How to handle pharmaceutical product's Recall

  There shall be two types of recall: 

 Voluntary Recall and 

  Forced Recall 

 Voluntary Recall: This is recall of product from the market or   distribution network of entire available quantity at the time of initiation of recall, based on decision by Quality unit. In following cases:

• Quality complaint from market
• Discovery of some deficiency that would impact the  consumer health safety
• Deterioration in quality, safety, identity or purity of the drug product identified during product review or stability studies subsequent to dispatch
• Report of an adverse drug reaction
• Mislabeling that may impacting negatively on the identity, strength, quality and purity of the product.
• Evidence is received / established that a product causes health hazard may cause potential health hazard as determined by Pharmacovigilance
• Post dispatch discovery of unacceptable non compliance to cGMP or regulatory requirements
• Visually detected physical deterioration

Forced Recall: This is recall forced by a regulatory agency upon discovery / reporting of violation or deficiency in the product.

The recall is classified on the basis of health hazard and it is classified as Class I, Class II, Class III and Caution in Use dependent on the hazard.

Class I: Involves a health hazard situation where there is a reasonable probability that use of product will cause serious adverse health consequences or death. This is the most serious recall. All Class I defects shall require immediate attention by all reasonable means whether in or out of business hours. For such, help of mass media like radio, TV (Radio: www.allindiaradio.org;  TV : www.ddindia.net and www.indiantelevision.com or private television channels like www.colorstv.in, www.ndtv.com etc. or private radio channels like Red FM, 92.7 FM, etc.) Setting up of hotlines for 24-hour telephone backup shall be considered fornotifying the public in mass. Product to be recalled to the respective depot at the earliest, but not later than 10 days after the receipt of this communication

Class II: Involves a potential health situation where there is a remote probability of

adverse health consequences from the use of the product. The defect may cause  mistreatment or harm to the patients, but it is not life threatening or serious. Product to be recalled to the respective depot at the earliest, but not later than 15 days after the receipt of this communication 

Class III: Involves a situation where the use of product is not likely to cause adverse

health consequences. The defect is unlikely to cause harm to the patient, and recall is carried out for other reasons such as non-compliance with marketing authorization or specifications. Product to be recalled to the respective depot at the earliest, but not later than 45 days after the receipt of this communication

The product recall proposal shall be approved within 3 days of initiation of proposal. For class – I recall, the recall process shall be initiated by Head Quality. The recall committee comments shall be received, may be awaited, but not beyond 3 days in such a recall.

The regulatory authority of the concerned country shall be informed and further more request to competent authorities/ MAH / QP and customers for recall the product, the serious quality related issues or even only suspected quality related issues, shall be informed to competent authorities in advance, attempts shall be made to agree with competent authorities.

Without the approval and agreement of competent authorities  no decisions of recall execution shall be done, In case of contract manufacturing, contract giver should be responsible to take decision of withdrawal of product from market and notification to respective regulatory body. In case of overseas locations they should meet respective local regulatory requirements. Contract giver shall be responsible to co-ordinate and supervise entire activity. All necessary assistance and information, if required, should be provided to contract giver by contract acceptor.

some terms also use in this section like 

Recall: Recall refers to the removal of specific products or specific batches of the product from market, for reasons relating to deficiencies in the quality, safety or efficacy.

Mock Recall: Tracing of specific batches of the product in the market to assess the preparedness and efficacy of the distributor / Carry and forwarding agents / global distribution centre to get back details of the product in shortest possible time.

Withdrawal: Total withdrawal of a medicinal product from the market.

Voluntary Recall: Recall of specific products or specified batches of a product including physician sample from the market or distribution network of entire quantity based decision by quality unit.

Forced Recall: Recall forced by a regulatory agency upon discovery / reporting of violation or deficiency in the product

Contract Giver: Marketing Authorization Holder or agency responsible for sale of product in country