Regulatory Framework for Fixed Dose Combination Drugs in India – Prelims Specific

Introduction

Fixed Dose Combination (FDC) drugs consist of two or more active pharmaceutical ingredients combined in a single dosage form. While intended to improve patient compliance, many FDCs in India lack scientific evidence of therapeutic superiority over individual drugs, posing risks like adverse side effects and increased antimicrobial resistance (AMR).

Why in News?

• The Union government is implementing bans on various FDC drugs identified as irrational by expert committees.
• The move is a regulatory crackdown to eliminate pharmaceutical products that lack clinical justification or efficacy data.
• This initiative is part of a broader effort to ensure safety standards and align state-level licensing with national requirements.

Static Link

• The regulatory oversight is grounded in the Drugs and Cosmetics Act, 1940.
• This topic is linked to the UPSC syllabus under Governance, specifically the regulation of health sectors and public policy.
• UPSC often examines the legal mandate of national regulators and the mechanism for curbing hazardous medical practices.

Institutional Link

• Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India. It functions under the Ministry of Health and Family Welfare. It is responsible for the approval of new drugs and clinical trials.
• Drug Technical Advisory Board (DTAB): A statutory body constituted under the Drugs and Cosmetics Act, 1940. It acts as the highest decision-making body on technical matters related to drug regulation.
• Kokate Committee: An expert committee appointed to review the safety and efficacy of various FDC drugs circulating in the Indian market.

Core Prelims Facts

• FDCs are classified as irrational if they do not demonstrate a clear therapeutic advantage over single-ingredient medications.
• The irrational use of antibiotic FDCs is a major contributor to Antimicrobial Resistance (AMR) in India.
• The power to prohibit the manufacture and sale of drugs rests with the Central government under the Drugs and Cosmetics Act when a drug is found to be lacking in therapeutic value or presents a health risk.

Important Terms and Concepts

• Polypharmacy: The practice of prescribing multiple drugs simultaneously, which can lead to unnecessary chemical exposure and adverse interactions.
• Antimicrobial Resistance (AMR): The phenomenon where microorganisms evolve to survive exposure to medicines, often exacerbated by the irrational use of antibiotics.

Bodies / Organisations / Institutions

• CDSCO: Responsible for standardizing quality and safety; works in coordination with State Licensing Authorities (SLAs).
• Ministry of Health and Family Welfare: The parent ministry providing executive oversight for national health standards and drug regulation.

Schemes / Laws / Reports / Conventions

• Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, distribution, and sale of drugs in India.
• WHO Global Action Plan on AMR: Provides the international framework for managing the threats posed by antimicrobial resistance.

Possible UPSC Prelims Traps

• Ministry Trap: Candidates may mistakenly associate CDSCO with the Ministry of Chemicals and Fertilizers. It functions under the Ministry of Health and Family Welfare.
• Statutory Trap: While the Drugs and Cosmetics Act governs drug regulation, the specific composition and mandates of committees like DTAB are statutory, not executive.
• Jurisdiction Trap: The assumption that the Central government approves all drugs is a trap; historically, State Licensing Authorities have had the power to approve drugs, leading to regulatory fragmentation that the Central government is currently attempting to harmonize.
• Absolute Word Trap: Avoid assuming that all FDCs are banned; only those categorized as irrational based on scientific review are subject to prohibition.

One-Minute Revision Notes

• CDSCO is the primary national regulator for drugs, functioning under the Health Ministry.
• DTAB is the statutory technical advisory body under the 1940 Act.
• The Kokate Committee was instrumental in reviewing FDC safety.
• Irrational FDCs contribute to AMR, a major global and national public health concern.
• Regulatory control involves both central and state-level coordination.

Practice MCQ for Prelims

1. With reference to the drug regulatory mechanism in India, consider the following statements:

1. The Central Drugs Standard Control Organisation (CDSCO) is the apex body responsible for the regulation of cosmetics and medical devices.

2. The Drug Technical Advisory Board (DTAB) is a statutory body constituted under the Drugs and Cosmetics Act, 1940.

3. The power to prohibit the manufacture of a drug in the public interest lies exclusively with State governments.

Which of the statements given above are correct?

A) 1 and 2 only

B) 2 and 3 only

C) 1 and 3 only

D) 1, 2 and 3

Answer: A

Explanation: Statement 3 is incorrect because the Central government has the power to prohibit the manufacture or sale of drugs under the Drugs and Cosmetics Act if they are deemed unsafe or lack therapeutic value.