Drug regulator to reduce time for licence approvals

NEW DELHI: Drug manufacturing companies, which had to wait for up to nine months for various licences, can now look forward to much faster clearances. The drug quality regulator has expedited the process of clearing applications for export licence, import licence and test licences and is trying to hand them out in one-third the usual time required. The idea is to help the industry conduct clinical trials and move medicines, both domestically and outside the country, faster and with fewer hindrances.

���We are trying to reduce the time frame for clearances. Applications for import licences are now being processed by us in less than 12 weeks, though the Drugs and Cosmetics Act (DCA) gives us a leverage of nine months to clear them,��� the drug controller general of India (DCGI) Dr Surinder Singh said. In case of export licences, the regulator would now clear applications within two weeks and test licences would be approved in six weeks.

According to industry sources, pharmaceutical exporters have been facing serious problems in international markets due to delay in getting approvals from the government. Companies have to get clearances periodically from the DCGI to be able to conduct trials and export or import medicines. The reduction in the time taken for granting clearances will help boost sales and exports, sources said.

���We have put in checks and balances in our system to address problems of the industry,��� Dr Singh said. The status of applications would also be posted on DCGI���s website, he said.

The Indian drug market is estimated to be at Rs 70,000 crore. Of this, exports account for Rs 25,000 crore as Indian manufacturers supply drugs at low prices to many countries. Pharmaceutical imports is estimated to be about Rs 15,000 crore.