Drug Scandal worth 7 Billion ....... Parhta ja sharmata ja!

Daily Express Karachi , March 30, 2012


The Daily Jang Karachi March 30, 2012

ISLAMABAD: The Supreme Court turned down on Thursday a request by the Anti-Narcotics Force (ANF) for withdrawal of a case against the import of a proscribed chemical — a scandal that allegedly involves the prime minister’s younger son, Ali Musa Gilani.

Musa Gilani was recently elected member of National Assembly from Multan on a seat vacated by former foreign minister Shah Mehmood Qureshi after joining the Pakistan Tehrik-i-Insaaf.

Earlier, the name of the prime minister’s elder son, Abdul Qadir Gilani, had surfaced in the 2010 Haj corruption case.

A three-judge bench, comprising Chief Justice Iftikhar Mohammad Chaudhry, Justice Khilji Arif Hussain and Justice Tariq Parvez, had taken up a petition moved by the regional director of ANF Islamabad.

The court ordered the ANF to submit an investigation report on out-of-turn quota for import of the raw material granted to two pharmaceutical companies by the federal health ministry allegedly under the influence of Musa Gilani.

The ANF Commander, Brig Faheem, informed the court that a quota of 9,000kg, instead of 1,000kg, had been granted to Berlex Labs International and Denis Pharmaceutical.

Commonly known as poor man’s cocaine, the chemical is also used to manufacture a medicine called ‘Ephedrine’ to cure common cold, flu and asthma.

Advocate Raja Shahid Mehmood Abbasi, representing the ANF, submitted before the court that Brig Faheem intended to withdraw the petition.

“Who gave you the authority to withdraw the case and under what reasons you have decided to withdraw it; something is wrong,” the chief justice suspected.

“Are you scared when you should be setting an example,” the chief justice said.

Brig Faheem said he was not scared and added that the name of Tauqir Ahmed Khan had surfaced during investigations. The man said he was personal secretary to Musa Gilani and got the quota approved by the health ministry against rules and regulations.

Brig Faheem read out a report of an inquiry committee which determined that the two pharmaceutical companies had misused the quota and allegedly sold it to smugglers, instead of using it for the medicine.

“The situation is bringing a bad name for the country as such things are happening at the official level,” the chief justice regretted.

The report said every pharmaceutical company was entitled to a quota of 500kg of the ingredient used to make Ephedrine tablet, but the health ministry had doled out a quota of 9,000kg to Berlex Labs and Denis Pharmaceutical while ignoring 20 other pharmaceutical companies.

The issue was raised in the National Assembly in 2009 and former health minister Makdoom Shahabuddin had set up a fact-finding committee.

The ANF’s investigation officer informed the court that he had issued a notice to Musa Gilani on March 12 last year to join investigation for evidence because Tauqir Khan claimed that he was private secretary to the prime minister’s son. Neither Musa Gilani nor Tauqir Khan appeared.

A letter written by Health Secretary Zafar Abbas to the ANF was also read out. It said evidence against Tauqir Ali Khan should be brought for prior approval for proceedings.

The court adjourned the matter to April 20.

Toll Manufacturing of Pharmaceuticals become illegal in Pakistan .........

( The daily Jang Karachi March 29, 2012 Main Page)



What is toll manufacturing?
In simple words (with respect to pharmaceuticals) toll manufacturing can be simplified as:


A company has registered drugs but dont have adequate or insufficient manufacturing facilities so they request other manufacturing units having adequate facilities and valid manufacturing license to manufacture their registered drugs (against pre determined fee), so that they can meet the market demands.


Various Munti national companies like Aventis, Otsuka, GSK are using the benefit of contract manufacturing. Searle, Zafa ,Efroze and some other National companies are major toll manufacturers

CEO of DRAP: Who and When?

ISLAMABAD, March 13 (Daily Dawn) : 

The federal government on Tuesday appointed Syed Arshad Ali, an additional secretary, as the chief executive officer of the newly-established Drug Regulatory Authority of Pakistan (DRAP) in violation of the spirit of the ordinance under which the regulatory body was established, Dawn has learnt.


The DRAP was set up in the wake of the deaths of over 100 people due to adverse drug reaction in Lahore, mainly after intervention of the Supreme Court which directed the government to establish the authority.
A senior official of the government said Mr Ali, a district management group officer, was working as executive director in State Life Corporation, Karachi.


The ordinance stated: “The federal government may appoint a person as CEO who has a postgraduate degree in pharmacy, public health or medicine with a minimum of 20 years experience in pharmacy services, public health, management or regulatory affairs from either public or private sector.
The term of appointment will be for a period of three years and extendable for one tenure period only.”


The ordinance further said: “The head of the agency shall discharge such duties and perform such functions as are assigned to him by or under this ordinance or as may be prescribed (by the government).”
A source attached with the division looking after the affairs of drugs added that Mr Ali’s appointment was not as per the ordinance. “Mr Ali is a DMG officer and this is not business as usual, instead linked with regulation of drugs industry which has around 700 pharmaceutical companies in the country. Expertise and technical knowledge will be a key to resolving major issues of licensing, pricing and registration.”


According to a notification issued by the Cabinet Division: “All the staff and officers of the Drug Control Wing have been transferred to DRAP with immediate effect.”


Meanwhile, despite repeated attempts, spokesman for the Cabinet Division Omar Ahmed could not be contacted for comments.
A senior official of the division, however, told Dawn that a notification had been issued regarding the ad hoc appointment of Syed Arshad Ali for three months. “Mr Ali is a respectable official of the 9th common (batch of DMG).”
He said there was nothing wrong with the appointment. “The posting is within the defined framework of the government rules for appointment on such positions.”


He said it was a stopgap arrangement and the post would be filled with an individual having requisite qualification.
“Please don’t attach any controversy with this matter since an advertisement for appointment of a CEO will be published by Wednesday and we will be hiring the best individual from the market on merit.”










Business Recorder is of the opinion that:

The government has appointed Syed Arshad Ali, Joint Secretary of the Cabinet as the Chief Executive Officer (CEO) of the Drug Regulatory Authority (DRA) for a temporary period of three months in order to regulate the registration and manufacturing of drugs according to the Drugs Act of 1976.

Well-placed sources told Business Recorder here on Wednesday that subsequent to the death of around 117 heart patients in Punjab Institute of Cardiology (PIC) there was dire need to establish a body that could regulate and monitor drug related issues.

"The sad incidence of PIC compelled all the four provinces to pass a resolution in favour of establishment of a DRA.

Therefore, the President Asif Ali Zardari promulgated an ordinance on February 16 to form the DRA", sources added.

"But after the promulgation of the Ordinance, the appointment of a CEO was necessary as per the Drugs Act 1976.

Earlier, the government decided not to allow the import or export of medicines until and unless a CEO is appointed as the head of the Authority to regulate the licensing and registration of the drugs under the Act.

But this led to an increase in the price of medicines in the domestic market as hoarding of the medicines especially the life saving drugs, vaccines, expensive medicines of cancer and HIV AIDS began", sources revealed.

Sources said that keeping in view the increasing prices of medicines in the local market; the government allowed their import and export and also decided to appoint a CEO as well for a temporary period of three months.

The medicine responsible for the deaths in PIC was generating an unknown chemical in the body that was deposited in the bone marrow and resulted in eliminating the body's resistance.

That led to an end to the generation of white blood cells in the body as well as a severe chest infection.

(http://www.brecorder.com/general-news/172/1165427/ )





















The Daily Jang Karachi March 22, 2012.

My Opinion:

Mr Arshad Ali nominated CEO of DRAP may be and he is highly competent DMG officer, but would it not be better if an officer from former ministery of health pharma division was given the said responsibility.

He has been nominated for 3 months, whereas, the advertiement for the CEO says, applications will be entertained till March 30, 2012.

To my understanding, it will take further more period of say 15 days to finalize the name of new CEO, and GOD knows will it be finalized or not.

I hope and pray that DRAP become functional as soon as possible, but what i see is........an old ad hoc policy.

Qualified, Registered and Licensed Pharmacist: What does it mean?

Very often we come to know the terms of qualified, registered and licensed pharmacist.

Some of us regard these terms as synonyms, and some others (like me, in recent past :) ) didn't bother to understand the meanings of these discrete terms.

As to my understanding:

Qualified Pharmacist is one who has completed all pre-requisites to become a  graduate from any pharmacy school. In simple words, He possesses a basic degree in pharmacy. 

Registered Pharmacist is one who has completed all pre-requisites to get registered by the concerned council or board of pharmacy. To become a registered pharmacist one has to qualify for the basic degree in pharmacy and have to pass the test if any, conducted by the council or board of pharmacy. In Pakistan, no such test has yet been set up; all you need to do is to become pharmacy graduate ;).

Licensed Pharmacist is one who is qualified and registered by the concerned board or council of pharmacy, and the very same council or board granting him permission to practice as a pharmacist. In Pakistan, as profession of pharmacy has not been developed, therefore licensed pharmacist here means a pharmacist who has been granted by pharmacy council to supervise the sale and distribution of drug at retail drug store or pharmacy; as well as to supervise the manufacturing of drugs in pharmaceutical industries.

In Pakistan:

Qualification of Pharmacist is the purview of the Institutions of Pharmacy recognized by Pharmacy Council.

Registration of Pharmacist is the duty of Provincial Pharmacy Council

and

Grant of License to sale of drugs is also the purview of Provincial Pharmacy Council.

Pharmacist Vs Customer (No Offence)

Pharmacist Vs Physicians ( No Offence )

Oil Prices in real time

1 barrel = 158.984 Liters

Abbreviations in Prescritption (7 of 7): ROUTE OF ADMINISTRATION OR ADMINISTRATION SITE (Inscription or Subscription)

Abbreviations used to indicate Route of Administration or Administration Site

a.d.	right ear, (the dexter ear)
a.s.	left ear, (the sinister ear)
a.u.	both ears
Aur	ear, ears
D.	Right
IA	intraarterially, inject into artery
ID	intradermal, inject into skin
IM	intramuscular, inject into muscle
IV	intravenous, inject or infuse into vein, rate specified. For intravenous fluid therapy IV also refers to the infusion fluid.  IV bottles are consecutively numbered.  Ex: IV #10 NS 1000 mL @ 125 cc/h, IV #11 D5W 1000 mL @ 125/hr
IMP, IV bolus	intravenous push, a rapid injection into vein
IVPB	intravenous piggy back. infuse solution into primary intravenous infusion, rate specified Ex:  Ampicillin 250 mg IVPB over 30 min q 6 h
KVO	keep vein open.  A slow infusion.  The rate is set by institution policy or specified used to maintain an intravenous catheter patent.
via Hep Loc	Inject through heparin lock. A small indwelling intravenous cannula filled with a dilute heparin solution to maintain patency.  After injection, the heparin lock needs to be flushed and refilled with a dilute heparin solution.
Ocul	eye
o.d.	right eye (the dexter eye)  in the right eye
o.l., o.s	left eye, (the sinister eye) in the left eye
o.u.	both eyes, in each eye
p.o., per os	by mouth, take orally
R, pro rect	rectal
S.	left
SL	sublingual, Place under tongue and allow to dissolve
subq., s.c	subcutaneously,  inject below the skin
Top	topically,  apply locally to affected area
vag.	vaginally
NB     The oral route is always assumed if no route is specified for a drugs which can be administered orally.  If it is not possible to give the drug orally, (i.e. NPO), the alternative route must be explicitly specified by the prescriber.

To see more abbreviations used in prescription click on the respective links, given below:

Abbreviations in Prescritption (1 of 7):	DOSAGE FORMS (Subscription or Signa)
Abbreviations in Prescritption (2 of 7):	PRESCRIPTION FORMULA (Inscription)
Abbreviations in Prescritption (3 of 7):	DIRECTIONS FOR THE PHARMACIST ( Subscription)
Abbreviations in Prescritption (4 of 7):	UNITS OF MEASURE (Inscription or Subscription)
Abbreviations in Prescritption (5 of 7):	DIRECTIONS TO THE PATIENT OR INSTRUCTIONS TO CARE PROVIDERS CONCERNING DOSE AND DOSING FREQUENCY (Signa)
Abbreviations in Prescritption (6 of 7):	DIRECTIONS TO THE PATIENT OR INSTRUCTIONS TO CARE PROVIDERS (Signa)
Abbreviations in Prescritption (7 of 7):	ROUTE OF ADMINISTRATION OR ADMINISTRATION SITE (Inscription or Subscription)

Abbreviations in Prescritption (5 of 7): DIRECTIONS TO THE PATIENT OR INSTRUCTIONS TO CARE PROVIDERS CONCERNING DOSE AND DOSING FREQUENCY (Signa)

Abbreviations used in the directions to the patient or instructions to care providers concerning Dose and Dosing Frequency - The Signa

ad lib., prn	use when or as needed. Ex. 1 cap hs prn sleep
a.	before
a.c.	before meals.  Take before meals.  Usually  used in conjunction with q.d., tid etc.
a.m.	morning, before midday
h.	hour
d.	day
q.	every
q4h	every 4 hours, Also specified by the degree symbol. Ex. q 4deg.
q.d.	every day, take one dose a day
q.o.d.	every other day, Take one dose every other day
bid	twice a day, Take one dose twice a day.  N.B. does not mean every 12 hours. Loosely means morning and evening.
Tid	three times a day,  NB. Take one dose three times a day.  N.B. does not mean very 8 hours.  Loosely means morning, evening, and night.
Qid	four times a day.  NB.  Take one dose four times a day.  N.B. does not mean every 6 hours.  Loosely means morning, afternoon, evening, and night.
t.i.w.	three times a week,  Take a dose three times a week.  For example M, W, F (Monday, Wednesday, Friday)
h.s.	at bed time.  Take at bedtime
ATC	around the clock,  Doses administered at equal time intervals.  Ex: q. 6 h. ATC.
m2, M2	square meter
BSA	body surface area
p.	after
p.c.	after meals.  Take after meals.  Usually used in conjunction with q.d., bid, tid etc.
p.m.	evening, afternoon, after midday
noct.	night
STAT	immediately, give at once
s.o.s.	if there is need.  Administer again if required.  Example:  MS 2 mg IV STAT and q 30 min s.o.s. bucking ventilator

To see more abbreviations used in prescription click on the respective links, given below:

Abbreviations in Prescritption (1 of 7):	DOSAGE FORMS (Subscription or Signa)
Abbreviations in Prescritption (2 of 7):	PRESCRIPTION FORMULA (Inscription)
Abbreviations in Prescritption (3 of 7):	DIRECTIONS FOR THE PHARMACIST ( Subscription)
Abbreviations in Prescritption (4 of 7):	UNITS OF MEASURE (Inscription or Subscription)
Abbreviations in Prescritption (5 of 7):	DIRECTIONS TO THE PATIENT OR INSTRUCTIONS TO CARE PROVIDERS CONCERNING DOSE AND DOSING FREQUENCY (Signa)
Abbreviations in Prescritption (6 of 7):	DIRECTIONS TO THE PATIENT OR INSTRUCTIONS TO CARE PROVIDERS (Signa)
Abbreviations in Prescritption (7 of 7):	ROUTE OF ADMINISTRATION OR ADMINISTRATION SITE (Inscription or Subscription)