India’s alarming ‘fixed dose combination’ problem
- Academics from India, Qatar, and the UK recently published a study in the Journal of Pharmaceutical Policy and Practice.
- The study highlighted the concerning prevalence of unapproved and banned Fixed Dose Combination (FDC) antibiotics in India.
Key Findings
- In 2020, 60.5% of antibiotic FDCs (with 239 formulations) were unapproved, and 9.9% (with 39 formulations) were being sold despite being banned.
- Antibiotic FDCs are worrisome due to the growing antibiotic microbial resistance (AMR) in India.
Purpose and Risks of FDCs
- FDCs combine multiple drugs to improve patient compliance, reducing the chance of missing doses.
- For diseases such as AIDS, FDCs have proven to be very useful in improving patient compliance, which improves treatment outcomes.
- However, formulating FDCs is complex, as interactions between active ingredients and excipients can impact efficacy or create toxic elements.
Pharmaceutical Industry's Motivation
- The Indian pharmaceutical companies use these FDCs to escape liability under multiple laws without much concern for public health.
- They use FDCs to evade drug price control regulations under the Drugs (Prices Control) Order (DPCO).
- Under DPCO, the government fixes the prices of individual drugs.
- The industry introduced a vast array of FDCs lacking medical rationale, combining unrelated drugs.
- For example, anti-inflammatory drugs were combined with vitamins.
Lack of Standards and Quality Testing
- Because of the bewildering variety of FDCs in the market, there are no standards set by bodies such as the Indian Pharmacopoeia Commission for testing these drugs for quality of manufacture.
- With no standards recognised by the law, there is no question of manufacturing “not of standard quality” drugs.
- Hence there is no possibility of prosecution under the Drugs & Cosmetics Act, 1940.
- Manufacturers often provide their own testing protocols to government laboratories.
Pricing Strategy
- Creating FDCs provide companies the opportunity to charge higher prices for drugs, avoiding intense market competition.
- Pseudo-innovation through FDCs is rewarded by the regulatory structure, allowing higher pricing until similar products emerge.
Regulatory Issues
- Regulatory problems with FDCs date back to 1978, with the first committee acknowledging the issue.
- At the time, there was no system under the colonial-era Drugs and Cosmetics Act, 1940 to vet drugs for safety and efficacy prior to their sale in India.
- Amendments in 1982 and 1988 gave the central government power to prohibit and require safety and efficacy proof for new drugs, respectively.
Regulatory Framework Inefficiency
- Despite clear laws, State drug controllers have ignored regulations, issuing manufacturing licenses for unapproved FDCs.
- The Ministry of Health has issued numerous orders to prohibit specific FDCs, engaging in legal battles but with inconsistent outcomes.
Conclusion
- The study underscores the urgency for immediate action, as unregulated FDCs may contribute to the AMR problem in India.
- The Ministry of Health must address the issue promptly, considering the potential public health risks associated with unapproved and banned antibiotic FDCs.