National Informatics Centre (NIC), of the Government of India, has installed its software at the Karnataka Drugs Control department which would allow it to keep tabs of manufacture and pharmacy outlets dealing with the drugs. The software which is presently undergoing the operational trials to link the entire state regulatory departments will require another 45-60 days to streamline the process. Karnataka is the third state in the country after Gujarat and Maharashtra to install the NIC software.
Although the state drugs control authority has issued two circulars to this effect, warning the manufacturing companies not to manufacture and chemists not to stock and sell any of the banned drugs i.e. Nimesulide, sibutrimine, R sibutrimine, cisapride, decongestant drug Phenylpropanolamine (PPA) and human placenta extracts, it will commence its surprise inspections in a few days to ascertain the extent of compliance of the warning notice, Dr BR Jagashetty, Karnataka drugs controller told Pharmabiz.
The networking of all the Circles of the state drugs control department will help to keep a close watch of pharma units and pharmacy outlets across the state. While the process has been implemented in Gujarat, it has clearly indicated the ease of keeping tabs and monitor all the companies and sales outlets at a click of a button. “In the meanwhile, we are making efforts to provide laptops to all assistant drug controllers and desktops to all inspectors including the new entrants who are currently undergoing training. The state’s drug enforcement team is extremely enthusiastic and are eager to maintain an updated database of the records of all licensees, product permissions, sub-standard quality drugs etc. The move will create higher efficiency levels, more accountability and total transparency,” he added.
The software will have the records of all pharma industries, products produced, details of licenses and cancellations. A similar exercise will also be made on all pharmacy outlets.
Early this year the state drugs control department had commenced its audit of GMP or Schedule M compliance adhered to by the units across the state. A team of four drug inspectors are carrying out the audit of 236 plants which is an inspection-cum-survey. The state drugs controller is also gearing up to implement the project on drug sampling to assess the quality of drugs and check the sale of not-of-standard quality medicines in circulation.
In the state Budget allocation for 2011-12 announced in February end the drugs control department has received a total sum of Rs.23 crore which covers Rs.10 crore under Plan category and Rs.13 crore under the Non-Plan component.
Considerable efforts are also on to improve the infrastructure/own buildings of the drugs control department across the state which covers at present offices in Mysore, Belgaum, Hubli, Bagalkot and Gulbarga. In addition, two drug test labs at Bellary and Hubli are also coming up. Further, at its headquarters in Bangalore a six storied enforcement wing and a Drug Test Lab are expected to be complete in 2012.