The Bangalore District Chemists & Druggists Association (BDCDA) has intimated to all pharmacy trade outlets about the Karnataka drugs control department's order on the five manufacturers who are now permitted to sell the fixed dose combinations (FDCs). The five manufacturers are Anglo French Drugs & Industries, Cipla, Pfizer, Alkem Laboratories and Micro Labs. These five companies had filed writ petitions before the High Courts of Karnataka and Delhi challenging the Union government’s notification prohibiting 344 FDCs for human use via its order on March 10, 2016.
“The government has banned the sale of 344 FDCs for human use under section 26A of the Drugs & Cosmetics Act for manufacture and sale in the country”, said Raghurama Bhandary, Karnataka drugs controller in his office order dated May 10, 2016.
“Various manufacturers had filed writ petitions before the High Courts of Karnataka and Delhi. Accordingly the High Court has issued interim stay order. The direction was that the stay order will be brought to the notice of the state licensing authorities,” said the Karnataka drugs controller.
“The manufacturers submitting the stay order copies to the department are Anglo French Drugs & Industries, Cipla, Pfizer, Alkem Laboratories and Micro Labs. These manufacturers may now sell the FDCs prohibited under the notification mentioned against them for which the High Courts have granted stay order subject to the final verdict in the writ petitions”, said Bhandary.
The directive from the state drugs control department came in after the BDCDA sought a clarification as over 28,000 pharmacy outlets in the state were unsure on the status of sale of FDCs after companies went on to file the writ petitions and the High Courts granting stay order, said V Hari Krishnan, president, BDCDA.
“Our effort was to ensure all the chemists who are members of the BDCDA need to adhere to the Drugs & Cosmetic Act and Rules thereunder,” he added.
Now we have indicated to all the outlets that as per the order of the Karnataka drugs control office, the FDCs of these five companies could be stocked, distributed and sold even if they have been prohibited by the Union government order, said the BDCDA president.