Timeline Summary to keep the record straight

Timeline Summary
Roohi B. Obaid, R. Ph., M. Phil. Karachi Pakistan
Alumni CDER-USFDA & HPFB, Health Canada, Member ISPE & PDA
Timeline Highlights indicating silence of parent organization on complaints/ grievances and victimization Page 1/22
(1) 29 Oct 2013 (Annexure 001): A drug product must be safe, effective and of quality. It
should contain the right dose and should be able to deliver inside the body appropriately.
It must fulfill the promise on the label. Drugs are registered before they are developed
and allowed for marketing. Without assessment of developmental data, a drug can never
be considered safe and assumed of appropriate quality to deliver therapeutic promise. The
tools and approaches used by the organization (DRAP) are unable to assess the safety of
patients and quality of drugs under the prevailing practices. No example of such practice
exists in any part of the world, in the best of my knowledge. This assessment to ensure
safety, efficacy and quality of drugs is not optional but an obligation by regulation.
Nothing is still responded yet from any concerned quarter.
(2) 29 Oct 2013 (Annexure 001): Furthermore, the drug products should be manufactured in
an environment that does not render it unsafe. They should be effective and of quality,
manufactured in a consistent manner, free from contamination/ cross-contamination and
mix up. This is possible when good manufacturing practices are followed. The approval
procedure of map (manufacturing facility design) by DRAP for its process segments,
flows and utility supplies is so theoretical that a number of companies do not qualify for
its adherence to Good Manufacturing Practices (GMP) standards and intent of regulation.
It is a reality that the manufacturing facilities qualified by the DRAP have not yet
succeeded in approval from any developed country for its compliance. A document was
written highlighting these issues. The same was not responded. Appropriate design is an
obligation by law and intent of GMP regulations. Nothing is still responded yet from any
concerned quarter.
(3) Safety Alerts (Annexure 002): Monitoring of drug’s unwanted/unreported responses
after it is introduced in the market is done to uncover any adverse effects that were not
known before its inception in the market. It is one of the tools to keep an eye on the
safety of consumers. Post marketing surveillance is a critical element of the drug
regulations where safety alerts are being issued from time to time. In Pakistan, even after
establishment of potential safety risks and request for issuance of safety alerts (that were

Timeline Summary
written and prepared for just publication), DRAP did not take interest to issue the safety
alert and to amend the label of drug products. This is also not an option but required by
regulations under the Drugs Act, 1976. A list of number of safety alerts is shown in
Annexure 002. Nothing is still responded yet from any concerned quarter.
(4) 27 March 2014 (Annexure-003): Despite conducting the debate and discussion on
scientific aspects raised by the officer or giving the opportunity to explain the facts,
observations on inspection reports were discouraged and practically thrown away without
assigning any reason. In this regard, a letter was written through proper channel to
competent authority that is Chairman Central Licensing Board and the Director Quality
Assurance and Lab Testing on the subject “Public Safety and CLB Decisions”. This letter
narrated the actual realities that pose public safety under threat and quality of drugs
questionable. For the sake of example, Chemistry Manufacturing Controls (CMC)
document, batch size, stability frequency are not in accordance with the principle of
science that is otherwise cross-referred in DRAP Act, 2012. Nothing is still responded yet
from any concerned quarter.
a. GMP inspection of multiple drug and dosage manufacturing facility in few
hours: Can a manufacturing facility of multiple dosage forms (which has to produce
a life saving products) of pharmaceutical/biological product inspected for GMP in
few hours, be allowed to manufacture drug by CLB? If not, why it is considered?
b. Efroze Tragedy of GMP Failure and CLB: Has CLB courage to accept its
conclusive responsibility of granting Drugs Manufacturing License and its continuous
renewals, where design of flow was found one of the major reasons of mix-up of
material and took worthy lives of over 100 people. Could CLB please recall the
difference of opinion of undersigned recorded on Efroze Chemical Industries
inspection book in 2005?

Timeline Summary
c. Theoretically contaminated dressing subject to be applied on open wounds: Can
an unsterile (not free from microorganism) product (which is to be applied on cut
wound where blood supply is punctured) be allowed manufacturing under street air
and for marketing by CLB? If not, please share what are the scientific bases to
consider?
d. Import restrictions on CLB declared “very good GMP Facilities” in a country
like Sudan: Is it not true that country like Sudan etc. is now disqualifying the
facilities, which are otherwise declared “very good” by CLB? Does CLB ever tried to
revisit the procedure and identify the potential mistake(s) or ongoing dishonesty with
the mission of protection of public health. Does giving recommendations of GMP
compliance to the facilities by the members, who have insufficient experience and
formal qualification to determine GMP compliance levels, is not dishonesty? Could
CLB please share the credential of members regarding GMP Inspections and its
acceptance from any international regulatory authority?
e. Credential of CLB approved drugs manufacturing facilities around the modern
world: As a matter of fact, none of the CLB approved facilities are qualified by USA,
Japan, Europe, Australia, New Zealand, Canada, Singapore, Saudi Arabia, GCC etc.
for any product, whereas, about 300 facilities of the next door neighbor are qualified
for their products by above countries. Could CLB please identify the reason(s) and
remedy to supply drugs to our nation as safe as they should be?
f. Registration of drugs without real data as a token of motivation under Board
Policy: Does granting of registration of drug products for market consumption by
default upon issuance of DML not possess potential to harm the public, if not, can
CLB please refer any reference country where someone is allowed to manufacture
products without assessment of their real data?

Timeline Summary
(5) Neither CLB nor DRB included my name for any inspection on wishes of the companies
as I am not ready to give promise of good remarks before inspections. In last about 5
years, I am the only officer of my batch even junior batches who was forcedly kept away
from inspections that is my indeed area of expertise. DRAP preferred to engage people
even from pricing section for inspections. If data of every individual is compiled to see
the engagements of batch mates and even juniors in inspections, it will show a huge gulf
in between me and my colleagues. I am of strong opinion that inspections conducted by
our colleagues are not up to the level recognizable by the international world. We can see
more than one inspection in a day; we can see teachers of universities without any
relevant practical experience being included in inspection team. We may see
professionals of other fields like hospital pharmacy and medicine are authorized to
conduct GMP inspections. This is just a professional dishonesty and fun as a cardiologist
may never be considered as a mechanical engineer just because he knows mechanics of
heart.
(6) 11 March 2015 (Annexure-004): I have applied for long leave as per offer of Minister/
Secretary given publicly by the then Director QA & LT in a joint meeting of officers and
officials of DCA and CDL office at Karachi in presence of CEO, DRAP. Accordingly, I
applied and followed, but nothing was responded.
(7) 16 March 2015 (Annexure-005): I was transferred instead of being granted leave. This
was 5th
transfer in last 33 months across the Pakistan and was continuation of consistent
exploitation, visible discrimination due to insusceptibility to pressure, standing on
honesty and recording of truth. This transfer was indeed an attempt to stop me from my
duties where I have to conduct GMP inspections and have written several policies,
guidance documents, safety alerts etc. I persuaded for rule of law and identified
discrimination and forceful/ unlawful resistance to stop me from my legitimate duties.
Following is extracted for quick reference, however, nothing is still responded yet from
any concerned quarter.

Timeline Summary
a. Contempt of Court Orders: I am still in civil service and transferred (without
any explanation and reason) more frequently than other colleagues (Colleagues
who are posted in same office for more than 5 years but not considered for
transfer due to the reason best known to God or competent recommending
authority). People from outside the DRAP are placed at high positions of DRAP
with unwritten discretionary powers that are certainly against the spirit of
judgment of Honorable Supreme Court, what I believe.
b. Parking of Officer without any Job: Instead of considering my recorded grave
concerns about the safety of drugs and protection of public health, I was forcedly
kept away from any job and DRAP did not bother to respond a series of
communications. I was not allowed and deliberately kept away from any job for
more than two years, don’t I have the right to know, who is responsible and what
action can protect reoccurrence of such practice in future for any other officer? Is
it not against the spirit of Honorable Court Order?
c. Sincere Efforts for Waste: Despite of the above facts, the undersigned realized
her moral duty and voluntarily engaged her in writing of Regulatory Initiatives,
Guidance Documents, Drug Safety Alerts, Scientific Policies and organizing free
of cost Training Initiatives of key Pharmaceutical Professionals from
manufacturing industries (Over two hundreds). During this tenure, several
important issues of public safety were raised with recommendation of appropriate
frameworks for response. All the work was accordingly communicated to
Director Pharmacy Services, Quality Assurance & Lab Testing and Chief
Executive Officer (CEO) Office but never considered and this way practice of
throwing the sincere efforts is being continued.
(8) 01 Jun 2015 (Annexure-006): Upon rejection of my concern without assigning any
reason and permission to continue manufacturing and supply of potentially contaminated
dressings by granting renewal of Drug Manufacturing License by the authority was
challenged as a Civil service officer and citizen of Pakistan, but not responded. It was

Timeline Summary
challenged/ filed complain because Saniplast and similar bandages that are claimed to be
applied on open wounds and cuts, where blood supply is open and prone to get infection.
This Saniplast is manufactured in an open environment where street air is exposed to the
manufacturing process and bandages. It may lead to irreversible damages to the customer
without any sound. All over the world, such types of dressings or even cleansing pads are
subject to free of microorgansms. i.e. sterile. Ignoring the legitimate duties and functions,
neither CLB nor the Quality Directorate or even the Drug Appellate Board responded and
maintained their silence on such a critical issue.
(9) 01 Jun 2015 (Annexure-006): In this context, I had followed and for the sake of
example a letter of 01 Jun 2015 indicating follow up dated 12 May 2015, 20 Apr 2015,
27 Mar 2015, 12 Feb 2015, 10 Jun 2014, 28 Apr 2014, 08 Apr 2014, 27 Mar 2014, 22
Nov 2013, 18 Nov 2013 to all concerned quarters in hierarchy step by step with subject
“Appeal related to Public Safety and CLB Decisions” was written but no one came
forward to rescue the interest of patient and intent behind regulations. Nothing is still
responded yet from any concerned quarter.
(10) 29 July 2015 (Annexure 007): An outline assessment of CDL operations and its
Quality Management System (QMS) against standard of WHO Prequalification program
was done that categorically identified the integrity of results for its reliability,
reproducibility and auditability under the scientific standards laid down in documents of
WHO upon which we rely under the Act of Parliament. We are issuing report of
test/analysis while we know that our laboratory lacks in terms of requisites required to
make results auditable, reliable and reproducible such as use of reference standards,
qualification of individuals, qualification of methods, calibration and maintenance
practices etc. etc. these qualifications and validation are mandatory required by rule of
law too. WHO and USP teams visited several times but their reports are not available on
public domain. It is a reality that neither USP nor WHO trust on our test report that is
used for regulatory actions knowingly that it is not based on scientific principles such as
method transfer studies, qualification of instruments, calibration tracking and traceability,

Timeline Summary
data integrity etc. It is not out of the place to mention that donor agencies get help from
foreign laboratories to test drugs that are to be distributed here in Pakistan. They
absolutely do not rely on our expertise and test report. This is mainly absence of policies
and procedures and Quality Management System for governance. Without any reason,
authority transfers anybody to any place without knowing his/ her ability and sensitivity
of the work. In an organization (CDL) it is a matter of fact that two officers having
exactly equal and similar length of experience, where one is considered for three posts
with a staff of more than 50 while the other one is kept free without any allocation of
staff. The other one never engaged in any decision driving procedure for years.
(11) 11 Aug 2015 (Annexure 008): DRAP instead of any inquiry or asking
clarification issued a warning vide Letter No. PF.1696. RO-Admn-II dated 03 Aug 2015
(Annexure 008-A) with remarks that my communications (as described above in Para 1
to 10) are unwarranted/ unnecessary/ inappropriate correspondence. DRAP letter
threatened for action in account of misconduct under Civil Servant Rules, 1964. This
letter itself reveals that the competent authority has taken lenient view. This way DRAP
tried to kill all the concerns and issues that were followed by me. DRAP’s this letter was
responded with a written letter. Following words are extracted from the letter:
a. “The said letter does not specifically refer to any word or phrase or sentence or
paragraph or letter that was termed unwarranted/unnecessary/inappropriate
correspondence but an attempt to twist the subject & to paint a false impression
on record. I feel to make it loud, clear and simple that I stand with my all official
letters (None of them responded yet for neither its content nor ever asked for any
explanation). It is kindly requested that do not threat or be lenient but to take
action. In any case, I am not prepared to be the part of wrong, unlawful work or
negligence of my responsibility as a civil service officer” and
b. “Please indicate which word is not correct and which sentence is not true that
is indispensible part of rule of business, for which I will be thankful”.

Timeline Summary
(12) 11 Aug 2015 (Annexure 008): DRAP failed to take action for which they
threatened (Annexure 008-A) with words “…. Misconduct and entail disciplinary action
…” and the same was requested by me (Annexure 008) with words “Don’t be lenient
and take action”.
(13) 23 Nov 2015 (Annexure 009): An interested DRAP Memorandum followed by
warning was issued with the approval of Secretary, Ministry of NHS,R&C on 16 Nov
2015 referring the above warning (Annexure 008-A). It confirms that DRAP had
received my more than 20 letters or applications and termed them unnecessary/
unwarranted. They again threatened for disciplinary action under Government Servant
(Efficiency & Discipline) Rules, 1973 and asked for explanation. In response under the
subject “Safety and Advancement of Public Health & Rule of Law” it was clearly said by
me:
a. “My all communications/writing is my explanation indeed. Please let me know
the sentence or word or paragraph of any note that is unclear and requires further
elucidation, so that I will try my best to unfold by transforming it simply point
wise or question wise. May Allah bless me and everyone, I am not afraid if any
action organization wishes to take on speaking truth and seeking justice”.
(14) 23 Nov 2015 (Annexure 009): It was also responded as:
a. “For the sake of record, I have never persuaded for any specific seat/post
throughout my career, but unfortunate discriminative actions are visible in the
matter of posting, training opportunities within and outside Pakistan among batch
mates and other colleagues. I am least interested in personal matters but request to
pay attention on the issues of public safety and for the justice across”.
(15) 23 Nov 2015 (Annexure 009): DRAP failed to take action for which they
threatened (Annexure 009-A) with words “….strict disciplinary action will be initiated
against you…” and the same was responded by me under the subject “Safety and
Advancement of Public Health & Rule of Law” (Annexure 009) with words “…. I am

Timeline Summary
not afraid if any action organization wishes to take on speaking truth and seeking justice
….”. Nothing is still responded yet from any concerned quarter.
(16) 25 May 2016 (Annexure 010): The response of 23 Nov 2015 (Annexure 009)
and subsequent reminder was followed in which attention and review of the materials
under the subject “Safety and Advancement of Public Health & Rule of Law” was sent to
CEO of DRAP through proper channel and the copies were sent to Secretary, Ministry of
NHS, R&C, Chairman CLB, Chairman DRB, Chairman Quality Control and concerned
Section Officer of Admn-I. Nothing is still responded yet from any concerned quarter.
(17) 07 & 10 Oct 2016 (Annexure 011): A meeting was requested with the Secretary,
Ministry of NHS, R&C through proper channel on the following agenda, but not
responded.
a. In DRAP operations quality and effectiveness of pre-registration and post
registration documents screening, assessment, review and evaluation.
b. Good Manufacturing Practices (GMP) compliance determination in pre-approval
inspections, surveillance inspections and post approval inspections.
c. Operation and effectiveness of analytical testing laboratories in strengthening
sustainable quality of drugs, safety of consumers and credibility of the country
and organization.
d. Past performance in comparison to the organizational claim to assess ground
realities for alignment and sustainable corrective measures.
e. Misuse of powers in administration, public safety affairs, drug quality affairs, and
not responding on written related concerns, notes, complaints, explanations etc.
f. Increasing exploitation and revenge trend by misusing authority and to promote
injustice, discrimination as an organizational characteristic.

Timeline Summary
(18) 11 Nov 2016 (Annexure 012): Upon continued silence from the Secretary office
and Minister Office a letter entitled “Distance from the Service with Best Wishes and
Thanks” was written and supported by a list of 49 communications from 27 March 2014
to 10 Oct 2016. It was sent to Secretary, Ministry of NHS, R&C and asked for long leave
to avoid wastage of God gifted time.
(19) 11 Nov 2016 (Annexure 012): My 5 to 10 year junior colleagues and a number of
batch mates were allowed for long Ex-Pakistan leave. They had availed and a number of
colleagues are still availing for more than 3 to 7 years. I have earned enough leaves
during my 16 year regular service that are on my credit and certified by AGPR too.
Nothing is still responded yet from any concerned quarter.
(20) 11 Nov 2016 (Annexure 012): Keeping in view of historical behavior of not
responding/ considering applications, encashment of due committed leaves was requested
and if they have reason for not addressing the concerns related to safety of patient, quality
of drugs and specific discrimination with us, retirement may be offered. Nothing is still
responded yet from any concerned quarter.
(21) 28 Nov 2016 (Annexure 013): A letter as a reminder was re submitted to
Secretary, Ministry of NHS,RC through proper channel (for availing the potential
opportunity that was killed like ever before by maintain the silence and ignoring all the
follow up and requests) where it was indicated as:
a. “Ex-Pakistan traveling may come across any time in coming months to explore
the opportunity for our future professional engagements. Your kind office is well
aware with the facts that the department (DRAP) is used to take heartless revenge
by misusing the powers and unfortunately not held accountable for their
continued act of discrimination and injustice”.
(22) 13 Dec 2016 (Annexure 014): A complaint on the subject entitled “Distance from
the Service with Best Wishes and Thanks” was filed to the office of Prime Minister
through Proper Channel. This complaint sought intervention from the PM Office on my

Timeline Summary
pending applications. I have never been intimated that my compliant has been forwarded
to Honorable PM Office or not. Nothing is still responded yet from any concerned
quarter.
(23) 15 Dec 2016 (Annexure 015): A letter of DRAP Islamabad dated 08 Dec 2016
(Annexure 015-A) referred in letter of 13 Dec 2016 (Annexure 015-B) suggested/
indeed pressurized me that “… she may specifically write for resignation from service if
she wishes to resign …”. A responding letter was sent to the CEO, DRAP, Director QA
& LT, DRAP, Director Administration, DRAP, Islamabad and Director, CDL, DRAP,
Karachi with the following remarks, but nothing is still responded yet from any
concerned quarter.
a. “It is worthy to know that the my said letter on the subject was carefully read with
great interest and came up with above quoted advice on the 3rd Para, that
confirms the acceptance with the facts described in pre-paras” …. and ….
b. “You will agree that like Civil Service Officers, I am neither duty bound to take
unreasonable dictation or to give undue respect to the unjustified wishes of
anyone during the dispensing of official duties or personal affairs. On the other
hand, it is bottom line that I do prefer to leave or resign (if you wish to use this
word instead of distance) but not to be a part of visible compromise on quality of
drugs and safety of patients at large”.
(24) 19 Jan 2017 (Annexure 016): A reminder was submitted on the subject entitled
“Distance from the Service with Best Wishes and Thanks” to the office of Honorable
Prime Minister through proper channel where it was indicated as:
a. “….We feel insecure and serious threats upon triggering the realities and
proposing the procedures in line with the quality of drugs, protection of public
and enhancement of health. It is clear that the leadership of our Islamabad office
(Drug Regulatory Authority of Pakistan) is determined to work otherwise” ….
and ….

Timeline Summary
b. “I am a continuous victim of discrimination, and fundamental freedoms/rights, I
approached step by step to everyone, but nothing yet responded, while Esta Code
gives 30 days for decision in case of resignation. I am confident and hope that
your office will intervene and take strict action to establish high standard of
justice, for which I shall be obliged. Our all prayers go for the strengthening of
institutional dignity and prosperity of our beloved country”.
(25) 19 Jan 2017 (Annexure 016): It sought intervention from the PM Office on my
pending applications. I have never been intimated that my compliant has been forwarded
to Honorable PM Office or not. Nothing is still responded yet from any concerned
quarter.
(26) 20 Feb 2017 (Annexure 017): Another reminder was submitted on the subject
entitled “Distance from the Service with Best Wishes and Thanks” to the office of
Honorable Prime Minister through proper channel. It sought intervention from the PM
Office on my pending applications. I have never been intimated that my compliant has
been forwarded to Honorable PM Office or not. Nothing is still responded yet from any
concerned quarter.
(27) 10 March 2017 (Annexure 018): Before approval of product for market
consumption, careful scientific evaluation of application is required by law that is
supposed to be notified by Summary of Approval or Complete Response for Notice of
Rejection. Data generated on prescribed lowest batch size is fundamental to be assessed
for applicant product safety, efficacy and quality. Substantive reduction in the lowest
batch size and its acceptance is against the scientific standards and has no meaning to
have confidence on product. This practice obviously end up in supply of questionable
quality of drugs that people are compelled to consume against hard earned money and
may experience harm that remains undetectable in our society. A document on such
practices seeking attention of the all concerned and supervising authorities of DRAP and

Timeline Summary
Ministry to avoid introduction of unsafe drugs and putting risk on public health that
remains undetected was written entitled “Burden of Hollow Tools & Approaches in
Product Development & Stability Studies” (Annexure 018) that is not responded so far.
(28) 20 Mar 2017 (Annexure 019): A third reminder was submitted on the subject
concerned quarter.
(29) 21 Mar 2017 (Annexure 020): Upon surfacing of mega issue in public notice
related to permission of DRAP and availability of poor quality injections containing
particles and with possible breech of sterility by my husband (Dr. Obaid Ali, R. Ph., Ph.
D.) who is also a civil service officer; a Show Cause Notice was issued to me to
pressurize us. Response was given against the unjustified, unlawful, without any inquiry,
Show Cause Notice (Annexure 020-A) threatening for dismissal of service as:
a. “ … I am not begging you or Government, you are free to decide whatever you
have threatened time and again about the dismissal of service, if you think it is an
offence to stand against a bad and dishonest system and say "NO" for being an
instrument in supply of substandard quality drugs and putting public safety on risk
… ”
(30) 21 Mar 2017 (Annexure 020): They failed to take action as threatened that
confirms that the Show Cause Notice was issued malafied and relied on commissioning
of false allegations to tarnish the image and to aggravate harassment/ mental torcher.
(31) 24 Apr 2017 (Annexure 021): A fourth reminder was submitted on the subject

Timeline Summary
concerned quarter.
(32) 13 Jun 2017 (Annexure 022): Another request as an appeal was sent to the
Secretary, Ministry of NHS, R&C through proper channel entitled “Approval of Long
Leave or Retirement or Resignation” where it was submitted that “… My husband may
be working and traveling abroad for strengthening of his professional knowledge,
technical skills and deliverable abilities to have sustainable effect in the years ahead and I
wish the same for myself too as an opportunity. It is a practical limitation to manage
alone here as our dependent children will also accompany us …” but the same was not
responded that acted as one of the major reasons in killing a knocking opportunity for my
husband and me too in a systematic and planned strategy.
(33) 18 Jul 2017 (Annexure 023): A letter was written to Minister of State for NHS,
R&C through proper channel under the subject “Denial of Basic Constitutional Rights &
to Serve Legitimate Duties” where attention of her good office was invited as:
a. “A) Safety of patients and quality of drugs is not a privilege but the right of
our citizens. Considering it as an official obligation, I have always raised evidence
based concerns in simple and clear language on various regulatory affairs that
have potential of serious and horrible consequences. Nevertheless, regulatory
frameworks (smart, progressive, open, transparent and knowledge based doable
solutions) were always proposed for opening discussions and implementation.
Regrettably, your sub-offices are well aware that DRAP by misusing powers in
response restricted me to perform legitimate duties for which I am drawing salary
from the money of our tax payer citizens.

Timeline Summary
b. B) Interestingly, every concerned competent office is well aware that none of
the issues/concerns formally communicated and followed (as indicated in A) were
denied for its consequences or ever attended to address.
c. C) In the scenario described in A and B, I have submitted voluntary resign
and followed; the same is not yet responded after passing more than 7 months that
is otherwise contrary to the Esta Code, but seems that the rule of law does not
matter to DRAP.
d. D) The worst discrimination and the warmth of DRAP revenge for
performing legitimate duty and saying facts is visible and does not look nice to
reproduce time and again. The DRAP and concerned Ministry upon DRAP
influence threatened for removal from service and consequences, but failed to
initiate and rather to keep their own words. Alhamdolilah, I never begged but
asked to do what they wanted (For the sake of reference, a letter and its response
is attached to enlighten the chain of events, prevailing scenario and leadership
strength, wisdom, honesty & competency of leadership).
e. E) To make the record straight, let me reiterate that I am not ready to be a
part of current dishonest and fairly incompetent system that promotes and
believes on blind registration leading to questionable quality of drugs, generally
fake inspections and licensing of manufacturing sites, use of wrong tools for
surveillance and vigilance. The pharmaceutical business revolves around quality
and transparency all over the world, nothing more, and nothing less. It is not a
doubt on the intent of Government but a matter to stand with ground reality, truth
and competency. Your office is well aware that drug products manufactured in
Pakistan by any company, no matter corporate or national, does not have yet got
access on the shelves of any developed country, whereas, the weakest country of
even North Africa does not have confidence on DRAP and conducts their own
inspections here in Pakistan.”

Timeline Summary
(34) 18 Jul 2017 (Annexure 023): In the same letter it was informed that Government
is continuously paying salary while I am denied of my basic constitutional rights and to
serve my legitimate duties by hook or by crook, therefore, it was requested that please
stop my salary with prior intimation and unblock my worthy time to utilize Allah’s gifted
life in serving humanity by performing other jobs. I have never been intimated that my
compliant has been forwarded to Minister Office or not. I kept practice of sending
advance copy to the addressee maintained, nothing is still responded yet from Minister
Office or concerned offices through which application was moved.
(35) 18 Aug 2017 (Annexure 024): The reminder of the same letter (Annexure 023)
written to the Federal Minister for NHS, R&C and copied to PS to PM, Secretary,
Ministry of NHS, R&C, Secretary Cabinet & Secretary Establishment through proper
channel under the subject “Denial of Basic Constitutional Rights & to Serve Legitimate
Duties” was submitted. Nothing was responded from Minister Office, whereas, my
complain was later on forwarded to Ministry of NHS, R&C from Cabinet and
Establishment with remarks for redressal of the grievances, however, neither
request/direction of Cabinet Division or Establishment Division was respected nor my
voice was heard or addressed.
(36) 05 Sep 2017 (Annexure 025): A clear and candid note on unjustified
memorandum dated 25 Aug 2017 received on 05 Sep 2017, of subordinate office (DRAP)
followed by Show Cause Notice of Controlling Ministry (Add. Secretary) was sent back
to the SPS to Secretary, Ministry of NHS, R&C, PS to CEO, DRAP, Islamabad, Director,
CDL, Karachi, S.O. (Admn-I) and M/o NHS, R&C, Islamabad. Memo itself declared my
reply (Annexure 025) unsatisfactory and tried to close the Show Cause Notice with
passing the remarks that they have taken a lenient view. It was categorically and
immediately responded as:

Timeline Summary
a. “Please don’t twist the record and speak truth. Let me know why did you failed to
take action as threatened. I will rather suggest don’t take lenient view and do your
job”
(37) 05 Sep 2017 (Annexure 025): The same is not yet responded and practically their
silence proves the health of allegations and malafied intentions that was with reasons
including attempt to tarnish the image and to aggravate harassment/ mental torcher.
(38) 19 Oct 2017 (Annexure 026): Another reminder of the same letter (Annexure
023) written to the Federal Minister for NHS, R&C and copied to PS to PM, Secretary,
Ministry of NHS, R&C, Secretary Cabinet & Secretary Establishment through proper
channel under the subject “Denial of Basic Constitutional Rights & to Serve Legitimate
Duties” was submitted. Nothing was responded from Minister Office or concerned
offices. However, my application was sent by the Cabinet Division for consideration to
the Secretary, Ministry of NHS, R&C (Annexure 027) but the same is not responded so
far.
(39) 20 Nov 2017 (Annexure 028): Another follow up reminder of the same letter
(Annexure 023) written to the Federal Minister for NHS, R&C and copied to PS to PM,
Secretary, Ministry of NHS, R&C, Secretary Cabinet & Secretary Establishment through
proper channel under the subject “Denial of Basic Constitutional Rights & to Serve
Legitimate Duties” was submitted. Nothing was responded from Minister Office or
concerned offices.
(40) 13 Dec 2017 & 16 Jan 2018: Additional Secretary, Ministry of NHS, R&C
visited the office of the applicant where I briefed on all concerns/ complaints in detail.
Annexure 029 was given by hand that described the following but not limited to:
“A) PROFESSIONAL AFFAIRS:
Questionable Quality of Drugs & Unreasonable Safety Threats

Timeline Summary
a. (Injections and potential microbial contamination, drug release pattern of solid
dosage forms, storage and transportation)
Wrong Tools & Wrong Approaches in Regulatory Decisions
b. (Basis on which drug is approved or rejected are not recorded, open letters of
registrations, open labels/ claim and drug sampling/ testing)
Incredible Performance & Worst Professional Dishonesty
c. (Inspection through reviewers and even pricing section, teachers etc.,
Members of Registration and Licensing Boards)
Competency & Capability to understand Safety Concerns
d. (Continuous meaningful education, impact indicator, international acceptance,
contribution profile in Regulatory Sciences)
Willful & Organized Efforts to stop Evolution Process
e. (Whistleblowers protection, non-responding behavior, disregard to science
and issues of patient safety)
B) PERSONAL AFFAIRS:
Discrimination
f. (International tours, posting, privileges, inspections, trainings, financial
victimization)
Attempt to Damage Professional Dignity
g. (Driven by the choice of companies openly, disregard to knowledge, use of
official office for negative propaganda)
Attempt to Defame

Timeline Summary
h. (Loose comments before public, irresponsible media talks, provoke others to
paint a wrong image)
Freedom of Movement
i. (Restriction by hook and crook, damaging of personal repute and killing of
opportunity to learn or speak upon invitations from international
organizations)
Cruel Conspiracies
j. (Attempt to indulge in unreasonable issues with outside agencies, encourage
companies to lobbying and execute plan against me)”
(41) 09 Jan 2018 (Annexure 030): Director QA & LT was approached through
Annexure 030 against recent memo (Annexure 030-A) on his behalf submitting the
serious governance issues neglecting the chain of command and approving everything
without consulting number two of the organization (whether financial, technical or
administrative affairs) and misleading public statements by DRAP leadership about
sample testing and qualification of laboratory by WHO. Nothing is responded by the
concerned authorities. For the sake of quick reference, a paragraph from Annexure 030
is referred as below:
“It is very typical here in Karachi offices where chain of command is neither build
up nor engaged in any shape to have comment on options presented, supporting
evidence appended before putting recommendation for assent. To avoid comment
from chain of command must not be an option for any decision. Every decision
must be structured and reasons must be written in permanent official record.
Please share the master plan, the proceedings of WHO, the inspection report of
WHO and USP. Share the basis on which it was publicly announced a number of
times by CEO and higher authorities that this laboratory will be qualified by end
of 2017. Please share what went wrong, where we stand and why we did not
apologize to the public upon failure to keep our commitment for which we are

Timeline Summary
paid for. We must have a project plan in black and white and written approved
policies before writing procedures. Please read my assessment report (10 pages),
different articles on the relevant subject that categorically identifies the
weaknesses of ongoing regulatory practices to align with workable plan of
action.”
(42) 25 Jan 2018 (Annexure 031): Another follow up reminder of the same letter
(Annexure 023) written to the Federal Minister for NHS, R&C and copied to PS to PM,
Secretary, Ministry of NHS, R&C, Secretary Cabinet & Secretary Establishment through
proper channel under the subject “Denial of Basic Constitutional Rights & to Serve
Legitimate Duties” was submitted. The letter added
a. “ …It is honestly believed that continuance conscientious unfamiliarity and
sincere ignorance to pay regard to someone against the merit on things that matter
may augment the unfavorable situation, and put social justice on thin ice.
Government is continuously paying salary while I am yet denied of my basic
constitutional rights and to serve my legitimate duties by hook or by crook (as
explained in previous communications). Since, silence of Government both on my
concerns and resignation is continued and no one is accountable to waste the
taxpayer money, therefore, request made on 18 Jul 2017 and religiously followed
to stop my salary with prior intimation and unblock my worthy time to utilize
Allah’s gifted life in serving humanity by performing other jobs is again stressed.
I will be thankful in both capacities as a duty bound civil service officer and as a
taxpayer citizen”.
(43) 25 Jan 2018 (Annexure 031): Nothing was responded from Minister Office or
concerned offices.
(44) 29 Jan 2018 (Annexure 032): Letter of Establishment Division (Annexure 032-
A) dated 08 Jan 2018 asking Secretary, Ministry of NHS, R&C for redressal the
grievances was acknowledged and informed them about the freezing status of grievances.

Timeline Summary
The Secretary, Ministry of NHS,R&C was kept informed in this communication through
CC.
(45) 29 Jan 2018 (Annexure 033): A letter was written to Secretary Cabinet copied to
Secretary, Ministry of NHS,R&C acknowledging of their letter dated 25 Oct 2017
(Annexure 027) asking Secretary, Ministry of NHS, R&C to consider my request as:
a. “ …within the ambit of law/rules/regulations and strictly on merit …” .
(46) 29 Jan 2018 (Annexure 033): It has been informed to them that nothing has been
done for redressal of the grievances by the Ministry of NHS, R&C so far.
(47) 12 Feb 2018 (Annexure 034): A fifth reminder seeking for approval or decision
on my pending Ex-Pakistan leave written to the Federal Minister for NHS, R&C and
copied to PS to PM, Secretary, Ministry of NHS, R&C, Secretary Cabinet & Secretary
Establishment through proper channel under the subject “Denial of Basic Constitutional
Rights & to Serve Legitimate Duties” was submitted.
(48) 15 Feb 2018 (Annexure 035): I was served a notification of acceptance of my
resignation on 15 Feb 2018 in which the resignation was accepted from back date i.e. 30
January 2018 without referring any specific letter. It is interesting that the same was not
written in vacuum but with reasons and conditions against the silence on concerns related
to public safety and drug quality, unlawful, discriminative and dishonest actions of parent
organization.
(49) 18 Feb 2018 (Annexure 036): DRAP issued a press release that they did not
discriminate. It is for record that particularly during the last five years:
a. Application of my long earned leave was not considered, neither for grant nor for
encashment, whereas, a number of colleagues and juniors were granted long
leaves

Timeline Summary
b. I was transferred five times in 33 months without assigning any reason contrary to
the honorable Supreme Court judgment, while my other junior colleagues and
batch mates are not treated in the same manner.
c. In any national training I was not included but all other colleagues and batch
mates were considered several times across the Pakistan (USP and WHO trainings
may be persuaded for reference).
d. In any international assignment, I was never considered, while all my batch mates
were repeatedly sent for foreign tours. Even my juniors not related to particular
assignment of inspections such as from pricing section were also considered for
inspection.
e. My colleagues, batch mates, juniors and even outsiders were unlawfully given
additional charges of more than two posts at same time on their own pay scale for
years, while I was kept away from my area of professional expertise, for example
one officer for whole of the province KPK for years.
f. I am the only person who was kept away from GMP inspections while I am the
only one who is internationally considered as a Consultant on the topic and
participated in international program as a trainer. My colleagues enjoyed misuse
of the power by conducting short visits in the name of inspections. Please see the
record of Licensing and Registration Directorates to see one individual has
conducted how many inspections in a year beside his other jobs. We may take
2016 and 2017 as a reference.

Timeline Summary to keep the record straight

Empfohlen

Empfohlen

Weitere ähnliche Inhalte

Was ist angesagt?

Was ist angesagt? (8)

Ähnlich wie Timeline Summary to keep the record straight

Ähnlich wie Timeline Summary to keep the record straight (20)

Mehr von Obaid Ali / Roohi B. Obaid

Mehr von Obaid Ali / Roohi B. Obaid (20)

Kürzlich hochgeladen

Kürzlich hochgeladen (20)

Timeline Summary to keep the record straight