Pharmaceutical industry feels that the government should relax its stand on fixed dose combinations (FDCs) to ensure that its enforcement does not impact the flow of foreign direct investment (FDI) into the pharma sector. Experts say that as FDCs contribute substantially to the companies' turnover, having a rigid stand on this issue may diminish chances to attract FDI which is primarily done by MNCs eying the huge generic market.

This demand comes in the wake of tough position taken by the Drug Controller General of India's (DCGI's) office last year requiring manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012. Apart from demanding the safety and efficacy report, the Centre also simultaneously banned the FDCs approved after October 2012 by the State licencing authorities (SLAs) that where given without that the permission of the DCGI.

As a relief to the industry, the Centre did exclude the manufacturers engaged in production of FDCs licensed prior to September 21, 1988 from the requirement of proving the safety and efficacy data of FDC drugs licenced by the SLAs. However, considering the huge loss the industry is estimating, Arun Naik, past president Goa Pharmaceutical Manufacturer's Association (GPMA) pointed out that more steps need to be taken on this front, to ensure that the business interest is not affected because of the same.

He stressed that though the government has relaxed some of its norms on the FDCs, they are not enough to assuage their doubts and confusion over their future and strongly feels that the CDSCO should engage in more meetings with the industry to understand the ground realities.

He further informed that the main point of contention is rationality of these combinations as well as their safety. “Whilst the industry is of the view that since these FDC’s have been in the market for almost a couple of decades and no serious side effects or adverse reactions have been noted, the safety of the FDC’s may be deemed to be established. No serious attempts have been made to establish the safety independently. To consider a drug or a combination safe without going through the established protocols of proof of safety is hazardous particularly in Indian conditions.”

Naik who is also the managing director of Merit Pharmaceuticals suggested that it is therefore absolutely essential for the industry and manufacturers and marketers of these combinations to independently assess the safety of these FDC’s, at the same time the government should also help the industry in facing this challenges.

He stressed that,“What makes the Indian pharma industry stand out is its stronghold in manufacturing safe and efficacious generic drugs. Interestingly FDCs make up a huge part of this industry and having a ban on their marketing will gradually kill the industry. The USP of our industry is its expertise in manufacturing generic drugs and the hold over large market share, attracting multinationals to invest in their generic counterparts.