Drugs in batches or lots, which are asked to be removed from the market, could either be substandard or adulterated or simply fake. These recalls may also be triggered when a drug is banned in the country by the regulator or when a certain drug is known to be causing serious adverse side effects, or is just mislabelled.
On the lines of US Food & Drug Administration, the most referred regulator worldwide, the Drug Controller General of India (DCGI) has sorted types of recalls into three classes, depending on the urgency and potential impact they could have.
Once alerted by the central or the state regulator, pharma firms may have to recall drugs within 72 hours or get up to a months time to do so, depending on the urgency of the reasons that prompted such a call. The government, which regularly tests drugs in its laboratories, would base its decision on the results, an official said.
A recall would be labeled as class I type when the drug in question can cause serious side effects or death or if a drug is banned in the country. In this case, the drugmaker would have to ensure that the sale of such products is stopped within 24 hours and the entire recall process is completed within 72 hours, according to a draft document on drug recall prepared by the DCGI office.
A class II drug recall may be set in motion when the drug in question can cause some temporary side effects, but not serious adverse-impact. For such recall, the firm would be given 10 days to pull out the affected batches or lots. Finally, class III drug recall is the mildest wherein the drugs in question are not known to cause any side effects and the pharma company would be given a month to pull out its products.
While in a class I drug recall, the pharma companies would be asked to withdraw drugs from consumers, retailers as well as wholesalers, in a class II recall drugmakers would have to ensure the recall from wholesalers and retailers only. Similarly, for class III recall, the product just has to be called back from the wholesalers.
In fact, for a recall of class I category, the drug firms would also have to advertise in newspapers, television or radio so that consumers who have bought drugs from an affected batch can return the same, the official said.
US FDA has stringent rules on publicising a recall, particularly if it is a consumer product and has already reached the end user. A few months back, when we were asked to recall a product, we followed it up by issuing a press statement on our website and informed the stock exchange as per the requirement. Despite that, US FDA officials insisted that we call AP (Associated Press, an American new agency) to get the news carried so that it gets wider publicity. The US regulator is very strict on these protocols, a top executive of a leading Indian pharma firm told FE.
In exceptional cases, a rapid alert system may be activated to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission and on receiving such alerts, companies must act immediately.
In parallel, a voluntary recall system where companies detecting a fault in specific batches may initiate a recall process on their own is also being instituted.
This is something practiced by large drug firms in the R68,000 crore domestic market even today but without any significant government intervention.According to sources, erecting a robust drug recall mechanism is part of a government exercise to prepare the drug regulator for an upcoming inspection by World Health Organisation.