The Drugs Technical Advisory Board (DTAB) will likely meet later in the day to take a final call on the selected fixed-dose combination (FDC) medicines, CNN-News18 reported. The Central Drugs Standard Control Organisation (CDSCO) has made a list of 19 FDCs, which were deemed 'irrational'. These include Sumo, D’Cold Total, TeddyKoff, Tossex, Ascoril C, Codistar, Dolo Cold, Piriton, and Saridon.
Brands such as Ascoril C, Codistar, Sumo, TeddyKoff, and Tossex showed strong growth during the peak of the COVID-19 pandemic. The growth has been in line with opportunities.
In March 2016, the government banned 344 FCDs, which impacted around 2,700 branded drugs. Since then, companies themselves have been a bit wary of FDC drugs. However, the COVID-19 pandemic led to a rise in these drugs, especially in the anti-infective (cough and cold segment).
Hence, the government might now be looking to weed out the irrational combinations.
What is FDC?
Fixed dose combination or FDC combines more than one drug in a single pill. The fear is that these can have irrational combinations, and can result in building resistance to a certain molecule in the drug.
India is one of the few countries that allows FDCs. Hence, regulations are likely to move towards being at par with the developed world.
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The advantage of FDC is that it improves affordability by getting a combination of medicines in a single medicine and it is easier to administer,
Pharma companies and their FDC drugs
Following are some of the FDCs that Indian pharma companies manufacture:
Sales
When it comes to their sales, in 2020, Grilinctus and Sumo recorded Rs 209 crore and Rs 174 crore, respectively. Codistar, Pirition and Tossex recorded Rs 99 crore, Rs 62 crore and Rs 71 crore, respectively.
| 2020 | 2021 | 2022 | |
| Codistar | Rs 99 cr | Rs 109 cr | Rs 156 cr |
| Grilinctus | Rs 209 cr | Rs 222 cr | Rs 249 cr |
| Piriton | Rs 62 cr | Rs 47 cr | Rs 56 cr |
| Sumo | Rs 174 cr | Rs 205 cr | Rs 223 cr |
| Tossex | Rs 71 cr | Rs 68 cr | Rs 85 cr |
Meanwhile, Ascoril C's recorded sales of Rs 20 crore in 2022, Grilinctus' was Rs 249 crore and Sumo's was Rs 223 crore.
In 2022, quite a few pharma companies were also told to generate additional safety data. Most likely that the cough and cold//codeine- medicines-based were the ones of concern. Saridon was also on the list.
Conclusion
If any decision regarding FCDs is taken, it is most likely that the companies are prepared after the big hit in 2016, when 344 FCDs were banned. The companies have been lobbying hard, so the list is likely to be smaller this time. Codein-based drugs are likely to see a high, however, they are already tightly regulated.
First Published: Apr 20, 2023 12:22 PM IST
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