India’s ban on 344 fixed drug combinations (FDCs)—believed to cause drug-resistance and organ failure—is a positive step, as far as the intention is to curb the indiscriminate consumption. FDCs, often casually bought off the counter, contribute to needless consumption, given the patient may only need one compound from the combination and not the others. While many of the 344 drugs are banned in the US and the UK, India has allowed these drugs to be manufactured and sold despite the lack of approval from the Central Drug Standard Control Organisation (CDSCO). A 2015 study by PLOS Medicine shows that of 175 FDC formulations across 4 categories marketed in India, only 60 (34%) were approved by CDSCO with unapproved ones accounting for more than 50% sales in FY12 in certain categories. The findings also show that the sale of unapproved products was higher than that of approved ones, with the 175 FDC formulations appearing in the market as 4,000 products. This would, no doubt, justify the government’s drug ban.
At the same time, an analysis of PLOS data points out that the US and the UK had approved 13% and 8% of the 175 FDCs, respectively. In a list of 344 drugs, the likelihood of even those drugs approved by developed countries getting banned could be higher. The ban is expected to hit many pharma MNCs, Pfizer and Abbott being just two. Given the optics of the India’s pharma policy are already bad—the country’s IPR-hostile policies have been a sore point for global pharma—the government has to strike a balance. So, while globally banned drugs need to go, FDCs that have widespread approval do not merit a ban. Some onus must lie with patients and chemists as well. The government can consider banning sale of such drugs without a prescription being presented and enforcing mandatory billing, for instance.