Last month, the office of the DCGI said that it has received applications for regularising over 5000 fixed dose formulations (FDCs) not approved by the DCGI but still being marketed in the country. Licences for these products were issued by the State Licensing Authorities (SLAs) without verifying these products for their safety and efficacy. Many of them were found to be having no therapeutic justifications or rationality for their marketing. The SLAs before granting the licences to manufacture such combinations are required to ensure that the applicants have the approval in writing from DCGI as new drug. It was however, found that in many cases, the SLAs granted licences for manufacture of FDCs falling under the definition of the new drug without prior approval from the DCGI. The applications received for regularising these FDCs were already examined by CDSCO in consultation with the New Drug Advisory Committee constituted by the Ministry of Health recently. It was found that some of the FDCs have no therapeutic justification or rationality for their marketing in the country. In view of this no permission was granted to market these FDCs to the concerned companies.
In the face of large number of applications and in the absence of detailed guidelines and procedures for the examination of these FDCs, the Drug Technical Advisory Board has now decided to have a committee headed by Dr B Suresh, president of the Pharmacy Council, to draft a set of guidelines for examinations of such FDCs and appropriate action in such cases. The issue of weeding out irrational combinations from the market remains unsolved since 2007 as the DCGI has not been able to take a decision on the matter because of the court interventions. DCGI had directed the pharma companies to file safety and efficacy data of FDC drugs permitted by the State Licensing Authorities but not approved by DCGI before October 1, 2012. The last date for submitting the efficacy data of SLA approved FDCs to the DCGI office was September 30, 2013.
However, an interim stay was granted on DCGI order on September 27 by the High Court of Himachal Pradesh on the DCGI order. The petitioner claimed that some of these FDCs under question were being used for decades and no adverse effects were recorded proving their safety and efficacy. Now the decision of DTAB to entrust IPC to frame a set of guidelines for determining safety and efficacy should bring an end to this deadlock. For this pharmaceutical companies and their associations also need to co operate by giving up their adamant stand.