The setting up of the office of Central Drugs Standard Control Organization (CDSCO) in the Karnataka has come in a big relief for the pharma units in the state. There are two CDSCO offices opened in the state now. While one facility known is for the export office is at the Bengaluru International Airport, the other is located in the state drugs control office.
Having a CDSCO office will now bring down the cost overheads and prevent inordinate delays for pharma manufacturers to seek the export clearances. The State's total pharma earnings is estimated at Rs 3,850 crore ending March 31, 2009 of which exports account for 8 per cent. The leading exporters are Biocon, Micro Labs, Bal Pharma, Medriech, RL Fine Chem, Strides Arcolab to name a few.
All these years, companies sought the necessary clearances from the CDSCO at Chennai. The setting up of the CDSCO in Karnataka will now provide the much needed fillip to export activities. Right now there are two officials manning the operations. The procedural aspects for export import clearances are being worked out. The Central government has plans to strengthen the CDSCO with additional personnel, Dr BR Jagashetty, Karnataka drugs controller told Pharmabiz.
The CDSCO is also the Central License Approving Authority (CLAA). The Drugs & Cosmetics Act calls for joint inspections by the central and state teams to seek permission for manufacture of large volume parenterals and medical devices besides carrying out audit of blood banks. Once the state inspectors carry out the assessment, the central team is approached for inspection. The CDSCO office in the drugs control office will have both the state and central inspectors at one location which would see faster approvals to seek or renewal licenses, he added.
With the Karnataka government recognizing the critical role of the State drugs control department to monitor the manufacturing units and sales outlets, it has taken on a massive modernization of the facility here in Bangalore. The state's Public Works Department is carrying engaged in the redesign of the facility which includes drug test lab and the administration block. The renovated complex will be ready in six months time. Efforts are also on to network all the drugs control offices in the districts to the head office. This will provide instant information on the status of the inspections and the pending audits across all the state departments.