Karnataka drugs control department has now brought down the number of days for export clearances, thus helping the pharma manufacturers in the state access to speedy approvals. The clearances are now coming through within a week to ten days compared to the earlier 25-45 days.
The department has gone ahead to streamline the approval process by decreasing the number of steps in examining the documents submitted by the pharma companies. Earlier the files needs to be checked by the drugs inspector, assistant drugs controller, deputy drugs controller, additional drugs controller and finally the drugs controller. The entire practice of approvals was time consuming.
“We have looked into the issue and ensured that the files for export clearances only need the approval of the deputy drugs controller and the drugs controller,” Raghurama Bhandary, drugs controller, government of Karnataka told Pharmabiz.
This has helped to ensure quicker dispatch of files from the department. The department views that the efficiency would only help to swiftly export the products.
“We see a 90 per cent reduction in terms of timeline for clearances,” he added.
The key objective is to bring down the time of file approvals with computerization and all data of the companies accessible at the click of a button. The manufacturing licenses are also submitted and disbursed online which has transformed the functioning of the department.
In the case of non statutory certificates like tenders too, the department has brought down the time for clearances from the current 45 days to a week, said the Karnataka drugs controller.
In an earlier interaction, the Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA) stated that it was looking to augment its business prospects in the area of exports. In this regard, decreasing the time for clearances of the drugs for the international market is seen a big fillip for the industry.
For 2014-2015, while Indian pharma turnover is pegged at Rs.1.30 lakh crore of which Rs.80,000 crore is generated from the domestic sales and the remaining Rs.50,000 crore from exports earnings. In Karnataka, pharma revenues are at Rs.12,500 crore which is 9 per cent of the national turnover. The exports earnings are Rs.5,200 crore.
“It is a fact that the there is a significant decrease in the time taken for approvals of not just exports but also tenders. For instance, our company received a clearance to apply for a Rajasthan tender within 24 hours, said Harish K Jain, treasurer,” KDPMA and director, Embiotic Laboratories (P) Ltd.