The Central Drugs Standard Control Organisation (CDSCO) has constituted 10 expert committees to examine the huge number of applications for regularization of fixed dose combinations (FDCs). These applications were received in response to the instruction by the Drugs Controller General of India (DCGI) to the manufacturers to prove the safety and efficacy of those FDCs permitted without due approval from his office.

The DCGI has also asked the manufacturers to submit additional documents, if they had not submitted earlier with their applications so that the same may be included along with the applications for examination by the expert committee.

“The State Drug Controllers were requested by vide letter of even number dated 15.01.2013 that manufacturers are required to prove the safety and efficacy of such FDCs which are licensed by State Licensing Authorities without prior approval of DCGI before the office of the DCGI within 18 months. In this connection, a subsequent letter was issued on 05.07.2013 and 26.08.2013 that in order to examine the safety and efficacy of such FDCs in timely manner, the manufacturer should submit the application to the office of the DCGI or the respective zonal/sub-zonal officers of the CDSCO by 30.08.2013 in Form 44 along with requisite fees and supporting documents,” a notice by the DCGI said.

“The CDSCO has received applications of many such FDCs from the manufacturers for the regularization in the country. In order to evaluate these applications, 10 expert committees have been constituted to examine the rationality as well as safety and efficacy of the FDCs,” the DCGI said.

According to information available, the CDSCO had received applications for regularizing over 5000 FDCs, after the directive was given by the DCGI. Many of them were found to be having no therapeutic justification or rationality for their marketing in the country, it is learnt.

In the absence of detailed guidelines and procedures for the examination of these FDCs, the Drug Technical Advisory Board (DTAB) had recommended the formation of a sub-panel headed by Dr B Suresh, president of the Pharmacy Council of India (PCI), to give its recommendations and suggest guidelines for examinations of such FDCs and the action to be taken in such cases.