Fixed Dose Combination Drugs

Posted 12 Sep 2024

Updated 14 Sep 2024

4 min read

Why in the News?

The Ministry of Health and Family Welfare prohibited the manufacture, sale or distribution of 156 fixed-dose combination (FDC) medicines.

Ministry has banned FDCs in accordance with the power enshrined under the Drugs and Cosmetics Act 1940.
- Earlier in 2023, Ministry banned 14 FDCs.
Banned FDCs posed risk to human beings whereas safer alternatives to the said drug are available.
- The expert committee appointed by the central government and the Drugs Technical Advisory Board (DTAB), recommended that there is no therapeutic justification for the ingredients contained in the banned FDCs.
Banned FDCs include antibiotics, painkillers, and multivitamins such as Aceclofenac and Paracetamol.

Definition: FDCs refer to products containing two or more active ingredients also referred as cocktail drugs used for a particular indication(s) (as per Drugs & Cosmetics Rule 1945).
- Active Ingredient is the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects.
As per the Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs and the Central Drugs Standard Control Organization (CDSCO) issues approval.
Mostly FDCs are in combinations of cough, cold, and fever preparations; antimicrobials; vitamins and minerals etc.

Enhanced efficacy: Achieves better therapeutic outcomes than using them individually.
Cost-effectiveness: More affordable than purchasing individual medications separately.
Reduced pill burden: Taking fewer pills can improve convenience and patient compliance.
They have a pharmacokinetic advantage.

Pharmacokinetics is defined as the study of absorption, distribution, metabolism, and excretion of drugs by the body

Lack of individual dose flexibility: FDCs offer a fixed dose of each component, which may not be suitable for all patients.
Unapproved and Banned FDCs: The easy access to untested and unlicensed FDCs in countries like India creates a potentially hazardous situation for public health.
Increased risk of Anti-microbial Resistance (AMR): due to potential overuse.
Ethical concern: India imposed ban on certain FDCs, however, there is no ban on same drugs being exported to African or SAARC countries (Lancet, 2016)

Reformulation of Drugs: To evade the drugs price control, some companies reformulate the individual drugs into an FDC.
Compromised quality: New FDCs after 4 years can be produced by other manufactures by getting license from State Licensing Authorities (SLAs) without checking laxity with regard to pharmacological studies.
Approval Process: The Parliamentary Standing Committee on Health and Family Welfare in its 59th report pointed out that some SLAs have been issuing manufacturing licenses for FDCs without prior clearance CDSCO.
Other:

Adverse drug reaction reporting system is poor in India.
Lack of Data as India does not have the exact database of currently available FDCs in the market, their sales turnover and use pattern.

Drugs & Cosmetics (Amendment) Act, 2008 provide stringent penalties for manufacturer of spurious and adulterated drugs and certain offences have also been made cognizable and non-bailable.
Testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
Drugs and Cosmetics Rules 1945 amended in 2017: Providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing License of oral dosage form of drugs.

Need periodic surveys: Drug manufacturers and wholesale and retail outlets periodic surveys can be conducted to get a measure of the existing problem of sector.
National Drug Authority (NDA): Establishing this body to ensure quality of drugs by an Act of Parliament as envisaged by Hathi committee and as well as in Drug Policy of 1994.
Strong punitive action: As suggested by Mashelkar Committee (for regulatory infrastructure and problem of spurious/substandard drugs) against those involved in drug-related cases of corruption will act as deterrence for others.
- Like for manufacture or sale of spurious drug punishment should change from life imprisonment to death penalty as recommended by Committee.
Multistep approach: To curb the irrational use of FDC in India, multistep approach involving all stakeholders, for example, consumers, physicians, regulatory authority, industry, and the academicians, is needed.