Fixed-dose combination medicines such as Dialex DC, Grilinctus, Codistar, Tedykoff LX and other cocktail cough syrups will be taken off the shelves after the central government banned them recently.
The banned 14 combination medicines were found to lack therapeutic relevance.
Fixed-dose combinations (FDCs) are medicines that combine more than one drug in a single pill and are also referred to as “cocktail” medicines.
While the industry is still evaluating the effect of the ban in terms of the number of brands impacted and their market value, top pharma companies including Dr Reddy’s, Intas Pharma, Franco Indian Pharmaceuticals, Alkem and Mankind Pharmaceuticals have started recalling their products falling under the banned list.
According to the notification, the expert committee recommended that “there is no therapeutic justification for this FDC and they may involve risk to human beings”.
Now, the companies have asked the distributors, stockists, dealers, retailers, institutions and hospitals to immediately cease the sales and distribution of their medicines.
For instance: Dr Reddy’s wrote to stockists to stop the sale of “Dialex DC”, which is a drug fixed dose combination of Chlorpheniramine Maleate + Codeine Syrup “with immediate effect”.
“It is to bring to your kind attention that in view of the notification, the company’s distributors, stockists and retailers are hereby advised to ensure compliance to the notification for the below-mentioned product/brand as it is banned and prohibited, more particularly stated below (product) covered by the notification until further directions,” Sudhir Patnaik, head of CFA management wrote in the letter seen by News18.com.
Meanwhile, pharmaceutical companies are also sending clarifications to distributors that their drugs are “not” part of the banned list.
For instance: US Pharma giant Pfizer wrote to its stockists on June 5 clarifying that their drug Corex Dx is not prohibited FDC as per the gazette notification and thus “there is no impact on this formulation”.
Drugmakers Recall Stock
Mumbai-based Alkem, impacted by the ban notification, will pull its five products from the market, which include cough syrups and tablets to cure dry cough. The brand names are Alkof C, Nakuf C SF, Alkof Q Tablet, Kofclear Q Tablet and Koflinctus.
Similarly, Intas Pharmaceutical has asked the distributors to stop the sales of its epilepsy drug Phenytal 30 and Phenytal 50.
Another Mumbai-based drugmaker, Franco Indian Pharmaceuticals has also asked its distributors to stop supplying its cough syrup “Grilinctus syrup 100 ml with immediate effect and return all the stocks.”
Similarly, the manufacturer of dry cough syrup Codelite 100ml, Chennai-based Tablets India is recalling its stock. Mankind Pharma’s “Tedykoff LX Cough Linctus and Codistar cough star” will also go off shelves immediately.
Chemist Body Writes to Pharma Heads on Brand Names
Meanwhile, the chemists and trade associations are still figuring out the name of brands, which are being impacted by the notification.
On June 5, the largest lobby of chemists, the All India Organisation of Chemists and Druggists (AIOCD), has written a letter to all distributors and marketing heads of pharmaceutical companies to help stockists and retailers in identifying the banned products.
“With reference to the notification, it was observed that numerous FDC (Fixed Dose Combination) are marketed with a number of companies with various brands. It is difficult for stockists and retailers to identify brands falling into particular banned combinations. You are requested therefore a detailed list of brands (formulations) need to be made available immediately,” the letter said.
AIOCD has requested the companies and their distributors for “immediate action with clear communication” to avoid the sale of a banned combination of drugs “even by oversight”.