India, as a country with multiple states each with their own degree of independence, has seen drugs passed onto the market that haven’t yet been approved by the central government.
Under India’s complex drug-approval process, in which pharmaceutical manufacturers are required to obtain permission from a single state and then from the central government, many manufacturers are simply putting their products on the market after the first step. This has seen many new combination drugs on the market, and upped the profit of a select few companies.
Combination drugs, or FDCs, are those composed of two or more drugs combined into a single pill. Not only is there a potential danger through combination of two or more drugs due to the increased exposure for patients with allergy to the components involved, but there is also the heightened risk of creating a superbug – a strain of bacteria that would be resistant to the typical antibiotic.
In fact, many doctors and public health experts are in consensus that the increased presence and widespread misuse of FDCs in India are contributing to antibiotic resistance. India has been discovered as the origin in many cases of superbugs discovered in more developed countries.
“The Threat is Real” to the Entire World
A director for the Center for Disease Dynamics, Economics & Policy, who is also a lecturer on public health at the prestigious Princeton University, commented that the threat was very real. He verified that strains that were very hard to cure have spread worldwide and that it was extremely difficult to contain them strains due to global migration.
The Indian pharmaceutical industry has the largest proportion of FDCs in the world. Approximately every one in two pills sold is an FDC with the majority of them being made up of three or more drugs. In comparison with the more developed and regulated markets, the US only has about 14% with China at only 14.3%, as per an IMS Health report.
The report also stated that there were many accomplices who may not be fully aware of the role they play. The majority of the FDCs were sold by local firms with multinationals responsible for the sales of the rest at a ratio of 3:1.
FDCs Are Needed – but Only to a Degree
However, FDCs themselves are not inherently bad. The problem here is the widespread misuse of the drugs to treat every little cold or symptom, which would eventually lead to the creation of superbugs.
FDCs are very much preferred by doctors and pharmaceutical companies.
Doctors see them as a “one-stop solution” for their patients because of two reasons. Firstly, with a combination of many drugs, FDCs are able to treat a multitude of symptoms. Local doctors are able to prescribe these to almost every patient. Secondly, patients are also more receptive to them. FDCs are used worldwide for the treatment of many complicated conditions. It is much easier to convince a patient to take one pill rather than many.
With such conditions, FDCs are in very high demand. A doctor commented, “The market needs it and demands it.” With high demand come higher profits, especially in the drug industry. The drug companies have taken full advantage of this high demand boasting growth in the Indian FDC market by more than 40% since 2011. In fact, in India FDCs are now more widely found than single ingredient pills.
Government Has Cracked Down, but no Success
Even though the central government has attempted to tackle this issue, it still faces many obstacles. An attempt in 2007 was met with insurmountable resistance from the drug companies and industry-related associations.
With the current situation, the central government has launched another initiative. However, this time instead of just going for the instant removal of FDCs from the market, the government is giving the companies a chance to justify the presence of these products in the market.
A representative from the Indian Drugs Controller spoke out that patient safety was their number one priority and that they will do everything in their authority to make sure that. He also stated that there will no longer be new FDCs on the market that have not been approved by the central government.
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