The decision to ban fixed dose combinations (FDCs) by the Drugs Controller General of India (DCGI) should not have been with immediate effect.  These drugs are neither spurious nor of substandard quality drugs which could be of a threat to the patient safety. Instead, these are drugs which have been in the market and few of the combinations approved by DCGI. Therefore, the regulatory authority should have given a timeframe of anywhere between 15-30 days, said Dr BR Jagashetty, former national advisor, (drugs control) to MoHFW and project in-charge for the implementation of two schemes of Central Drugs Standards Control Organization (CDSCO).

The FDC drugs are banned under Rule 26-A stating that they are likely to involve risk to human beings whereas safer alternatives to the said drug are available based on the recommendation of the Expert Committee appointed by Central government which has found that these drugs are not having therapeutic justification. While these FDCs are seen to be irrational combinations, it is a right step to dig out these drugs from the market. However this banned list also comprises the FDCs approved by DCGI, for example: metformin + gliclazide + pioglitazine (SO 810E) which has proved beneficial for the patients. So this move to stall circulation of FDCs is definitely going to create a major chaos. It is not just pharma companies which are seriously impacted but also the pharmacy outlets in the country, though the industry is aware of the said action since long time now, he added.

The fixed dose combinations have been the thorn in the flesh of pharma companies. The prohibition to market these fixed dose combinations is big dent to the revenues of the pharma companies. It is also a major burden on pharmacy outlets to relocate the storage of these drugs within the premises to ensure that they are not dispensed at any cost.

Now the biggest concern is that despite this ban, pharmacy outlets located in every nook and corner of India cannot be monitored. There is the absence of networking between state drugs control departments and the DCGI office to closely monitor the 8 lakh pharmacy outlets in the country. Adding to the woes of lack of surveillance technology within the regulatory departments is the issue of enforcement team shortage, pointed out Dr Jagashetty.

Thus DCGI should have given time for the manufacturers to stop production and recall stocks from pharmacy outlets though the regulatory authority is aware that the latter process is a cumbersome exercise, he said.