The government had in August this year banned 156 fixed-dose combination drugs, prescribed as painkillers, multivitamins and antibiotics for fever, cold and other ailments.

In 2016, the health ministry banned the sale of 344 fixed-dose combination drugs. However, after the move was challenged in the Delhi High Court by drug manufacturers, only 14 drugs were banned.

There are countless fixed dose combination medicines in circulation in the market and it is slowly becoming known that they are becoming unscientific and harmful to patients.

Once considered at the top of their game, fixed-dose combination drugs have become a major threat to India’s public health system.

What are fixed dose combination drugs?

Fixed-dose combination (FDC) drugs are formulations that contain two or more active pharmaceutical ingredients (APIs) in a single dose.

The Central Drugs Standard Control Organization (CDSCO) defines FDC drugs as “products that contain two or more active ingredients used for a particular indication.”

FDCs are often used to simplify treatment regimens, improve patient compliance, and address multiple health conditions at once, such as in the treatment of HIV, tuberculosis, and hypertension.

By reducing the number of pills a patient has to take, FDCs help ensure better adherence to prescribed therapy.

When used rationally, fixed dose combination medications allow the drugs to work synergistically, enhancing each other’s effects while reducing the overall dose compared to taking them separately.

For example, the combination of metformin and glyburide has been shown to manage diabetes more effectively at a lower dose in the FDC form than when administered as separate tablets. This may improve patient outcomes and reduce potential side effects.

However, the Indian government has banned some FDCs due to concerns over safety, efficacy, and potential abuse. Many of these combinations have not undergone rigorous clinical trials to establish their effectiveness or safety.

Why has the government banned some FDCs?

Some combinations may contain drugs that are incompatible or have conflicting actions, resulting in side effects or ineffective treatment.

In response, the government has investigated thousands of FDCs, resulting in bans on those that were deemed irrational or unsafe.

Dr Pawan Gupta, Senior Consultant, Pulmonary Medicine, BLK-Max Super Speciality Hospital, New Delhi said, “These combinations can lead to adverse effects that can have serious implications on health. These can range from arrhythmia, rapid breathing, hypotension or allergies to life threatening conditions such as hypersensitivity reactions. These can be temporary or long lasting.”

Dr Narendra Saini, former honorary president of the Indian Medical Association, said most of the fixed dose combination drugs that have been banned are antibiotics, painkillers and anti-allergic cocktails. These have been banned for having “no therapeutic benefit and increasing side effects”.

In India, fixed-dose drug combinations have become more popular due to their affordability and ease of administration. However, concerns have been raised about their irrational use, especially since many of these drugs were approved at the state level without proper monitoring by central regulatory authorities.

This resulted in the Supreme Court banning 328 FDCs in 2018, citing public health risks.

Although fixed-dose combination pills have made it easier for patients to reduce the risk of overmedication, they also pose increased health risks.

“If a patient needs a different dose of one ingredient, they may have to adjust the entire combination, potentially leading to undertreatment or overtreatment. Combining multiple active ingredients may increase the risk of adverse effects, making it difficult to identify which ingredient is causing them,” said Dr Vibhu Kawatra, a pediatric pulmonologist and allergist in New Delhi.

In cases such as with antibiotics, the use of FDCs can sometimes promote resistance if not all components are effective against the targeted pathogen.

Given that the threat of antimicrobial resistance is growing in India, banning several fixed-dose combination drugs could be a step towards unwanted sale of these drugs.