Archive for month: December, 2023

New Delhi: After a two-year delay, the proposal to notify women-friendly amendments in the Medical Termination of Pregnancy (MTP) Act that provides for universal access for women to comprehensive abortion care has been approved by Lieutenant Governor V K Saxena.

LG V K Saxena has directed the health department to investigate the lapses that led to delays in the processing of the matter.

Delhi will soon notify women-friendly amendments to the Medical Termination of Pregnancy Act, with Lieutenant Governor V K Saxena approving the city government’s proposal in this regard, Raj Niwas officials said on Thursday.  

However, Saxena expressed “grave displeasure” and “surprise” that the matter was presented for approval after a lapse of more than two years, they added.

The communication for notifying the Act was mailed by the Centre to the Delhi government in December 2021, he added.

Saxena directed the health department to ascertain the lapses leading to the “inordinate delay” in processing the matter and asked to assign the responsibility and exercise caution in the future, the official said.

The Act was amended by the Centre in 2021, after which the opinion of only one RMP is required up to 20 weeks of gestation and of two RMPs to terminate pregnancy of 20-24 weeks of gestation under special circumstances. The amended Act provided for the constitution of a medical board for granting permission to terminate pregnancy beyond 24 weeks under circumstances to be decided by it.

The Ministry of Health and Family Welfare conveyed in 2021 that the forms for the documentation of medical termination of pregnancy (which were earlier issued in terms of the MTP Act, 1971) were updated in consonance with the Medical Termination of Pregnancy (Amendment) Act and Rules, 2021.

The ministry had directed the states and Union territories to notify Forms 1, 2 and 3 in the official gazette under the MTP Regulations, the official explained.

The amendments carried out in Form 1 (RMP Opinion Form) require the name, qualifications and address of only one RMP and the words “married woman” have been replaced with “woman” and the word “husband” has been replaced with “partner”.

In Form 2, which stipulates the regulations, three additional sub-heads regarding the duration of pregnancy have been added, and the reasons for termination of pregnancy have been divided into A, B and C categories, depending on the number of weeks of gestation.

Form 3 concerns the admission register in which a phrase has been added for pregnancy beyond 24 weeks and which says that the names of the medical board members have to be mentioned.

The LG was informed that the Department of Health and Family Welfare’s proposal regarding the notification of the statutory forms has been endorsed by the health minister and approved by the chief minister.

This came after the firm presented the proposal for extrapolation of indications in line with the innovator-approved indications for Adalimumab 100mg/mL approved in India for the indication of Rheumatoid Arthritis (RA) in adult patients.

The committee noted that the firm has recently launched the drug product in the market and has not yet submitted the first PSUR.

Adalimumab injection products are in a class of medications called tumor necrosis factor (TNF) inhibitors. They work by blocking the action of TNF, a substance in the body that causes inflammation.

Adalimumab is a type of drug known as a biological therapy. In rheumatoid arthritis and some other conditions, too much of a protein called TNF is produced in the body. This causes inflammation, pain, and damage to your joints.

Adalimumab is the first fully human recombinant immunoglobulin G1 monoclonal antibody that binds and neutralizes soluble and membrane-bound tumor necrosis factor (TNF) so that it cannot interact with p55 and p75 cell-surface TNF receptors.

At the recent SEC meeting for analgesic and rheumatology held on 8th and 9th November 2023, the expert panel reviewed the proposal for extrapolation of indications in line with the innovator-approved indications for Adalimumab 100mg/mL approved in India for the indication of Rheumatoid Arthritis (RA) in adult patients presented by drug major Shilpa.

After detailed deliberation, the committee recommended that the firm should submit PSUR data for the first six months for consideration of approval for the additional indications.

Also Read:Ajanta Pharma Gets CDSCO Panel Nod To Study Antihypertensive FDC

We come to the end of 2023. Here are top ten pharmacological
agents that received US-FDA approval throughout this year, across key therapy
areas:

1) Zilucoplan

Zilucoplan
is a complement inhibitor indicated for the treatment of generalized myasthenia
gravis in adult patients who are anti-acetylcholine receptor antibody
positive.

It
is available in the form of single-dose pre-filled syringe injections in dosage
strengths, 16.6 mg, 23 mg & 32.4 mg.
It is available under the brand name ZILBRYSQ, It is a product of the
UCB group of companies, Georgia, USA

2) Etrasimod

Etrasimod
is a sphingosine 1-phosphate receptor modulator indicated for the treatment of
moderately to severely active ulcerative colitis in adults. It is available in
the form of 2 mg tablets. It is available under the brand name, VELSIPITY. It
is a product of Pfizer Labs, a division of Pfizer, NYC, USA

3) Gepirone

Gepirone,
a plausible serotonergic modulator is indicated for the treatment of major
depressive disorders in adults. It is available in the form of extended-release
tablets of 18.2 mg, 36.3 mg, 54.5 mg, and 72.6 mg respectively. It is available
under the brand name EXXUA. It is a product of Fabre Kramer, headquartered in
Houston, Texas, USA

4) Motixafortide

Motixafortide
is a hematopoietic stem cell mobilizer, is indicated in combination with
filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood
for collection and subsequent autologous transplantation in patients with
multiple myeloma. It is available in injection form, 62 mg as a lypophilised
powder in a single-dose vial for reconstititution. It is available under the
brand name APHEXDA. It is a product of Bioline Rx, Waltham,
Massachusetts, USA.

5) Ritlecitinib

Ritlecitinib
is a kinase inhibitor indicated for the treatment of severe alopecia areata in
adults and adolescents 12 years and older. It is available in 50 mg capsules,
with once-daily dosing among eligible patients. It is available under the brand
name LITFULO. It is a product of Pfizer Inc., NYC, USA.

6) Sotagliflozin

Sotagliflozin
is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the
risk of cardiovascular death, hospitalization for heart failure, and urgent
heart failure visits in adults with heart failure, or type 2 diabetes mellitus,
chronic kidney disease, and other cardiovascular risk factors. It is available
in the form of tablets of 200 mg and 400 mg.
It is available under the brand name INPEFA. It is a product of Lexicon,
based in Texas, USA

7) Sulbactam/Durlobactam
Injection

Sulbactam/Durlobactam is a
co-packaged product containing sulbactam, a beta-lactam antibacterial and beta-lactamase
inhibitor, and durlobactam, a beta-lactamase inhibitor, indicated in patients
18 years of age and older for the treatment of hospital-acquired bacterial
pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused Acinetobacter
baumannii-calcoaceticus complex.

It is an injection available as a co-packaged
kit containing the following two components as sterile powders for
reconstitution.

•
1 clear single-dose vial of sulbactam for injection 1 g and

•
2 amber single-dose vials of durlobactam for injection 0.5 g.

It is available under the brand name
XACDURO. It is a product of Entasis Therapeutics Inc, Waltham, Massachusetts,
USA.

8) Perflurohexyloctane

Perfluorohexyloctane ophthalmic
solution is a semifluorinated alkane indicated for the treatment of the signs
and symptoms of dry eye disease.

It
is available as a topical solution for ophthalmic use containing 100%
Perfluorohexyloctane. It is available under the brand name, MIEBO. It is the
product of Bausch & Lomb Inc., New Jersey, USA

9) Zavegepant

Zavegepant
is a Calcitonin gene-related peptide receptor antagonist indicated for the
acute treatment of migraine with or without aura in adults. It is available in
the form of 10 mg nasal spray formulation. It is available under the brand name
Zaxzpret. It is a product of Pfrizer, Inc., NYC, USA.

10) Bexagliflozin

Bexagliflozin is a sodium-glucose
co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus. It is
available in the form of 20 mg tablets. It is available under the brand name,
BRENZAVVY. It is a product of Theracos Bio, LLC, Marlborough,
Massachusetts, United States.