Table of Contents

• Statistical Overview Page 3 – 8

• Major Policy Decisions Page 9 – 18
• Subsequent Position of Decisions Page 19 – 22
• Special Guidelines for Applicants Page 23 - 26
to Avoid inconveniences for future
Statistical Overview
NO. OF REGISTRATION
CASES FROM SOUTH
Total Cases Discussed
468
1789 NO. OF REGISTRATION
CASES FROM NORTH

1321

3
Statistical Overview
APPROVED CASES SOUTH

Approved Cases
353
1278 APPROVED CASES NORTH

925

4
Statistical Overview
DEFERRED CASES SOUTH

Deferred Cases
115
511 DEFERRED CASES NORTH

396

5
Statistical Overview
Toll Manufacturing South

Toll Manufacturing Total Cases Total Cases 21

86
Approved Cases 14
Deffered Cases 7

Toll Manufacturing North

Total Cases 65

Approved Cases 53
Deffered Cases 12

6
 Top 15 companies with highest number of registration

NO. COMPANY NAME REGISTRATION

1. Haarolds Pharmaceutical Pvt Ltd, Bhimber AJK 283
Statistical Overview 2. Daneen Pharma Pvt Ltd Lahore 34
3. Grand Pharma Pvt Ltd, Rawat, Rawalpindi 30
4. MALLARD PHARMACEUTICALS (PVT) LTD. 27
5. Medisave Pharmaceuticals. Lahore 27
6. Semos Pharmaceuticals Pvt Ltd. Karachi 26
7. Neutro Pharma, Lahore 25
8. Biogen Pharmaceuticals Rawalpindi 24
9. Bio Labs Pvt Ltd. Islamabad 23
10. Mega Pharmaceuticals Limited. Lahore 23
11. Nabiqasim Industries (Pvt) Ltd.,Karachi 23
12. Selmore Pharmaceuticals Pvt Ltd, Lahore 22
13. Demont Research Laboratories. Sheikhupura 21
14. Radiant Pharma Pvt Ltd. 19
15. Sami Pharmaceuticals (Pvt) Ltd. Karachi. 19

7
 Top 15 companies with highest number of
approved registration cases
NO. COMPANY NAME REGISTRATION
Statistical Overview 1. Haarolds Pharmaceutical Pvt Ltd, Bhimber AJK 175
2. MALLARD PHARMACEUTICALS (PVT) LTD. 26
3. Daneen Pharma Pvt Ltd Lahore 25
4. Neutro Pharma, Lahore 21
5. Biogen Pharmaceuticals 8Km, Rawalpindi 20
6. Demont Research Laboratories. Sheikhupura 20
7. Radiant Pharma Pvt Ltd. 19
8. Semos Pharmaceuticals Pvt Ltd. Karachi 19
9. Sami Pharmaceuticals (Pvt) Ltd. Karachi. 18
10. Nawan Laboratories (Pvt) Ltd, 17
11. Pacific Pharmaceuticals Ltd. Lahore 17
12. Manhattan Pharma. Karachi 16
13. Mega Pharmaceuticals Limited. Lahore 16
14. Bio Labs Pvt Ltd. Islamabad 15
15. Caliph Pharmaceuticals Pvt Ltd, Risalpur, KPK 15

8
MAJOR POLICY DECISIONS

9

Product Registrations Not to be
Deferred on Fees Payment Issues
During the 297th DRB meetings it was decided that
the practice to defer cases due to irregularities /
shortcomings due to official fees payment by what
so ever reason will not be continued and instead
the registrations shall be granted to the applicant
on the basis of the technical documents / dossiers
submitted by the applicant and a special condition
as to payment of pending/ differential fees be
imposed before issuance of registration letter to
the applicant.
10

Requirement for API Specific GMP
Replaced with API Manufacturer’s GMP
for Issuance of NOC and Other Approvals
During the meeting it was discussed and strongly
advocated by the PPMA representative that the
requirements for product specific GMP for APIs
specially being imported from China is too harsh
due to intellectual property issues in China and
various other inherent limitations prevailing
thereon. Thus, It was decided, approved and
instructed that instead of Product Specific GMP
the evidence of the API manufacturer’s facility
GMP shall form sufficient evidence as to its GMP
compliance and import NOCs shall be processed
accordingly.
11

Patent Linkage Not to be Practiced While
Granting Product Registration
It was a long debate at the 297th DRB that
whether DRB should entertain the branded
generic applications received against the patented
drugs or not. Pharma Bureau and the legal
department were of the opinion that the patented
drugs should not be granted / considered for
generic drug registration as it might be against
the court orders and may even fall under the
contempt of court. However, PPMA representative
strongly opposed and referred various decision of
court cases where the local industry successfully
won the cases (like Alendronate Sodium,
Escitalopram Pregabalin, etc.) against the MNC’s
filed patents. Moreover, the PPMA and its
members are regularly filing revocations against
the patents filed / granted to the MNCs at various
High Courts of Pakistan.
12

Patent Linkage Not to be Practiced While
Granting Product Registration
It was also advocated that patent linkage falls under the
umbrella of “TRIPS Plus” concept which the developing
countries like Pakistan cannot afford at all.
It was further elaborated that the patents awarded in
Pakistan had been quite irrational and there are process,
product and even indication patents that are granted to the
MNCs in the past, thus, linkage of IP and Patents to Drug
Registration is not advisable at all. Finally we emphasized
that the referred decision of Sindh High Court in case of
Linagliptin in no manner restricts the DRB or DRAP not to
consider, evaluate or grant the drug registration to the
applicants and neither directs DRAP to create patent
linkage. Therefore, DRB should consider the applications on
the technical grounds and not on the issues which are being
finalized by the Honourable Court of Pakistan.
Thus, it was decided that since there is no clear directive
issued to DRAP regarding patent linkage by any of the
Honourable Court of Pakistan, therefore, the applied
registrations shall be only considered on the technical
grounds as all other regular drug registration applications
and decisions thereon shall be made accordingly.
13

Issue for Declaring Products as
“MISBRANDED” for Stating “Manufacturer’s
Specs” on the Product Pack
During the meeting it was discussed that the manufacturers
using their own specifications are facing huge problems as
the PQCB in Punjab and other regions have started declaring
the products “MISBRANDED” despite the manufacturers are
following their approved specifications. The case was
further elaborated that the DRAP through its letter in 2019
directed all manufacturers to strictly follow the
pharmacopeia reference for their products and not to use
the term “manufacturer specs” for the products which fall
under BP, USP, JP etc. on which both PPMA and Pharma
Bureau representative responded accordingly. Pharma
Bureau was of the opinion that the relevant pharmacopeia
has actually adopted their specification so they should be
granted the permission to use their specification as they
were the ones who successfully worked and developed/
validated the specifications initially.
14

Issue for Declaring Products as
“MISBRANDED” for Stating “Manufacturer’s
Specs” on the Product Pack
PPMA representative commented that the
specifications claimed on their product packs are
finalized and validated after detailed workings,
deliberations and rationale, they acknowledge the idea
that manufacturers should shift from the
manufacturer’s specs to Pharmacopeial specs to
maintain uniformity; but a reasonable period of time
should be extended to effect this change /
transformation in a swift manner.
Hence, it was decided that DRAP shall issue a
notification that during next 6 months, all
manufacturers should shift to pharmacopeia specs for
their products and the same must be mentioned on
their relevant product packs. Moreover, the same
instructions for relaxation of 6 months period shall be
communicated SUBSTANDARD or MISBRANDED” on this
particular ground. Moreover, the DRB also extended
their cooperation to manufacturers for getting their
those specifications approved from DRAP that are more
stringent than the relevant Pharmacopeia Specifications
of any particular product.
15

Contract Manufacturing Facilities To
Maintain Adequate Testing Facilities
During the meeting the DRB despite the penal inspection
report critically reviewed the testing capabilities of the
contract manufacturer to ascertain their capacities for
testing the contract manufactured product. This point is
mentioned as we observed that the limited number of
vital QC testing equipment may lead to rejection in
contract manufacturing applications ion future. Thus,
members are advised to choose those manufacturing
partners wisely and for contract manufacturers it is
advised that they should enhance their QC Testing
capacities as well.
16
 • For APIs which are not supported by Zone IV-A
Stability studies the Mandatory Data Logger
requirement has been removed /relaxed;

• Degradation studies of 1 year for APIs not providing

CTD Dossier: Relaxation in Dossier Zone IV-A Stability studies has now been reduced to
Requirement 6 months;

• Product development data including stability study

data along with related documents shall be
acceptable after completion of 3 months. These shall
be evaluated and shortcomings (if any) will be
communicated to the applicant. The case will be
presented before the Board upon the submission of 6
months stability study data after its necessary
evaluation.

17
 • For Generic Products whose originator is available in
CTD Dossier: Relaxation in Dossier Pakistan, CDP with the innovator brand shall be
Requirement accepted, in all other cases CDP of the reference
product available in the market shall be accepted by
the DRB for the registration of such product.
However, it must be ensured that the generic
formulation is registered and approved by any of the
reference regulatory authority like USFDA, EMA. UK-
MHRA. TGA, Health Canada etc.

18
 Subsquent Position
of Decisions Taken During 297th DRB

19
Circular to Resolve the Issue of
Mislabeled and Misbranded Products

20
Acceptance of Form 5 F with 3
Months Product Development and
Stability Data

21
Circular for Establishments of
Facilitation Desk for Submission of
Form 5F (CTD Dossier)

22
Special Guidelines to Avoid Deferment
for the Applicants

24

Special Guidelines Based on the
Observations at DRB Meeting for the
Applicant
During the meeting a lot of product registration got
deferred due to careless or casual attitude or even lack
of follow-up with relevant DRAP officials of the applicant
companies which needs to be addressed to avoid the
deferment of cases these included the following:
• Declaration of Form 5 was not submitted
• Product Registration Details in Reference
Regulatory Authority not mentioned
• Errors while disclosing the brand name or the
company name of the reference product
• Comparative studies data of the leading brand
instead of innovator brand in the country
• Wrong origin/ information about reference
product / Reference Regulatory Authority
23
 • Trying to convince alternate method of testing
when pharmacopeia method exist ( Colecalciferol
Injection multiple cases were deferred)

Special Guidelines Based on the • Dissolution test performed at wrong time

Observations at DRB Meeting for the intervals
Applicant • Errors while mentioning the label claim

• Not mentioning the relevant salt of the API in the

dossiers

• Lack of follow-up to acknowledge that the data/

documents submitted whether suffice the queries
or not

• Errors in mentioning dosage form like capsules

mentioned in place of tablets and vice versa .

25
 • Not mentioning the exact final packaging for each
strength applied – especially in cases of Veterinary
Products as range started from 5 gms to 150 Kg or
from 1 ml 1000 liters

Special Guidelines Based on the • Stating confused conclusion of the conducted

Observations at DRB Meeting for the studies
Applicant
• Not mentioning / providing the evidence of
approved relevant manufacturing section

• Failing to attach the GMP status / certificate of

Applicant or Manufacturer of API , etc.

26
Thank You