Pharma companies take FDC drugs off shelves after central govt ban

Following the ban on the 14 fixed dose combinations, the top pharma companies have written to their distributors for stopping the sales with immediate effect.

Days, after the Union government notified a ban on 14 fixed-dose combination (FDC) drugs, pharma majors, including Cipla, Dr Reddy’s, Mankind, Alkem and Intas, have written to their distributors to stop and return the medicines immediately.

In a letter to stockists, the firms have enlisted their banned cocktail formulations along with the brands manufactured by them, urging the distributors to stop the sale and return the stocks.

The letter from Hyderabad-based Dr Reddy’s has enlisted the DIALEX-DC cough syrup, which had codeine phosphate as one of the ingredients.

“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 with the notification for DIALEX-DC cough syrup, as it is banned,” Sudhir Patnaik, Head, Dr Reddy’s CFA Management said in the letter.

Also read: Govt bans 14 cocktail drugs for posing health risks, lack of therapeutic justification

When asked about the financial impact of this move on Dr Reddy’s, a company spokesperson said Dialex DC wasn’t a significant product for them.

“We have not been actively promoting this product for several months. It is not a significant product for us,” the spokesperson told Moneycontrol.

The FDC drug ban

The Union government last week banned 14 FDC drugs in India on the recommendation of an expert committee, which said there was "no therapeutic justification" for these medicines and that they may involve "risk" to people.

FDCs are drugs, which contain one or more active drug ingredients and are used for a particular disease indication.

Cipla in its letter mentioning three cough syrups — Cofdex Syrup, Cofton Expectorant, Cofdex Plus Syrup — and one tablet Cof-Q-Tab, has asked its distributors to stop the sale and distribution of these drugs.

Also read: Govt tweaks policy to prevent export of spurious cough syrup

Mankind Pharma in a letter has asked retailers to stop the sale of Tedykoff-LX and Codistar cough syrups.

Alkem has told its distributors, stockists and retailers to immediately cease the sales and distribution of five products; Alkof-C Cough Syrup, Nakuf C SF Cough Syrup, Alkof-Q Tablet, Kofclear-Q Tablet, Alkem's Koflinctus Syrup, containing the banned FDC.

Mumbai-based Franco-Indian Pharmaceutical in a circular has asked its distributors to stop the sale of Grilinctus syrup 100 ml with immediate effect and return all the stocks immediately.

Meanwhile, US pharma giant Pfizer, in a letter, informed its stockists that Corex Dx (Dextromethorphan Hydrobromide and Chlorpheniramine maleate cough Syrup) hasn’t been banned by the Indian authorities.

“It can kindly be noted that our drug Corex Dx contains only Dextromethorphan Hydrobromide and Chlorpheniramine maleate in a fixed dose combination and hence is not a prohibited FDC as per the aforesaid gazettes and thus there is no impact on this formulation,” Pfizer said.

Impact on the market

According to Pharmatrac’s April data, the ban on the 14 FDCs last week will see an impact of Rs 807 crore on the market. Meanwhile, the respiratory portfolio had a lion’s share of 95 percent (Rs 770 crore) share in the Rs 807 crore. The neurological/CNS segment had only 5 percent (Rs 37 crore) share.