Pharmaceutical firms in India often pass unapproved drugs onto the market. Corruption in India, weak regulations, and a difficult process for drugs to be approved seem to be the cause.
India’s has a complex drug-approval process. Pharmaceutical manufacturers must obtain permission from a single state, and then from the central government.
However, some manufacturers are just 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. There’s a potential danger through combination of two or more drugs due to the increased exposure for patients with allergy to the components involved. But more importantly, there’s also a heightened risk of creating a superbug – a strain of bacteria resistant to the typical antibiotic.
In fact, many doctors and public health experts agree that widespread misuse of FDCs in India are contributing to antibiotic resistance. India is the origin of many superbugs found in 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 which are very hard to cure have spread worldwide. He added that it was extremely difficult to contain these 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. The majority of them consist of three or more different 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. Local firms sell the majority of FDCs. Multinationals are responsible for the rest of sales at a ratio of 3:1.
FDCs Are Good, But Overuse is Bad
However, FDCs themselves are not inherently bad. The problem is widespread misuse of the drugs to treat every little cold or symptom. This can would eventually lead to the creation of superbugs.
Doctors and pharmaceutical companies very much prefer FDCs, considering them a “one-stop solution” for their patients because of two reasons.
First, with a combination of several drugs, FDCs are able to treat a multitude of symptoms. Local doctors are able to prescribe these to almost every patient.
Second, patients are also more receptive to them. FDCs are used worldwide to treat 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. One doctor commented, “The market needs it and demands it” with high demand come higher profits, especially in the drug industry.
Drug companies have taken full advantage of this high demand, boosting growth in the Indian FDC market by more than 40% since 2011. In fact, India FDCs are now more common than single ingredient pills.
Government Fighting Corruption in India, But no Success
Even though the central government has attempted to tackle this issue, it still faces several obstacles. Their attempt in 2007 faced insurmountable resistance from drug companies and industry-related groups.
With the current situation, the central government has launched another initiative. However, instead of just going for the instant removal of FDCs from the market, the government is giving firms 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. He also said there will no longer be new FDCs which are not approved by the central government.
Will India continue along this road? Time will tell. But inaction toward stopping corruption in India could start a health crisis, putting a halt to the nation’s rapid economic growth.
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