Fixed-dose combinations banned in India: is it the right decision? An eye-opening review

ABSTRACT

Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government’s ban on 328 irrational FDCs in September 2018. The Drug Technical Advisory Board (DTAB) recommended that ‘there is no therapeutic justification’ for the active ingredients in the banned FDCs and accordingly these combinations ‘may involve a risk to human beings’.

Areas covered: The review illustrates the present status of FDCs, its regulatory framework, approvals in India and discusses the substantive cause behind the ban on FDCs in India.

Expert opinion: The expert stress to establish a robust regulatory system for the approval of FDCs in India. The pharmaceutical industries should not perceive the ban against irrational FDCs as an impediment; rather, they should view as an opportunity to establish a stronger healthcare system. The current review is an eye-opener for the section of people who consider that the ban on FDCs is irrational. However, the ban on 328 FDCs may prove a landmark decision for the development of stronger healthcare policy in India.

KEYWORDS:

• Fixed dose combination
• CDSCO
• pharmaceutical industry
• government
• ban

Article highlights

• The Indian health ministry banned 328 irrational FDCs on 14 September 2018.

• The case studies on FDCs pointed out the lack of updated knowledge among medical fraternity about FDCs.

• A new FDC needs DCGI approval to market in India for which it is mandatory to submit safety and efficacy data.

• The state has approved many ‘irrational’ FDCs without the recommendation from the central regulatory body, which is imperative for all new drugs including FDCs.

• A robust regulatory system and updated policies are required to impregnate into the Indian pharmaceutical market.

• Pharmaceutical companies in India should follow the stringent regulations and not to be compromised with the efficacy and safety of the product.

• This box summarizes key points contained in the article.

Acknowledgments

The authors wish to acknowledge the N.G.S.M Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Mangaluru, Karnataka, India for providing necessary facilities and financial support to carry out this study.

Authors’ contributions

Study conception and design: MRH Miranda. Acquisition of data: A Dubey and Ravi GS. Analysis and interpretation of data: A Dubey, and Ravi GS. Drafting of the manuscript: Ravi GS and A Dubey. Critical revision: A Dubey, Ravi GS, and R Narayana Charyulu. All authors agree to be accountable for all aspects of the work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.