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Drug Recalls

 What is a drug recall?

Recall is an action taken to withdraw/remove the drugs from distribution or use in the market when any deficiencies are reported in quality, safety or efficacy of the drug product.

As per the CDSCO, the defective products related to quality include:

Not of Standard Quality

Adulterated or Spurious drugs.

Safety and efficacy related recalls include serious adverse reactions and death.

If any drugs prohibited under the Provisions of Drugs & Cosmetics Act and if the product licenses are suspended/cancelled, it must be recalled by the companies.

When companies announced the drug recall?

A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because it is found to be either defective or potentially harmful.

Why are drugs recalled?

There are number of reasons that may cause a drug to be recalled.

A recall may be issued if a medicine is:

(A) If Drug product has a health hazard to patients:

Some health risks associated with certain medications are unfortunately not realized until after they become widely used. The most classical recent example of this situation was the Vioxx voluntarily recall by Merck in September, 2004.

As per the US food and drug administration, the Vioxx recall was occurred based on clinical trials findings which showed an increased risk of cardiovascular problems, such as heart attacks and strokes, compared to those receiving the placebo. However during the first 18 months this study did not show an increased risk of such cardiovascular problems for patients who was taking Vioxx.

Vioxx is a COX-2 inhibitor that was originally approved by the FDA in 1999 for the treatment of pain and reducing inflammation for patients with osteoarthritis, as well as for menstrual pain. It was later approved to be used for rheumatoid arthritis (Source:USFDA)

(B) If Drug product has potentially contaminated:

During production or distribution, a medicine may become contaminated with a harmful or non-harmful substance.

(C) If Drug product is poorly packaged or mislabeled:

For example, you may think you are taking a pain reliever based on the package material, when in fact what is inside the box is something else.

(D) If Drug product is poorly manufactured:

Some time manufacturing defects related to a product’s quality, purity and potency may be ignored during manufacturing which may later cause for a drug recall.

Internationally agreed classification system for medicines recalls:

Class of Recall Description

Class I recall

USFDA defines class-I recalls as “A situation in which there is a reasonable probability that the use of or exposure to a defective or violative product will cause serious adverse health consequences or death.”

Europe defines class-I recalls as “The defect presents a life threatening or serious risk to health”

Canada terms class-I recalls as Type-I

Class II recall

USFDA defines class-I recalls as “A situation in which use of or exposure to a defective or violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

MHRA defines class-II recalls as “The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious”

Canada terms class-II recalls as Type-II

Class III recall

USFDA defines class-I recalls as “A situation in which use of or exposure to a defective or violative product is not likely to cause adverse health consequences.”

Europe defines class-II recalls as “The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification”

Canada terms class-III recalls as Type-III

 

As per the US Food and Drug Administration Dr Reddy’s Laboratories Ltd has voluntarily recalled over 13000 bottles of the high blood pressure drug metoprolol succinate in the United States after it failed a dissolution test, in may 2014. In another news, Wockhardt Ltd also recalled same drug three times in year 2014 citing the same reason. Both are the examples of class-II recall.

As per the CDSCO, all banned Drugs & Products for which license is suspended, cancelled which are in circulation in market shall also be considered to be Class I recalls only

 

Types of Recall:

  •  Voluntary Recall: A recall initiated by the licensee (in case of loan licensee jointly the contract giver and contract acceptor) as a result of abnormal observation in any product quality during periodic review (Internal / External) or investigation of a market complaint or any other failures.
  • Statutory Recall: A recall directed by Drug Control Authorities after notifying that product is considered to be in violation of the laws. e.g., Declared as Not of Standard Quality by Government Analyst and Banned under 26A of Drugs and Cosmetics Act 1940 (as amended from time to time)and as well as contravention of Rule 104-A of Drugs & Cosmetics Rules1945(as amended from time to time).

 

Levels of Recall:

The level (or depth) of recall of a product/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: which may vary with product, including any intermediate wholesale or retail level. Consumer or user may include individual consumers, patients, physicians and hospitals.

 

  • Retail Level:- recall to the level immediately preceding consumer or user 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.

All Class I recalls shall be executed to the levels of Wholesale/Distributors, retail, and consumer. In such cases, public announcements shall be made using print/electronic media aids viz. Newspapers, Television, Radio etc.

 

All Class II recalls shall be executed up to the levels of wholesale and retail.

All Class III recalls shall be executed up to the levels of wholesale.

 

Time Lines for Effective Recall System & Rapid Alert:

CDSCO suggested different timelines of recall, based on the category of risks involved;

For Class- I Recall: shall be ensured within 24 hours and the physical recall being completed within 72 hours.

For Class- II Recall: shall be ensured up to 10 days.

For Class- III Recall shall be ensured up to 30 days.

January 8, 2018

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