The Office of the Drugs Controller General of India (DCGI) has created a record of sorts by clearing 83 import registration applications for formulations and 52 bulk drug applications within just two months. With the extended deadline for registration of applications for the import of medicines into the country coming to a close by the end of this month, the authority seems to be determined to keep the industry in good humour by going for swift clearances. Pharmaceutical industry associations have welcomed the DCGI move and feel that the authority would be able to clear all pending applications within the stipulated time itself.

Speaking to Pharmabiz.com, industry sources said that another request from the industry for "further extension" would be unlikely given the pace with which the authority is issuing import registration certificates. The clearances for 83 formulations and 52 bulk drugs were given during a period from December 15, 2002 to February 15, 2003. The authority is in the process of coming out with a fresh list indicating the clearances issued during the current month.

The DCGI has issued 268 registration certificates for finished formulations as on February 15, 2003. In the case of bulk drugs, the number is 364.

The drug companies had made the extension for registration possible through its representations made to the Union Ministry of Health and Family Welfare. The companies represented by Indian Drug Manufacturers Association (IDMA) had secured the extension by three months, after pointing out the impracticability in properly scrutinizing all pending applications by the concerned authority.

The complete list of registration certificates issued for both bulk drugs and formulations along with their manufacturing sites and authorized agents in the country are given below.

View Table-I

View Table-II