The government has taken the right step in moving against fixed combination drugs

The government’s decision to ban the manufacture, distribution and sale of 328 fixed dose combination (FDC) drugs is welcome. The latest ban includes commonly used painkillers that are outdated and harmful for human use. While these have no medicinal value or therapeutic use for people and are banned in several countries, the Indian government had dragged its feet thus far before finally cracking the whip. The ban covers just the tip of the iceberg as several top drug companies revenues rely heavily on FDCs with over Rs 2,500 crore accounted for on just these 328 drugs that are sold in over 500 different brands, packs and range of doses.

A mafia of sorts that includes unscrupulous pharma companies, doctors and distribution networks seem to have made merry while patients remained totally ignorant on these phased out formulations. In fact, the government should initiate criminal proceedings against companies and brands that pushed FDCs that have otherwise been discontinued in geographies like US, Europe or other Asian markets.

Most of FDCs marketed aggressively after having tampered with processes or chemical combinations will have to seriously be considered for outright ban or withdrawal from the Indian market. They cannot be allowed to use Indian consumers as guinea pigs for profiteering by drug majors that have been allowed access to 1.3 billion Indians. In March 2010, restrictions on the sale of an additional 344 drugs were slapped. These outdated formulations may have to be completely banned. In the latest case, respected companies like Pfizer and Glenmark also have their formulations that were taken off the saleable list. Will these very companies be able to sell the banned FDCs in countries of their origin like Germany and the US? Tightening the noose around companies that are ‘repeat offenders’ should be seriously considered setting aside the specious arguments about supporting the domestic drug industry, their principals abroad and collaborators elsewhere. Safety, efficacy and affordability, apart from medicinal value, should be the guiding factor to allow or disallow drugs, either standalone or fixed dose combination of two or more drugs. The Drugs Technical Advisory Board (DTAB) will have to undertake a comprehensive review of all fixed dose combinations and standalone single formula based drugs. DTAB will have to make time-bound recommendations and the government may have to comply with the board’s findings. All stakeholders will have to find a way out in countering delaying tactics adopted by companies that filed frivolous cases in courts that hardly have time to hear these pertinent issues. On technical issues or parameters, courts and judges will have to go by the experts recommendation rather than dragging their feet on key questions relating to medicines.