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Unit- 1 Drugs Standards and Legislation

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Unit- 1 Drugs Standards and Legislation

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nadinaluster23
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UNIT 1

INTRODUCTION TO PHARMACOLOGY

DRUGS STANDARDS AND LEGISLATION

Nizar Muhammad (Pharm-D, R.Ph.)


Ayub Medical Complex, Abbottabad,
Pakistan
Discuss the drugs standards and legislation.

• Every country has its own defined rules and regulations for dealing with the
pharmaceutical standards covering the following aspects
– Definitions of products for inclusion or exclusion criteria of medications, drugs or
pharmaceutical substances
– Import and export of raw materials
– Manufacturing of medications
– Quality control
– Label accuracy
– Purity of ingredients
– Safety of patients
– Projected efficacy
– Price control
– Distribution, Whole sale and retail under the supervision of professionally qualified
personnel
– Inspections rules, inspectors and their scope
– Formation of governing bodies and boards
– Penalties and jurisprudence
[email protected] 2
Drug Regulation and Legislation, by WHO
 WHO provides the following Drug Regulation and Legislation rules.

1. Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-
Medication
2. Effective Drug Regulation. A Multi country Study and Annex 1: Guide for Data Collection to
Assess Drug Regulatory Performance,
3. Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality WHO Policy
Perspectives on Medicines, No. 07, 2003
4. How to Implement Computer-Assisted Drug Registration. A Practical Guide for Drug
Regulatory Authorities
5. Pharmaceuticals and the Internet Drug Regulatory Authorities' Perspective. Joint NLN-
WHI Workshop, 24-25 September 2001
6. Marketing Authorization of Pharmaceutical Products with Special Reference to
Multisource (Generic) Products: A Manual for Drug Regulatory Authorities
 The following link can be followed for further detail
 https://www.who.int/medicines/technical_briefing/tbs/2009_drugregulation_rdg_
prs/en/

[email protected] 3
Food and Drug Administration (FDA)

• The mission of FDA is to enforce laws enacted by the U.S.


Congress and regulations established by the Agency to protect
the consumer's health, safety, and pocket book.
• The Federal Food, Drug, and Cosmetic Act is the basic food and
drug law of the U.S. With numerous amendments, it is the
most extensive law of its kind in the world.
• The law is intended to assure the consumer
– that foods are pure and wholesome, safe to eat, and produced under
sanitary conditions;
– that drugs and devices are safe and effective for their intended uses;
– that cosmetics are safe and made from appropriate ingredients;
– and that all labeling and packaging is truthful, informative, and not
deceptive.

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CODE OF FEDERAL REGULATIONS(CFR), USA

• Code of Federal Regulations for Investigational New Drugs (INDs),


New Drug Applications (NDAs), Abbreviated New Drug
Applications (ANDAs) and Biologics License Applications (BLAs)
• The following Code of Federal Regulations(CFR) sections provide
regulations for INDs, NDAs and BLAs. All parts of section 21 of
the Code of Federal Regulations are also available.
• CFR Sections for INDs
• CFR Sections for NDAs
• CFR Sections for ANDAs
• CFR Sections for BLAs
• Follow the following link for further details
• https://www.fda.gov/drugs/development-approval-process-drug
s/laws-regulations-policies-and-procedures-drug-applications
[email protected] 5
Drugs related rules and legislation in
Pakistan
• Following are some of the government bodies for drugs regulation in
Pakistan:
– Senate, National and Provincial Assemblies
– Federal and provincial Ministries of Health
– Drug Regulatory Authority Pakistan (DRAP)
– Federal Quality Control Board (FQCB)
– Provincial Quality Control Board (PQCB) for each province
– Pharmacy council of Pakistan
– Appellate boards
– Drug courts
– Provincial Health Secretariats
– District Management Authorities

Follow this link for further details


https://www.dra.gov.pk/Home

[email protected] 6
Manual of Drug Law Pakistan
• The DRAP act 2012 and the following
• SROs
• The Drugs Act, 1976.
• The Drugs (Labelling and Packing) Rules, 1986.
• The Drugs (Labelling and Packing) Rules, 1982.
• The Drugs (Labelling and Packing) Rules, 1978.
• The Drugs (Licensing, Registering & Advertising) Rules, 1976.
• The Drugs (Appellate Board) Rules, 1976.
• The Drugs (Research) Rules, 1978.
• The Drugs (Federal Inspectors, Federal Drug Laboratory & Federal Government Analysts)
Rules, 1976.
• The Drugs (Imports & Exports) Rules, 1976.
• The Drugs (Specifications) Rules, 1978.
• The Northern Areas Drugs Rules, 1996.
• The narcotics act
• Drug sale rules KPPRA
Follow this link for further details on the above rules and regulations
https://www.dra.gov.pk/Home/DownloadsAllDocs

[email protected] 7

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