Famotidine Shortage In US May Benefit Indian Pharmaceutical Companies

After common anti-acid 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 market. Some see this as an opportunity for Indian firms like Alembic, Aurobindo who make both the bulk drug and the formulation.

Meanwhile, the Indian government too, has taken note of the demand, and has decided to undertake a stock-taking exercise for the drug in case of a sudden jump in export demand, besides procuring it for Jan Aushadhi stores. However, 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. It is also a cheap drug, costing about 40 paise per tablet. However, the 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. Since famotidine is an old generation anti-acid, the safety profile of the drug is established.

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The US Food and Drug Administration (USFDA) has 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 of famotidine (used in high intreavenous 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 1174 patients, is likely to come up with results in the next few weeks. These patients are receiving famotidine intravenously, 9 times the heat burn dose, the Science magazine reported.

It all started in China, where some doctors noticed that hospitalised patients 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 replicate.

Back home, no surge in the demand has been reported yet for famotidine. "It is an old generation drug and now the common antacids are usually proton pump inhibitors (PPIs) like omeprazole etc. 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 All India Organisation of Chemists and Druggists, the umbrella association that represents around 850,0000 chemists across the country. said that not many are aware of this drug's potential use in Covid-19, and 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, Facid by Intas Pharma. Alembic, Aurobindo are the major exporters to the US. Alembic said that it also makes the active pharmaceutical ingredient (API) for the drug and can also source it from outside if demand surges.

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A government official commented 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 increased the production of the drug from 12.23 crore tablets in March to 30 tablets in May.

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