Supreme Court refers fixed dose combination drugs issue to govt expert body

All India Drugs Action Network says the Supreme Court's directive clears the way for the govt to take steps to weed out large numbers of irrational, unscientific and hazardous fixed dose combination drugs

Priyanka Mittal, Teena Thacker
Updated15 Dec 2017
An FDC drug contains two or more active ingredients in a fixed dosage ratio. Photo: iStockphoto
An FDC drug contains two or more active ingredients in a fixed dosage ratio. Photo: iStockphoto

New Delhi: The Supreme Court on Thursday referred the issue of fixed dose combination (FDC) drugs to the government’s expert body, Drugs Technical Advisory Board (DTAB), for a fresh review of their safety, efficacy and therapeutic justification before recommending action.

After the examination by the DTAB or a sub-committee constituted by it and hearing all stakeholders concerned, the expert body will be required to forward its report to the government for action within six months, held a bench headed by justice Rohinton F. Nariman.

The court, however, kept out of the purview of its order the 15 FDCs that were licensed prior to 1988.

It also held that status quo be maintained in the case of the 329 FDCs being referred to DTAB for review.

Welcoming the order, the All India Drugs Action Network said that the court’s directive clears the way for the government to take steps to weed out large numbers of irrational, unscientific and hazardous FDCs prevalent in India.

“The 344 FDCs account for only about 5% of the value of total FDCs in India, approximately half of which are considered to be irrational. The government should proactively take advantage of the space afforded by this order to weed other irrational FDCs in the interest of patient safety,” said S. Srinivasan, co-convenor of the network.

Pfizer Ltd, the Indian unit of US-based drug maker, whose Corex cough syrup was part of the FDC drugs banned by the centre, said it “fully supports the government in its goal of eradicating irrational combinations and medicines not duly approved by state and central regulators through a consultative process”.

In January, the centre had filed an appeal against a December 2016 ruling of the Delhi high court quashing its 10 March, 2016 notification banning 344 FDC drugs citing health risks and lack of therapeutic justification.

On 31 March, the apex court had stayed proceedings in all high courts against the ban on 344 FDC drugs.

An FDC drug contains two or more active ingredients in a fixed dosage ratio.

The ban covered about 6,000 brands from major pharma houses including Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd, and Sun Pharmaceutical Industries Ltd. It was enforced following a report by a six-member committee headed by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka.

The Kokate panel, which submitted its report on 20 January 2015, had termed 963 FDCs “irrational”, posing health threats.

Justice Rajiv Sahai Endlaw of the Delhi high court had quashed the notification, holding that the government had failed to consult statutory authorities like DTAB and the Drugs Consultative Committee before the ban.

Catch all the Industry News, Banking News and Updates on Live Mint. Download The Mint News App to get Daily Market Updates.MoreLess
HomeindustrymanufacturingSupreme Court refers fixed dose combination drugs issue to govt expert body

Most Active Stocks

Ashok Leyland

210.55
10:29 AM | 24 MAY 2024
-1.85 (-0.87%)

Bharat Electronics

297.10
10:28 AM | 24 MAY 2024
8.7 (3.02%)

GAIL India

204.40
10:29 AM | 24 MAY 2024
3.95 (1.97%)

Tata Steel

174.80
10:29 AM | 24 MAY 2024
-0.65 (-0.37%)
More Active Stocks

Market Snapshot

  • Top Gainers
  • Top Losers
  • 52 Week High

Inox Wind

164.20
10:21 AM | 24 MAY 2024
13.25 (8.78%)

BHARAT DYNAMICS ORD

1,527.50
10:22 AM | 24 MAY 2024
120.8 (8.59%)

Amara Raja Energy & Mobility

1,209.10
10:17 AM | 24 MAY 2024
94.85 (8.51%)

Vodafone Idea

15.11
10:29 AM | 24 MAY 2024
1.06 (7.54%)
More from Top Gainers

Recommended For You

    More Recommendations

    Gold Prices

    • 24K
    • 22K
    Bangalore
    73,829.00577.00
    Chennai
    73,325.00-1,008.00
    Delhi
    73,252.00-433.00
    Kolkata
    73,469.00-432.00

    Fuel Price

    • Petrol
    • Diesel
    Bangalore
    99.84/L0.00
    Chennai
    100.88/L0.13
    Kolkata
    103.94/L0.00
    New Delhi
    94.72/L0.00
    OPEN IN APP
    HomeMarketsPremiumFor youGet App