TO BE PUBLISHED IN PART-III OF THE GAZETTE OF PAKISTAN

Government of Pakistan
Drug Regulatory Authority of Pakistan
Ministry Of National Regulations Services, Regulations and Coordination,
********
Islamabad, the 29th July, 2013.
NOTIFICATION
S.R.O.684(I)/2013.In exercise of the powers conferred by section 23 of the Drug
Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), read with clause (a) of section 7 thereof
and section 43 of the Drugs Act, 1976 (XXXI of 1976), the Drug Regulatory Authority of Pakistan,
with the approval of the Federal Government, is pleased to direct that in the Drugs (Licensing,
Registering and Advertising) Rules, 1976 the following further amendments shall be made, the
same having been previously published as required by sub-section (3) of the said section 43,
namely:-.
In the aforesaid Rules,(a)

in rule 8,(i)

for sub-rule (1) the following shall be substituted, namely :(1) The Central Licensing Board shall consist of the following members,
namely:(a)

the Director Drugs Licensing, Drug Regulatory Authority of

Pakistan, who shall be its ex-officio Chairman;

(b)

One representative of Directorate of Quality Assurance and

Laboratory testing;

(c)

the Drug Controller or Chief Inspector of Drugs of the

provinces of Punjab, Sindh, Khyber Pakhtunkhwa and
Balochistan;

(d)

two experts having at least fifteen years working experience in

production of drugs to be nominated by the Federal
Government on recommendations of the Authority;

(e)

two experts of quality control or quality assurance having at

least fifteen years experience of quality control or quality
assurance in drugs to be nominated by the Federal
Government on recommendations of the Authority;

(f)

two professors of pharmacy from public or private universities

in Pakistan;
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(ii)

(g)

one law expert to be nominated by the Law, Justice and

Human Rights Division who shall not be below BPS-19; and

(h)

the Deputy Director General Licensing, Drug Regulatory

Authority of Pakistan who shall be its ex-officio Secretary.;

for sub-rule (7) the following shall be substituted, namely :(7) The Chairman himself or on the directions of the Chief Executive
Officer of Drug Regulatory Authority of Pakistan, may call meeting of the
Board.; and

(iii).

for sub-rule (8) the following shall be substituted, namely :(8) In the absence of Chairman, the Board may elect one of the members
to preside over the meeting.; and

(b)

in rule 24,-

(i)

for sub-rule (1) the following shall be substituted, namely :(a)

the Director Pharmaceutical Evaluation and Registration, Drug

Regulatory Authority of Pakistan who shall be its ex-officio
Chairman;

(b)

one representative of Directorate of Biological Drugs;

(c)

one representative of Directorate of Medical Devices and Medicated

Cosmetics;

(d)

one representative of Directorate of Quality Assurance and

Laboratory Testing;

(e)

the Director, Drug Testing Laboratory of the Punjab, Sindh, Khyber

Pakhtunkhwa and Balochistan;

(f)

one expert having at least fifteen years experience in the field of

veterinary medicine to be nominated by the Federal Government on
recommendations of the Authority;

(g)

one expert having at least fifteen years experience in the field of

biologicals to be nominated by the Federal Government on
recommendations of the Authority;

(h)

one expert having at least fifteen years experience in the field of

pharmacology to be nominated by the Federal Government on
recommendations of the Authority;

(i)

one expert having at least fifteen years experience in the field of

hospital pharmacy to be nominated by the Federal Government on
recommendations of the Authority;
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(ii).

(j)

one physician having at least fifteen years experience to be nominated

by the Federal Government on recommendations of the Authority;

(k)

one expert having at least fifteen years working experience in

manufacturing of drugs to be nominated by the Federal Government
on recommendations of the Authority;

(l)

one representative of Intellectual Property Organization of Pakistan

(IPO-Pakistan);

(m)

one law expert to be nominated by the Law, Justice and Human

Rights Division who shall not be below BPS-19; and

(n)

the Deputy Director General, Registration, Drug Regulatory Authority

of Pakistan who shall be its ex-officio Secretary.;

for sub-rule (7) the following shall be substituted, namely:(7) The Chairman himself or on directions of the Chief Executive Officer
of Drug Regulatory Authority of Pakistan, may call meeting of the Board.;
and

(iii).

for sub-rule (8) the following shall be substituted, namely:(8) In the absence of Chairman, the Board may elect one of the members
to preside over the meeting..

[No.F.13-3/2013-DDC(LA)]

(Muhammad Arshad Khan)

Director (Legal Affairs)
Drug Regulatory Authority of Pakistan
The Manager,
Printing Corporation of Pakistan,
Islamabad.