An attempt to weed out harmful drug combinations and regulate the marketing of fixed dose combinations (FDCs) was made for the first time in the country in 2007 by the then Drugs Controller General of India. The initiative was badly needed as the country was flooded with hundreds of irrational and harmful fixed dose drug combinations approved and licensed by state drug controllers ignoring the relevant provisions in the Drugs & Cosmetics Act. These products used to be aggressively marketed and promoted by the pharmaceutical companies with the support of medical practitioners. The harm such products with no therapeutic rationale and without conducting clinical trials could have done to patients should be quite huge. As a first step towards regulating irrational FDCs, a list of 294 products was prepared by the office of DCGI and ordered their withdrawal from the market. But the whole objective got defeated soon after as some of the members of the pharmaceutical industry moved the Madras High Court against DCGI order and obtained a stay. Now, even after six years of granting the stay, the Madras High Court is yet to pass an order on the matter.
As no action could be taken on 294 FDCs because of the stay, DCGI prepared another list of 200 FDCs and asked the manufacturers to submit the safety and efficacy data before October 1, 2012. These FDCs are also approved by the state drug controllers and without the clearance of DCGI. In January this year, the DCGI again directed the State drug controllers to obtain the safety and efficacy data of these 200 FDCs. With no response coming from the manufacturers a new deadline of August 30 has been now given for submission of data failing which such FDCs will be prohibited for manufacture and marketing. FDCs fall under the definition of new drug and granting of manufacturing licences for FDCs should be with the approval of the DCGI. Weeding out harmful combinations or regularising the FDCs with therapeutic rationale is of utmost importance for the patient community and to retain the credibility of Indian regulatory machinery. And the pharmaceutical industry should not keep creating roadblocks to the efforts of regulatory authorities in this regard. By challenging the order in the Madras High Court, industry had already stalled the government initiative for six years. In matters involving public health, support of judiciary by way of early disposal of cases is certainly encouraging to regulatory authorities for carrying out their job.