Pfizer gets CDSCO Panel nod to study antimicrobial FDC Avibactam plus Aztreonam

New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 2A clinical study of the antimicrobial drug combination Avibactam 0.5 g plus Aztreonam 1.5 g Powder for Concentrate for Solution for Infusion.

This came after the firm presented phase 2A clinical study protocol no. C3601010 dated 27 September 2023.

Avibactam is a non-β-lactam β-lactamase inhibitor used in combination with ceftazidime for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital or ventilator-acquired pneumonia.

Avibactam is a non-β lactam β-lactamase inhibitor that inactivates some β-lactamases (Ambler class A β-lactamases, including Klebsiella pneumoniae carbapenemases, Ambler class C and some Ambler class D β-lactamases) by a unique covalent and reversible mechanism, and protects ceftazidime from degradation by certain β-lactamases. Avibactam rapidly reaches the periplasm of bacteria at high enough concentrations to restore activity of ceftazidime against ceftazidime-resistant, β-lactamase-producing strains. Avibactam does not decrease the activity of ceftazidime against ceftazidime­ susceptible organisms.

Aztreonam is a beta-lactam antibiotic used to treat select aztreonam-sensitive gram-negative bacteria.

The bactericidal action of aztreonam results from the inhibition of bacterial cell wall synthesis due to a high affinity of aztreonam for penicillin binding protein 3 (PBP3). By binding to PBP3, aztreonam inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that aztreonam interferes with an autolysin inhibitor.

At the recent SEC meeting for Antimicrobial and Antiviral held on September 19, 2024, the expert panel reviewed the phase 2A clinical study protocol no. C3601010 dated 27 September 2023 presented by the drug major Pfizer.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

Also Read:Torsemide, Dapagliflozin FDC not rational: CDSCO Panel Rejects Syngene’s Proposal for BA/BE study

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Homoeopathic doctor, 5 others arrested for illegally manufacturing psychotropic drug

Busting an illegal supply of drugs racket in the capital, the Delhi police recently arrested a homoeopathic doctor previously honoured with the prestigious Indian Achiever’s Award along with five others for illegally manufacturing Alprazolam, a psychotropic drug used to treat anxiety disorders.

According to the police, around 18 kg of Alprazolam powder was recovered in the possession of one of the accused Rajender Prasad Mishra who worked as a carrier in a drug cartel involved in the racket. Additionally, the police recovered the drugs worth Rs 4.20 crore from the accused.

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Health Bulletin 30/ September/ 2024

Here are the top health news for the day:

Eye hospital, Ophthalmologists slapped Rs 15 Lakh compensation for vision loss due to Surgical Negligence

Holding a private eye institute, its director and two ophthalmologists guilty of medical negligence, the District Consumer Disputes Redressal Commission-II, Visakhapatnam directed them to pay Rs 15 lakh to the patient who lost vision in one eye.

The history of the case goes back to February 2019 when the patient was chatting with his friend while another friend was playing with an air rifle. One of the pellets from the air rifle touched the complainant’s left eye and due to this, he sustained bleeding injury.

For more details, click the link below

Vision loss due to negligence in surgery: Eye Hospital, ophthalmologists slapped Rs 15 lakh Compensation

HC attaches salary of State Health Secretary as hospitals unpaid despite Ayushman Bharat funds release

While considering the pleas filed by several hospitals in Punjab seeking the release of pending dues from the State Government under the Ayushman Bharat Scheme, the Punjab and Haryana High Court till October 16, attached the salaries of senior officials, including the Principal Secretary of the Health Department of the State, for failing to release the pending dues.

“Let an affidavit be filed by the State Government of Punjab giving the details of the payments that have been made against bills since 30.12.2021 to 24.09.2024 alongwith the date on which such payment was released, within a period of two weeks from today. The salaries of Kumar Rahul, IAS, Principal Secretary, Department of Health, Ms. Babita, Chief Executive Officer, Mr. Deepak, Director and Ms. Sharanjit Kaur, Deputy Director, State Health Agency, Department of Health and Family Welfare, Punjab shall remain attached till the next date of hearing,” ordered the HC bench.

For more details, click the link below

Hospitals Not Paid Despite Release of Funds Under Ayushman Bharat: HC Attaches Salary of State Health Secretary among Others

Andhra announces NEET PG bond policy: 10 Years service, Rs 50 lakh penalty for in-service candidates

Doctors getting admitted to PG medical courses (degree and diploma) in the Competent Authority Quota seats at Andhra Pradesh-based Dr. NTR University of Health Sciences will have to compulsorily serve the State Government or pay a penalty of Rs 40 lakh and Rs 50 lakh

In the case of service candidates, they will have to serve the State Government for a minimum period of 10 years after completion of in-service PG Degree/Super Specialty course in any Government institution/health facility of the State. For them, the amount of bond penalty is Rs 50 lakh, in addition to the pay and allowances received during the years of study.

For more details, click the link below

10 years of service, Rs 50 lakh penalty for Inservice candidates: Andhra notifies bond policy for NEET PG admissions this year

Homoeopathic doctor and 5 others arrested for running drug racket,
Rs 4.2 crore worth anxiety drug seized

Busting an illegal supply of drugs racket in the capital, the Delhi police recently arrested a homoeopathic doctor previously honoured with the prestigious Indian Achiever’s Award along with five others for illegally manufacturing Alprazolam, a psychotropic drug used to treat anxiety disorders.

According to the police, around 18 kg of Alprazolam powder was recovered in the possession of one of the accused Rajender Prasad Mishra who worked as a carrier in a drug cartel involved in the racket. Additionally, the police recovered the drugs worth Rs 4.20 crore from the accused.

For more details, click the link below

Homoeopathic doctor, 5 others arrested for running psychotropic drug manufacturing racket, 4.2 crore drug seized

UP medical student allegedly dies by suicide in Car

A 28-year-old Master of Surgery
student from Moti Lal Nehru Medical College has reportedly died by suicide in
his car at a hospital affiliated with the college, according to police reports
on Sunday.

According to DCP (City) Abhishek
Bharti, doctors at SRN Hospital reported on Saturday night that a medical
professional working at the hospital had committed suicide.

The individual, a resident of Kotdwar
in Uttarakhand, is believed to have injected himself with a poisonous
substance. ACP Kotwali Manoj Kumar Singh stated that a field unit, dog squad,
and surveillance team have been dispatched to the scene, and evidence is
currently being collected.

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IRGMA Welcomes CDSCO’s New Guidelines, Urges to stop import of substandard gloves

New Delhi: Welcoming the updated guidelines detailing the functions and responsibilities of the zonal, sub-zonal, and port offices issued by the Central Drugs Standard Control Organization (CDSCO), the Indian Rubber Gloves Manufacturers Association (IRGMA) has urged the government to take stringent measures to implement the order effectively to stop the import of substandard gloves in the country.

The CDSCO issued the new Guidance Document for Functions and Responsibilities of Zonal, Sub-zonal, and Port offices on September 12. The guidelines were last released in 2011, and the recent changes include the introduction of new rules and regulations and the online system through the SUGAM portal, which necessitated the revised order in line with the procedures followed in CDSCO offices.

Guidance documents for Zonal, Sub zonal and Port offices were prepared in 2011 and implemented since then. It sets out the nature of work that Zonal, sub-zoneal, and port offices generally carry out and the guidelines about the policy that should be followed in disposing of work and duties.

Recently, there have been many changes in the procedures of Zonal, Sub-Zonal, and Port Office activities due to the introduction of new rules and regulations, online systems through the SUGAM portal, and delegation of some activity to the state Drugs Authority, etc.

Hence, it was needed to amend/revise the guidance documents in line with the recent procedures followed by the zonal, sub zonal and port offices.

In order to undertake the revision of guidance documents for zonal, sub-zoneal, and port offices, a team was constituted via order ref. no. GBT /RS /SS /NRS /2023-24 dated.26.12.2023.

The team submitted the draft document with respect to their responsibilities for the preparation of the first draft by a team comprising officials from CDSCO.

The guidance drafted and reviewed was shared with all officials (DDC (I) level) of CDSCO HO/Zones/Sub-Zone/Port offices to provide comments/suggestions/inputs if any, and the same was deliberated on 02.09.2024 virtually with all CDSCO Zonal, Sub-Zonal, and Port offices and CDSCO (HQ) officials.

Accordingly, revised and finalized guidance documents for Zonal, Sub-Zonal, and Port offices (revision: 01, 2024) are prepared to ensure uniform procedures in the execution of various regulatory processes by Zonal/Sub-Zonal and port offices of CDSCO.

Speaking on the new CDSCO guidelines, IRGMA General Secretary Man Mohan Singh Gulati said, “The new guidelines issued by CDSCO are a welcome step. However, the implementing authorities, including ADCs posted at ports, must be made aware of the document to effectively control the import of substandard bulk-packed gloves.”

The association has long been demanding the Quality Control Order (QCO) for gloves to keep substandard imports at bay and urged the government to expedite its process. This will not only help Indian manufacturers but also contribute to the union government’s Make in India initiative to achieve self-sufficiency and reduce dependence on other countries.

The IRGMA general secretary added that the new CDSCO guidance document will bring uniformity, transparency, predictability, and accountability to all offices, incorporating risk-based inspections as part of the organization’s technical functions.

The risk-based inspection guidelines outline uniform enforcement procedures for onsite inspections to evaluate compliance with quality systems and infrastructure, adhering to nationally and internationally accepted Good Manufacturing Practice (GMP) standards.

The guidelines also set timelines for processing various applications in the medical devices sector, including procedures for granting licenses to manufacture drugs for examination, testing, or analysis under the New Drugs & Clinical Trials Rules, 2019, and the issuance of No Objection Certificates (NOCs) for cargo clearance at CDSCO port offices, among other matters.

According to the guidelines, each drug inspector will collect at least ten samples each month, comprising nine samples of drugs (APIs, excipients, and formulations) and one sample of cosmetics or medical devices. Each inspector shall maintain data on sampling and submit it to their controlling authority monthly to facilitate the execution of the sampling plan. The inputs from the monthly sampling data will be used to plan the next month’s sampling strategy.

To view the updated guideline for the functions and responsibilities of the zonal, sub-zonal, and port offices of the Central Drugs Standard Control Organization (CDSCO), click the link below:

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