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DRAP

The Drug Regulatory Authority of Pakistan issued a notification to amend the definition of "essential drugs and biologicals" in the Drug Pricing Policy of 2018. The new definition expands what is considered an essential drug to include all strengths of a dosage form if any strength is listed by the WHO, as well as interchangeable dosage forms. Combination vaccines and biologicals are also considered essential if all individual ingredients meet the essential criteria. Unregistered primary drugs or biologics listed as essential by WHO will be considered essential for alternative molecules registered in Pakistan.

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113 views2 pages

DRAP

The Drug Regulatory Authority of Pakistan issued a notification to amend the definition of "essential drugs and biologicals" in the Drug Pricing Policy of 2018. The new definition expands what is considered an essential drug to include all strengths of a dosage form if any strength is listed by the WHO, as well as interchangeable dosage forms. Combination vaccines and biologicals are also considered essential if all individual ingredients meet the essential criteria. Unregistered primary drugs or biologics listed as essential by WHO will be considered essential for alternative molecules registered in Pakistan.

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iloveit52252
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To be published in the extra ordinary Gazette of Pakistan, Part-II

Governnment of Pakistan
Ministry of National Health Services, Regulations and Coordination
(Drug Regulatory Authority of Pakistan)

NOTIFICATION

Islamabad, the 9th June, 2023.


S.R.O. 6781)/2023.- In pursuance of sub-clause (vii) of clause (c) of section 7 of the
Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) read with section 12 of the
Drugs Act, 1976 (XKXI of 1976), the Drug Regulatory Authority of Pakistan with the
approval of the Federal Government is pleased to direct that the following amendments shall
be made in the Drug Pricing Policy, 2018, namely:
In the aforesaid Policy, in paragraph 2, in sub-paragraph (1), for clause (xi), the
following shall be substituted, namely:
"(xi) "essential drugs and biologicals" for the purposes of this Policy means the
drugs and biologicals included in the list of essential medicines as published by
the World Health Organization (WHO) and notificd by the Ministry of
National Health Services, Regulations and Coordination and as updated or
revised from time to time, subject to the following conditions, namely:
a) all strengths of a particular dosage form of drug and biological shall be
considered as essential, if any of the strength of that dosage form is
present in notified WHO Model List of Essential Medicines (MLEM);
(b) Dosage forns mentioned below in each row shall be considered as
interchangeable with each other in the same row and essential if any of
the strength in one dosage form is present in WHO MLEM;
Tablets and capsules;
Oral suspension, syrup, solution, emulsion, elixir and other oral
liquids;
(ii) Cream, ointment, gel, lotion and paste;
(iv) Eye and ear drops;
(v) Nasal drops and nasal spray;
(vi) Liquid inhaler, dry powder inhaler and rotacap inhaler;
(vii) Intravenous, intramuscular, subcutaneous and other injectable
forms; and
(vii) Injection, vial and ampoule and pre-filled syringe and pen
cartridge;
(c) if any biological drugs is present in WHO MLEM, it shl be
considered as essential irrespective of its source (human, anifnal,
microbial etc.) and process or technology;
(d) for combination formulations of vaccines and biologicals, if all of
combo ingredients are individually labelled and categorized as essential
in WHO MLEM, the combination in all strengths shall be considered as
essential; and
(e) If primary drug or biological present in WHO MLEM is not registered
in Pakistan, the altermative(s) mentioned against that particular
molecule shall be considered as essential in that dosage form.
[No. F.9-13/2016-DDCP)]

AAMAR LATIE,
Deputy Director (Legal Afairs).
The Manager,
Printing Corporation of Pakistan Press,
Islamabad.

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