Takedown of Grilinctus, Tedykoff LX, Codistar, and Other Cocktail Drugs; Industry to Determine Impact
Following a recent prohibition by the central government, fixed-dose combination medications including Dialex DC, Grilinctus, Codistar, Tedykoff LX, and other cocktail cough syrups will be removed off the market.
It was determined that the 14 combination medications that were prohibited lacked therapeutic value.
Fixed-dose combinations (FDCs), sometimes known as “cocktail” medications, are pharmaceuticals that mix several medications in a single tablet.
Top pharmaceutical companies like Dr Reddy’s, Intas Pharma, Franco Indian Pharmaceuticals, Alkem, and Mankind Pharmaceuticals have started recalling their products that fall under the banned list, though the industry is still evaluating the impact of the ban in terms of the number of brands impacted and their market value.
The expert group advised, per the announcement, that “there is no therapeutic justification for this FDC and they may involve risk to humans.”
Distributors, stockists, dealers, merchants, institutions, and hospitals have now been requested by the corporations to immediately stop selling and distributing their medications.
For instance, Dr. Reddy’s requested in writing to stockists that “Dialex DC,” a medication fixed dosage combination of Chlorpheniramine Maleate and Codeine Syrup, not be sold going forward.
Sudhir Patnaik, the head of CFA management, wrote in a letter obtained by News18.com that “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 specifically stated below (product) covered by the notification until further directions.”
Pharmaceutical firms are also informing distributors that their products are “not” on the list of substances that are prohibited.
For instance, US pharmaceutical behemoth Pfizer clarified in a letter to its distributors on June 5 that their medicine Corex Dx is not a banned FDC according to the gazette announcement and that, as a result, “there is no impact on this formulation.”
A RECALL OF STOCK BY DRUGMAKERS
Due to the prohibition notice, Mumbai-based Alkem would remove five items from the market, including cough syrups and pills to treat dry cough. Alkof C, Nakuf C SF, Alkof Q Tablet, Kofclear Q Tablet, and Koflinctus are the brand names.
Similar to this, Intas Pharmaceutical has requested the distributors to halt sales of Phenytal 30 and Phenytal 50, two of its medications for treating epilepsy.
Franco Indian Pharmaceuticals, a different pharmaceutical company located in Mumbai, has also requested that its distributors cease selling their cough medicine, “Grilinctus syrup 100 ml with immediate effect and return all the stocks.”
Similar to this, Chennai-based Tablets India, the producer of the dry cough medication Codelite 100ml, is recalling its stock. The “Tedykoff LX Cough Linctus and Codistar cough star” from Mankind Pharma will likewise be removed off the market right now.
CHEMIST BODY COMMENTS ON BRAND NAMES IN LETTER TO PHARMA HEADS
The names of the brands affected by the notice are still being determined by chemists and trade organisations.
The All India Organisation of Chemists and Druggists (AIOCD), the biggest chemist lobby, sent a letter to all distributors and marketing directors of pharmaceutical businesses on June 5 asking them to assist stocks and retailers in identifying the prohibited items.
Regarding the notice, it was found that multiple FDCs (Fixed Dose Combinations) are sold by a variety of businesses under different labels. Identifying brands that fit within certain prohibited combinations may be challenging for stockists and retailers. As a result, you are thus required to provide us with a complete list of trademarks (formulations) as soon as possible,” the letter said.
AIOCD has urged businesses and their distributors to take “immediate action with clear communication” in order to prevent the sale of a prohibited medicine combination, even accidentally.
