A move to weed out thousands of irrational drug combinations marketed in the country for several years was launched by the former DCGI, Dr. M. Venkateshawarlu, in June 2007. He had then ordered the state drug licensing authorities to withdraw licenses of 294 FDCs but the pharma companies have been objecting to the move on various grounds. Now, for the last three years the exercise has been going on but no final decision could be taken for their withdrawal. The expert panel on FDCs, headed by the present DCGI and Dr Y K Gupta, chief pharmacologist at AIIMS and Dr Sanghavi of IDMA as members, had subsequently cleared 236 of the 294 combination drugs as safe. Although the committee found that these drugs are rational and good, the DCGI is of the view that these combinations should have clinical trial data to support them. Incidentally, most of these drugs have been in the market for more than 10 years and are widely prescribed. Pharmaceutical industry is of the view that the clinical trials of such old FDCs are not necessary at this stage. As clinical trials take two to three years and if the production of these FDC drugs have to be therefore stopped, many companies will lose the market which they got established over the years. Besides, the patients will also lose the benefit of such established products. The stand of the industry, therefore, is not totally out of place.
Officials in the Union health ministry are of the view that fixed dose combinations have been in the market with no therapeutic rationale and safety profile and no serious attempt has been ever made to identify and withdraw them from the market. FDCs are considered as new drugs under Rule 122 (E) (c) of the Drugs & Cosmetics Rules and they need to be approved by DCGI after submission of all clinical data. A majority of these FDCs, available in the market, were approved by State Drug Licensing Authorities and not by DCGI. It is important that unsafe drugs have to be taken out of the market at the earliest in the interest of millions of patients. At the same time it is not fair on the part of the DCGI to delay a decision on FDCs which are accepted as good by the expert panel. Now as the DCGI office is taking time in sending the list of FDCs, accepted as good by the expert panel to the states, the pharma units are in a dilemma as they are not getting the drug licenses renewed. It cannot take a stand that clinical trials are mandatory for these combinations for getting their licenses renewed. What made the whole matter complicated is the issuance of licenses by DCGI to certain large companies for some FDCs as new drugs after they submitted BA/BE studies. Once a company receives a license for a new drug, no other company can receive a license for the same drug combination for the next four years. This would mean that DCGI is denying a legitimate right to a company just because someone else came a little early and obtained the marketing permission for marketing the same product.