Karnataka drugs control department has served show cause notices on 236 pharmacy outlets in the state during last month. It has also suspended 110 sales licenses and cancelled 88 licenses. The action is subsequent inspections carried out by a team of enforcement officers during the month.
The cancellations of licenses were done as these establishments were found to have violated provisions of Rule 65 of Drugs & Cosmetics Act. During the time of inspection and on analysis, the drugs were found to be not-of-standard quality and the outlets are implicated for the alleged infringement of the Act. The Department has cancelled three manufacturing licenses besides issuing three show cause notices and one stop production order.
The department has also issued 279 fresh licenses and two new drug manufacturing licenses.
During the month, the department has filed two cases for prosecution in the court. Of the six earlier cases, four were convicted. From the public, the department received 10 complaints which are being investigated.
In its efforts to contain manufacture and sale of drugs of not-of-standard quality or misbranded or adulterated, the drugs inspectors collect certain number of samples every month from the market. Periodic raids are conducted under the supervision of state drugs controller or the assistant drugs controller or senior drugs inspectors. The seized drug samples are analysed at the in-house drug test lab in Bangalore. In June, drug test lab received a total of 304 samples for analysis and had 13 products declared as not-of-standard quality and investigation is being carried out. These included Rabes, Raberprazole tablets manufactured Alliance Biotec and Orazep -Z : Lorazepam tablets by Mission Laboratories at Baddi in Himachal Pradesh.
There are also two Karnataka companies which have been issued notices for not-of- standard quality. These are Embiotic Laboratories for Dicyclomine tablets and Karnataka Antibiotics & Pharmaceuticals Ltd for Nufenac which is a Diclofenac sodium tablets.
Other companies are Rexer Pharma at Hyderabad for Ciprex (ciproloxin hydrocholride) and Chennai based Sai Mirra Innopharm for Durandil tablets.
There are 22,520 pharmacy sales outlets, 173 blood banks, 29 blood storage centres, 230 drug manufacturing companies and 92 cosmetic manufacturing units in the State. Over the last 30 days, the enforcement officers have carried out 1,753 inspections of retail outlets, 27 inspections of blood banks and 25 inspections of manufacturing units.