Meaning of term Recall for Pharma Companies and procedure involved
It means action taken by the enlistment holder of a product such as a manufacturer, exporter or PCD Pharma Companies to remove or retrieve from any person or distributor to whom it has been supplied because of the following reason
- may be hazardous to health
- May fail to conform to any claim made by its enlistment holder relating to the quality, safety, and usefulness.
- may not meet the quality requirements
Affecting factors of Product Recall:
Pharma products may recall for many reasons as discussed above but because of a distribution system and time taken to process, recall of all products from the market is not possible. It is depending on many factors like:
- The time duration between batch manufacturing and product recall
- Product batch size
- Nature of Product (Prescribed or OTC)
- Persons involves in Distribution
- Demand and Supply of Product
- Catchment Area of Product
- Available transportation facilities, time and expenses during the recall process
- Product expiry date
Product Recall Types:
- Voluntary Product Recall
- Requested by Concern Drug Authorities
Voluntary Product Recall:
If product manufacturer, marketer, PCD Pharma companies or any other person involved in distribution recall the product by itself by finding a product of inferior or lower quality in re-testing or any other way then it is Known as Voluntary Product Recall.
Requested by Concern Drug Authority:
If any concerned or government authority responsible for quality and standards of pharmaceutical products, finds a product is not up to standard quality may request to concern organization to recall that product from the market in the Public interest. If concern organization doesn’t recall product then concern drug authority may force manufacturer or use power to recall that product from the market.
Product recall procedures:
When a pharma product is identified as of lower quality or not up to required standards, the product is recalled by its manufacturer, marketer, PCD Pharma companies or any person involved in a distribution channel. A procedure of product recall involves following steps:
Step 1: If product recalled on request by concern drug authority, Authority issues a letter of confirming that given product found of lower quality and not comply with given standards as prescribed by the manufacturer, marketer or any person involved into the distribution channel. Concern person has to give the reply to this letter within a specific time period. This letter may also contain other required details given by concern drug authorities as given below:
- Confirmation of supply from source
- Detail of distribution report of that product
- Issuing Recall letter to concern person
- List of test report issued by concern drug laboratory
- Any other detail ( as per requirement)
Step 2: Receiver of recall letter has to reply and Issue further recall letter to all concern persons or organizations to whom product has been supplied. Product manufacturer needs to submit the certificate, analysis report and details of testing quality reports carry during product manufacturing.
Step 3: Manufacturer will issue Recall letter to CNF agents or marketer. A marketer will issue recall letter to stockists or distributors. A Distributor will issue this letter to pharmacies, retailers or chemist. The further chemist may ask for a return of product from patients but it is not possible because a patient may have consumed it or it is difficult to find patient easily.
Step 4: Receiving of all recalled stock and destroyed by a manufacturer in presence of concern drug authorities.