Covid-19 impact: Indian firms look to fill in for US' Famotidine crunch

The US Food and Drug Administration (USFDA) has added famotidine in its drug shortages list
After common antacid drug Famotidine shot to the limelight for being a potential treatment for Covid-19, the demand surge for the drug has led to a shortage in the US.

Some see this as an opportunity for Indian firms like Alembic and Aurobindo that make both the bulk drug and the formulation.
Meanwhile, the central government, too, has taken note of the demand and decided to undertake a stock-taking exercise for the drug in case of a sudden export demand, besides procuring for Jan Aushadhi stores.

So far, there has not been any significant jump in demand for the over-the-counter (OTC) drug in the domestic market.

“Famotidine may become the next hydroxychloroquine (HCQ). It is also a cheap drug, costing about 40 paise per tablet. However, findings of the studies are yet to come. So, it is too early to comment on the efficacy,” said Dinesh Dua, chairman of the Pharmaceutical Export Promotion Council of India. It is an old generation antacid, and therefore, the safety profile is established.

The US Food and Drug Administration (USFDA) added Famotidine in its drug shortages list. The shortages have come in the last one month. Researchers at Northwell Health in New York are testing the effects on Famotidine (used in high intravenous doses) on patients as a potential treatment. The drug shortages surfaced after the hospital announced its clinical trials. In the US, the drug sells under the Pepcid brand.

The Northwell trial, initiated in the first week of April on 1,174 patients, is likely to come up with results in the next few weeks. These patients are receiving Famotidine intravenously, nine times the heat burn dose, the Science magazine reported.

It all started in China where some doctors had noticed that hospitalised patients who were on pre-existing Famotidine dose fared better compared to others. The researchers are trying to check if Famotidine binds itself with a particular protein which helps the coronavirus to replicate.

Back home, there has not been any surge in the demand for Famotidine yet. “It is an old generation drug and now the common antacids are usually proton pump inhibitors (PPIs) like omeprazole. Famotidine falls under a category called H2 blockers like ranitidine. So, the demand is not very high – around Rs 40 crore in annual sales,” said a pharma industry insider.

Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists, the umbrella association that represents around 850,000 chemists across the country, said not many are aware of this drug’s potential use in Covid-19. Hence, there has been no surge in domestic demand.

In India, the well-known Famotidine brands include Famocid (Sun Pharmaceuticals), Famtac by Abbott, Topcid by Torrent Pharmaceuticals and Facid by Intas Pharma. Alembic and Aurobindo are the major exporters to the US. Alembic said it also makes the active pharmaceutical ingredient (API) for the drug and can also source it from outside if demand surges.

A government official said that India makes enough quantities of Famotidine.

The government, nonetheless, has taken note of the fresh interest in this old drug and would now seek information from manufacturers on inventory, capacity and exports.

After US President Donald Trump spoke about HCQ’s efficacy against the coronavirus, the export demand had suddenly surged. India is one of the largest producers of the drug (Ipca and Cadila Healthcare along with several smaller domestic players), and the country raised the production of the drug from 122.3 million  tablets in March to 300 million tablets in May.

“There is a plan to procure (Famotidine) for the Jan Aushadhi stores as this is also an affordable drug and in case of a demand surge, it would be available with the government. However, unless clear trial reports emerge, we do not plan to ramp up production of famotidine,” the official said.


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