Expert Committee Recommends Rationalization of FDCs in India’s Pharma

The Ministry of Health and Family Welfare then constituted the expert committee led by Dr M S Bhatia.

January 13, 2024

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Expert Committee Meeting — Picture: Pixabay

Table of Contents

Last Updated on January 20, 2024 by The Health Master

Expert Committee

In a significant development, the expert committee has revisited the landscape of Fixed Dose Combinations (FDCs) in India, paving the way for potential changes in the pharmaceutical industry.

Last year, 14 FDCs faced the banhammer due to concerns about their safety and efficacy.

However, recent recommendations from the committee, chaired by Dr M S Bhatia, bring a ray of hope, marking certain FDCs as rational, albeit with specific conditions.

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Understanding the Committee’s Recommendations

1. Rationalizing Antidepressant FDCs

The committee has given the nod to the FDC combination of antidepressant Imipramine hydrochloride IP + diazepam IP in tablet form and a cough syrup amalgam of chlorpheniramine maleate IP + ammonium chloride IP + sodium citrate IP.

The approval comes with conditions, including a limited treatment duration for the antidepressant combination and a clear dosage schedule for the cough syrup.

2. Green Signal for Common Cold Remedy

The committee recommends continued manufacturing and marketing of the common cold drug combination paracetamol 500mg + phenylephrine hydrochloride 10mg + caffeine anhydrous 32 mg tablets.

However, the firm must generate safety and efficacy data through a Phase IV clinical trial within a year.

Click for more on (FDCs) Fixed Dose Combinations

3. Cautionary Approval for Caffeine-Infused Tablets

The combination of caffeine anhydrous + paracetamol + phenylephrine hydrochloride + chlorpheniramine maleate in tablet form gets a cautious green light.

The committee insists on selling it only on a registered medical practitioner’s prescription, with a minimum 500 mg dose of paracetamol.

Additionally, a randomized comparative Phase IV clinical trial is recommended within a year.

4. Headache Relief Combination

For the combination of paracetamol 250mg + propyphnazone 150mg + caffeine 30 mg tablets meant for headache relief, the committee allows continued manufacturing and marketing.

However, there are conditions, including a restriction on usage to 5-7 days and sale only on a registered medical practitioner’s prescription.

An Active Post Marketing Surveillance study is also mandated.

Implications for Major Pharma Brands

This development is poised to benefit major pharmaceutical brands, including Crocin, Piriton, D Cold Total, and Dolopar.

These brands had faced challenges following the blanket ban on certain FDCs, affecting their market presence.

The conditional approval now provides an opportunity for them to make a comeback, albeit with adherence to stringent guidelines.

Pathway for Licensing and Regulatory Compliance

The article explores the detailed pathway outlined by the Drugs Controller General of India, Dr Rajeev Singh Raghuvanshi, for obtaining product licenses for the approved FDCs.

This includes communication with state and union territories’ drug regulators, emphasizing adherence to the expert committee’s recommendations.

Backdrop of the Ban and Legal Proceedings

1. Ban on 14 FDCs in 2023

In June 2023, the Central Government enforced a ban on 14 FDCs licensed before 1988.

The decision was based on recommendations from an expert committee highlighting potential risks to human health.

Many pharmaceutical companies challenged the ban through petitions in various High Courts, leading to ongoing legal proceedings.

2. The Kokate Committee’s Influence

The ban on these FDCs traces back to a 2016 order prohibiting 344 combinations, acting upon recommendations from the Professor Kokate Committee.

The expert committee formed later found irregularities in state licensing authorities issuing manufacturing licenses without Central Drugs Standard Control Organisation (CDSCO) clearance.

3. Supreme Court’s Intervention

The Supreme Court recommended referring the banning of 349 FDCs to the Drugs Technical Advisory Board.

However, it set aside the banning of pre-1988 approved FDCs, emphasizing that such cases were not meant for the Kokate Committee‘s scrutiny.

The Ministry of Health and Family Welfare then constituted the expert committee led by Dr M S Bhatia.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

Q: What led to the ban on FDCs in 2023?
- A: The ban on 14 FDCs in 2023 was based on recommendations from an expert committee highlighting potential risks to human health associated with these combinations.
Q: How are major pharmaceutical brands affected by the recent recommendations?
- A: Major brands such as Crocin, Piriton, D Cold Total, and Dolopar stand to benefit as the conditional approval provides an opportunity for them to reintroduce certain FDCs.
Q: What conditions are imposed on the approval of the common cold drug combination?
- A: The committee recommends continued manufacturing and marketing with the condition to generate safety and efficacy data through a Phase IV clinical trial within one year.
Q: Why did the Supreme Court set aside the banning of pre-1988 approved FDCs?
- A: The Supreme Court deemed that cases involving FDCs approved before 1988 were not meant to be referred to the Kokate Committee, leading to the setting aside of the ban on these combinations.
Q: How can pharmaceutical companies obtain product licenses for approved FDCs?
- A: The detailed pathway for obtaining product licenses involves communication with state and union territories’ drug regulators, emphasizing adherence to the expert committee’s recommendations.