Weeding out of irrational and harmful combinations of drugs marketed in the country has been a serious issue the drug control authorities failed to find a solution for several years now. The first genuine attempt in this regard was initiated by the then Drug Controller General of India in 2007 when he directed state drug controllers to withdraw 294 fixed dose combinations (FDCs) from the market. The order could not be enforced as the drug companies opposed the move and challenged it in the Madras High Court. The case is not yet settled even after six years. Now any action in respect of these 294 FDCs can be taken only after the outcome of the case in the Madras High Court. The former DCGI identified this list of 294 FDCs on the basis of his detailed examination of irrationality and harmfulness of these combinations. Approvals for these combinations by the state licensing authorities were also found to be illegal as any combination drug is considered to be a new drug under the Drugs & Cosmetics Act and its marketing approval has to be issued by DCGI only. Somehow, this aspect of the Act was not being followed by the previous DCGIs for whatever reasons. The pharmaceutical companies have been taking advantage of this situation and have been obtaining product licences for irrational combinations from SLAs as many of them were lax in granting permissions for several years. Once the product licences are issued by one SLA, the company can market the product all over the country.
While the Madras High Court is yet to decide on 294 FDCs, the Union health ministry started preparing another long list of irrational FDCs to be withdrawn from the market last year. The ministry has already drawn up a list of around 200 irrational FDCs and was expected to be sent to the SLAs for withdrawal of their licences. These 200 include a number of combinations of atorvastatin, rabeprazole, and paracetamol with other drugs besides some multivitamin combinations. Whether this list was received by SLAs or not is very unclear. Now, last month the office of the DCGI in a fresh directive, asked the manufacturers to prove the safety and efficacy of FDCs approved before October 1, 2012 and all those FDCs approved by the SLAs after October without the permission of the DCGI will be considered for ban. Whether DCGI will be able to ban such combinations is something to be seen considering the ongoing legal hurdles on the matter. Product licences for irrational combinations continues to be issued by SLAs in violation of the D&C Act as the Madras HC is yet to decide on 294 FDCs. The Parliamentary Standing Committee, in its recent report on the functioning of the CDSCO, also pointed out that some state authorities were issuing licences for a very large number of FDCs without prior approval of the DCGI. This is causing the increased availability of many FDCs in the market which have not been tested for efficacy and safety. This can put patients at risk, the panel noted. It is unfortunate that the neither the Union health ministry nor the office of DCGI is able to bring some check on the vexed issue of free marketing of irrational combinations in the country. This is a serious matter affecting the public health needing urgent attention of the Central government.