NNMRA orders Benaragama’s company to withhold 9 more products from Maan Pharmaceuticals!
The National Medicines Regulatory Authority (NMRA) has issued a letter to PTC Medical (Pvt.) Ltd. today (Dec. 16) urging the company to immediately withhold all parenteral products manufactured by Maan Pharmaceuticals Ltd, as a precautionary action, until further investigations.
The letter lists 09 more pharmaceutical products in addition to the Ondansetron injections which was withheld earlier this week. The letter states that this is with reference to the decision of the safety and risk evaluation subcommittee taken today, based on ;
Continuous adverse drug reaction reports the NMRA had received (including fatal reactions)
The recommendation in the preliminary investigation reports of consultant microbiologist of the National Hospital in Kandy
The letter further states that relevant product testing at NMQAL and further investigations have been initiated to ensure the product quality, safety and efficiency.
It concludes that as the market authorization holder, PTC Medical (Pvt.) Ltd. must ensure that all the mentioned products are withheld in the entire private sector immediately.
The letter containing the list of 10 products, is shown below.This measure follows regulatory concerns involving the company, with regard to issues over a cataract lens tender 02 years ago, was also reported.
According to the website of PTC Holdings (Private) Limited, Mr. Gihan Beneragama, Mrs. Gimhana Wickramasurendra, and Mr. Jaliya Wickramasurendra are named as their Director Board members.
Mr. Gihan is the son of former NMRA Director Dr. Hemantha Benaragama.
