TPW_May-June 2022

Medicine exports to developed GLEANINGS FROM LOCAL PRESS
markets on the rise

Medicine exports to the developed coun- Square Pharmaceuticals has also secured
tries are steadily growing riding on the FDA approval.
attainment of regulatory approval from
the US, European and some other countries “Our pharmaceuticals products are being in-
helped by Bangladesh’s capacity to produce creasingly accepted in developed countries as
high-quality drugs at affordable prices. we produce cheaper, high quality, and patent-
free medicines,” said Prof ABM Faroque, a for-
As a result, shipment rose significantly in the mer dean of the Faculty of Pharmacy, DU.
markets of the US, the UK, Australia, Canada
and Denmark in the last three years. “There is no question about the quality of our
products as we can manufacture world-class
This marks a major change in the pharma- lifesaving medicines. Besides, we can make any
ceuticals industry since it largely relies on the generic version of drugs that are helping us en-
Asian and African markets as overseas destina- ter the market of the developed countries.”
tions and the domestic market to drive growth.  
Another factor, according to him, is pharma-
Bangladesh shipped drugs worth $14.97 mil- ceuticals products produced in Bangladesh are
lion to the US in the last fiscal year of 2020-21, cheaper than in any other country owing to low-
strongly rebounding from the coronavirus-in- er production costs as companies can hire pro-
duced slowdown a year ago when manufacturers fessionals and skilled human resources locally.
could bring in $1.05 million only. The shipment
stood at $13.6 million in FY2018-19, data from the Bangladesh has already had a strong foot-
Export Promotion Bureau (EPB) showed. print in the pharmaceuticals market of Africa
and Asia. “Now, the time has come to expand to
Among the developed countries, Denmark regulated markets,” ED, Marketing and sales of
has emerged as the second-largest export des- Eskayef Md. Mujahidul Islam said.
tination for Bangladesh, with receipts surging
nearly 14 times to $2.43 million in FY21 from Abdul Muktadir, chairman and managing di-
$0.18 million in FY20. The exports to Canada rector of Incepta Pharmaceuticals Ltd, says lo-
rose to $1.34 million in FY21, up 62 per cent from cal pharmaceutical companies are manufactur-
$0.83 million the year prior. Medicine sales ing high-quality drugs and are getting approval
fetched $2.42 million from the UK in the last fis- from international regulatory bodies.
cal year, an increase from $0.47 million in FY20
but a decrease from $2.6 million in FY19. “This is raising our exports to the developed
countries. Now we are in the initial stage. The
The shipment is increasing in Japan and Aus- export will go up rapidly in coming days.”
tralia as well. And the upward growth in over-
seas sales has been driven by the market ac- He thanked the regulators of Bangladesh for
cess to the highly regulated markets. extending support to local medicine makers to
explore opportunities in the foreign markets.
In a major development, the US Food and
Drug Administration (US FDA) has given approv- Beximco Pharmaceuticals accounts for 90
al to a facility of Eskayef Pharmaceuticals Ltd, per cent of the medicines shipped to the US,
an achievement that would allow the company said an official of the company.
to enter the world’s largest drug market.
Before entering a regulated market, a compa-
The medicine-maker submitted an abbrevi- ny has to obtain a good manufacturing practice
ated new drug application, which contains data certification from the regulatory body of the im-
submitted to the US regulator for the review porting nation, according to Monjurul Alam, glob-
and potential approval of a generic drug prod- al business director of Beacon Pharmaceuticals.
uct, for Pregabalin capsules in eight different
strengths: 25mg, 50mg, 75mg, 100mg, 150mg, Pharmaceuticals shipments from Bangla-
200mg, 225mg, and 300mg. desh grew 25 per cent year-on-year to $169 mil-
lion in FY21 thanks to the addition of anti-coro-
In August 2016, Bangladesh entered the US navirus drugs to the export basket, continuous
market through Beximco Pharmaceuticals Ltd, improvement of quality and policy support.
a manufacturer of generic drugs and active
pharmaceutical ingredients. Overseas sales brought in $130.57 million in
the June-February period of FY22, up 21.28 per
cent year-on-year, according to the state-run EPB.

Source: The Daily Star

THE PHARMA WORLD 101

FACTS on Symptoms: Signs and symptoms of a Being female: The urethra is shorter in
kidney infection might include: women than it is in men, which makes
FINGER TIPS it easier for bacteria to travel from
• Fever outside the body to the bladder.
PYELONEPHRITIS • Chills
• Back, side (flank) or groin pain • Having a urinary tract blockage. 
Kidney infection (pyelonephritis) is • Abdominal pain • Having a weakened immune
a type of urinary tract infection (UTI) • Frequent urination
that generally begins in your urethra • Strong, persistent urge to urinate system. 
or bladder and travels to one or both • Burning sensation or pain when • Having damage to nerves
of your kidneys.
urinating around the bladder. 
• Nausea and vomiting • Using a urinary catheter for a
• Pus or blood in your urine
time
(hematuria)
• Urine that smells bad or is cloudy Prevention: Reduce your risk of kid-
ney infection by taking steps to pre-
Causes: Bacteria from an infection or vent urinary tract infections-
elsewhere in your body can spread
through your bloodstream to your kid- • Drink plenty of fluids, especially
neys. Although it’s unusual to develop water
a kidney infection, it can happen — for
instance, if you have an artificial joint • Urinate as soon as you need
or heart valve that becomes infected. to. Avoid delaying urination when
you feel the urge to urinate.
Risk factors: Factors that increase
your risk of a kidney infection include: • Empty the bladder after inter-
course

• Avoid using feminine products
in the genital area

GLOSSARY OF
NEPHROLOGY TERMS

Acute kidney injury (AKI): Is a sudden and recent reduction in the control ESRF but cannot cure it. Once a patient has developed
level of kidney function ESRF, they will always have it, even after a transplant.

Alport’s: Alport’s syndrome is an inherited kidney disease. This Fluid overload: Fluid overload occurs in kidney failure because
means it runs in families and is caused by a genetic mutation. one of the main functions of the kidneys is to remove excess wa-
Men are more severely affected than women. It can lead to deaf- ter. Fluid overload often occurs with high blood pressure.
ness as well as kidney failure. 
Peritonitis: Inflammation of the peritoneum, caused by an infec-
CAPD: Abbreviation for continuous ambulatory peritoneal dialy- tion. People on peritoneal dialysis risk getting peritonitis if they
sis. A continuous form of PD in which patients perform the ex- touch the connection between their PD catheter and the bags of
changes of dialysis fluid by hand. The fluid is usually exchanged dialysis fluid. Most attacks are easily treated with antibiotic drugs.
four times during the day and is left inside the patient overnight.
Polycystic kidney disease  (PCKD):  An inherited disease (a dis-
CC (Creatinine Clearance): A test done in addition to blood tests ease that runs in families) in which both kidneys are full (‘poly-
for measuring either kidney, dialysis or transplant function. The ’ means ‘many’) of cysts (abnormal lumps). PCKD is one of the
normal level for the kidney(s) is about 120 ml/min (1200 litre/ causes of kidney failure. It is diagnosed by an ultrasound scan.
week) whilst for CAPD patients it is 50 l/week, CCPD 65 l/week
and Haemodialysis 100 l/week. Pyelonephritis: Inflammation of the drainage system of the kid-
neys, one of the causes of kidney failure. It can be diagnosed by an
CCPD:  Stands for «continuous cycling peritoneal dialysis.» A ultrasound scan or by an intravenous pyelogram (IVP).
machine performs the peritoneal dialysis solution exchanges in
regular cycles usually during the night. Renal bone disease: A complication of kidney failure, in which
bone health is affected by abnormally low blood levels of cal-
End-stage renal failure (ESRF): A term for advanced chronic kid- cium and vitamin D and high levels of phosphate.
ney failure. People who develop ESRF will die within a few weeks
unless treated by dialysis or transplantation. These treatments Wegener’s granulomatosis: A type of kidney disease where blood
vessels in the kidneys and other parts of the body are affected.

102 THE PHARMA WORLD

A finish study pub- Don’t go bananas – HEALTH TIPS
lished in the Journal of But maybe eat one
Science and Medicine
in Sport has found da Banana is the world’s most popular fruit and have been
simple step to take cultivated for perhaps 10,000 years. The fruit is noted for being
towards preventing a good source of potassium. According to the U.S. Department
Type 2 diabetes and of Agriculture, one medium banana provides 375 milligrams.
heart disease: stand Bananas also are a source of magnesium (32 mg), beneficial
more. Specifically, the phytochemicals and antioxidants. However, certain special
researchers discov- situations call for caution. People with late-stage kidney failure
ered that standing for need to closely monitor potassium consumption. Foods high in
a longer amount of potassium also can interfere with some medications for high
time during the day blood pressure and heart failure. It certainly would take more
is associated with im- than one banana to raise potassium levels to a dangerous level
proved insulin sensitiv- for the average person. So, it’s always safer to check with your
ity. When that function primary care physician to see if bananas are safe for you.
is impaired, the body
does not respond prop- Natural remedy for enlarged prostate
erly to insulin, which
can have led to the The extract of saw palmet- that decrease prostate in- you take? Experts recom-
aforementioned dis- to has been used for centu- flammation. mend a daily intake of 320
eases. If you work sit- ries in relieving symptoms milligrams of saw palmetto
ting down or spend a of prostate enlargement. Saw palmetto also alters split into two doses. It may
lot of your day seated, It is derived from a fan- certain hormone levels that take 4 to 6 weeks for you to
the researchers recom- shaped plant that is native affect prostate size. How feel its effects.
mend taking frequent to North America. Experts much saw palmetto should
standing breaks with consider saw palmetto as
the goal of reducing a gold standard for herbal
daily sitting time by at prostate treatments. The
least on hour. Medical National Institutes of
research studies show Health (NIH) has compiled
that  standing as little numerous  studies  that
as 30 minutes a day can support the  benefits of
lower your risk of death saw palmetto. Experts
from cardiovascular agree that saw palmetto
disease. Standing for 90 contain fatty acids,  flavo-
minutes can lower that noids, and beta-sitosterol
risk by more than 33%.

THE PHARMA WORLD 103

FDA UPDATE Tirzepatide injection for FDA approves
the treatment of adults Pluvicto
with Type 2 Diabetes
FDA Approves Pluvicto (lutetium Lu
USFDA approved Mounjaro (tirzepatide) injection, Eli 177 vipivotide tetraxetan) Targeted
Lilly and Company’s new once-weekly GIP (glucose- Radioligand Therapy for Treatment of
dependent insulinotropic polypeptide) and GLP-1 Progressive, PSMA-Positive Metastat-
(glucagon-like peptide-1) receptor agonist indicated ic Castration-Resistant Prostate Can-
as an adjunct to diet and exercise to improve glyce- cer. Metastatic prostate cancer has a
mic control in adults with type 2 diabetes. Mounjaro 5-year survival rate of less than 30%;
is not indicated for use in patients with type 1 dia- mCRPC patients who progress on
betes mellitus. As the first and only FDA-approved multiple lines of therapy have limited
GIP and GLP-1 receptor agonist, Mounjaro is a sin- treatment options. Pluvicto combines
gle molecule that activates the body’s receptors for a targeting compound (ligand) with a
GIP and GLP-1, which are natural incretin hormones. therapeutic radioisotope (a radioac-
The approval was based on results from the phase 3 tive particle). FDA approval was based
SURPASS program, which included active compara- on pivotal Phase III VISION trial.
tors of injectable semaglutide 1 mg, insulin glargine
and insulin degludec.  Mounjaro contains a Boxed Mavacamten
Warning regarding thyroid C-cell tumors. Mounjaro is for obstructive
contraindicated in patients with a personal or fam- Hypertrophic
ily history of medullary thyroid carcinoma or in pa- Cardiomyopathy
tients with Multiple Endocrine Neoplasia syndrome
type 2. The USFDA has approved Bristol Myers
Squibb’s  Camzyos  (mavacamten cap-
FDA approves Tlando for sules) for the treatment of adults with
male Hypogonadism symptomatic NYHA class II-III obstruc-
tive hypertrophic cardiomyopathy (ob-
Antares Pharma announced that the USFDA granted structive HCM) to improve functional
final approval for  TLANDO™ (testosterone unde- capacity and symptoms. Camzyos is the
canoate), an oral treatment for testosterone re- first and only FDA-approved allosteric
placement therapy (“TRT”) indicated for conditions and reversible inhibitor selective for
associated with a deficiency or absence of endoge- cardiac myosin that targets the under-
nous testosterone, or hypogonadism in adult males. lying pathophysiology of obstructive
TLANDO’s oral formulation and convenient dosing, HCM. This approval is based on data
which requires no titration, differentiates it from from the Phase 3 EXPLORER-HCM trial.
other treatment options. Camzyos has shown to interact with
certain CYP450 inhibitors /inducers.

Triple and Dual Paks Phathom Pharmaceuticals an- new drug class approved in the U.S.
for the treatment of nounced that the USFDA approved in over 30 years. The two New Drug
H. pylori Infection both Voquezna Triple Pak™ (vono- Applications for these products were
prazan tablets, amoxicillin capsules, given priority review designation by
clarithromycin tablets) and Voquez- the FDA and previously granted as
na™ Dual Pak™ (vonoprazan tab- qualified infectious disease products
lets, amoxicillin capsules), for the (QIDP). Voquezna Triple Pak and Vo-
treatment of  Helicobacter pylori  (H. quezna Dual Pak are contraindicated
pylori) infection in adults. Voquezna in patients with known hypersensitiv-
treatment regimens contain antibiot- ity to vonoprazan or amoxicillin, any
ics conveniently packaged with vono- other components of the formula-
prazan, a novel potassium-competi- tion, any other beta-lactams, or in
tive acid blocker (PCAB) and the first patients receiving rilpivirine-contain-
innovative acid suppressant from a ing products.

104 THE PHARMA WORLD

FDA APPROVALS

Brand Name Generic Name Manufacturer Date of Treatment
Approval

Radicava ORS Oral Edaravone Mitsubishi Tanabe May 12, 2022 Treatment for Amyotrophic
Suspension Pharma Corporation Lateral Sclerosis

Voquezna Triple Pak Co- Amoxicillin, Clarithro- Phathom May 03, 2022 Treatment for Helicobacter Pylori
Packaged mycin & Vonoprazan Pharmaceuticals, Inc. Infection

Voquezna Dual Pak Co- Amoxicillin & Phathom May 03, 2022 Treatment of Helicobacter pylori
Packaged vonoprazan Pharmaceuticals, Inc. (H. pylori) infection in adults.

Camzyos Capsules Mavacamten Bristol-Myers Squibb Treatment for Hypertrophic
Company Cardiomyopathy.

Cuvrior Tablets Trientine Orphalan SA Apr 28, 2022 Treatment for Wilson’s disease.
Tetrahydrochloride

Vivjoa Capsules Oteseconazole Mycovia Apr 26, 2022 Treatment for Vaginal Yeast
Pharmaceuticals, Inc. Infection.

Epsolay Cream (Benzoyl Peroxide) Sol-Gel Technologies, Apr 22, 2022 Treatment of inflammatory
Ltd. lesions of rosacea in adults

Alymsys Injection Bevacizumab-maly Amneal Pharmaceuticals Apr 13, 2022 Treatment for Colorectal Cancer,
LLC Non-Small Cell Lung Cancer,
Glioblastoma Multiforme, Renal
Cell Carcinoma, Cervical Cancer,
Ovarian Cancer, Fallopian Tube
Cancer, Peritoneal Cancer.

Vijoice Tablets Alpelisib Novartis Pharmaceuticals Apr 5, 2022 Treatment for PIK3CA-Related

Corporation Overgrowth Spectrum.

Igalmi Sublingual Film Dexmedetomidine BioXcel Therapeutics, Inc. Apr 5, 2022 Treatment of agitation

Tlando Capsules - formerly Testosterone Antares Pharma, Inc. Mar 28, 2022 Treatment for Hypogonadism,
LPCN 1021 Male.

Pluvicto Injection Lutetium lu 177 Novartis Pharmaceuticals Mar 23, 2022 Treatment for Prostate Cancer.

Vipivotide Tetraxetan Corporation

Xelstrym Transdermal Dextroamphetamine Noven Pharmaceuticals, Mar 22, 2022 Treatment for ADHD.
System Inc.

Ztalmy Oral Suspension Ganaxolone Marinus Mar 18, 2022 Treatment for CDKL5 Deficiency
Pharmaceuticals, Inc. Disorder.

Opdualag Injection Nivolumab and Bristol-Myers Squibb Mar 18, 2022 Treatment for Melanoma.
Relatlimab-rmbw

Nasonex 24HR Allergy Nasal Mometasone furoate Perrigo Company Mar 17, 2022 Treatment for Allergic Rhinitis

Spray monohydrate

Adlarity Transdermal System Donepezil Corium, Inc. Mar 11, 2022 Treatment for Alzheimer's disease.

Vonjo Capsules Pacritinib CTI BioPharma Corp. Feb 28- 2022 Treatment for Myelofibrosis.

Carvykti Suspension for Ciltacabtagene Janssen Pharmaceuticals, Feb 28, 2022 Treatment for Multiple Myeloma.
Intravenous Infusion autoleucel Inc.

Releuko Injection Filgrastim-ayow Amneal Pharmaceuticals Feb 25, 2022 Treatment for Neutropenia
LLC Associated with Chemotherapy,
Neutropenia.

Norliqva Oral Solution Amlodipine besylate CMP Pharma, Inc. Feb 24, 2022 Treatment for High Blood Pressure,
Coronary Artery Disease, Angina.

NephroScan Injection Kit Technetium Tc 99m ROTOP Pharmaka GmbH Feb 22, 2022 Treatment for Diagnosis and
succimer Investigation.

THE PHARMA WORLD 105



The global nephrology drugs market was valued FORECAST
at $14,501.75 million in 2020, and is projected
to reach $23,405.42 million by 2030, registering
a CAGR of 5.0% from 2021 to 2030

Market Dynamics COVID-19 Impact Analysis
The growth of nephrology drugs is fueled by fac- The coronavirus outbreak is causing havoc in
tors such as an increase in kidney failure cases, clinical trials worldwide, affecting the man-
an increase in unhealthy lifestyle adaptation, an agement of present trials and the planning of
increase in the prevalence of chronic nephrology future trials. Market competitors and research
diseases, an increase in the geriatric population, institutions, on the other hand, are focusing
an increase in demand for diagnostic tests, an on starting clinical trials related to COVID-19
increase in excessive alcohol consumption, and to understand better the impact of chronic re-
an increase in the obese population. nal disease therapy medications on COVID-19
patients.
Product approvals and launches are expected
to drive market growth over the forecast period. Segment Analysis
The ACE inhibitors segment is expected to grow
Key market players focus on novel product at the fastest CAGR during the forecast period
launches and approvals to expand their prod- (2022-2029). ACE inhibitors currently domi-
uct portfolio and strengthen their global market nates the global nephrology drugs market by
presence. For instance in April 2021, Farxiga is ap- drug class, and this is expected to continue
proved in the United States for the treatment of during the forecast period due to an increase
chronic kidney disease in patients with and with- in the prevalence of various cardiovascular
out type 2 diabetes who are at risk of progression. conditions, as well as changing lifestyles.
In April 2020, GSK has received the first regulatory
approval for Duvroq (daprodustat) in Japan to In 2019, an estimated 17.9 million people
treat anemia caused by chronic kidney disease. died from CVDs, accounting for 32% of glob-
In August 2017, Amgen, Inc. has received approval al deaths. A heart attack or a stroke caused
from the European Commission (EC) to expand Eighty-five percent of these deaths.More than
the use of Mimpara (cinacalcet) for the treatment three-quarters of CVD deaths occur in low- and
of secondary hyperparathyroidism (HPT) in chil- middle-income countries.Cardiovascular dis-
dren aged three years and older who are on dial- eases were responsible for 38 percent of the 17
ysis and whose secondary HPT is not adequately million premature deaths (under the age of 70)
controlled with the standard of care therapy. caused by noncommunicable diseases in 2019.
(Source:World Health Organiation). ACE inhibi-
Furthermore, Amgen, Inc. received FDA ap- tors are used to prevent and cure kidney dis-
proval in February 2017 for its Parsabiv (etelcal- ease (nephropathy) in people suffering from
cetide) indicated for the treatment of secondary hypertension or diabetes.
hyperparathyroidism (sHPT) in adult patients with
chronic kidney disease (CKD) on hemodialysis.

Nephrology Drugs Market 2020
2030
By Drug Class
Ace Indibitors
segment dominated
the market in 2020
and would continue
to maintain the lead
over the forecast
period.

Ace Inhibitors Calcium Channel Beta Blockers Diuretics Others
Blocker THE PHARMA WORLD 107

Wish to Export to Nigeria?

General: Applications:
1. These Guidelines are for the interest of the gen- 1. A written application for registration of im-

eral public and in particular Importers of Phar- ported drug should be made on the company’s
maceutical and Veterinary Drugs in Nigeria. letter head paper to the Director-General (NAF-
DAC), ATTENTION: The Director, Registration &
2. It is necessary to emphasize that, no drug shall Regulatory Affairs (R & R) Directorate, Ground
be manufactured, imported, exported, adver- Floor, NAFDAC Office Complex, Isolo Industrial
tised, sold, distributed or used in Nigeria un- Estate, Oshodi-Apapa Express Way, Isolo, and
less it has been registered in accordance with Lagos State.
the provisions of NAFDAC Act CAP N1 (LFN) 2004, 2. The application letter should include the ge-
other related Legislations and the accompany- neric name of product and brand name (where
ing Guidelines. applicable).
3. An online application form for Product Regis-
tration should be purchased at; http://regis-
tration.nafdac.gov.ng and completed.
4. A separate application form should be submit-
ted for each product.

NIGER CHAD Documentation:
1. The following documents (all originals) and
NIGERIA
BENIN two (2) sets of photocopies (including print-
CAMEROON out of the completed online Registration form)
are to be submitted at the Liaison Office of the
Director (LOD), R & R Directorate, Ground Floor,
NAFDAC Office Complex, Oshodi-Apapa Express
Way, Isolo, Lagos State or any NAFDAC Office
(outside Lagos).
2. Notarized Declaration (Appendix I), to be com-
pleted (typed), signed by Declarant and nota-
rized by a Notary Public in Nigeria.
3. Power of Attorney or Contract Manufacturing
Agreement. An applicant on behalf of a manu-
facturer outside Nigeria must file an evidence
of Power of Attorney from the manufacturer
which authorizes him to speak for his Princi-
pal; on all matters relating to the latter’s spe-
cialties.
4. Contract Manufacturer Agreement. An ap-
plicant filing an application on behalf of his
company, and being the owner of the product,
shall provide a Contract Manufacturing Agree-
ment.
5. Evidence of Business Incorporation of the im-
porting Company with Corporate Affairs Com-
mission in Nigeria.
6. Manufacturing License/Certificate of Free Sale.
7. Evidence that they are licensed to manufac-
ture drugs for sale in the country of origin
(Manufacturer’s Certificate). The license shall

108 THE PHARMA WORLD

be issued by a relevant Health/Regulatory k. Quantitative listing of all the active in- REGISTRATION RULES
Body in the country of manufacture. gredients per unit dose
8. Certificate of Pharmaceutical Product
(COPP-WHO Format) 3. Adequate warnings where necessary.
9. There must be evidence by the competent 4. Where a brand name is used, there MUST be
Health Authority, that the sale of the
product does not constitute a contraven- the generic name which should be conspic-
tion of the drug laws of that country. uous in character, written directly under the
10. Current Good Manufacturing Practice brand name.
(cGMP) of the manufacturing facility. 5. Any drug product whose name or package
11. Dossiers: The applicant shall submit two (2) label bears close resemblance to an already
copies of the Dossiers. registered product or is likely to be mistak-
12. Evidence of Registration of Brand Name en for such registered product, shall not be
with Trademark Registry in the Ministry of considered for registration.
Industry, Trade and Investment. This should 6. See the Agency’s Drug Labeling Regulations
be registered in the name of the owner of and other relevant Regulations for specific
the Trademark/Brand name as the case details.
may be (Trademark Class 5 for Drugs).
13. Copy of valid Annual License to practice for Note:
the Superintendent Pharmacist issued by 1. For New Chemical Entities (NCE), there must
Pharmacists Council of Nigeria.
14. Evidence of valid Premises Retention Li- be evidence that Clinical Trials have been
cense for the facility. undertaken in the relevant population.
15. Comprehensive Certificate of Analysis for Such clinical trial reports must be submit-
product(s) ted and reviewed
16. The Certificate of Analysis must be pre- 2. No combination drug product shall be reg-
sented on a letter-head paper of the qual- istered or considered for registration unless
ity control laboratory where the sample was there is scientific documented evidence to
tested/evaluated prove that such a product has clinical ad-
17. Label or artwork of the product vantage over the single drug available for
18. Letter of Invitation for Good Manufacturing the same indication(s).
Practice (GMP) Inspection: A letter of invita- 3. Failure to comply with these requirements
tion to inspect the factory abroad shall be may result in the disqualification of the ap-
written by the manufacturer plication or lead to considerable delay in
the processing of registration.
Labeling Guidelines for Imported Drugs: 4. A successful application will be issued a
1. Labeling should be informative and accurate. Certificate of Registration with a validity
2. Minimum requirements on the package la- period of five (5) years.
5. NAFDAC reserves the right to revoke, sus-
bel in accordance with the Drug Labeling pend or vary a certificate during its validity
Regulations include: period.
a. Name of product (brand name) where 6. Filing an application form or paying an ap-
plication fee does not confer registration
applicable and generic name. status.
b. Name and full location address of the 7. Failure to respond promptly to queries or
enquiries raised by NAFDAC on the applica-
manufacturer. tion (within 90 working days) will automati-
c. Provision for NAFDAC Registration Num- cally lead to the closure of the Application.
8. The time line for product registration from
ber on product label acceptance of submissions to issuance of
d. Batch No., Manufacturing date and Ex- Registration number is one hundred and
twenty (120) working days.
piry date.
e. Dosage form & strength
f. Indications, frequency, route, conditions

of administration (Over the counter; OTC
drugs).
g. Dosage regimen on the package (Over-
the-Counter; OTC drugs).
h. Patient Information Leaflet (PIL)
i. Prescribing information (for POM).
j. Net content of product

THE PHARMA WORLD 109



Celebrating successful 20 years POST EVENT
presence in Bangladesh

13th asia pharma expo 2022 exhibition

The 13th ASIA PHARMA EXPO 2022 Local International Visitor’s profile
(APE 2022) & ASIA LAB EXPO 2022, Exhibitors Exhibitors
an international exhibition on 06% 04%
COMPLETE pharma manufactur- 44% 56% 21% 27%
ing technologies concluded at 27% 15%
ICCB, Dhaka, Bangladesh. The ASIA LAB EXPO 2022, more than
3-days Exhibition was held from 387 companies from 24 countries ized by the Bangladesh Associa-
May 19 to 21, 2022 at Dhaka. The across the world exhibited and tion of Pharmaceutical Industries
Exhibition celebrated 20 highly displayed their latest products / and GPE EXPO PVT LTD at Dhaka,
successful years in Bangla- services to upgrade the pharma Bangladesh since 2003, offering
desh and helping to develop manufacturing standards of an unparalleled international
the pharmaceutical industry of Bangladesh to a newer height. business and technologies plat-
Bangladesh and making signifi- The 2022 edition was attended form specifically to the entrepre-
cant contribution to Bangladesh by 11,934 trade visitors to explore neurs and the corporate giants
economy. the complete spectrum of latest manufacturing and exporting the
pharma manufacturing tech- pharma medicines globally.
BAPI President, Nazmul Has- nologies & services. The trade
san, MP inaugurated the exposi- professionals attended the Exhi- The Exhibitions are nurtur-
tion as the Chief Guest. Director bition represented Pharmaceu- ing the growth by empower-
General of Drug Administration ticals, Healthcare, Biotech, API, ing the local pharma and allied
(DGDA) Major General Mohammad Neutraceuticals, Personal Care, manufacturing industries on
Yousuf was the Special Guest and Cosmetics, Beverages, Distilleries technological aspects to scale
high officials from various pharma segments from the industry. up the manufacturing practices.
companies were also present.     An overwhelming response by
ASIA PHARMA EXPO and ASIA the local Business Associates as
In his inaugural speech, LAB EXPO - the international ex- well technology solution provid-
Nazmul Hassan said, “Asia Phar- hibitions are being jointly organ- ers from outside Bangladesh was
ma Expo continues to play a very noticed.
important role by providing great
insights into current industry
trends and developments, and
opening up new opportunities
for all the stakeholders from
around the world.”

At ASIA PHARMA EXPO 2022 /

THE PHARMA WORLD 111

ASIA
PHARMA
EXPO
2022
IN
PICTURES

112 THE PHARMA WORLD

THE PHARMA WORLD 113

APPOINTMENTS & PROMOTIONS Imran Hassan has joined Kumar Shuvrojjwal Sampad Md.ZubaidulIslam has recent-
General Pharmaceuticals as with his existing Headship ly joined Everest Pharmaceu-
General Manager, Market- of PMD of Orion Infusion Ltd ticals as a Deputy Manager of
ing & Sales. Prior to this, he and IMD of Orion Pharma Ltd, International Marketing. He
served as Senior Manager, has recently been assigned as started his career with Del-
Product Management De- Head of PMD for Orion Pharma ta Pharma in 2009. In his 12
partment of Square Phar- Ltd as an additional respon- years of professional career,
maceuticals. He started his sibility. He has been serving he has gained diversified ex-
career at Square Pharma in the pharmaceutical market for perience in the field of PMD
2002. He had completed his more than 14 years having a & International Marketing.
B. Pharm and M. Pharm from vast experience in cardiology, Zubaidul Islam completed
University of Dhaka. He also immunology, biotech market, his Post-Graduation in Bio-
obtained MBA from South LVPs – covering both chronic chemistry & Molecular Biol-
East University. care, specialty care and mass ogy from Rajshahi University.
market. He worked for several
local pharmaceuticals and
MNCs. He completed his grad-
uation from Khulna University.

Shagufta Shahzeen Siddiqui Mohammad Ruman Chowd- Anindya Dhar has recently
has recently been promoted hury has recently been pro- been promoted as Senior
as Assistant Manager, Prod- moted as Assistant Manager, Product Executive, Product
uct Management Dept. at Product Management Dept. Management Dept. at Orion
Orion Pharma Ltd. Earlier she at Orion Pharma Ltd. Earlier Pharma Ltd. Prior to this he
served for Novartis Pharma- he served as product execu- has been working as Prod-
ceuticals Limited Bangladesh tive for NIPRO JMI Pharma uct Executive, PMD in same
and Square Pharmaceuticals Limited. Prior to this he was organization. He completed
Limited. She completed her designated as Sr. Product Ex- his B.Pharm from USTC and
Masters from University of ecutive, PMD in same the or- M.Pharm from State Univer-
Glasgow, UK; MBA from North ganization. He had completed sity of Bangladesh (SUB).
South University and B.Pharm his both B.Pharm & M.Pharm
from East West University. from East West University.

114 THE PHARMA WORLD

Diponcor Ghosh has re- Md. Saidul Islam has re- Sheikh Nafeesur Rahman Md. Ariful Islam has re-
cently been promoted to cently been promoted as has recently been pro- cently been promoted as
Senior Product Execu- Senior Product Execu- moted as Senior Product Senior Executive, Interna-
tive, Product Management tive, Product Management Executive, Product Man- tional Marketing Depart-
Dept. at Orion Infusion Dept. at Orion Pharma agement Dept. at Orion ment at Orion Pharma Ltd.
Ltd. Prior to this, he has Ltd. Prior to this he has Pharma Ltd. Prior to this Prior to this he has been
been working as Prod- been working as Product he has been working as working as Executive, IMD
uct Executive, PMD in the Executive, PMD in same Product Executive, PMD in in same organization. He
same organization. He organization. He had same organization. He has completed his B. Pharm
completed his B.Pharm & completed his B.Pharm completed his B.Pharm & M. Pharm from North
M.Pharm from the UODA. from Stamford University and M.Pharm from North South University.
Bangladesh and M.Pharm South University.
from State University Ban-
gladesh.

FAST  10% of the population worldwide is affected by We Mourn
chronic kidney disease (CKD), and millions die
FACT each year because they do not have access to
affordable treatment
THE PHARMA WORLD deeply
 More than 850 million people worldwide have mourns the sad demise of
some form of kidney disease, which is roughly Prof. Dr. Khoorsheed Jahan
double the number of people who live with dia- Maula, an eminent Gynoco-
betes (422 million) and 20 times more than the logic Oncologist, wife of Prof.
prevalence of cancer worldwide (42 million) or MA Salam, renowned Uro-
people living with AIDS/HIV (36.7 million) oncologist of the country
and honorary advisor of THE
 Over 2 million people worldwide currently re- PHARMA WORLD.
ceive treatment with dialysis or a kidney trans-
plant to stay alive, yet this number may only Prof. Khoorsheed was the
represent 10% of people who actually need first gynecologic oncologtist
treatment to live at National Cancer Research
Institute and Hospital.
 In middle-income countries, treatment with di-
alysis or kidney transplantation creates a huge THE PHARMA WORLD 115
financial burden for the majority of the people
who need it. In another 112 countries, many peo-
ple cannot afford treatment at all, resulting in
the death of over 1 million people annually from
untreated kidney failure.

 AKI, experienced by 13.3 million people each
year, may resolve or lead to CKD or kidney failure
in the future.

Doctor’s Diary

Dr. Rafia Alam
Clinical Staff, Department of Neuro-ICU,Square Hospitals Ltd., Dhaka

Time to know LONG COVID Some difficult issues

I am writing this article, remembering my COVID ICU days, Among the long-term effects, Stroke and Myocardial Infarc-
which has been a lifetime experience for me. Those mo- tion are two life threatening complications. Even if these
ments of suffocation inside the PPE, the fuzzy goggles, the patients survive, usual lifestyle is greatly hampered. As I
gloved hands, the praying souls - all were part of the uncer- work in Neuro-ICU, I can visualize all the sufferings imme-
tain war. That was certainly a call for the country, a call for diately while discussing about stroke. The after-effects of a
the humanity. Many a doctors, nurses and other front-lin- stroke can be so severe, that a patient can be disabled for
ers has been infected, has become ‘patients’ themselves. life, and along with it comes the psychological trauma as
well. have already mentioned - younger age groups are not
Now, how is the time going on for all the COVID survi- ‘immune’ from long COVID. Though the incidence is lower,
vors? Study shows, more than 40% of people has reported children and adolescent may also suffer from some forms
persistent or new medical issues months after their ini- of long COVID, which needs much attention from the family
tial COVID infections — a collection of symptoms known as well as the community (i.e., school or college authority).
as long Covid. Among people who needed hospitalization,
the stats go up to 57%. And it does not matter whether a Combating long COVID
patient was healthy or had any co-morbidity before get-
ting infected with SARS CoV-2. It’s time to think about Long We need to empathize with the people suffering from
COVID or post-COVID conditions (PCC), which is also known the lingering symptoms and support them to the best of
as post-acute sequelae of SARS CoV-2 infection (PASC), our abilities- physical, social, and psychological. There is
post-acute COVID-19 or chronic COVID. Severe COVID-19 or no alternative to seeking medical help and vaccination.
patients without COVID vaccine are prone to develop long Checking in with the doctors is a good first step. Doctors
COVID. Though there may be some risk factors (hyperten- can recommend tests and treatments that helps with the
sion, diabetes, smoking, obesity etc.) for developing long lingering symptoms. Listening to the patients carefully and
COVID, even young, healthy people, without any underly- advising the right - both are important. It may take quite a
ing medical conditions, can also experience some debili- long time to recover from long COVID.
tating long-term residual symptoms.
Post-COVID care is as essential as ever. Prevention of
Let’s know some symptoms COVID itself will naturally prevent long COVID. As many
people have already been in a post-COVID state, ensuring
Long COVID can even be a problem up to years. The mani- balanced diet, peaceful sleep, regular exercise is manda-
festations of Long COVID are so varied that one study tory. Stretching exercises are helpful. Smoking, alcohol-
evaluated  203 symptoms  that may fluctuate or even ap- ism, and drug abuse are strictly prohibited. Enjoy life to
pear suddenly after patients seem to have recovered fully. the fullest. Do not forget the value of life, the value of time
[1] Fatigue (chronic fatigue syndrome) and post-exertional
malaise are among the most common symptoms. Long A simple smile can change the world. Why not to try
COVID can also present with cardiac, respiratory, gastroin- that change in this post-COVID Bangladesh? Helping a sick
testinal or even neurological symptoms. Patients may have neighbor can be as simple as helping him/her to carry a
respiratory distress, cough, chest pain, palpitation, head- bag upstairs or even just keeping in touch.
ache, sleep disturbance, lightheadedness, difficulty in con-
centrating, changes in smell or taste. Cognitive and neuro- Every moment of life is a blessing. Sharing our time with
logical symptoms are common in people with long COVID. the ‘near’ ones can add so much value to their daily lives.
Some can develop anxiety or depression. Brain fog, lack of So, it is my earnest request to all the readers, please do
clarity, difficulties in concentration, forgetfulness etc. are not forget to share your time with your near and dear ones.
also among the cognitive effects. SARS-CoV-2 infection has
also been reported to cause brain inflammation and even One can easily think of the colorful lives of the young
cell death, among other forms of brain injury. people before the time frame of COVID-19. How lively that
could be- only if there was no such thing as a novel Corona
Among the COVID survivors who had to stay in Inten- virus!
sive Care Unit, may develop post-intensive care syndrome
(PICS), which include muscle weakness and symptoms of References
post-traumatic stress disorder (PTSD). Davis, H. E., Assaf, G. S., McCorkell, L., Wei, H., Low, R. J., Re’em, Y., ...
& Akrami, A. (2021). Characterizing long COVID in an international
cohort: 7 months of symptoms and their impact.  EClinicalMedi-
cine, 38, 101019.

116 THE PHARMA WORLD

Event Venue Date UPCOMING EVENTS

INTERPHEX Week Tokyo Tokyo, Japan  July 13–15, 2022
Medical 2022 Chennai, India July 29 –31, 2022

INTERPHEX KOREA 2022 Seoul, Korea  Aug 03 – 05, 2022 

Vietnam Medi-Pharm Expo 2022 Ho Chi Minh City, Vietnam  Aug 11 – 13, 2022 

Medical Japan 2022 Osaka, Japan Aug 12–14, 2022

2nd Global Conf. on Pharmacy & Pharmaceutical Science Ontaria, Thailand Aug 22 – 23, 2022 

Medical Fair China 2022 Shanghai, China  Aug 21–24, 2022

Medical Philippine 2022 Aug 24–26, 2022

Indohealthcare Expo 2022 Jakarta, Indonesia Aug 25 – 27, 2022

MEDICAL FAIR ASIA 2022 Singapore  Aug 31–Sep 02, 2022 

MEDIC WEST AFRICA 2022 Lagos, Nigeria Sep 07–09, 2022

Thailand LAB International 2022 Bangkok, Thailand  Sep 14 – 16, 2022 

India Lab Expo & analytica Anacon India 2022 Hyderabad, India Sep 15 – 17, 2022 

Asian Healthcare & Pharma Show 2022 Kuala Lumpur, Malaysia  Sep 19 – 21, 2022 

Oman Health Exhibition & Conference Muscat, Oman Sep 26 – 28, 2022 

Jeddah Health 2022 Jeddah, KSA Oct 09–11, 2022

All Pack Indonesia 2022 Jakarta, Indonesia  Oct 12 – 15, 2022 

MYANLAB 2022  Yangon, Myanmar  Oct 14 – 16, 2022 

The Saudi International Medlab Expo 2022 Riyadh, KSA Nov 07–09, 2022

Vietnam Medi-Pharm Expo 2022 Hanoi, Vietnam Dec 01 – 03, 2022

CR EXPO 2022 Beijing, China  Dec 03 – 05, 2022

2nd Pharma Middle East Congress Abu Dhabi, UAE Dec 05 – 06, 2022

12th World Gastroenterology & Hepatology Conference Dubai, UAE Dec 10 – 11, 2022

CPHI China 2022 Shanghai, China Dec 20 – 22, 2022

Maghreb Pharma Expo 2023 Algeria Feb 07–09, 2023

PharmaLab Expo OSAKA 2023 Osaka, Japan  Mar 08–10, 2023

Global Pharma & Drug Delivery Summit 2023 Frankfurt, Germany Apr 24–26, 2023

THE PHARMA WORLD 117