By Gauri Kamath
The Lancet, a reputed scientific publication, has found that diabetes patients in India are being sold a whole lot of untested, unproven fixed dose combinations (FDCs) to control their blood sugar levels. FDCs combine two or more drugs in a pre-determined ratio. The Lancet report observes that many of these drug combinations are on the market without adequate (or any) testing for safety and efficacy or even a therapeutic rationale.
What The Lancet details is no nefarious drug racket but a legitimate operation carried out by reputed companies with the blessing of the Indian drug regulatory system.
FDCs per se are not bad or unscrupulous science. World over, they are developed for reasons such as greater efficacy, reduced frequency of dosage or even greater chance of keeping drug-resistance at bay (as is the case with anti-malarials). Indeed, from a “patient compliance to therapy” point of view, drug combinations are highly desirable. For instance, anti-HIV drug combos or “cocktails” have greatly reduced the number of pills that a patient has to take every day.
But they need to be proved to be safe and effective. There must be scientific/ medical reasons for their existence, not just the manufacturer’s need to differentiate itself in a crowded market. This is where the Indian regulatory system has slipped up.
The drugs that The Lancet listed are merely the tip of the iceberg. In 2012, a committee of parliamentarians found that a “very large number of drug combinations” for a variety of diseases have been put on the market with go-aheads from state drug authorities without being tested. The main problem here appears to be the division of responsibility between the states and the Centre. Once a drug approved by the Centre has been in the market for four years, companies can go directly to state regulators and secure licences for their versions. The states hand out licences if the drugs in the combinations have been individually approved by the Central Drugs Standard Control Organisation (CDSCO), the apex regulatory body at the Centre, four or more years ago.
However, drugs could work differently inside the body if they are combined. A “sum-of-parts” approach is not just simplistic but could be dangerous to the consumer, as a British Journal of Clinical Pharmacology article pointed out some years ago. “The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions,” it said. Despite repeated attempts, the CDSCO has been unable to purge these combinations from the market. It has also been unable to get all of them tested for safety and efficacy.
A bid to strip state regulators of licensing powers for these and other drugs has only succeeded in putting them on the defensive. They argue that the CDSCO is not as well equipped as they are, either in terms of manpower or experience. Besides, the CDSCO itself has long been criticised for not having appropriate guidelines to approve FDCs. As The Lancet points out, it has given the go-ahead for 41 combinations of the diabetes drug, Metformin, with other medicines but “does not publish the jusification” for these approvals. Even as the CDSCO has made attempts to specify guidelines, it has reportedly been inundated by requests to “regularise” 5,000 FDCs already on the market. A sort of retrospective approval based on documents submitted by manufacturers.
FDCs are just the latest symptom of a system rigged to ill-serve consumers. There are others. Regulation of medical devices started only eight years ago. And even today, not all of them are regulated. The rulebook used for their governance appears to be all wrong — it was written with drugs in mind.
The CDSCO has made belated attempts to improve transparency and governance. But to reverse decades of neglect, what India really needs is a quantum leap, not baby steps.
There is a way out of this imbroglio. And that is to overhaul the system and beef it up with resources such as trained manpower and technology. A key requirement is that parliamentarians pass a law that gives the CDSCO (or an equivalent agency) more teeth. This, by the way, has been in the making for at least six years. And who knows, it might take another six. In the meantime, try to stay healthy.
The writer is a Mumbai-based commentator on pharmaceuticals and healthcare and founder, Apothecurry