More Fixed-dose Combination Drugs May Enter Ban List: Report

Moneylife Digital Team 27 August 2024

After banning 156 fixed-dose combinations (FDCs), the Indian government is likely to add more FDC drugs to the list, says a report from Economic Times (ET). This move, the report says, could hurt pharmaceutical makers more.

Earlier, the government had banned 156 fixed-dose combinations—including antibiotics, antiallergics, painkillers, multivitamins and combination doses for treatment of fever and hypertension—after a review found they posed health risks in the biggest crackdown since 2016 when 344 FDCs were prohibited.

Quoting people in the know, the report says an expert committee has been reviewing more FDCs and has found that they lack therapeutic justification and have recommended the government to ban them.

According to a 2 August 2024 gazette notification from the Union ministry of health and family welfare (MoHFW), an expert committee appointed by the Union government considered FDCs as irrational. The FDCs examined by the expert committee include amylase, protease, glucoamylase, pectinase, alpha-galactosidase, lactase, beta-glucanase, cellulase, lipase, bromelain, xylanase, hemicellulase, malt diastase, invertase and papain.

The drugs technical advisory board (DTAB) also examined these FDCs and recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may pose a risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940."

According to the Central Drugs Standard Control Organisation (CDSCO), FDC refers to products containing one or more active ingredients used for a particular indication.

Some of the popular FDCs banned by the government include: a combination of mefenamic acid and paracetamol injection used for pain relief, fever and swelling, and omeprazole magnesium and dicyclomine HCl used for the treatment of abdominal pain, ET says.

Earlier in September 2018, MoHFW prohibited the manufacture for sale or distribution for human use of 328 FDCs.

In March 2016, the Union government prohibited the manufacture, sale, and distribution of 349 FDCs, but this was contested by the affected manufacturers in high courts (HCs) and the Supreme Court.

Complying with the December 2017 Supreme Court judgment, the DTAB examined the matter. In its report to the MoFWA, the DTAB recommended the prohibition of the FDCs, saying there was no therapeutic justification for the ingredients contained in them and that these FDCs may pose risks to human beings.

Comments

User

Life

Patanjali, Baba Ramdev Asked to Take Down Claims that Allopathy Led to COVID Deaths

Prashant Jha (Bar and Bench) 29 July 2024

The Delhi High Court on Monday ordered Patanjali Ayurved and its promoters, including Baba Ramdev, to take down claims that allopathy doctors were responsible for the deaths of lakhs of people during the COVID-19 pandemic, while...

Life

Gender Budget Gets 19% More, but Health, Nutrition Remain Underfunded

Nileena Suresh (IndiaSpend) 25 July 2024

This year, the Union government allocated Rs 3.27 lakh crore or 6.8% of total expenditure under the gender budget, which includes schemes for the welfare of women. This represents a 19% increase compared to the revised estimate for...

Life

30-minute Workout Enhances Cancer-fighting Immune Cells, Research Shows

Akshay Naik 24 July 2024

A recent study conducted by the University of Turku in Finland has revealed that just 30 minutes of exercise can significantly increase the proportion of tumour-killing white blood cells in the bloodstream of breast cancer patients....