DRUG AND THERAPY BULLETIN - hpspc.in 2019.pdf · 2019-02-21 · Ref: Andhra Pradesh Pollution Control Board (APPCB) is set to implement the barcode labelling system for biomedical

DRUG AND THERAPYBULLETIN

HIMACHALPRADESHSTATEPHARMACYCOUNCIL

DRUGINFORMATIONCENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Toll Free: 18001210443

Issue 17|Volume 3|February 2019

ContentsDrug Updates

Pharma News

Public Notices

Local News

Awards and Recognition

1

DRUG AND THERAPY BULLETIN

Content

EDITORIAL

AdvisoryBoard

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

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

Drug Updates

Jeuveau for Glabella lines ..............................................................................................................................................................3

stAlimta with keytruda: 1 line for NSCLC ................................................................................................................................3

Tosymra Nasal Spray for Acute Migrains ...............................................................................................................................3

Ontruzant: Third biosimilar to Herceptin ....................................................................................................................................................3

Adacel for Repeat Tdap Vaccination ........................................................................................................................................3

Cabometyx now for advanced HCC ..........................................................................................................................................4

Vaxelis: New Hexavalent Vaccine ..............................................................................................................................................4

Pharma News

Nagpur: Forum slaps Rs1.15L penalty on medical store for selling wrong medicine ..........................................4

Scientists Develop Arti�icial Pancreas Smartphone App For Diabetics ...................................................................4

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101


2

Content (Continued)

NPPA �ixes retail price of 29 formulations under DPCO-2013 ......................................................................................5

Barcode labelling system to be implemented by March .................................................................................................5

50 cancer, rare disease drugs to get cheaper .......................................................................................................................5

FDA approves �irst generic version of Sabril to help treat seizures in adults and pediatric patients with

epilepsy ................................................................................................................................................................................................6

FDA unprecedented new efforts to support development of over-the-counter naloxone to help reduce

opioid overdose deaths .................................................................................................................................................................6

Nearly 5000 people lost lives in 'clinical trials' since 2005 ...........................................................................................6

PublicNotices

Amendment to the drugs and cosmetics rules, 1945.....................................................................................................15

LocalNews

Swine Flu ..........................................................................................................................................................................................18

Causes ................................................................................................................................................................................................18




New 3D-printed device may cut chemotherapy's side effects .....................................................................................6

First government-run human milk bank in Bengaluru ...................................................................................................7

List of drugs, declared as not of standard quality for the month of December 2018.........................................8

Poor sleep may increase Alzheimer's risk: Study.............................................................................................................14

People prone to swine �lu ..........................................................................................................................................................19

Diagnosis ............................................................................................................................................................................................19

Risk Factors .....................................................................................................................................................................................20

Prevention ........................................................................................................................................................................................20

Ms. Abhilasha Bharti .............................................................................................................................................................. 21

AwardsandRecognition

3

Drug Updates

JeuveauforGlabellalines

P re s c r i b i n g i n f o rma t i o n c an b e f o und a t :

https://info.evolus.com/hubfs/Jeuveau_USPI.pdf

On February 1, 2019, the US FDA approved

Jeuveau(TM) (prabotulinumtoxinA-xvfs) IM

i n j e c t i o n i n d i c a t e d f o r t h e t e m p o r a r y

improvement in the appearance of moderate to

severe glabellar lines associated with corrugator

and/or procerus muscle activity in adult patients.

Jeuveau, the �irst neurotoxin for aesthetic use only,

carries a boxed warning regarding the spread of

botulinum toxin effect.

stAlimtawithkeytruda:1 lineforNSCLC

On January 31, 2019, the US FDA approved a new

indication for Alimta(R) (pemetrexed) IV injection

i n c o m b i n a t i o n w i t h K e y t r u d a ( R )

(pembrolizumab) and platinum chemotherapy for

the �irst-line treatment of patients with metastatic

non-squamous non-small cell lung cancer

(NSCLC) with no EGFR or ALK genomic tumor

aberrations. Alimta demonstrated ef�icacy in the

KEYNOTE-189 clinical trial in which patients

treated with pemetrexed plus pembrolizumab and

platinum-based chemotherapy had a signi�icantly

greater overall survival rate and progression-free

survival compared with those treated with

pemetrexed and platinum chemotherapy with

placebo.

P re s c r i b i n g i n f o rma t i o n c a n b e f o und a t :

https://www.accessdata.fda.gov/drugsatfda_docs/label

/2019/021462s053lbl.pdf.

TosymraNasalSprayforAcuteMigrains

On January 28, 2019, the US FDA approved Tosymra(TM) (sumatriptan) nasal spray indicated for the acute treatment of migraines .with or without aura in adult patients. Tosymra is

Ontruzant:Thirdbiosimilarto

Herceptin

On January 21, 2019, the US FDA approved

Ontruzant(R) (trastuzumab-dttb) IV injection as

an adjuvant treatment of HER2-overexpressing

breast cancer, metastatic breast cancer and

metastatic gastric cancer or gastroesophageal

junction adenocarcinoma in patients who have not

received prior treatment for metastatic disease.

Ontruzant, which is the third biosimilar to

Herceptin(R) (trastuzumab) to gain FDA approval,

carries a boxed warning for cardiomyopathy,

infusion reactions, embyro-fetal toxicity, and

pulmonary toxicity.


https://www.accessdata.fda.gov/drugsatfda_docs/labe

l/2019/761100s000lbl.pdf.

AdacelforRepeatTdapVaccination

On January 14, 2019, the US FDA approved an

expanded indication for Adacel(R) (tetanus

toxoid/reduced diphtheria toxoid/pertussis

vaccine, acellular (Tdap)) IM injection to include

repeat Tdap vaccination 8 years or more after the

�irst vaccination in patients 10 through 64 years of

age. A clinical study showed no signi�icant

differences in adverse effects in adult patients

treated with Adacel 8 to 12 years after the previous

dose compared with those treated with a tetanus-

diphtheria vaccine 8 to 12 years after a previous

dose of Adacel




formulated using a proprietary excipient, Intravail(R), which achieves similar blood levels tothat of a 4-mg sumatriptan subQ injection providing a rapid onset of action for patients

P r e s c r i b i n g i n f o rma t i o n c a n b e f o und a t :https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210884s000lbledt.pdf.

4

On January 14, 2019, the US FDA approved a new

indication for Cabometyx(R) (cabozantinib

malate) oral tablets to treat adult patients with

hepatocellular carcinoma (HCC) who have been

previously treated with sorafenib. Approval for

this indication was based on results from the

CELESTIAL trial in which patients with advanced

HCC previously treated with sorafenib who were

t re a te d w i t h C a b o m e t y x ex p e r i e n c e d a

signi�icantly increased median progression-free

survival compared with those treated with

placebo. Cabometyx was originally approved to

treat patients with advanced renal cell carcinoma.


https://www.cabometyx.com/downloads/CABOMETYX

USPI.pdf.

Vaxelis:NewHexavalentVaccine

Nagpur:ForumslapsRs1.15LpenaltyonmedicalstoreforsellingwrongmedicineMany a times pharmacists hand over a medicine of another brand instead of the one prescribed by the doctor, claiming they have similar contents. A woman handed over a face ointment of another brand by a Mouda-based medicine shopkeeper won Rs1.15 lakh compensation from the consumer court recently, since the alternate medicine caused a reaction on her face leaving dark spots.

ScientistsDevelopArti�icialPancreas

SmartphoneAppForDiabetics

Pharma News





https://www.merck.com/product/usa/pi_circulars/v/v

axelis/vaxelis_pi.pdf.

On December 26, 2018, the US FDA approved

Vaxelis(TM) (diphtheria toxoid, adsorbed/tetanus

toxoid/pertussis vaccine, acellular/hepatitis B

vaccine recombinant/poliovirus vaccine,

inactivated/haemophilus B conjugate vaccine) IM

injection to prevent diphtheria, tetanus, pertussis,

poliomyelitis, hepatitis B, and invasive disease due

to Haemophilus in�luenzae type b. Vaxelis is

approved for use as a 3-dose series in pediatric

patients 6 weeks through 4 years of age (prior to

the 5th birthday). A 3-dose series of Vaxelis does

not constitute a primary immunization series

against pertussis; an additional dose of pertussis-

containing vaccine is needed to complete the

primary series.

Ref:www.micromedexsolutions.com

Taking cognisance of her complaint , the

Additional District Consumer Disputes Redressal

Forum slapped a cost of Rs1.15 lakh on Saurabh

Medical and General Stores, Mouda, Ramtek. The

forum agreed the store caused mental and

physical harassment, and needs to pay treatment

cost to the woman, who's still undergoing

treatment over three-and-a-half-years after she

purchased the product.

CabometyxnowforadvancedHCC

Ref:www.health.economictimes.indiatimes.com

Scientists have developed anarti�icialpancreas

smartphone app that will help in regulating

blood sugar levels in diabetes patients. This

app is capable of interfacing wirelessly with

glucose monitors, insulin pump devices, and

decision-making algorithms.

P r e s c r i b i n g i n f o rma t i o n c a n b e f o u n d a t :

https://www.vaccineshoppe.com/image.cfm?doc_id=14

071&image_type=product_pdf

5

A clinical trial showed that the arti�icial pancreas system (iAPS) app is safe. The app is effective in regulating glucose levels under challenging c o n d i t i o n s a n d i s s u i t a b l e f o r u s e i n u n c o n s t r a i n e d e n v i r o n m e n t s . Ref:www.bankersadda.com

Andhra Pradesh Pollution Control Board (APPCB) is set

to implement the barcode labelling system for

biomedical waste by mid-March. Under the Union

e n v i r o n m e n t m i n i s t r y ' s b i o m e d i c a l w a s t e

management rules 2016, the Central Pollution Control

Board (CPCB) has drafted guidelines for effective

m a n a g e m e n t o f b i o m e d i c a l w a s t e .

The barcoding system will help track waste from the

source where it is generated to the destination where it

is treated. Under the rule, every healthcare centres,

including hospitals, laboratories, diagnostic centres,

clinics, blood banks, nursing homes and other

premises, which generate biomedical waste will have to

establish a barcode system for bags or containers,

w h i c h w i l l b e s e n t o u t o f t h e p r e m i s e s .

The operator, responsible for handling the biomedical

waste is also required by law to establish the barcode

system. This will help identify the waste from the

source of generation and the quantity of waste that is

generated. The system will contain information like

name of the healthcare centre, place, pincode and a

unique ID, which will be issued by the APPCB to the

healthcare centre.




NPPA�ixesretailpriceof29formulationsunderDPCO-2013

The NPPA has �ixed the retail price of 29

formulations under Drugs Price Control Order

(DPCO), 2013 through a noti�ication dated 25

January 2019.

The formulations are telmisartan+cilnidipine +

chlorthalidone tablet, paracetamol + diclofenac

podium table, hydrochloride + diclofenac

potassium tablet, atorvastatin + clopidogrel

capsule, rosuvastatin + clopidogrel capsule,

rosuvastatin + clopidogrel capsule, diclofenac

sodium + chlorzoxazone tablet (Diclotal M),

telmisartan + amlodipine + hydrochlorothiazide

tablet (Telmiwock - AMH), metformin Hcl +

glimepiride tablet (Glitop - M1), metformin Hcl +

glimepiride tablet (Glitop - M2), amoxycillin +

potassium C lavulanate tablet, paracetamol +

phenylephrine Hcl + caffeine + diphenhydramine

Hcl tablet, voglibose + metformin Hcl tablet,

metoprolol tartrate + ramipril tablet, rosuvastatin

+ clopidogrel + aspirin capsule, methylcobalamin

+ alpha lipoic acid + pyridoxine hydrochloride +

folic acid + vitamin D3 tablet (Nervijen D3),

atorvastatin + clopidogrel capsule, etc

The manufacturers of above said scheduled

formulations shall furnish quarterly return to the

NPPA, in respect of production/import and sale of

scheduled formulations in Form - III of Schedule -

II of the DPCO, 2013 through IPDMS.

Any manufacturer intending to discontinue

production of said scheduled formulation shall

furnish information to the NPPA, in respect of

discontinuation of production and/or import of

scheduled formulation in Form -IV of Schedule - II

Ref:www.pharmatutor.org

50cancer,rarediseasedrugstogetcheaperIn a move to curtail pro�iteering on crucial medicines, the Centre is set to cap trade margins charged by drug retailers and stockists at around 25-30% for over 50 non-schedule medicines for cancer and rare diseases, which are currently exempted from price regulation, of�icial sources said. The decision was taken at a high-level meeting with the Prime Minister's Of�ice earlier this month. The list of around 50 drugs, drawn by the Directorate General of Health Services (DGHS), includes 39 anti-cancer medicines and orphan drugs used in treatment of rare diseases. “The PMO had asked the health ministry to prepare a


of the DPCO, 2013 at least six months prior to the i n t e n d e d d a t e o f d i s c o n t i n u a t i o n .

BarcodelabellingsystemtobeimplementedbyMarch

6




list of non-schedule anticancer and orphan drugs which are currently outside price control but require intervention to make them affordable. sale and distribution with immediate effect under section 26A of Drugs and Cosmetics act, 1940 based on the recommendations of DTAB as there is no therapeutic justi�ication for the ingredients contained in these 80FDCs and these FDCs may involve risk to human beings as mentioned in the noti�ication.

Prohibitionof80�ixeddosecombinationsbytheCentralGovt.The central government vide gazette noti�ication no. S.O. 180(E) to S.O. 259(E) dated 11.01.2019 has prohibited 80 �ixed dose combinations for manufacture, sale and distribution with immediate effect under section 26A of Drugs and C o s m e t i c s a c t , 1 9 4 0 b a s e d o n t h e recommendations of DTAB as there is no therapeutic justi�ication for the ingredients contained in these 80FDCs and these FDCs may involve risk to human beings as mentioned in the noti�ication.

Ref:www.cdsco.gov.in

FDAapproves�irstgenericversionofSabriltohelptreatseizuresinadultsandpediatricpatientswithepilepsy

The U.S. Food and Drug Administration approved the �irst generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several a l t e r n a t i v e ( r e f r a c t o r y ) t r e a t m e n t s . . Ref:www.pharmatutor.org

Ref:www.pharmatutor.org

Nearly5000peoplelostlivesin'clinicaltrials'since2005

An estimated �ive thousand people from across the country have lost their lives as the clinical t r i a l s o f a d r u g c o n d u c t e d b y va r i o u s pharmaceutical �irms went wrong. Since 2005, over 17 thousands trials were conducted in the country and the negative effect of the medicines administered to them were seen in several of them. The clinical trials are conducted on animals, before giving them to humans to check their side-effects."Since 2005, nearly 17 thousands clinical drug trails were conducted in the country. However, 4967 people lost their lives in various trials. Whereas, hundreds of patients were diagnosed for Cancer, Paralysis, Asthma, Skin related diseases among others,"said Amulya Nidhi, convener of Swasthya Adhikar Manch. In 2007, to keep track of the clinical drug trials, the government formed a registry, making it


FDAunprecedentedneweffortstosupportdevelopmentofover-the-counternaloxonetohelpreduceopioidoverdosedeaths

The number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017. This includes new ways to increase availability of naloxone, a drug

used to treat opioid overdose. However, if naloxone is administered quickly, it can counter the overdose effects, usually within minutes. While the person administering naloxone should also seek immediate medical attention for the patient, the bottom line is that wider availability of naloxone and quick action to administer it can save lives.Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority. Increased availability of naloxone for emergency treatment of overdoses is an important step. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren't under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an approved OTC product, is an important public health advance.

7




Inside the cylinders was a square lattice structure that would allow blood cells to pass through it, with a copolymer coating that binds to doxorubicin. The researchers tested these absorbers in pigs, inserting them into a vein. When they injected doxorubicin into the same vein, the drug �lowed in the bloodstream to the device. By measuring the doxorubicin concentration in the vein at a location after the absorber, the researchers determined that it captured about 64 per cent of the drug from the bloodstream.

The device could open a new route to help patients �ight cancer, enabling reduced side effects or an increased chemotherapy dose, the researchers said.uman beings as mentioned in the noti�ication.

Firstgovernment-runhumanmilkbankinBengaluru

Vani Vilas women and children's hospital is going to become �irst government hospital to have Human Milk Bank. Vani Vilas hospital comes under Bengaluru Medical College and Research Institute (BMCRI) and will soon establish the Human Milk Bank with project of Rs 1 crore and tender process has been completed now. There is demand for the milk for Preterm babies and low weight babies. Considering this, the team decided to establish a milk bank. This bank will help Vani Vilas, Indira Gandhi Children's hospital, Gousia hospital and others. Everyone cannot donate milk. The quality of milk needs to be tested and then has to be pasteurized and stored under 20 degree C temperature. When feeding to baby, it has to be brought to the normal temperature, says experts.Ref:www.health.economictimes.indiatimes.com


mandatory for scientist and pharma companies to register about the trails. In 2013, since there was a provision of giving compensation to those affected in trails, the government made the changes to the Drugs and Cosmetics Act, 1940. However, till date, only 508 affected people have received compensation. Stating that it would have a 'serious impact' on the health of people, in 2018, the Supreme Court had directed the Centre to come out with rules to regulate clinical drug trials on humans by pharmaceutical �irms.


New3D-printeddevicemaycutchemotherapy'ssideeffects

Doxorubicin, like many chemotherapy drugs, kills more tumour cells when given at higher doses, said researchers, including those from the University of California, Berkeley in the US. However, most patients cannot tolerate large amounts of the drug because it can cause heart failure, among other side effects. The researchers wondered if they could make a device that would �ilter out doxorubicin from blood at locations outside of the tumour to reduce the likelihood that the drug would harm healthy cells.

They used a 3D printer to fabricate tiny cylinders made of poly(ethylene glycol) diacrylate.

Scientists have developed a novel 3D-printed device that may reduce the side effects of chemotherapy such as hair loss, nausea and heart failure. The device absorbs excess chemotherapy drugs before they spread throughout the body.

8

2.

3.

4.

MIKACIN INJ. 2 ML (Amikacin Sulphate

Injection I.P.)

Description and Particulate

Matter

CDSCO, Hyderabad

CDL, Kolkata

VOLTANEURON DN

(Benfotiamine, Alpha

Lipoic Acid,

Methylcobalamin,

Pyridoxine

Hydrochloride and

Inositol Tablets)

B. No.: VDN1018D, Mfg dt: 01/2018, Exp dt: 06/2019, Mfd by: M/s. Pulse Pharmaceuticals Pvt. Ltd., Khasra No 400, 407, 409 Karondi, Roorkee,

Uttarakhand 247667.

Assay of

Methylcobalamin

CDSCO,

South Zone,

Chennai

DEXAMETHASONE

Tablets I.P. 0.5 mg

B. No.: DU16002, Mfg dt: 03/2016, Exp dt: 02/2019,

Mfd by: M/s. Baader Schulz Laboratories,

Pharma Division, Plot No. J- 6, OIDC, Mahatma Gandhi

Udyog Nagar, Dabhel, Daman 396 210,

U.T., India.

Assay CDSCO,

South

Zone,

Chennai

CDL,

Kolkata

CDL,

Kolkata




Listofdrugs,declaredasnotofstandardqualityforthemonthofDecember2018

Sr.No NameofDrugs

BatchNo./Dateof

Manufacture/Date

ofExpiry/

ManufacturedBy

Reasonforfailure DrawnBy From

1.CELPARIN 5000

(Heparin Injection I.P. 5000 IU

per 5ml vial)

B. No.: HPI1702AC, Mfg dt: 01/2017, Exp dt: 12/2019,

Mfd by: M/s. Celon Laboratories

Pvt. Ltd., Plot No. 2, ALEAP Industrial

Estate, Gajularamaram, Ranga Reddy

District, T.S. - 500 090

PH CDSCO,

Hyderabad

CDL,

Kolkata

B. No.: B02H028, Mfg dt: 08/2018, Exp dt: 07/2021,

Mfd by: M/s. Aristo Laboratories Pvt. Ltd., Village Makhnumajra,

P.O. Bhud, Baddi, Dist.Solan (H.P.) - 173205.

9

5. LOPRIN-DS (Aspirin

Gastro-Resistant

Tablets I.P.)

B. No.: DLS-17002, Mfg dt: 01/2017, Exp dt: 12/2018,

Mfd by: M/s. Kalindi Medicure

Pvt. Ltd., Plot No. 25 & 26, Pharma City, Selaqui Industrial Area, Dehradun (Uttarakhand).

Description, Dissolution and test for

Salicylic Acid

CDSCO, East Zone,

Kolkata

CDL,

Kolkata

6. LEVOCETIRIZINE

Tablets I.P. 5 mg

B. No.: 9700617, Mfg dt: 01/2017, Exp dt: 12/2019,

Mfd by: M/s. Karnataka

Antibiotics & Pharmaceuticals

Limited, Plot No:14, II Phase, Peenya,

Bangalore 560058.

Related

Substances

CDSCO, East

Zone, Kolkata

CDL,

Kolkata

7. B. No.: 9702217,

Mfg dt: 07/2017,

Exp dt: 06/2020

Mfd by: M/s.

Karnataka Antibiotics

& Pharmaceuticals

Limited, Plot No:14,

II Phase, Peenya,

Bangalore 560058

Related

Substances

CDSCO,

East Zone,

Kolkata

CDL,

Kolkata

8. LEVOCETIRIZINE

Tablets I.P. 5 mg

B. No.: 9701816,

Mfg dt: 08/2016,

Exp dt: 07/2019,

Mfd by: M/s.

Karnataka Antibiotics

& Pharmaceuticals

Limited, Plot No:14,

II Phase, Peenya,

Bangalore 560058.

Related

Substances

CDSCO,

East Zone,

Kolkata

CDL,

Kolkata

9. Assay of

Neomycin

Sulphate

BETNOVATE-N (Betamethasone

Valerate and Neomycin Skin

Cream)

CDSCO,

East Zone,

Kolkata

CDL,

Kolkata




CDL,

Kolkata

B. No.: EW834,

Mfg dt: 11/2017,

Exp dt: 04/2019,

Mfd by: M/s.

Glaxo SmithKline

10

P-ZIDE 500

(Pyrazinamide

Tablets I.P.)

B. No.: JK18003,

Mfg dt: 04/2018,

Exp dt: 03/2022,

Mfd by: M/s. Cadila

Pharmaceuticals

Limited, Industrial

Growth Center,

Samba – 184 121

State of J & K.

10. Dissolution CDSCO,

East Zone,

Kolkata

CDL,

Kolkata

11. SERATID – 10

TABLETS

(Serratiopeptidase

Tablets I.P. 10 mg)

B. No.: SMD-17K240,

Mfg dt: 11/2017,

Exp dt: 04/2019,

Mfd by: M/s. SMD

Chemi Pharma

Pvt. Ltd., Kumarhatti,

Distt. Solan-

173 229 (H.P.).

Assay CDSCO,

SubZone

Goa

12. AMLOMAX

(Amlodipline

Tablets I.P. 2.5 mg)

B. No.: AMLT505, Mfg dt: 11/2017, Exp dt: 10/2019,

Mfd by: M/s. Unicure India Ltd.,

C-21, 22 & 23, Sectore-3,

Noida-201301, Distt. Gautam

Budh Nagar (U.P.).

Related

Substances

CDSCO,

West

Zone,

Mumbai

CDTL,

Mumbai

13.




Pharmaceuticals

Limited, At: Plot No.

C-1, Madkaim

Industrial Estate,

Post -Mardol,

Ponda, Goa

– 403 404.

CDL,

Kolkata

CANDIZOLE 15 GM (Clotrimazole

CreamIP)

B. No.: 08016,

Mfg dt: 01/2018,

Exp dt: 12/2019,

Mfd by: M/s. ION

healthcare Pvt. Ltd.,

Baddi Barotiwala

Road, Baddi, Dist,

Solan, H.P. 173205.

Test for 2-

Chlorotitanol

CDSCO,

West Zone,

Mumbai

CDTL,

Mumbai

11




14.

15.

Paracetamol Tablets

I.P. 500 mg

(relieve Tablets)

B. No.: T-1805009, Mfg dt: 05/2018, Exp dt: 04/2020,

Mfd by: M/s. Jeoffrey Laboratories, Village Harbanspura,

G.T. Road, Sirhind, Distt. Fatehgarh

Sahib (P.B.) 140406.

Assay,

Dissolution &

Uniformity of

Weight

CDSCO,

West

Zone,

Mumbai

CDTL,

Mumbai

Atenolol &

Amlodipine Tablets

B. No.: 707470,

Mfg dt: 10/2017,

Exp dt: 09/2019,

Mfd by: M/s. Ciron

Drugs &

Pharmaceuticals

Pvt. Ltd., Plot No.

35 to 37, 43 to 45,

CFCB, Dewan

Udyog Nagar

Aliyali, Palghar,

Dist. Palghar

-401404.

Assay of

Amlodipine

CDSCO,

Sub Zone,

Indore

CDTL,

Mumbai

B-29 (Alpha Lipoic

Acid, Folic Acid,

Methylcobalamin

Pyidoxine

Hydrochloride

& Vitamin D3 Tablets)

B. No.: CG18094,

Mfg dt: 05/2018,

Exp dt: 04/2020,

Mfd by: M/s. Corona

Remedies Pvt. Ltd.,

Village Jatoli,

Post Of�ice-Oachghat,

Tehsil-Solan, Dist.

Solan( HP)- 173223.

Disintegration TimeCDSCO,

West

Zone,

Mumbai

CDTL,

Mumbai

Enalapril Maleate

Tablets IP 2.5 mg

(ENARIL-2.5 TABLETS)

Dissolution (Enalapril Maleate)

and Assay of Enalapril Maleate

CDSCO,

N.Z., GZB

RDTL, Chandigarh

16.

17. B. No.: T-15884,

Mfg dt: 01/2018,

Exp dt: 12/2019,

Mfd by: M/s. Jackson

Laboratories Pvt. Ltd.,

Bye Pass, Majitha Road,

Amritsar-143001.

12




RAMIPRIL

TABLETS IP 5 MG

B. No.: HRPT17003,Mfg dt: 08/2017,Exp dt: 07/2019,

Mfd by: M/s. RAVIAN LIFE SCIENCE PVT. LTD., Plot

No.34, Sector-8A, IIE,SIDCUL, Haridwar

-249403,Uttarakhand, INDIA

Assay of Ramipril CDSCO,

N.Z.,

GZB

RDTL,

Chandigarh

CHLORZOXAZONE,

DICLOFENAC

POTASSIUM and

PARACETAMOL

Tablets (MYOSPAZ

FORTE TABLETS)

B. No.: PA0048, Mfg dt: 01/2018, Exp dt: 12/2019,

Mfd by: M/s. G.S.PHARMBUTOR

PVT.LTD., PLOT NO.58, 59, 66 & 67,

SECTOR-3, I.I.E., PANTNAGAR,

RUDRAPUR- 263153, DIST UDHAM SING NAGAR

UTTARAKHAND, INDIA.

Disintegration Test CDSCO, N.Z., GZBNCT,

Delhi,

RDTL,

Chandigarh

LEVOCETIRIZINE

HYDROCHLORIDE

TABLETS IP 5 MG

B. No.: SHT7550,

Mfg dt: 12/2017,

Exp dt: 11/2020,

Mfd by: M/s.

SYNCOM Healthcare

Limited, D -42, IIE,

SIDCUL, Selaqui,

Dehradun- 248197,

Dissolution

(Levocetirizine

Hydrochloride)

CDSCO,

N.Z.,

GZB

RDTL,

Chandigarh

18.

19.

20.

21. DICLOFENAC

SODIUM TABLETS

IP 50 MG

B. No.: DFT 17021, Mfg dt: 11/2017, Exp dt: 10/2019,

Mfd by: M/s. VIVEK PHARMACHEM

(INDIA) LTD., NH-8, Chimanpura,

Amer-303102

Disintegration Test CDSCO,

N.Z.,

GZB

RDTL,

Chandigarh

13




B. No.: A198003A, Mfg dt: 04/2018,

Exp dt: 03/2020, Mfd by: M/s. ANG

Lifesciences India Ltd., Village Kishanpura,

Nalagarh Road, Tehsil Baddi, Distt.Solan, H.P.174101

DICLOFENAC

PROLONGED

RELEASE TABLETS IP

B. No.: T7051,

Mfg dt: 03/2017,

Exp dt: 02/2019,

Mfd by: M/s. Zest

Pharma. Plot No.275,

Sector 'F'Sanwar Road,

Indore-452015

Dissolution NCT, Delhi RDTL,

Chandigarh

22.

23.

24.

25.

26. OMEPRAZOLE

CAPSULES I.P.

(Ome�ine-20)

B. No.: CML-18128, Mfg dt: 05/2018, Exp dt: 04/2020,

Mfd by: M/s. Prochem Pharmaceuticals (P)

Ltd. 140- 141, Makkanpur, Bhagwanpur, Roorkee, Dist-Haridwar,

Uttarakhand 247661

Dissolution Drugs

Control

Department

Tripura

RDTL,

Guwahati

CEFTAZIDIME

INJECTION IP

Identi�ication

for Ceftazidime

Bemina,

Srinagar.

RDTL,

Chandigarh

Ferrous Ascorbate,

Zinc and Folic Acid

Tablets (ALFEE-F

TABLETS)

B. No.: ALC-695,

Mfg dt: 07/2017,

Exp dt: 06/2019,

Mfd by: M/s. Alice

Healthcare, 81-C/2,

EPIP-I, Jharmajri,

Baddi, Distt.Solan (H.P.)

Assay of Ferrous

Ascorbate and

Folic Acid

CDSCO,

Sub Zone,

Baddi.

RDTL,

Chandigarh

Syrup of Iron and

Folic Acid in a

�lavoured base

(HEXX FORTE SYRUP)

B. No.: HXF-1801,

Mfg dt: 07/2018,

Exp dt: 12/2019,

Mfd by: M/s. NDH

Pharmaceuticals

Pvt.Ltd., Village

Kishanpura, Paonta

Sahib-173025 (H.P.)

Assay of Iron (III)

Hydroxide

Polymaltose

Complex calculated

as Elemental Iron

and Folic Acid

H.Q.,

Himachal

Pradesh

RDTL,

Chandigarh

14




OMEPRAZOLE

CAPSULES I.P.

(Ome�ine-20)

B. No.: CML-18056, Mfg dt: 03/2018, Exp dt: 02/2020,

Mfd by: M/s. Prochem Pharmaceuticals (P)

Ltd. 140- 141, Makkanpur,

Bhagwanpur, Roorkee, Dist-Haridwar, Uttarakhand-247661.

Dissolution Drugs

Control

Department

Tripura

RDTL,

Guwahati

Diclofenac Sodium,

Paracetamol &

Chlorzoxazone

Tablets (Powergesic)

B. No.: PGT041562,

Mfg dt: 10/2015,

Exp dt: 09/2019,

Mfd by: M/s.Acme

Lifesciences Village

Katha, Baddi Ind. Area,

Tehsil, Nalagarh,

Dist Solan, H.P.- 173205.

Disintegration Drugs

Control

Department

Assam

RDTL,

Guwahati

27.

28.


Sleep deprivation may increase the risk of developing Alzheimer's disease by raising the levels of tau

proteins in the brain associated with the neurodegenerative disease. Researchers at Washington

University in the US found that sleeplessness accelerates the spread through the brain of toxic clumps of

tau ― a harbinger of brain damage and decisive step along the path to dementia. The �indings, published in

the journal Science, indicate that lack of sleep alone helps drive the disease, and suggests that good sleep

habits may help preserve brain health.

Tau is normally found in the brain — even in healthy people — but under certain conditions it can clump

together into tangles that injure nearby tissue and presage cognitive decline. Recent research has shown

that tau is high in older people who sleep poorly. A sleepless night caused tau levels to rise by about 50 per

cent, the researchers found.

PoorsleepmayincreaseAlzheimer'srisk:Study


15




PublicNotices

Amendmenttothedrugsandcosmeticsrules,1945

The ministry of health and family welfare has issued a gazette noti�ication dated 10-01-2019, amending

the drugs and cosmetics rule 1945 by inserting rule 84AB- information to be uploaded by the licensee on

the online portal SUGAM. As per the inserted rule all the licensee shall register with the portal SUGAM and

upload information as per the format provided in the said portal, pertaining to the licences granted for

manufacture for sale or distribution of drugs and information so provided shall be updated from time to

time and such information uploaded by the licensee shall be veri�ied by the concerned licencing authority.


Ref:AmarUjala;29-01-2019.

LocalNews

16




Ref:AmarUjala;29-01-2019.

Ref:AmarUjala;10-01-2019

17




Ref:Amarujala;13-12-2018

Ref:AmarUjala;19-01-2019

18




SwineFlu

The signsandsymptomsofswine�lu are similar to

those of infections caused by other �lu strains and

can include:· Fever

· Chills

· Cough

· Sore throat

· Runny or stuffy nose

· Watery, red eyes

· Body aches

· Headache

· Fatigue

· Diarrhea

· Nausea and vomiting

· chest congestion

· Loss of appetite

Flu symptoms develop about one to three days after you're exposed to the virus.

Causes

Swine �lu disease spreads among pigs through direct and indirect contact and from infected pigs that do

not experience symptoms. Signs of swine �lu in pigs that do experience the symptoms include fever,

depression, breathing dif�iculties, coughing continuously, discharge from the nose or eyes, sneezing, eye

redness or in�lammation, not eating. In�luenza viruses infect the cells that line your nose, throat and lungs.

The virus enters your body when you inhale contaminated droplets or transfer live virus from a

contaminated surface to your eyes, nose or mouth.

Swine �lu, also known as the H1N1 virus, made

headlines in 2009 when it was �irst discovered in

humans, and became classi�ied as a pandemic. It

originated from pigs and now spreads from

person to person. It is a new strain of

in�luenzaand the symptoms are very similar to

regular �lu. Technically, the term "swine �lu"

refers to in�luenza in pigs. Occasionally, pigs

transmit in�luenza viruses to people, mainly to

hog farmers and veterinarians.

19




There are three different types or strains of in�luenza

virus that affects humans - A, B, and C. Strains A and B

are more hostile than C. They cause the annual

endemic with many people suffering from the

symptoms of high fever, coughing, headaches, snif�ling,

and body aches. Swine �lu is of the H1N1 in�luenza

subtype of In�luenza A. However, swine �lu viruses can

sometimes come from other subtypes, such as H1N2,

H3N1, and H3N2.

Youcan'tcatchswine�lufromeatingpork.

Peoplepronetoswine�lu

People who at a risk of contracting swine �lu include:

· New born babies and children up to 16 years of age.

· Pregnant women

· Those who are 50 years of age and older

· Those suffering from medical conditions, such as heart

or lung disease, diabetes or those with weakened immune systems

· Those who are morbidly obese

· Those who are immune suppressed due to certain medications or HIV

Diagnosis

You can visit a general practitioner if you think you have symptoms

of swine �lu. To diagnose swine �lu, the doctor will swipe the inside

of your nose or mouth with a swab and sends the swab for testing.

No blood test is required for diagnosing, though at times, the doctor

may suggest blood tests to rule out any other form of infection apart

from swine �lu.

20




RiskFactors

Prevention

If you've lived in or traveled to an area where many

people are affected by swine �lu, you may have been

exposed to the virus.

Swine farmers and veterinarians have the highest

risk of exposure to true swine �lu because they work

with and are near pigs.

These measures also help to prevent �lu and limit its

spread:

· If you have the �lu, you can give it to others. Stay

home for at least 24 hours after your fever is gone.

·Washyourhandsthoroughlyandfrequently. Use

soap and water, or if they're unavailable, use an

alcohol-based hand sanitizer.

· Cover your mouth and nose when you sneeze or

contaminating your hands, cough or sneeze into a

tissue or the inner crook of your elbow.

TreatmentofSwine�lu

Antiviral agents prevent, shorten, and reduce the severity of �lu. Antiviral agents used for treatment and

prevention of swine �lu are oseltamivir and zanamivir. Oseltamivir and zanamivir are approved by the

U.S. Food and Drug Administration (FDA) for treatment and prevention of �lu in adults and children. They

are most effective when administered within two days of an infection. Oseltamivir is administered as a

capsule, and zanamivir is administered by oral inhalation.

Like seasonal �lu, most people will recover from swine �lu (H1N1 �lu) within a week without any antiviral

medications. The U.S. centers for Disease Control and Prevention (CDC) recommends that all individuals

with suspected or con�irmed swine �lu infection be considered for treatment with antiviral agents,

especially hospitalized patients and patients at higher risk for complications.

Ref:www.rxlist.com

cough. Wear a face mask if you have one. To avoid

·Avoidcontact. Stay away from crowds if possible.

And if you're at high risk of complications from the �lu.

21




AwardandRecognition

Ms. Abhilasha Bharti has been honored for the exceptional services in the following area:

Non-communicabledisease(NCD)program: They run NCD programme where patients suffering

from hypertension and diabetes are specially cared and counselled every Wednesday, irrespective of

busy schedule with routine out-patient department (OPD), they counsel each patient for about half

hour which is remarkable. All these patients are online with IGMC.

Ÿ

Ÿ Awarenesscampsforpublicandstudents: They organize awareness camp twice in a year for the

Ms.AbhilashaBharti, a Pharmacist serving at Primary Health Centre (PHC), Annandale Dist. Shimla

has been recently awarded as the best employee in Kayakalp for the year 2018 for her exemplary

efforts at district level PHC.

22




Assessment bodies are very happy for their extraordinary service. We wish all the PHCs could emulate these good characteris�cs for an improved quality service for the public. It

is the effort of pharmacists like Ms. Abhilasha Bhar�, that makes all our registered pharmacists proud and incites them to do be�er each day

Ÿ Medicinesstock: Their PHC, makes sure they stock all the necessary medicines for the convenience

of patients. This PHC never falls short of any necessary medicines which the needy public wants.

Ÿ Counselling services: Though not mentioned in the routine OPD, they perform ECG on needy

senior/elderly patients. Every Tuesday and Saturday, these patients are counselled for healthy life

and positive attitude. The public is overwhelmed with the service and their feedback is being

documented.

Ÿ Herbalgarden:In addition to above services, they are maintaining herbal garden at PHC by giving

extra time after the of�ice hours. Unlike other employees, they come to PHC by early morning 7

o'clock and leave of�ice after 6 o'clock. They themselves source medicinal plants, soil and manure to

nurture the plants by watering it timely. They have also displayed plant's names which is highly

Commendable.by watering it timely. They have also displayed plant's names which is highly

Commendable.

Ÿ Cleanliness: They are also known for the cleanliness of the PHC both inside and outside

public and students aged 10-19 years. They are counselled for personal hygiene, adolescence age

issues, awareness against bad effects of smoking, alcohol etc.

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TollFree:18001210443|Phone:09218428042/9459220253

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DRUG AND THERAPY BULLETIN - hpspc.in 2019.pdf · 2019-02-21 · Ref: Andhra Pradesh Pollution Control Board (APPCB) is set to implement the barcode labelling system for biomedical