COMPARATIVE STUDY OF DRUG PRODUCT RECALL REGULATIONS IN USA, UK AND AUSTRALIA AND DRAFT GUIDELINES FOR INDIA

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About Authors: 
Bane Singh Rajput*
Research Scholar of Lachoo Memorial College of Science & Technology
Pharmacy Wing, Jodhpur (Raj.)
*bnsingh29@gmail.com

Abstract
Drug product recall is an action taken to withdraw or remove a batch or an entire production run of a drug product from distribution or use and return them to the manufacturer. It is usually done due to the discovery of deficiencies in quality, efficacy or safety in the marketed drug products. Defective drug products related to quality includes adulterated or spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the law and also those products for which product licenses are suspended/ cancelled. In USA, guidelines for drug product recall are described under 21 CFR Parts 7, 107 and 1270.  In Australia, guidelines for drug product recall are described under section 65F of the Trade Practices Act 1974. Sections 2(2), 4, 5 and 7 of the European Communities Act 1972 and Directive 2001/95/EC on general product safety are followed in UK for drug product recall. In India, references for drug product recalls, complaint and adverse reactions are mentioned in Para 27, 28 of Schedule M and conditions of license for defective product recall in Rule 74(j) and Rule 78(i) of the Drugs and Cosmetics Act, 1940 and Rules there under. But no effective and uniform recall procedure and guidelines are formulated yet in India. This paper presents a comparative study of drug product recall guidelines in USA, UK and Australia. Based on this comparative study suggestions are provided to develop regulatory guidelines for drug product recall in India.

REFERENCE ID: PHARMATUTOR-ART-1721

Introduction
Drug product recall is a process to withdraw or remove the drugs from distribution or market for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality include Adulterated or Spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the laws and also those products for which product licenses are suspended/cancelled.1

Background
Prior to 1962, there was no mechanism in the countries to approve drugs before they went to market. So, many danger drugs are reached in the marketplace which causes the adverse affect to the public health and sometime death may be occur. But companies not recall their drugs product due to huge money loses. There has been an increasing trend in the number of prescription and over-the-counter drug recalls over the last 4 years. In 2009, the Food and Drug Administration (FDA) reported 1,742 drug recalls representing a 309% increase over the 426 recalls reported in 2008 and greater than 1,000 of the implicated medications were from the same drug repackaging firm. Now drug recalls still increased 50% between 2008 and 2009.2

Table No. 1 Regulatory Authority of Different Countries for Drug Product Recall

S. No

Countries

Regulatory Authority

1

United States


Food and Drug Administration (FDA)

2

United Kingdom


Medicines and Healthcare products Regulatory Agency (MHRA)

3

Australia


Australian Competition and Consumer Commission

Australian Product Recall Authority

4

India

Central Drugs Standard Control Organization (CDSCO)

United States: Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services. In USA, guidelines for drugs product recall are described under 21 CFR Parts 7, 107 and 1270. 3, 4

United Kingdom: Medicines and Healthcare products Regulatory Agency(MHRA) is the UK government agency which is responsible for ensuring that medicines and medical deviceswork are acceptably safe.

Manufacturers and importers are obliged to report to the Medicines & Healthcare Products Regulatory Agency (MHRA) any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this. Where a defect is considered to be a risk to public health, the marketing authorization holder withdraws the affected product from use and the MHRA issues a 'Drug Alert' letter.5, 6

Australia: AustralianCompetition and Consumer Commission (ACCC) is an independent authority of the Australia government. It was established in 1995 with the amalgamation of the Australian Trade Practices Commission (TPC).Where a recall is safety-related, there is a legal requirement underSection 65R and 65F (7)the Commonwealth Trade Practices Act 1974for the sponsor to notify the Commonwealth Minister via the ACCC, within two days of taking recall action.  Three points should be noted in connection with this requirement:
2. Where the word 'recall' is used in the Act, it refers to both permanent removals of goods from the market recall and to temporary removal, correction and returns to the market.
3. The requirement is for notification only; the Procedure as set out in this document is to be used for the actual recall.
4. The requirement for notification applies only to safety-related recalls and not to purely quality-related recalls.7, 8, 9

Major Drugs Product Recall of History

High Profile Global Drug Recalls

Company

Product

Therapeutic class

Year

Novartis

Excedrin and Nodoz

Pain -Reliever

2012

Glaxo

Avandia

Anti-diabetic

2010

Pfizer

Bextra

Anti-inflammatory

2005

Merck

Vioxx

Anti-inflammatory

2004

Bayer

Baycol

Anti-cholesterol

2001

Wyeth-Ayerst

Fenfluramine/Phentermine

Anti-obesity

1997

Table No.2 Comparative Parameters of US, UK and Australia

S. No

Parameters

US

UK

Australia

1


Definition of Drug Product  Recall

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues.

A product is the removal of therapeutic goods from the Australian market reason related to quality, safety and efficacy.

2

Drug Product  Recall Classification

3 Classes

4 Classes

3 Classes

3

Basis of Classification

Level of Risk

Classification Rule

Classification Rule

4

Who Need to Report

Manufacturer, Importer and Health Professionals

Manufacturer, User, Authorized Representative

Manufacturer, Importer and Health Professionals.

5

Recall

Manufacturer need to initiate recall

Manufacturer need to initiate recall

Sponsor  need to

initiate recall

6

Legal requirement

21CFR Part 7, Subparts A and C - Recalls - General guidelines
21CFR Part 107, Subpart E - Mandatory recall of Infant Formula
21 CFR Part 1270 - Human Tissue
PHS Act - 42 U.S.C. 262 - Mandatory recall of biological product

Under sections 4, 5, 7 and 2(2) of European Communities Act 1972 and transpose Directive 2001/95/EC

Trade Practices Act 1974(Section 65R) of Australian Competition and Consumer Commission (ACCC).







7

Recall Communication

Telephones, Telegrams, and Mailgrams, First classes letter approved by FDA.

Field safety notice approved by MHRA as per format within 48 hours of field safety corrective action agreement by Telephones, Telegrams and fax.

Recall letters approved within 48 hours of recall agreement paid advertisements to consumers/ retail level approved by TGA.

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