The Director of Drugs Control and Licensing Authority, Chennai, Tamil Nadu has directed the stopping of manufacture, sale and distribution of Hemocryl Gel in the state with immediate effect.
Coimbatore: The Director of Drugs Control and Licensing Authority, Chennai, Tamil Nadu has directed the stopping of manufacture, sale and distribution of Hemocryl Gel in the state with immediate effect.
Deo Pharmaceuticals Pvt Ltd based in Chennai has received notice after it was found to have violated various provisions of the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945 since they are the distributors of Hemocryl Gel which contains Ferracylum 1 %.
This decision was taken after the inspections conducted at the office premises of Deo Pharmaceuticals on August 25, 2020after receiving complaints of the Hemocryl Gel being of substandard quality when brought.
Examination of Hemocryl Gel samples revealed that the samples do not conform to the manufacturer’s specification with respect to the content of Iron in Feracrylum Gel and violates section 18(a)(i) of the Act for having manufactured for sale of not of standard quality drug.
It was also revealed that the firm did not maintain records/registers with the particulars in respect of tests of raw materials used for the manufacture of Feracrylum Gel as well as the finished product as specified under various sections of the Act.
Authorities have also found Deo Pharmaceuticals guilty of not conducting validation studies for processing, testing and cleaning procedures, thereby failing to comply with the requirement of Good Manufacturing practices under the Drug and Cosmetics Rules, 1945.