Needle in a haystack

The story around combination drugs may not engage a regular pill-popper, as the narrative weaves from Court cases to expert committees, and back.

But even a casual read of the 700-odd page Nilima Kshirsagar sub-committee’s report could have you raiding the medicine box to read the fine print on combination drugs that may have been prescribed at some point in life. And that’s why people need to tune into the discussion on FDCs or fixed dose combinations. They have become commonplace in our lives and with possible dangerous consequences.

FDCs are drugs that combine one or more medicines into a single pill. And to give credit where it is due, they have helped in improving patient compliance and convenience by reducing the pill-burden on an individual. So in treating Tuberculosis or HIV, for example, combination drugs had brought down the number of pills a patient had to take.

But the plot gets tricky, even dangerous, when an FDC combines three to seven drugs in some cases, in varying dosages that cannot be altered. FDCs were put under the scanner because many made it into the market without the right regulatory approvals or sound scientific backing.

Echoing the shocking findings of previous expert committees, the latest report points out that “most appellants had not generated safety and/or efficacy data of their own for their FDCs.” The published literature they provided was not relevant, not from India and their indications for which the medicine was to be prescribed “were too broad/absurd/vague and were not per the treatment guidelines.”

The Kshirsagar sub-committee was set up by the Drug Technical Advisory Board, as directed by the Supreme Court that was acting on FDC related cases. The issue has attracted attention for over 10 years and has gone through many committees and Court cases. But sticking with its original action, the Health Ministry acted on the latest report by banning the listed 300-plus drugs, which led to many court cases.

The sub-committee though is clear on why it outlaws FDCs. “For most FDCs, their use would lead to unnecessary overuse and the patients would be exposed to the risk of multiple ingredients when one would suffice.” Because of the “dosing mismatch” between ingredients, “FDC use would result in toxicity (wherein the ingredient is being administered more frequently than required) or lack of effect (wherein the ingredient has been administered less frequently than required). An inability to adjust the doses of individual ingredients is especially risky, if an ingredient has a narrow safety margin.”

Now, place this concern of over-dosing or under-dosing a person in the context of diabetes or antibiotics, and the life threatening implications hit home hard.

Follow this up with questions on the fate of patients who may have taken these irrational combinations till date? And home truths get revealed again, but from another ongoing controversy over faulty hip implants from Johnson & Johnson's Depuy Orthopaedics.

The company and the government are trying to trace patients on whom these implants had been used, eight years after the faulty product had been globally recalled.

So imagine where that puts a person who may have consumed a pill with an irrational combination? It becomes the search for a needle in a haystack. Now that’s a good enough reason for the government to ensure that only those combinations go into the market that have withstood stringent and scientific scrutiny.

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