare, chronic, and distressing disorder affects infants, children and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility. Living with EB entails daily challenges to navigate, including slow-healing wounds at risk of infection and painful dressing changes.

FILSUVEZ is administered at home, allowing for integration into existing treatment routines. FILSUVEZ is applied topically to the wound at each dressing change.

“At Chiesi Global Rare Diseases we are driven by a need to alleviate the burdens faced in the rare disease community by providing innovative therapies and solutions that address debilitating unmet needs.” Giacomo Chiesi, Head of Chiesi Global Rare Diseases, said. “We are grateful for the support of those living with EB and their dedicated caregivers which allowed us to reach this landmark FDA approval and proudly provide FILSUVEZ as a solution for wound care management.”

Brett Kopelan, Executive Director, debra of America, added, “The FDA’s decision to approve FILSUVEZ provides those living with EB a safe and effective treatment option for the most prominent and difficult symptom of EB, open wounds that may not heal.” Kopelan also commented that, “today marks an important milestone for those living with junctional EB, as FILSUVEZ is the first FDA approved treatment for this variant of the disease. I want to thank Chiesi for their years of close collaboration with debra of America and their dedication and commitment to bringing a treatment option forward for those with dystrophic and junctional EB. I also want to thank the patients who participated in the clinical trials to bring this therapeutic option to fruition.”

FILSUVEZ was previously approved in June 2022 by the European Commission for the treatment of skin wounds in adults and children, ages 6 months and older with both JEB and DEB.

About FILSUVEZ topical gel

FILSUVEZ® (birch triterpenes) topical gel, is a medicine that is used in adults and children aged 6 months or older with epidermolysis bullosa (EB). FILSUVEZ contains a dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid. FILSUVEZ is available as a gel that should be applied to the wound surface at a thickness of approximately 1 mm and covered by a wound dressing. The medicine can also be applied directly to the wound dressing.

About EASE Trial

The EASE trial (NCT03068780) is the largest ever global Phase 3 trial conducted in patients with EB, performed across 58 sites in 28 countries. It comprises a 3-month double-blind randomized controlled phase followed by a 24-month open-label, single-arm phase. Patients with EB target wounds of between 10 and 50cm2 in size that were present for > 21 days and < 9 months were randomized in the double-blind phase to study treatment in a 1:1 ratio and wound dressings applied according to the standard of care. 223 patients were enrolled in the trial including 156 pediatric patients. Of those who completed the double-blind phase, 100% entered the open-label safety follow-up phase. The primary endpoint of the trial was to compare the efficacy of FILSUVEZ topical gel versus control gel according to the proportion of patients with complete closure of the target wound within 45 days of treatment. The primary endpoint was achieved with statistical significance (p-value = 0.013). While the key secondary endpoints did not achieve statistical significance, a number of favorable differences were observed.

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Telangana Doctor’s Association calls off strike over pending stipends after assurance from Health Minister

Hyderabad: The Telangana Junior Doctors Association (TJUDA), who had planned to go on strike demanding their stipends, has called off their proposed strike after receiving assurance from Health Minister Damodar Raja Narasimha. The minister has promised that the stipends for junior and senior resident doctors will be paid on time by the 15th of each month.

The Telangana Junior Doctors Association, along with the Telangana Senior Resident Doctors Association (T-SRDA), had initially planned to hold a strike on Tuesday. The purpose of this strike was to express their dissatisfaction with the state government’s lack of concern regarding their stipend and the delay in receiving it. As part of the strike, the doctors intended to refuse to perform elective OP duties at government hospitals in the state.

However, the recent progress occurred as a result of a two-hour meeting convened on Monday, December 18 between the Minister, the Director of Medical Education (DME), JUDA, and SRDA. During the meeting, several discussions were conducted to address the doctor’s concerns.

Also read- Rajasthan Doctors Call Off Strike On RTH Bill After Govt Agreement

The association’s demands included the regular distribution of stipends, which meant that stipends had to be paid out on or before a specific date every month. In addition, they also demanded the appointment of an in-charge in the finance department who would get the medical bills cleared within 24 hours of the cheque release. 

In response to their requirements, the minister assured that stipends will be paid on time by the 15th of each month. Moreover, he also pledged the release of new software for smooth stipend processing within 20 days.

“Our primary demand was regular disbursal of stipends. We were assured that a green channel would be created to regularise stipends and stipends would be credited by the 15th of every month. The DME informed us that software will also be released within 20 days to make the process easier,” the president of T-JUDA, Dr Kaushik Kumar Pinjarala told Edexlive.

Apart from this, the minister assured DNB students of immediate eight-month stipend deposits and promised to resolve stipend delays for private college medical students. 

Speaking to Newsmeter, Dr Kaushik said “Regarding non-payment of stipends to PGs and Interns by private medical colleges in violation of National Medical Commission (NMC) guidelines and discrimination in stipend payment against Foreign Medical Graduate (FMG) interns, the health minister said that they will get back to us after discussion with the authorities concerned. About stipends of Diplomate National Board (DNB postgraduates), the minister spoke to the respective authorities and assured them that their eight months’ stipends would be deposited at the earliest.”

Previously, the association alleged that they had informed the government on several occasions about their pending demands that remained pending. In a letter to the DME, the association informed about their distressing situation due to the delay of stipends for second and third-year junior residents as well as house surgeons since September. 

“This delay in stipends is causing financial distress among the junior doctors. JUDA has already given multiple representations in the DME office, to the Health Secretary, to the Finance Secretary and even Health Minister. Still, the stipends have not been cleared,” reads the letter. 

Furthermore, the organization highlights that in the past, their stipends were only distributed after JUDA consistently advocated for and applied pressure on the appropriate authorities every month.

In another letter to the Health Minister on December 19, the association informed about the poor state of infrastructure at the Osmania General Hospital. They appealed for a new Osmania Hospital building to serve the citizens with better healthcare services. 

“We also informed the minister about the requirement of hostel rooms and facilities as with increased PG seats, more PG medicos are joining. He noted down the list of hospitals and colleges and the area available for the construction of new hostels. Where there is space, new hostels will be constructed and where there is a lack of space, hostels will be allotted in other nearby areas. The minister has also assured that work for a new building for Osmania General Hospital (OGH) will commence very soon,” said the T-JUDA president.

The association had expressed another significant worry about the mounting pressure on doctors caused by extended work hours and demanding schedules. In response to this concern, the authorities provided reassurance that a committee would be established to develop essential guidelines for the working hours of interns and postgraduate doctors.

Medical Dialogues had reported that the JUDA previously called off their strike in April this year after protesting by wearing black badges, highlighting the poor working facilities given by the government. They wore black badges demanding that PG students attending DRP be given sufficient accommodations, security, and food amenities. Their demands also included raising stipends by 15 per cent, providing a written guarantee that stipends would be credited by the 10th of each month, and clearing pending stipends for February and March. In response to this, the DME assured that their demands would be addressed. 

Also read- Telangana Junior Doctors Call Off Strike Over Pending Stipends After Assurance

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JB Pharma enters Opthalmology space, signs Rs 1,089 crore deal with Novartis for 10 brands

New Delhi: JB Chemicals & Pharmaceuticals Ltd (JB Pharma) has announced that the Company has inked a trade mark licence agreement along with promotion and distribution pact with Novartis for select ophthalmology brands entailing a total sum of Rs 1,089 crore.

The acquired brands include Simbrinza, Travatan, Travacom, Azopt, Azarga, Vigamox, Nevanac, Ilevro, Vigadexa, Pataday.

The board of directors at its meeting held on December 19, 2023 approved the execution of a trade mark licence agreement with Novartis Innovative Therapies AG, which is perpetual in nature for the Indian market, for a portfolio of select ophthalmology brands which will be effective in January 2027, JB Pharma said in a regulatory filing.

The board also approved the promotion and distribution agreement with Novartis Healthcare Pvt Ltd for the same portfolio of select ophthalmology brands for the Indian market for a period of three years starting December 2023, it added..
On the financial details of the agreements, JB Pharma said it will pay USD 116 million (Rs 964 crore), excluding applicable taxes, stamp duty and working capital, for the trade marks licence agreement to Novartis Innovative Therapies AG, Switzerland.
Another Rs 125 crore, excluding applicable taxes, stamp duty and working capital, will be paid to Novartis Healthcare Pvt Ltd, India under the promotion and distribution agreement.
“JB Pharma shall offer employment to the impacted associates working on these ophthalmology brands,” the filing said.
On the reasons for the acquisition, the company said, “Ophthalmology is one of the fastest growing therapies in the Indian pharma market and this deal will catapult JB Pharma to among the leading players in the ophthalmology segment.”
Overall, JB Pharma said the ophthalmology market is a structurally attractive market and major players have registered over 10 per cent value growth with structural tailwinds such as higher cataract surgeries driven by increased infrastructure and rising affordability, growth of 50-plus population and significant under-penetration.
“The brands enjoy strong recall with doctors with perception of better quality as compared to competition,” it said.
Citing IQVIA, MAT September, 2023 data, sales for this ophthalmology portfolio was at Rs 207.8 crore, the company said.

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Russia-Ukraine Conflict: Minister of External Affairs Informs LokSabha on NMC Initiatives Helping FMGs

New Delhi: During the conflict between Ukraine and Russia, around 18,282 Indian nationals, predominantly medical students were repatriated by the Government of India under “Operation Ganga” in the wake of the Ukraine Conflict, the Minister of External Affairs Dr. Subrahmanyam Jaishankar informed the Lok Sabha.

He further highlighted the fact that considering the challenges faced by the Indian students repatriated from Ukraine in continuing their medical studies, the National Medical Commission (NMC) offered several reliefs to such students such as allowing the final year students to appear in the Foreign Medical Graduate Examination (FMGE), issuing no-objection to the Academic Mobility Program offered by Ukraine etc.

The provisions of the NMC scheme, as mentioned by Dr. Jaishankar are as follows:

(i) Indian students who were in the last year of their undergraduate medicine course and have subsequently completed their studies and granted certificate of completion of course/degree on or before 30 June 2022, are permitted to appear in Foreign Medical Graduate (FMG) Examination.

(ii) After qualifying the FMG examination, such foreign medical graduates are required to undergo Compulsory Rotating Medical Internship (CRMI) for a period of two years enabling them for registration.

(iii) The NMC has conveyed No-objection to the Academic Mobility Program offered by Ukraine i.e. temporary relocation (for the period of conflict) to other universities in different countries (except India). Under this relaxation, the FMGs returning from Ukraine are allowed to avail one time opportunity to complete their remaining medical course. The Degree may, however, be awarded by the University where they shall migrate. On 22 November 2023, NMC extended the relaxation granted in such cases by 3 months.

Also Read:NMC Releases FAQs related to issues faced by Foreign Medical Graduates, Check Details

The Minister provided the information while responding to the queries raised by Shri N. K. Premachandran related to the Indian students studying abroad. He questioned the Minister if the Government has established an effective system for monitoring the issues of the Indian students studying abroad, whether the Government ensures that the concerned agencies who arrange admission of Indian Students abroad fulfill all the measures given to students/parents.

Further, he asked the Minister whether the Government has received any complaints regarding the frauds committed by various agencies with respect to the study of Indian students abroad and whether the Government has attended to issues faced by the Indian students due to Ukraine conflict. He also sought to know the details of action taken to protect the Indian students who have been studying in Ukraine and the action taken to resolve the mental issues due to the harassment of the Indian students abroad.

Responding to the queries, the Minister mentioned in a written statement, “The welfare of Indian students abroad is one of the foremost priorities for the Government of India. Indian Missions/ Posts abroad arrange welcome ceremonies for students enrolled for studying in foreign universities, encouraging them to register with the Missions/ Posts. Wherever Indian students are enrolled in Universities abroad, the Missions keep in regular touch with them. Heads of Mission/Post and senior officials visit Universities and educational institutions for regular interactions with Indian students and student associations.”

“Indian Missions/ Posts abroad respond to any issues faced by Indian students on priority basis. Grievances are responded through various channels like calls, walk-ins, e-mails, social media, 24×7 Helplines, Open Houses, and MADAD portal. Any complaints received from the students abroad are taken up with the concerned universities/ educational institutions and the host government as the case may be, for requisite action. Our Missions and Posts remain vigilant and closely monitor the well being of students. In case there is any untoward incident, it is immediately taken up with the concerned authorities of the host country to ensure that the incident is properly investigated and the perpetrators are punished. During emergency or crisis situations, our Missions/Posts abroad proactively help distressed /stranded Indian students in terms of providing food, shelter, medicine and return passage to India. Most recently, Indian students were repatriated under various operations such as Vande Bharat Mission, Operation Ganga and Operation Ajay from countries around the world,” he further added.

Referring to the Government’s measures to warn the Indian students against taking admission to fraudulent Universities, the Minister mentioned, “Seeking higher education overseas is mostly an individual decision made by Indian students, who often use services of private education consultancies. The Government is aware of some instances of fraudulent admissions in foreign universities through unscrupulous agencies, which are dealt with by the Ministry on case-to-case basis. Such cases are referred to the State Governments for strict legal action against such education agents. Missions/ Posts abroad issue regular advisories to warn students about fake Universities. Some Missions/Posts share the link of the list of genuine Universities on their website so that students may apply to these Universities only. Social media platforms are also utilized to sensitize the Indian students about the fake Universities.”

He also addressed the Indian students, who were studying in Ukraine during the war and informed that around 18,282 Indian nationals, predominantly medical students were repatriated by the Government of India under the “Operation Ganga” in the wake of the Ukraine Conflict.

To view the written statement, click on the link below:

https://medicaldialogues.in/pdf_upload/lok-sabha-ukraine-228028.pdf

Also Read: All FMGs who Returned Till 31.03.2022 can Avail Academic Mobility Programme till March 7, 2024: NMC

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