H.P. STATE
COUNCIL
DRUG AND THERAPYBULLETIN
HIMACHAL PRADESH STATE PHARMACY COUNCIL
Toll Free 18001210443
DRUG INFORMATION CENTER
LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
Contents |
Editorial
Drug Updates
Pharma News
Local News
Which kind of queries can be asked from Drug Information Center?
Issue: 14 ● Volume: 2 ● Nov 2018
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
2
DRUG AND THERAPY BULLETIN
Content
EDITORIAL
Patron
Mr. Gopal Krishan Sharma and Dr. Ran Singh
Editor-in-chief
Dr. Kamlesh Naik and Dr. M.S. Ashawat
Co-Editors
Dr. Vinay Pandit and Mr. Ankush Sharma
Advisory Board
Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma, Dr. Poonam Sandhu, Dr. Rajender Guleria,
Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr.
Lokesh Kumar, Mr. Vishal Kumar, Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda,
Dr. Parshuram
DRUG UPDATES
Lorbrena® for ALK positive NSCLC .......................................................................................................4
Sympazan™oral film for LGS ................................................................................................................4
New opiod for hospital use ..................................................................................................................4
Hyrimoz™: Third humira biosimilar .......................................................................................................5
Invokana for CV risk reduction ..............................................................................................................5
Keytruda Plus chemo for NSCLC ...........................................................................................................5
Xyrem® now for Pediatric cataplexy ......................................................................................................5
Bijuvia™ for Menopausal hot flashes .....................................................................................................6
Xofluza™ for flu treatment ...................................................................................................................6
Dupixent® now for Asthma ..................................................................................................................6
Rituxan®: New dosing for GPA/MPA .....................................................................................................6
3
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
Talzenna™ for metastatic breast cancer .................................................................................................7
Yutiq™ for Uveitis ...............................................................................................................................7
New Treatment for ADA-SCID ...............................................................................................................7
Tegsedi™: Approved ............................................................................................................................7
Nuzyra™ for CABP and ABSSS .............................................................................................................8
Seysara™ for moderate to severe acne ..................................................................................................8
Xyosted™ SubQ Testosterone ...............................................................................................................8
PHARMA NEWS
HC impleads online medicine traders in plea seeking ban on e-pharmacies ...............................................9
Ministry of Finance clarifies on procedure in respect of return of expired drugs under GST ...........................9
NPPA fixes retail price of 68 drug formulations .....................................................................................10
Antibiotics becoming ineffective for neonates .......................................................................................10
More than 90% of the world’s children breathe toxic air every day: WHO ................................................10
Banned ingredients in diet pills putting Indians at risk' ..........................................................................11
U.S. scientists create new drug to sustain oxygen-starved hearts ............................................................11
DCGI approves Brintellix in India for Major Depressive Disorder ..............................................................11
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old .........................12
FDA approves new DNA-based test to determine blood compatibility ......................................................12
FDA Removes 7 Synthetic Flavoring Substances from Food Additives List ................................................12
LOCAL NEWS
दवा उद्योगों को नालागढ़ में ही मिलेगा कच्चा माल ................................................................................13
जुबीलेंट कैदीस्टा ने वापस बुलाई १.५८ लाख बोतले ं ..................................................................................13
Content (Continued)
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
4
DRUG AND THERAPY BULLETIN
DRUG UPDATES
®Lorbrena for ALK positive NSCLC
®On November 2, 2018, the US FDA approved Lorbrena
(lorlatinib) oral tablets indicated to treat patients with
anaplastic lymphoma kinase (ALK)-positive metastatic
non-small cell lung cancer (NSCLC) whose disease has
progressed on crizotinib and at least one other ALK
inhibitor or whose disease has progressed on alectinib or
ceritinib as the first ALK inhibitor therapy for metastatic
disease. The approval of Lorbrena®, was based on a
clinical trial in which patients treated with lorlatinib had
a higher overall response rate.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2108
68s000lbl.pdf.
Sympazan™oral film for LGS
On November 2, 2018, the US FDA approved
Sympazan™ (clobazam) oral film indicated for
adjunctive treatment of seizures associated with Lennox-
Gastaut syndrome (LGS) in patients 2 years of age or
older. Sympazan™oral film offers a new formulation as
clobazam is currently only marketed as oral tablets and
oral suspension. Sympazan™, which provides for easier
administration to patients with LGS who often have
difficulty swallowing tablets and suspension, was
demonstrated to be bioequivalent to clobazam tablets
and has a comparable safety profile.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2108
33s000lbl.pdf.
New opiod for hospital use
On November 2, 2018, the US FDA approved Dsuvia™
(sufentanil citrate) sublingual tablets indicated for use in
adults in a certified medically supervised healthcare
setting (e.g., hospitals, surgical centers, and emergency
departments) for the management of acute pain severe
enough to require an opioid analgesic and for which
alternative treatments are inadequate. Dsuvia™, a 30-
mcg sublingual tablet administered by a healthcare
professional via a single-dose prefilled applicator, will be
available only through the Dsuvia™ Risk Evaluation and
Mitigation Strategy (REMS) due to the potential for life-
threatening respiratory depression from accidental
exposure.
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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2091
28s000lbl.pdf.
Hyrimoz™: Third humira biosimilar
On October 31, 2018, the US FDA approved Hyrimoz™
(adalimumab-adaz) subQ injection indicated for the
treatment of rheumatoid arthritis, juvenile idiopathic
arthritis in patients 4 years of age or older, psoriatic
arthritis, ankylosing spondylitis, adult Crohn disease,
ulcerative colitis, and plaque psoriasis. Hyrimoz™, the
®third biosimilar for Humira to gain FDA approval, was
approved based on its high degree of similarity to the
reference product and a biosimilarity study used to
confirm safety and efficacy.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/7610
71lbl.pdf.
Invokana for CV risk reduction
On October 30, 2018, the US FDA approved a new
®indication for Invokana (canagliflozin) oral tablets to
reduce the risk of major adverse cardiovascular (CV)
events (CV death, nonfatal myocardial infarction (MI)
and nonfatal stroke) in adults with type 2 diabetes
®mellitus and established CV disease. Invokana , which
is now the only approved oral diabetes therapy approved
to reduce CV risks, demonstrated a greater reduction
than placebo in the combined risk of MI, stroke, and CV
death in the CANVAS trial.
Prescribing information can be found at: http://www.
janssen labe ls .com/package- inse r t /p r oduct -
monograph/prescribing-information/INVOKANA-
pi.pdf.
Keytruda Plus chemo for NSCLC
®On October 30, 2018, the US FDA approved Keytruda
(pembrolizumab) IV injection in combination with
carboplatin and either paclitaxel or nab-paclitaxel for the
first-line treatment of patients with metastatic squamous
non-small cell lung cancer (NSCLC). Keytruda, which is
the first anti-PD-1 therapy to gain FDA approval for this
indication, was approved based on demonstrated
efficacy compared with chemotherapy alone in the
KEYNOTE-407 trial.
Pr e s c r i b i n g i n f o rma t i on can be f ound a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/
2018/125514s041lbl.pdf.
Xyrem® now for Pediatric cataplexy
On October 29, 2018, the US FDA approved an
®expanded indication for Xyrem (sodium oxybate) oral
solution to treat cataplexy or excessive daytime
sleepiness in patients 7 years of age or older with
®narcolepsy. Xyrem , which is already approved for the
same indication in adult patients, was approved in
pediatric patients 7 years of age or older based on data
from the EXPRESS clinical trial in which sodium oxybate
resulted in fewer weekly cataplexy attacks compared
with placebo.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/0211
96s030lbl.pdf.
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
6
DRUG AND THERAPY BULLETIN
Bijuvia™ for Menopausal hot flashes
On October 29, 2018, the US FDA approved Bijuvia™
(estradiol/progesterone) oral capsules for the treatment
of moderate to severe vasomotor symptoms (ie, hot
flashes or flushes) due to menopause in women with a
uterus. Bijuvcombination hormone therapy in a single
oral capsule to gia™ is the first bioidentical estradiol and
progesterone ain FDA approval. In the Replenish Trial,
Bijuvia™ demonstrated a significant reduction from
baseline in frequency and severity of hot flashes
compared with placebo.
Prescribing information can be found at: https://
www.bijuva.com/pi.pdf.
Xofluza™ for flu treatment
On October 24, 2018, the US FDA approved Xofluza™
(baloxavir marboxil) oral tablets indicated for the
treatment of acute uncomplicated influenza (flu) in
patients 12 years of age or older who have been
symptomatic for no more than 48 hours. Xofluza™ is the
first single-dose oral formulation for flu treatment to gain
FDA approval. Safety and efficacy were demonstrated in
2 clinical trials in which patients treated with baloxavir
marboxil had a shorter time to alleviation of flu
symptoms compared with those treated with placebo.
Prescribing information can be found at: https://www.
gene.com/download/pdf/xofluza_prescribing.pdf.
®Dupixent now for Asthma
On October 19, 2018, the US FDA approved a new
®indication for Dupixent (dupilumab) subQ injection as
an add-on maintenance therapy in patients 12 years of
age or older with moderate-to-severe asthma with an
eosinophilic phenotype or with oral corticosteroid-
®dependent asthma. Dupixent , which is already
approved for use in adults with moderate-to-severe
atopic dermatitis, was approved for asthma based on
data from 3 clinical trials in which dupiliumab reduced
exacerbations, improved lung function, and resulted in a
greater reduction in average daily oral corticosteroid use
compared with placebo.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/7610
55s007lbl.pdf.
®Rituxan : New dosing for GPA/MPA
On October 19, 2018, the US FDA approved an update
®to dosing for Rituxan (rituximab) IV injection to include
fo l low-up t reatment o f adu l t pat ients wi th
granulomatosis with polyangiitis (GPA) and microscopic
polyangiitis (MPA) who have achieved disease control
with induction treatment. Approval for the new dosing
comes after a study demonstrated fewer major relapses
by month 28 compared with treatment with
azathioprine. Rituxan, in combination with gluco-
corticoids, continues to be the only FDA-approved
therapy for these rare and potentially life-threatening
blood vessel disorders.
Prescribing information for rituximab can be found at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/
2018/103705s5451lbl.pdf.
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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
Talzenna™ for metastatic breast cancer
On October 16, 2018, the US FDA approved Talzenna™
(talazoparib) oral capsules for the treatment of adult
patients with deleterious or suspected deleterious
germline BRCA-mutated (gBRCAm) HER2-negative
locally advanced or metastatic breast cancer. Patients
must be selected for therapy based on an FDA-approved
companion diagnostic test for talazoparib. Talzenna™
approval was based on the EMBRACA trial in which
there was a significant improvement in progression-free
survival demonstrated with talazoparib compared with
chemotherapy. The FDA a lso approved the
BRACAnalysis CDx test to identify patients with breast
cancer with deleterious or suspected deleterious
gBRCAm who are eligible for talazoparib.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2116
51s000lbl.pdf.
Yutiq™ for Uveitis
On October 15, 2018, the US FDA approved Yutiq™
(fluocinolone acetonide) intraocular implant for the
treatment of chronic non-infectious uveitis affecting the
posterior segment of the eye. Yutiq™, which is the first
long-acting fluocinolone acetonide intravitreal implant to
gain FDA approval, is delivered consistently over 36
months using a drug delivery technology designed by the
manufacturer.
Prescribing information can be found at: https://
e y epo i n t pha rma . c om /wp - con t en t / up l o ad s /
2018/10/YUTIQ-USPI-20181013.pdf.
New Treatment for ADA-SCID
On October 5, 2018, the US FDA approved Revcovi™
(elapegademase-lvlr) intramuscular injection for the
treatment of adenosine deaminase severe combined
immune deficiency (ADA-SCID) in pediatric and adult
patients. The approval is based on 2 clinical trials that
demonstratedbolites, and improved total lymphocyte
counts increased adenosine deaminase activity,
r educed concen t r a t i ons o f t o x i c me taw i th
elapegademase-lvlr.
Prescribing information for elapegademase-lvlr can be
f ound a t h t t p s : / /www.acce s sda t a . f da . g o v /
drugsatfda_docs/label/2018/761092s000lbl.pdf.
Tegsedi™: Approved
On October 5, 2018, the US FDA approved Tegsedi™
(inotersen) subcutaneous injection for the treatment of
the polyneuropathy of hereditary transthyretin-mediated
amyloidosis in adults. Tegsedi™ is the first and only
RNA-targeted therapy that reduces the production of
transthyretin protein with a once-weekly subcutaneous
injection. Approval was based on the Phase 3 NEURO-
TTR study that demonstrated better outcomes in both
co-primary endpoints in patients treated with inotersen
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
8
DRUG AND THERAPY BULLETIN
compared with those treated with placebo. Tegsedi™,
which carries a black box warning regarding the potential
of thrombocytopenia and glomerulonephritis, is
available only through the Tegsedi™ REMS Program.
Prescribing information for inotersen can be found at
https://www.accessdata.fda.gov/drugsatfda_docs/label
/2018/211172lbl.pdf.
Nuzyra™ for CABP and ABSSS
On October 2, 2018, the US FDA approved Nuzyra™
(omadacycline) IV injection and oral tablets indicated for
the treatment of adult patients with community-acquired
bacterial pneumonia (CABP) and acute bacterial skin
and skin structure infections (ABSSSI). Nuzyra™ which
was approved based on data from multiple clinical trials
which demonstrated safety and efficacy, is specifically
designed to overcome tetracycline resistance.
Prescribing information can be found at: http://nuzyra.
com/PI.pdf.
Seysara™ for moderate to severe acne
On October 2, 2018, the US FDA approved Seysara™
(sarecycline) oral tablets indicated for the treatment of
inflammatory lesions of non-nodular moderate to severe
acne vulgaris in patients 9 years of age or older.
Seysara™, which is taken once daily, is a narrow
spectrum tetracycline antibiotic that has anti-
inflammatory properties.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2095
21s000lbl.pdf.
Xyosted™ SubQ Testosterone
On October 1, 2018, the US FDA approved Xyosted™
(testosterone enanthate) subQ injection indicated for
testosterone replacement therapy in adult males for
conditions associated with a deficiency or absence of
endogenous testosterone. Xyosted™, which is the first
subQ route testosterone enanthate product to gain FDA
approval, will be available in 50, 75, and 100 mg
strengths for once-weekly self-administration.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2098
63s000lbl.pdf.
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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
PHARMA NEWS
HC impleads online medicine
traders in plea seeking ban on e-pharmacies
The Madras High Court allowed firms involved in online
sale of medicines to be impleaded in a petition seeking a
ban on their business. Justice R Mahadevan, who has
granted an interim stay on sale of medicines online by
those not having required license, impleaded the
petit ioners, including New Delhi-based 1MG
Technologies Private Limited, as party to the petition
filed by the Tamil Nadu Chemists and Druggists
Association (TNCDA).
TNCDA has sought a ban on online sale of medicines
contending that purchasing drugs from unlicensed online
stores can be risky as they may sell fake, expired,
contaminated or unapproved drugs that are dangerous to
the health of patients. E-pharmacy was an initiative to
help the caregivers select the most appropriate health
care services at the best possible price, the counsels
said. The e-pharmacists have entered into facilitation
agreements with various third-party pharmacies across
the country and they neither stocked medicines nor were
having any shop. The orders were placed based on
prescription issued by the doctors, they said. Hence the
online firms were not obligated to procure a license under
the Drugs and Cosmetics Rules 1955, they reasoned.
Ref: www. health.economictimes.indiatimes.com
Ministry of Finance clarifies on procedure in
respect of return of expired drugs under GST
The Central Board of Indirect Taxes and Customs (CBITC)
under the Union finance ministry clarifies on procedure
in respect of return of expired drugs under Goods and
Services Tax (GST). The issues raised in the said
representations have been examined and to ensure
uniformity in the implementation of the law across the
field formations, the Board, in exercise of its powers
conferred under section 168(1) of the Central Goods and
Services Tax Act, 2017 (hereinafter referred to as the
“CGST Act”).
Generally, in the pharmaceutical sector is that the drugs
or medicines (hereinafter referred to as “goods”) are sold
by the manufacturer to the wholesaler and by the
wholesaler to the retailer based on an invoice/bill of
supply as case may be. It is significant to mention here
that such goods have a defined life term which is
normally referred to as the date of expiry. Such goods
which have crossed their date of expiry are colloquially
referred to as time expired goods and are returned to the
manufacturer, on account of expiry, through the supply
chain. The CBITC in a circular on October 26, 2018 said
that the retailer/wholesaler can either return the time
expired goods treating it as fresh supply or can return the
expired goods by issuing credit notes.
In case of return of time expired goods to be treated as
fresh supply, a registered person (other than a composition
taxpayer) can return goods by issuing an invoice for the
same. This will be referred to as return supply. The
wholesaler or manufacturer who is the recipient of such
return supply, shall be eligible to avail input tax credit (ITC)
of the tax levied on the said return supply as specified in
Section 16 of the CGST Act. In case the person returning
the time, expired goods are an unregistered person, he
may return the said goods by issuing any commercial
document without charging any tax on the same. If a
manufacturer destroys the time expired goods, returned by
the retailer/wholesaler, he/she is required to reverse the
ITC availed on the return supply as per clause (h) of sub-
section (5) of section 17 of the CGST Act.
The retailer or wholesaler can return the time expired
goods by issuing a delivery challan. There is no time limit
for the issuance of a credit note in the law except about
the adjustment of the tax liability in case of the credit
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
DRUG AND THERAPY BULLETIN
10
notes issued prior to September following the end of the
financial year and those issued after it. If a supplier
(manufacturer/wholesaler) receives expired goods till
September, he can issue credit note and the same needs
to be uploaded by him on the common portal.
Subsequently, tax liability can be adjusted by such
supplier provided the recipient (wholesaler/retailer) has
either not availed the ITC or or if availed has reversed the
ITC so availed against the goods being returned. If a
supplier (manufacturer/wholesaler) receives expired
goods after September, he can still issue credit note, but
cannot upload the same on the common portal as he is
not allowed to adjust tax liability by himself.
Ref: www.pharmatutor.org
NPPA fixes retail price of 68 drug formulations
Drug price regulator NPPA fixed prices as well as revised
ceiling and retail prices of 68 formulations, including
those used for treatment of diabetes, blood pressure and
HIV. The National Pharmaceutical Pricing Authority
(NPPA) said while the retail price of 55 scheduled
formulations has been fixed, that of 10 has been revised.
Further, the authority has also fixed ceiling prices of three
scheduled formulations. “NPPA has fixed/revised ceiling
prices/retail prices of 68 formulations under Drugs
(Prices Control) Order, 2013,” it said in a notification.
Ref: www. health.economictimes.indiatimes.com
Antibiotics becoming ineffective for neonates
First line antibiotics are becoming ineffective in
treatment of neonates (under-28-day children) suffering
from different sorts of bacterial infections, shows a study
conducted by city-based doctors. Commonly used
antibiotic cefepime was found ineffective in 36% of
patients suffering from sepsis and another most common
antibiotic amoxiclav was found resistant in 52% of sepsis
cases of neonates included in the study. State’s biggest
government-run child-specialty JK Lon hospital doctors
have come up with a study ‘Clinical and Bacteriological
Profile of Neonatal Sepsis with Emerging Resistance
Patterns’, which has also been published in International
Journal of Contemporary Paediatrics’ November-
December edition. The findings in the study have
expressed concern on neonatal sepsis with emerging
resistance patterns against commonly used antibiotics.
The doctors use first line antibiotics in combination form.
When a suspected sepsis neonate is brought to
the hospital, the doctors immediately provide him
treatment by using combination of drugs such as
cefotaxime and amikacin, cefotaxime and gentamycin,
ampicillin and amikacin and more such combination of
first line antibiotic drugs. In the combination of antibiotic
drugs, doctors use one antibiotic for killing gram positive
organism and one for killing gram negative organism.
They use combination of drug as they are yet to ascertain
what kind of organism (bacteria) is present in the blood
causing sepsis. For ascertaining the kind of bacteria
present in the blood, the doctors conduct culture test.
The report of culture test is issued after 48 hours. The
culture report also shows the sensitivity of drugs on
bacteria causing sepsis.
The study shows the antibiotic sensitivity pattern using
the culture report of 150 confirmed cases (neonates) of
sepsis. The sensitivity pattern shows a high degree of
resistance to commonly used antibiotics belonging to
cephalosporins class and aminoglycoside class such as
ampicillin, gentamycin, amikacin, cefotaxime,
ceftriaxone, cefepime and Amoxiclav.
Ref: www. health.economictimes.indiatimes.com
More than 90% of the world’s children
breathe toxic air every day: WHO
Every day around 93% of the world’s children under the
age of 15 years (1.8 billion children) breathe air that is so
polluted it puts their health and development at serious
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
11
risk. Tragically, many of them die: WHO estimates that in
2016, 600,000 children died from acute lower
respiratory infections caused by polluted air. A new WHO
report on Air pollution and child health: Prescribing clean
air examines the heavy toll of both ambient (outside) and
household air pollution on the health of the world’s
children, particularly in low- and middle-income
countries. The report is being launched on the eve of
WHO’s first ever Global Conference on Air Pollution and
Health. Air pollution also impacts neurodevelopment
and cognitive ability and can trigger asthma, and
childhood cancer. Children who have been exposed to
high levels of air pollution may be at greater risk for
chronic diseases such as cardiovascular disease later in
life. Newborns and young children are also more
susceptible to household air pollution in homes that
regularly use polluting fuels and technologies for
cooking, heating and lighting
Globally, 93% of the world’s children under 15 years of
age are exposed to ambient fine particulate matter
(PM2.5) levels above WHO air quality guidelines, which
include the 630 million of children under 5 years of age,
and 1.8 billion of children under 15 years. In low- and
middle-income countries around the world, 98% of all
children under 5 are exposed to PM2.5 levels above
WHO air quality guidelines. In comparison, in high-
income countries, 52% of children under 5 are exposed.
Ref: www.pharmatutor.org
Banned ingredients in diet pills putting
Indians at risk
Be careful while popping a pill for weight loss, muscle
building or sexual enhancement. Several dietary
supplements, most of which are widely available in
India, have been found adulterated with unapproved and
even banned pharmaceutical ingredients in the US with
potential to cause serious health risks. At least 776
dietary supplements sold over the counter in the US over
a period of 10 years from 2007 to 2016 were found
containing unapproved pharmaceutical ingredients such
as sildenafil, sibutramine and synthetic steroids —
which have potential to cause side-effects ranging from
stroke to kidney failure and even death, say researchers,
who extracted and analyzed data from the US Food and
Drug Administration's (US FDA) Center for Drug
Evaluation and Research.
Ref: www. health.economictimes.indiatimes.com
U.S. scientists create new drug to sustain
oxygen-starved hearts
U.S. scientists at University of California, San Francisco
(UCSF) have developed a new drug that can restore the
function of oxygen-starved heart tissue under the
conditions of hypoxia. The biopharmaceutical company
has been developing oxygen-delivery therapeutics for the
treatment of cancer, cardiovascular diseases, trauma
and other conditions in which low oxygen levels, or
hypoxia, negatively impact disease outcomes. The new
drug does not cause systemic side effects or overcorrect
with excessive blood oxygenation, which can itself be
toxic. It delivers its precious oxygen cargo only to the
tissues that need it most.
Ref: www. health.economictimes.indiatimes.com
DCGI approves Brintellix in India for Major
Depressive Disorder
Brintellix in India for the treatment of patients suffering
from Major Depressive Disorder(MDD) is approved by
Drug Controller General of India (DCGI). Brintellix, is a
novel multimodal antidepressant, which has been
specifically designed to inhibit serotonin reuptake and
modulate serotonergic receptor activity of the neurons in
the brain of affected patients.
Ref: www. health.economictimes.indiatimes.com
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
DRUG AND THERAPY BULLETIN
12
FDA approves expanded use of Gardasil 9 to
include individuals 27 through 45 years old
The U.S. Food and Drug Administration approved a
supplemental application for Gardasil 9 (Human
Papillomavirus (HPV) 9-valent Vaccine, Recombinant)
expanding the approved use of the vaccine to include
women and men aged 27 through 45 years. Gardasil 9
prevents certain cancers and diseases caused by the nine
HPV types covered by the vaccine. Gardasil, a vaccine
approved by the FDA in 2006 to prevent certain cancers
and diseases caused by four HPV types, is no longer
distributed in the U.S. In 2014, the FDA approved
Gardasil 9, which covers the same four HPV types as
Gardasil, as well as an additional five HPV types.
Gardasil 9 was approved for use in males and females
aged 9 through 26 years.
Ref: www.pharmatutor.org
FDA approves new DNA-based test to
determine blood compatibility
The U.S. Food and Drug Administration approved ID
CORE XT, a molecular-based assay used in blood
transfusion medicine to help determine blood
compatibility. The assay can be used to determine blood
donor and patient non-ABO red blood cell (RBC) types.
ID CORE XT is the second molecular assay approved for
use in transfusion medicine, and the first to report
genotypes as results. Human blood can be classified into
different groups based on the antigens on the surfaces of
red blood cells. In addition to the ABO blood group
antigens, the presence or absence of other specific blood
group antigens can be important when matching blood
for transfusions since some people develop antibodies to
non-ABO antigens. People who receive repeated blood
transfusions, such as individuals with sickle cell disease,
are more likely to develop these antibodies. If red blood
cells with poorly matched non-ABO antigens are
transfused, red blood cell destruction and a transfusion
reaction can occur in a transfusion recipient.
Traditionally, red blood cell antigens have been identified
using serological methods that involve the use of
antisera, a blood serum that contains antibodies for
testing. Serologic testing present limitations and certain
antisera may be scarce or unavailable.
Ref: www.pharmatutor.org
FDA Removes 7 Synthetic Flavoring
Substances from Food Additives List
The FDA is amending its food additive regulations in
response to two food additive petitions, to no longer
allow for the use of a total of 7 synthetic flavoring
substances and flavor enhancers. The FDA determined
that the data presented in one of the petitions submitted
to the FDA by Breast Cancer Fund, Center for
Environmental Health, Center for Food Safety, Center for
Science in the Public Interest, Consumers Union,
Environmental Defense Fund, Environmental Working
Group, Improving Kids’ Environment, Natural Resources
Defense Council, WE ACT for Environmental Justice, and
Mr. James Huff show that 6 of these synthetic
substances caused cancer in laboratory animals under
the conditions of the studies. The seventh synthetic
flavor is being de-listed because it is no longer used by
industry. The 6 flavoring substances include
synthetically-derived benzophenone, ethyl acrylate,
eugenol methyl ether (methyl eugenol), myrcene,
pulegone, and pyridine. These substances are being
removed from the food additive regulations under the
Delaney Clause of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (section 409(c)(3) of the FD&C Act). This
clause, enacted in 1958, requires that the FDA cannot
find as safe; i.e., cannot approve, the use of any food
additive that has been found to induce cancer in humans
or animals at any dose.
Ref: www.pharmatutor.org
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
13
LOCAL NEWS
दवा उ�योग� को नालागढ़ म� ह� �मलेगा क�चा माल |
Ref: Newspaper- Amar Ujala, 29-10-2018
जबील�ट कैद��टा ने वापस बलाई १.५८ लाख बोतल� |ु ु
Ref: Newspaper- Amar Ujala, 20-10-2018
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]
DRUG AND THERAPY BULLETIN
14
Which kind of queries can be asked from Drug
Information Center?
It is the matter of pride for all the population of Himachal
Pradesh that there is drug information center (DIC) in the
state which is giving the services to promote the rational
drug use. Maximum population of state knows that there is
DIC, but they are unaware about the services of the DIC.
They all are confused that which kind of queries they can ask.
There is no any restriction to take the drug query
information by any one. Any person (physician, pharmacist,
nurse, patient, people of community, old persons, students,
researchers etc.) can come in or call in the DIC office to take
drug information.
Following kinds of queries regarding drugs can be asked
from DIC:
Ÿ If patient is administering two medicines at the same
time then he/she before administering the medicine,
can confirm from DIC that this combination is safe or not
safe. If combination will be not safe then it may also be
life threatening.
Ÿ If patient is administering a medicine then he/she can
confirm which kinds of foods have to be avoided.
Ÿ Someone can confirm that use of any specific medicine
in particular condition (like as pregnancy/lactation) is
safe or not safe.
Ÿ General information about drug identification can also
be taken from the DIC, like as use and side/adverse
effects , t ime of administrat ion, durat ion of
administration, dose in different age groups etc. about
any drug.
Ÿ Information about substituted drugs with different
prices can also be provided by DIC.
Ÿ Any updation about medicines can be confirmed from
DIC.
DIC will provide the accurate information on request
without any fear and favor. In short, we can say that DIC can
provide any kind of information about any medicine to
anyone without any cost. Personnel can assess directly, can
call in the DIC office, sent the query by post, by E-mail
Toll Free 18001210443, Phone: 09218428042, 9459220253
Scan this Quick Response (QR)
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Personnel can assess directly, can call in the DIC office, sent the query by post, by E-mail on following address.
Note: If any want to publish his/her article in the monthly bulletin of Drug Information Center regarding Pharma updates, they can send their articles with their full address and professional status on the following reference before 25th of every month.
Toll Free 18001210443
DRUG INFORMATION CENTER
HIMACHAL PRADESH STATE PHARMACY COUNCIL
Laureate Institute of Pharmacy, Kathog, Jwala Ji, Distt. Kangra HP 177101
Website: www.hpspc.in | Mail ID: [email protected], [email protected]