India’s alarming ‘Fixed Dose Combination (FDC)’ problem

Source: This post on Fixed Dose Combinations (FDCs) has been created based on the article “India’s alarming ‘fixed dose combination’ problem” published in “The Hindu” on 9^th December 2023.

UPSC Syllabus Topic: GS Paper 2 Social Justice – Issues relating to Health.

News: The article discusses the growing concerns regarding Fixed Dose Combinations (FDCs).

A recent study shows that a large volume of unapproved and even banned fixed dose combination (FDC) of antibiotics are sold in India. According to the findings, in 2020, ~60% FDCs of antibiotics being sold were unapproved and ~10% were banned.

What are FDCs and why are they useful?

FDCs are combinations of one or more known drugs. For example, 3 medications are combined into one tablet or one syrup.

FDCs reduce the number of pills to be taken and hence can improve patient compliance (i.e. the patient taking all the medicines at the correct time). This eventually leads to enhanced treatment outcomes.

What are the issues with FDCs?

Reduces Efficacy of Drugs: When formulated together, the active or inactive ingredients may interact to affect the functioning of drugs. It may reduce the therapeutic efficacy of drugs or form toxic elements (metabolites).

Tool to Escape Legal Liabilities: Since FDCs are not covered under the Drugs (Prices Control) Order (DPCO) (which enables the government to fix the prices of individual drugs), manufacturing FDCs is a way to escape the ambit of the DPCO.

Unproductive Combinations Produced: A large variety of produced FDCs lack any medical rationale. For example, anti-inflammatory drugs combined with vitamins, vitamins combined with analgesics, etc.

Lack of Quality Standards: There are no standards set by regulatory bodies for testing the quality of these drugs. As a result, it is difficult to hold manufacturers accountable for producing poor-quality FDCs.

Higher Costs of Drugs: A new FDC may be claimed as a unique new product catering to a specific need. This allows them to charge a higher price until their competitors introduce similar products and the prices go down.

Failure of States to Implement Strict Licensing Norms: State drug controllers continue to ignore legal provisions and issue manufacturing licences for FDCs not approved by the Drugs Controller General of India (DCGI).

Prohibitionary Orders Stuck in Complex Litigation: The prohibition on the manufacture of specific FDCs by the Ministry of Health has been caught in complex litigation and inconsistent decisions by Courts.

Contributes to AMR: Unregulated FDCs contribute to the Anti-Microbial Resistance problem in India.

For more on AMR, read here.

It is crucial that all FDCs go through a scientifically designed approval process to make them safe for consumption. A strong regulatory framework is the need of the hour.

Question for practice:

What are Fixed Dose Combination (FDC) drugs? Mention the factors behind the prevalence of unsafe FDC drugs in the Indian markets. Also highlight their impact on public health.