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

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

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

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

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Drug Product Recall of 2013

Hospira, Inc. announced a voluntary user-level recall of one lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09 due to seen particulate matter in containers.¹⁰

Draft Guidelines for India
Introduction
Drug product recall is a request to return to the maker a batch or an entire production run of a productfrom distribution, usually due to the discovery of defects in safety, quality, and efficacy.

Background
In the Drugs & Cosmetics Act & Rules, there are references for drug product recalls, complaint and adverse reactions in Para 27 & 28 of Schedule M and also conditions of license for defective product recall in Rule 74(j) and Rule 78(i).

Scope
These guidelines are applicable to all quality defective product reports of safety and efficacy and these guidelines are expected to be followed by licensees of manufacturers, importers, stockiest, distributors, retailers.

Objective
To explain and standardize the procedure for classification and communications involved in drug product recall or withdrawal.

Purpose of Recall
To effectively remove from the market products that violate requirements and that may represent a health hazard to the consumers and users.

Definitions
Recall: Removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy and violation of the laws.

Batch Recall: Process for removal of selected batches of a product which are found to be defective and risky to the consumers.

Voluntary Recall: A recall initiated by the licensee as a result of abnormal observation in any product quality during periodic review or investigation of a market complaint.

Statutory Recall: A recall directed by drug control authorities after notifying that product is considered to be in violation of the laws.

Recall Classification
Recall classification is a numerical designation, I, II, or III, that is assigned to a particular product recall that indicates the relative degree of health hazard by country regulatory authorities.
Class I is a situation in which there is a reasonable probability that the use of defective product will cause serious adverse health consequences or death and as well as banned under of Drugs and Cosmetics Act 1940.
Class II is situation in which the use of a defective product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III is a situation in which the use of a defective product is not likely to cause any adverse health effect.

Recall Procedures
Voluntary Recall:
Voluntary recall can be triggered by any incident that affects the quality, safety and efficacy of the batch/product in question such as
1. If the batch or batches are found to be not complying with the regulatory specifications during the post marketing stability study.
2. If the batch is found to be defective during investigation of market complaint.
3. During any failure investigation, if it is observed that the failure under investigation might have adverse quality impact on already released batch.
4. If any unusual observation is noted during visual inspection of retention samples which indicate an impact on quality of the product after investigation.
5. If the post marketing surveillance reports or pharmacovigilance reports indicates that there is serious safety risk associated with the product.

Statutory recall can be triggered in response to the direction or mandate by the drug regulatory authorities (central/state) in one or more of the situations as follows:

1. To recall the drug product/batch, considered to be in violation of the laws.
2. To recall the banned drugs.
3. Labeling or Promotional materials, that are considered to be in violation of law.
4. Drugs under Schedule J

 Levels of Recall
The level or depth of recall of a product or batch shall be determined based on recall classification and level to which distribution has taken place.

There are three levels of recall such as consumer/user, retail and wholesale.

Consumer or User Level: Consumer or user may include individual consumers, patients, physicians and hospitals.

Retail Level: It includes retail groceries, pharmacies, hospital pharmacies, dispensing physician, institutions such as clinics and nursing homes, etc.

Wholesale Level: all distribution levels between the manufacturer and retailer.

Time Lines for Effective Recall System
Based on the category of risks involved, a time line of within 1 day up to a maximum of 2 days hours for Class I recall, for class II recall up to a maximum of 7 days and for Class III recall up to a maximum of 30 days is allowed.

Stepwise Recall Procedure:
The licensee or representative of licensee or quality head in charge shall enter the details in the Recall Log and assign a unique recall reference number representing the serial number for a particular year in which the recall has been initiated. Product or batch recall notice shall be filled and sent to the licensee or representative of licensee or quality head in charge.

Follow-Up Action of Recalled Drug Products
The follow-up action consists of a check on the effectiveness of the recall, an investigation of the reason for the recall and remedial action taken to prevent of the defect.

Conclusion
Drug product recall is crucial decision for the companies. Each of countries (US, UK, Australia) have their specific guidelines for drug product recall,  In India, there is no specific guidelines on drug product recall, so now, we have suggested the specific guidelines for India to regulate the procedure of drug product recall.

References
1. en.wikipedia.org/wiki/Product_recall accessed on 29/1/2013
2. drug-injury.com accessed on 29/1/2013
3. bio-link.org/GMP/KELPOST.html accessed on 29/1/2013
4. en.wikipedia.org/wiki/Food_and_Drug_Administration accessed on 29/1/2013
5.  burrillreport.com/article-2703.html. accessed on 30/1/2013
6.en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency accessed on 30/1/2013
7.  tga.gov.au accessed on 30/1/2013
8.  accc.gov.au/content/item.phtm accessed on 30/1/2013
9. en.wikipedia.org/wiki/Australian_Competition_and_Consumer_Commission accessed on 30/1/2013
10.    fda.gov/Safety/Recalls/ucm322961.htm accessed on 30/1/2013
11.  The WHO TRS for GMP Guidelines accessed on 31/1/2013
12. Work Shop on Recall & Rapid Alert System, held at New Delhi Office from 27th to 30th accessed on 31/1/2013
13. USFDA documents on recall accessed on 31/1/2013
14. The Guidelines on Recall & Rapid Alert System for Drugs including Biological and Vaccines accessed on 31/1/2013

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