The task of cleansing the country of irrational and harmful drug combinations has at last begun from last month. The expert panel headed by Dr B Suresh, president of the Pharmacy Council of India, has already commenced the work and recommended cancellation of licenses of some Fixed Dose Combinations (FDCs) sold in the market and gave a lifeline of three months to some others to prove the efficacy with additional data. The office of the DCGI has already received a total of 5000 applications for regularizing various types of fixed dose combinations not approved by the DCGI but still in the market. This is in response to the DCGI’s direction to the pharma companies to file safety and efficacy data of FDCs permitted by the SLAs 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. Pharmaceutical companies of all sizes have been marketing several thousands of FDCs permitted by State Licensing Authorities without the concurrence of the DCGI and in violation of the Drugs & Cosmetics Act for many decades. The SLAs before granting the licence to manufacture such combinations are required to ensure that the applicant has the approval in writing from DCGI as new drug. But it was found that in many cases the SLAs have been granting licences for manufacture of FDCs without approval of the DCGI.
The issue of weeding out irrational combinations from the market remained unsolved since 2007 as the office of DCGI has not been able to take a decision on the matter because of court interventions. This situation caught the attention of the Parliamentary Standing Committee on Health and Family Welfare and in its 59th Report the panel raised serious concern over the issue of continued marketing of irrational FDCs. The Committee observed that marketing of FDCs not tested for efficacy and safety can put patients at huge risk. Therefore, to remove such unauthorized FDCs from the market, the Central government can either issue directions under Section 33P to States to withdraw the licences of FDCs granted without prior DCGI approval or the Central government can itself ban such FDCs under Section 26A. Now the exercise of weeding out or regularizing of FDCs started since last month. It is expected to take several months to examine the safety and efficacy profiles of each one of these 5000 FDCs and take a right decision. It is likely that many of these FDCs may not qualify to be in the market and will have to be withdrawn. How the pharma companies will respond to the DCGI decision to disallow the FDCs if found to be irrational and harmful is something to be watched. Now the fact is that applications for examining the safety of only 5000 FDCs have come to the office of DCGI. There are many more thousands of FDCs circulating in the market and the companies marketing them are yet to respond to DCGI order. The next task for the DCGI is to track down these companies and their products. At the same time, a system needs to be developed by the office of DCGI to ensure that drug administrations of backward States and Union territories are refrained from further issuing product licenses for irrational and harmful FDCs.