Introduction:
Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. Recalls also include drugs prohibited under the Provisions of Drugs & Cosmetics Act and also those products for which product licenses are suspended/cancelled.
Rapid Alert System is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. Assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or harm to animals (in case of veterinary product), consumers, operators and the environment.
Background:
In the Drug and Cosmetic Act & rules, there are reference for product recall, complaint and adverse reaction in para 27 and 28 of schedule M and also condition of license for defective product recall in Rule 74(j) and Rule 78(i).
Definitions:
Recall:
Removal or correction of marketed product for the reason relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws.
Batch Recall:
Process of removal of selected batch/es of a product which are found to be deceive and pose health risk to be consumer if left in the market.
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)
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, or exposure to a defective product will cause serious adverse health consequence or death and as well as banned under the act.
Class II is situation in which the use of, or exposure to a defective product may cause temporary adverse health consequence or where the probability of serious adverse health consequence is remote.
Class III is a situation in which the use of or exposure to, a defective product is not likely to cause any adverse health consequences.
Recall Procedure
Any batch of a product not meeting the defined quality standards or serious complaints has to be recalled from the market. Recall can be of two type; Voluntary Recall and Statutory Recall.
Voluntary Recall:
Voluntary Recall can be triggered by any incident that affects the quality, safety and efficacy of the batch/product in such cases ( but not limited to)
- If the stability study failure with the regulatory specification during the post marketing stability study.
- If the batch is found defective during investigation of market complaint.
- If it is observed that the failure under investigation might have adverse quality impact on already released batch. (eg. possibility of contamination, mixup etc.)
- If any unusual observation is noted during visual inspection of retain samples which indicate an impact on quality of the product after investigation.
Statutory recall can be triggered in response to the direction or mandate by the Drug Regulatory Authorities in one or more of the situation as follows:
- To recall the drug product/batch, considered to be in violation of the laws, it administers such as not of standard quality etc.
- To recall the banned drugs.
- Labeling and /or promotional materials that are considered to be in violation of law.
- Product, violation rule 106 (Diseases under schedule J)
Level of Recall:
The level or depth of recall of a product and/or batch shall be determined based on the recall classification and level to which distribution has taken place.
There are three level 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.
Timeline for Effective Recall system and Rapid Alert:
Based on the category of risks involved,
For class I recall a time line of within 24 hours up to a maximum of 72 hours
For class II recall up to a maximum of 10 days and
For Class III recall up to a maximum of 30 days is allowed.
The timeline for intimation of recall process to commence from the receipt of information as notified by the concerned Drug control department under statutory recall or voluntary recall by the manufacturer on its own.
Procedure for Rapid Alert & Recall System:
As soon as the product/batch(es) to be recalled is/are identified, licensee or representative of licensee or QA in charge shall review the information related to the defective product/batch(es) and decide about recall as per the procedure established.
The licensee/representative of licensee where the product is marketed shall inform the concerned regulatory authorities where the product batch(es) in question was distributed immediately after the decision of recall has been taken. Further actions on recall will be undertaken according to class of recall.
The licensee/ representative of licensee/ Quality Head in charge shall inform the distributor with fasted mode of communication.
Distributor / Marketing Company shall immediately check the distribution record to identify the Customers and Warehouse, depots where the subject product / batches have been distributed and forward the copies of the Recall Notice to them for further necessary action.
The Head of warehouse shall send a periodical report to licensee of the stock available with them and the return received from depots.
The recall of the product/batch shall be completed depending on the class of recall within the stipulated time.
Follow up action of Recalled Goods:
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 a recurrence of the defect.
The stocks of recalled goods shall be placed under “Quarantine” and stored separately under lock and key in a secure area until further decision.
All material shall be accounted for the reconciliation
Based on conclusion of the investigation finding the QA head/representative of licensee shall direct the distributor / marketing company for appropriate disposition of the batches of the recall good as per the regulations.
Mock Recall:
Mock recall shall be carried out for at least one batch of any product, dispatched for sale where maximum distributors are involved, to test the effectiveness of the arrangements of recall. Effectiveness of recall procedure can also be checked by ‘evaluation of a real recall’.
During mock recall traceability shall be performed for at least, one of the raw material used in the batches identified for mock recall.
Records of such mock recall should be maintained by the QA Head of the company.
Reference:
Guidelines on Recall and Rapid alert system for Drugs (including Biologicals and Vaccines)
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