A piecemeal solution
The Union government’s decision to ban 156 Fixed Dose Combination (FDC) drugs through a gazette notification dated August 21 was not the first-of-its-kind move. Ever since 1982 when the Indian Parliament conferred upon the government the power to prohibit the manufacture of specific drugs—including FDCs—that lack therapeutic value or justification, the government is reported to have passed more than 444 orders, with no permanent solution in sight.
FDCs, or combination drugs, are made of two or more active ingredients within a single unit of medicine, say a pill. In theory, these combinations are claimed to be beneficial, especially in cases where multiple medications are required for treatment, such as with tuberculosis or HIV/AIDS. By reducing the number of pills a patient needs to take, FDCs are known to improve compliance and treatment outcomes. However, this potential benefit has been grossly misused, with numerous FDCs entering the Indian market without proper clinical justification or regulatory approval. A major loophole in the process is that pharmaceutical companies use the clearance for individual ingredients as a basis for approval of the final product. This extension is highly problematic as the end product resulting from non-risky ingredients may still be risky. Indeed, there is a clear lack of mechanism for trials to ensure that the combination drugs are safe and effective.
The pharma companies and the government are aware of this fact. Still, the unhindered continuance of the practice of flooding the drug market with unnecessary—and potentially risky—medicines remains unchecked. A part of the problem may be due to the profits involved in the FDC market. Owing to multiple combinations of existing drugs, the competition for cocktail drugs—as FDCs are popularly known—remains minimal, allowing medics to charge higher prices. In addition, these medicines are also attractive to the public at large.
The recent ban targets a wide range of FDCs, including those used as painkillers, multivitamins, and antibiotics, many of which are administered for common ailments like fever and cold. The expert committee appointed by the Central Government, along with the Drugs Technical Advisory Board, found that these combinations lack therapeutic justification and pose significant risks to human health. Against this backdrop, it can be said that the consequences of unchecked proliferation of FDCs could be alarming. Studies indicate that despite frequent bans by the government, a significant percentage of FDCs sold in India, particularly antibiotics, are either unapproved or banned—contributing to the growing problem of antimicrobial resistance (AMR). AMR is a ticking time bomb in India, wherein the misuse of antibiotics—often in the form of unnecessary FDCs—has led to the emergence of drug-resistant bacteria.
The Indian Pharmaceutical Alliance (IPA) has endorsed the government’s decision, recognising the need to prioritise patient safety over commercial interests. The government’s move is expected to eliminate a significant portion of the irrational FDCs currently available in the market, though some may linger as manufacturers seek legal recourse to sell off existing stock.
The medication needs and affordability of the general population are ever-increasing. In light of such advances, it is expected that the government would go for broader checks and balances, rather than merely banning the unnecessary and harmful FDCs. Attempts must also be made to ensure that state regulators do not have a window to bypass the regulatory authority of the Central Drugs Standard Control Organisation (CDSCO).
