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Home / UPSC Editorials / Indian Government Bans 156 Fixed Dose Combination Drugs(FDCs)

Indian Government Bans 156 Fixed Dose Combination Drugs(FDCs) | UPSC Editorials

Last Updated on Aug 29, 2024
Also Read Indian Government Bans 156 Fixed Dose Combination Drugs(FDCs) in Hindi
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In a major move to regulate the pharmaceuticals market and protect public health, the Indian government recently banned 156 fixed-dose combination drugs, including commonly used medicines such as Cheston Cold and Foracet. It is the widest action against FDC drugs since 2018, when 328 such drugs were banned. In all, 499 FDCs have been banned since 2014.

Analysis based on 

Editorial What are combination drugs; why have 156 of them been banned? published in The Indian Express on August 29th, 2024

Topics for UPSC Prelims

Fixed-Dose Combination Drugs, CDSCO, Drug and Cosmetic Act, National Drug Policy, Pharmacology

Topics for UPSC Mains

Regulation of Pharmaceuticals in India, Role of CDSCO in Drug Approval, Ethical Issues in Drug Regulation, Legal and Judicial Oversights in Pharmaceuticals, Public Health Challenges Related to FDC Drugs

What are Fixed-Dose Combination Drugs?

A Fixed-Dose Combination drug is that category of combination drug wherein the active ingredients are in fixed proportions among themselves within one dosage form. The main indications for FDCs include simplifying regimens, improving compliance, and ensuring that patients receive the right balance of their medications for their conditions. They find wide usage in management conditions such as HIV/AIDS, tuberculosis, and cardiovascular disorders. However, complications with their use may arise in terms of reduced dosing flexibility and the potential risk of exposing patients to a number of unnecessary drugs, thereby predisposing them to some side effects.

Historical Background on the Ban of FDCs

The move by the government follows years of scrutiny over irrational drug combinations. A parliamentary panel, for the first time in 2012, raised concerns over the approval of such combinations without proper clinical trials. Later, a committee reviewing 6,600 FDCs in 2014 found many of them irrationally formulated. Since then, new drugs and clinical trial rules in 2019 mandated FDCs be treated as new drugs, hence requiring central regulatory approval -which has curbed irrational combination proliferation.

Read the article on the United Nations Office on Drugs and Crime!

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Which FDCs have been Banned at Present?

The Fixed Dose Combination drugs list banned currently spans several categories:

  • Enzyme combinations for gastrointestinal treatments.
  • Anti-allergic drugs combined with decongestants and mucolytics.
  • Topical preparations for skin conditions.
  • Migraine medicine combined with anti-nausea medicines.
  • Combinations containing menstrual cramp relief medicines.
  • Sildenafil in combination with vasodilatory agents.

Reasons for the Current Ban

The major reason behind banning these FDCs is based upon the following:

  • Lack of therapeutic advantage: Almost all these combinations lacked scientifically proven advantages.
  • Irrational formulation: Some of the combinations have inappropriate ingredients which should not be combined or one or more components of them are not needed.
  • Public health risks: Inappropriate drug combinations can give rise to adverse drug reactions and also contribute to drug resistance, especially antibiotic resistance.
  • Regulatory non-compliance: Most of FDCs were approved at the state level without rigorous clinical trials anticipated by central authorities.

Read the article on the Drugs Controller General of India (DCGI)!

Implications of the Ban

The ban aims to eliminate irrational and unsafe drug combinations from the market in order to protect patients and reduce the risk of antibiotic resistance, an emerging threat to global health. Antibiotic resistance arises when bacteria evolve mechanisms to counter the action of antibiotics through a process usually encouraged by overuse and misapplication of these drugs. The removal of irrational FDCs containing antibiotics may, therefore, help to stem this dangerous trend.

Another related aspect of the ban has to do with price control. There is a ceiling price for essential medicines in India, fixed by the government. Pharmaceutical companies have attempted to circumvent such controls in the past by making FDCs. The ban aims to remove this loophole and ensure availability as well as affordability of essential drugs.

Read the article on the Central Drugs Standard Control Organization CDSCO!

Antibiotic Resistance

Antibiotic resistance is a process whereby bacteria develop mechanisms that render them insusceptible to the action of antibiotics. Improper and excessive use of antibiotics in medicine, agriculture, and animal husbandry further accelerates the problem. Antibiotic resistance is a serious global health threat because it can result in longer hospitalization, increased medication cost, and even mortality.

Challenges in the Development of Antibiotic Resistance

Several factors drive the development of antibiotic resistance:

  • Overprescription and prescribing a drug when it is not needed or in inappropriate dosage.
  • In agriculture, where antibiotics are used in the process of food production for growth enhancement and the prevention of diseases in livestock.
  • Poor infection control practices that help to spread resistant bacteria in health facilities.
  • The lack of new antibiotics coming out of the pharmaceutical industry, because developing new antibiotics is less profitable than other investments.
  • The fast movement of people can send the resistant bacteria across the globe in no time.

National Action Plan on Antimicrobial Resistance

NAP-AMR is the strategic initiative of India addressing antimicrobial resistance. In addition to increasing public and professional awareness for the prudent use of antibiotics, it also aims at enhancing surveillance to monitor resistance patterns, thus strengthening the infection prevention and control measures. It also involves regulatory efforts to contain the sale of antibiotics and encourages research and development for new antimicrobials and alternative treatments.

Read the article on Drug Abuse!

Issues Related to FDCs

Fixed-Dose Combination drugs, although useful in specific scenarios, have a host of issues tagged to them:

  • Irrational combinations: FDCs combine ingredients that may not be synergistic with each other.
  • Risk of overmedication: Unnecessary drugs which may expose the patient can cause side effects.
  • Dosing inflexibility: In case of FDC administration, the doses of individual components cannot be changed.
  • Quality control: Ensuring quality and efficacy pertaining to all ingredients being used in an FDC is difficult and non-economical on a routine and regular basis.
  • Antibiotic resistance: Unregulated use of antibiotic FDCs contributes to the development of resistant bacterial strains.

Read the article on Orphan Drugs!

How are New Drugs Approved in India?

New Drugs are approved in India under the preview of the Central Drugs Standard Control Organization (CDSCO). New drug approval has to go through the following:

  • Preclinical: Laboratory and animal studies are done to obtain preliminary efficacy, toxicity, and pharmacokinetic information.
  • IND Application: An Investigational New Drug application is submitted to CDSCO.
  • Clinical Trials: Phase I, II, and III trials are done, which provides very detailed safety and efficacy data.
  • NDA submission: Filing New Drug Application with accumulated data.
  • Review: The data is reviewed by CDSCO, and if further clarification or studies are required, they may be requested.
  • Approval: If satisfied, the CDSCO may grant marketing authorization subject to conditions like post-marketing surveillance.

Read the article on Bulk Drug Parks!

Conclusion

The recent ban on 156 FDC drugs in India represents a big step toward making the pharmaceutical market right and providing the public with safe and effective medications. FDCs have some advantages that enhance patient compliance, but an irrational and unregulated proliferation of FDCs carries significant risks. This bold step underlines the government's commitments toward public health and the rational use of pharmaceuticals and will set a precedent for more strict regulatory oversight in the times to come.

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UPSC Previous Year Questions

Year

Question

2014

Can overuse and free availability of antibiotics without Doctor’s prescription, be contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved.

UPSC Practice Questions

Q1. Discuss the key objectives of the Vigyan Dhara initiative launched by the Union Cabinet. How does this initiative aim to improve the efficiency and effectiveness of scientific research in India?

Q2. Analyze the challenges associated with the biotechnology sector in India. What regulatory and infrastructural measures are needed to overcome these challenges and promote research and development in biotechnology?

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