The manufacture, sale and distribution of Hemocryl Gel has been stopped in Tamil Nadu from Friday under the orders from the Director of Drugs Control and Licensing Authority, Chennai, Tamil Nadu.
A press release stated that Deo Pharmaceuticals Pvt Ltd based in Chennai and the distributors of Hemocryl Gel which contains Ferracylum 1 % Gel has been issued a show cause notice after it was found to have violated various provisions of the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945.
The decision was taken following inspections conducted at the office premises of Deo Pharmaceuticals on August 25, 2020 after complaints of the Hemocryl Gel being of substandard quality were bought to their notice.
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.
Also it was observed that the firm has not maintained 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.
The Authority 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.
Source : PR