The pharmaceutical companies can sell the 150 'under examination' category combination drugs which are at present lying with the distributors, stockists and retail shops till the expiry of these drugs. The drug department will seize these medicines only from C and F agents and company depots.

The Drug Controller General of India (DCGI) Dr M Venkateshwarlu has given an assurance to this effect to a delegation of Federation of Indian Pharma Entrepreneurs (FIPE) on October 30. This will be a relief to the besieged pharma industry as the state drug department, on DCGI directive, had already started the process of seizing combination drugs from the retail shops. The industry was upset as the field level staff of the drug department has been creating confusion in the trade.

FIPE general secretary BR Sikri said that an FIPE delegation met the DCGI on October 30 on the FDC issue. One of the major demands of the Federation was to give the industry sufficient time to apply to the office of DCGI for 150 FDC products which are "Under Consideration" category. The Federation demanded to the DCGI to allow the pharma companies to continue production of these 150 combination drugs as they are under examination only. But, the DCGI refused to budge from his stand of stopping production of these combination drugs with immediate effect.

"The DCGI has categorized these 150 products into three categories of clinical trial, bio-equivalence and stability study. Out of 150, more than 70 products have been included in the stability study category which will be approved by the DCGI office in Delhi within 30 days from the receipt of application," Sikri said.

He said that the industry has urged the DCGI to include more products in the stability study category. Though the DCGI did not give any positive response to the industry request, he has agreed to meet the FIPE delegation once again on November 14 to discuss the issue further.

Apart from Sikri, the delegation included FIPE chairman R K Arora, DC Jain, Umesh Sanghi, BK Gupta and other executive members.