Regulatory Affairs

1. Presenting by:
Tahira Sultana, Fariha Aziz, Aisha Faheem,
Tasaduq, Hamed, Shibly Shakil
IHM,DUHS
Regulatory affairs

2. Licensing
•It indicates- all the proper checks and the benefits of a medicine
believed to outweigh the risks.
•Licenses are granted- when high standards of safety and quality are
met during the development and manufacture of a medicine.
•In the UK, licenses can be granted by:
the Medicines and Healthcare Product Regulatory Agency (MHRA)
grant licenses for medicines only in the UK.
•Drug Regulatory Authority of Pakistan (DRAP) – grant licenses for
medicines in Pakistan.

3. What information does a license
include?

4. The license for a
medicine includes
information such as:
 what health condition it should be used to
treat
 what dose should be used
 what form it takes – such as a tablet or
liquid
 who can use the medicine – for example,
only people above a certain age
 how long treatment with that medicine
should last
 warnings about known safety issues – such
as side effects and interactions with other
medicines
 how the medicine should be stored
 when the medicine expires

5. Unlicensed medicines
Unlicensed medicines are commonly used in some areas of
medicine such as in pediatrics, psychiatry and palliative care.
They are also used, less frequently, in other areas of medicine.
Off-label use means that the manufacturer of the medicine
has not applied for a license for it to be used to treat your
condition.
In other words, the medicine has not undergone clinical trials
to see if it is effective and safe in treating your condition.
Many experts will use an unlicensed medication if they
think the medication is likely to be effective and the benefits
of treatment outweigh any associated risk.

6. Types of License:
1. Form-6 License: This type of Drug Sales license should be
used for Retail sales of Medicines.
2. Form-8 License: This type of Drug Sales license should be
used for Pharmacy type sales of Medicines.
3. Form-9 License: This type of Drug Sales license should be
used for sales of Narcotics Medicines by all ways like (Retail,
Whole sale or Manufacturer).
4. Form-7(a) License: This type of Drug Sales license should be
used for the sales of Medicines by way of Whole Sale or
Distribution.
5. Form-7 License: This type of Drug sales license should be
used for the sales of Medicines for Importers, Exporters,
Indenters and Manufacturers.

7. Drug Recall:-
Actions taken by firm to remove drug from market.
Conduct by a firm’s own initiatives.
OR
May conduct by FDA order under statutory authority.

9. 1- Hospira
Date Brand Name Product Description Reason Company
12/23/2014 Hospira MitoXANTRONE Hospira Inc.Due to
confirmed
sub
potency
and
elevated
impurity
levels.

10. 2-Baxter
Date Brand Name Product Description Reason Company
12/11/2014 0.9% Sodium Chloride
Injection USP
Contains
Particulate
Matter
Baxter Baxter
International
Inc.

11. 3-Gastrotec
Date Brand Name Product
Description
Reason Company
12/12/2014 Gastrotec Combination of
Omeprazole
and Misoprostol
in a paste
Not approved
for use as an
animal drug
Tristar Equine
Marketing, LLC.

12. 4-Heart Sync Inc.
Date Brand Name Product
Description
Reason Company
11/26/2014 Heart Sync Multi-function
Defibrillation
Electrodes
Electrodes will
not connect
with Philips FR3
or FRx AED
units.
Heart Sync Inc.

13. 5- Forever Beautiful
Date Brand Name Product
Description
Reason Company
11/19/2014 Forever
Beautiful
Dietary
Supplement
Unapproved
new drug
REFA
Enterprises,
LLC

14. 6- Mayhem dietary supplement
capsules
Date Brand Name Product
Description
Reason Company
11/14/2014 Mayhem
dietary
supplement
capsules
Dietary
Supplement
Unapproved
new drug
Chaotic Labz

15. 7- Sagent Pharmaceuticals
Date Brand Name Product
Description
Reason Company
10/03/2014 Sagent
Pharmaceutical
s
Ketorolac
Tromethamine
Injection, USP,
30mg/mL
single-dose
vials
Due to labeling
the product
with the
incorrect
expiration
date/The
labeled
expiration date
is longer than
the known
stability of the
product.
Sagent
Pharmaceutical
s

16. 8- Wyked Labs and Anabolic
Science Labs
Date Brand Name Product
Description
Reason Company
12/12/2014 Wyked Labs
and Anabolic
Science Labs
Dietary
supplement
capsules used
for body
building and
weight loss
Undeclared
Synthetic
Hormone/Proh
ormone
Ingredient
Wyked Labs

17. 9- ABC Dophilus Powder
Date Brand Name Product
Description
Reason Company
11/17/2014 ABC Dophilus
Powder
Dietary
Supplement
Contains
Rhizopus
oryzae
Solgar, Inc.

18. 10- Saba
Date Brand Name Product
Description
Reason Company
10/17/2014 Saba Salmonella AMS Health
Sciences, LLC
Shark
Cartilage
Complex
Dietary
Suppleme
nt

19. 11- Pharmacy Creations
Date Brand
Name
Product Description Reason Company
09/06/2014 Pharmacy
Creations
Ascorbic Acid,
Glutathione, Magnesium
Chloride,
Tropi/Cyclo/Phenyl/Tobra
/Flurb
Lack of sterility
assurance
Pharmacy
Creations

20. 12- RegeneSlim
Date Brand Name Product
Description
Reason Company
08/27/2014 RegeneSlim Appetite
control dietary
supplement
Presence of 1,3-
dimethylamyla
mine (DMAA),
methylhexana
mine, or
geranium
extract
Regeneca
Worldwide, a
division of
VivaCeuticals,
Inc.

21. 13- Vibrant Health
Date Brand Name Product
Description
Reason Company
08/01/2014 Vibrant Health Dietary
Supplements:
Green Vibrance
and Rainbow
Vibrance
Salmonella New England
Greens LLC

22. 14- American Health Packaging
Date Brand Name Product
Description
Reason Company
07/21/2014 American Health
Packaging
Ibuprofen Tablets,
600 mg &
Oxcarbazepine
Tablets, 300 mg
mislabeled
inner unit dose
blister
packaging
American
Health
Packaging

23. 15- B-Lipo
Date Brand Name Product Description Reason Company
12/19/2014 B-Lipo Dietary supplement
capsules used for weight
loss
Undeclared
Drug
Ingredient
Bethel
Nutritional
Consulting, Inc.

25. Date Brand
Name
Product Description Reason Company
12/01/2015 OmniPod
OmniPod Insulin
Management System
Failure to
deploy or
delay in the
deployment
of the needle
mechanism
Insulet
Corporation
16-Omni Pod

26. Date Brand
Name
Product Description Reason Company
06/12/2015 Pyrola
Advanced Joint Formula
capsules
undeclared
diclofenac
and
chlorphenira
mine
G&C Natura
17-Pyrola

27. Date Brand
Name
Product Description Reason Company
06/03/2015 Smart Lipo
Smart Lipo (800, 900,
950 mg) capsules
Undeclared
sibutramine,
desmethylsib
utramine,
and
phenolphtha
lein.
SmartLipo365
18-Smart Lipo

28. Date Brand Name Product Description Reason Company
04/22/2015
Mucinex Fast-
Max
Mucinex Fast-Max
Incorrect
labeling -
Undeclared
levels of
Acetaminoph
en,
Dextrometho
rphan,
Guaifenesin,
Phenylephrin
e and/or
Diphenhydra
mine
RB (formerly
Reckitt
Benckiser)
19-Mucinex Fast-Max

29. Date Brand
Name
Product Description Reason Company
11/25/2015 Glades Drugs
Compounded
Multivitamins
Contains
high
amounts of
Vitamin D3
Glades Drugs
20-Glades Drugs

30. Date Brand
Name
Product Description Reason Company
10/30/2015 Auvi-Q
Epinephrine injection,
USP (0.15 mg and 0.3
mg)
Potential
Inaccurate
Dosage
Delivery
Sanofi US
21-Auvi-Q

31. Date Brand
Name
Product Description Reason Company
10/09/2015
Medline
Industries,
Inc.
Over the counter
Acetaminophen tablets.
The
Acetaminop
hen tablets,
500mg is
incorrectly
labeled as
325 mg
tablets.
Medline
Industries, Inc.
22-Medline Industries, Inc.

32. Date Brand
Name
Product Description Reason Company
07/30/2015 Unichem
Hydrochlorothiazide
Tablets 25 mg 1000-count
bottle
Potential
presence of
foreign
tablets
Unichem
Pharmaceuticals
(USA), Inc.
23-Unichem

33. Date Brand
Name
Product Description Reason Company
07/13/2015
Mylan
Institutional
LLC
Calcium Chloride
Intravenous Infusion 10%
in 10 mL prefilled glass
syringes
Incompatibil
ity between
syringe and
needleless
adapters
Mylan
Institutional
LLC
24-Mylan Institutional LLC

34. 25- Medline Industries, Inc.
Date Brand Name Product Description Reason Company
10/09/2015 Medline
Industries,
Inc.
Over the counter
Acetaminophen tablets.
The
Acetaminop
hen tablets,
500mg is
incorrectly
labeled as
325 mg
tablets.
Medline
Industries,

35. 26- REFRESH®, FML® and Blephamide®
Date Brand Name Product Description Reason Company
08/24/2015 REFRESH®, FML® and
Blephamide®
REFRESH® Lacri-Lube®, REFRESH
P.M.®, FML® (fluorometholone
ophthalmic ointment) and
Blephamide® (sulfacetamide sodium
and prednisolone acetate ophthalmic
ointment, USP)
Contains
particulate matter
Allergan plc

36. 27- Teva Parenteral Medicines Inc.
Date Brand Name Product Description Reason Company
07/24/2015 Teva
Parenteral
Medicines
Inc.
Adrucil (fluorouracil
injection, USP) 5 g/100
mL (50 mg/mL)
Potential
presence of
particulate
matter
Teva Parenteral
Medicines Inc.

37. 28- Akttive
Date Brand Name Product Description Reason Company
07/23/2015 Akttive High Performance Fat
Burner Gold capsules
Undeclared
Drug
Ingredients
Life & More,
LLC

38. 29-PharMEDium
Date Brand Name Product Description Reason Company
12/31/2015 PharMEDium Norepinephrine
Bitartrate added to
Sodium Chloride
Discoloratio
n
PharMEDium
Services, LLC

39. Date Brand
Name
Product Description Reason Company
Dec 2015 Effexor XR Antidepressant
(venlafaxine HCl)
packaging
mix-up /
capsule of
the
(dofetilide)
was found
in a bottle
of
antidepress
ant Effexor
XR
pfizer
30-pfizer

40. The government should develop the infrastructure and expertise required
for basic drug manufacturing.
it should ensure local production of drugs whose patents have run out to
lower the prices of drugs.
 it should allow import of basic raw materials from India in view of the
latter's expertise in this sector till Pakistan's pharmaceutical industry comes
of age.
 Despite of all this, many developing WTO member countries have
granted compulsory licenses for patented essential medicines .
it is crucial time that Pakistan must ensure that drugs are available in
domestic markets at affordable prices as lives and health of millions of its
people depend on access to these medicines.
conclusion

41. It's too easy for drug manufacturers to continue to
save dollars instead of lives
It's difficult to inform patients when drugs are are
recalled.
We can all likely agree we're lucky drugs aren't recalled as
frequently as cars.
But when the Food and Drug Administration or a manufacturer
recalls medicine, it's particularly troublesome because getting to
the patient who is prescribed that medicine is not as easy as
informing people who drive a Chevy Cobalt with a faulty ignition,
or one of 34 million owners with defective air bags.