Why India doesn’t have an edge in exports of azithromycin, the other Covid-19 ‘wonder drug’

Unlike hydroxychloroquine (HCQ), several other countries also produce azithromycin, an antibiotic for bacterial infections.

Medicines | Representational image | Pexels

New Delhi:  The humble hydroxychloroquine (HCQ) has granted India an unlikely global strategic asset, as countries around the world have begun stockpiling the drug to fight the coronavirus pandemic.  

But with some recent studies suggesting that the efficacy of HCQ in treating Covid-19 is enhanced by a dosage of azithromycin, there is now set to be a growing clamour for the antibiotic primarily used to treat bacterial infections.  

The demand for azithromycin, however, doesn’t give the Indian pharmaceutical industry any edge. For one, unlike HCQ, several countries in the world produce azithromycin.  

And also unlike HCQ, India is not self-sufficient in the production of azithromycin as New Delhi imports the majority of its raw material for the drug, called active pharmaceutical ingredients (APIs), from China. 

Despite the challenges, the country’s largest producer of Azithromycin, the Gujarat-based Alembic Pharmaceuticals, has started receiving orders from across the world, especially the United States and Europe.

Other players including Macleods Pharmaceuticals and Mankind Pharma said the domestic demand has noticeably gone up. Macleods also said that it has been receiving international orders.

“We have noticed an increase in demand in a few countries where we have on-ground operations” said Shailesh Pednekar, senior vice-president at Macleods Pharma. He, however, refused to disclose the names of the countries. 

Azithromycin is an antibiotic used in the treatment of bacterial infections mostly in and around the respiratory tract including tonsils, throat, soft tissues and lungs. It is also used in the treatment of pneumonia and typhoid. 

It prevents the synthesis of essential proteins required by bacteria to grow and hence, prevents the infection from spreading.

Touted as possible cure for Covid-19 along with HCQ 

Several ongoing research appears to suggest a combination of azithromycin and hydroxychloroquine  is effective in treating Covid-19. 

For instance, scientists at the Rutgers Cancer Institute of New Jersey are researching “if the combination of the two, azithromycin combined with hydroxychloroquine, is better for covid-19 than simply hydroxychloroquine alone.” 

And much like HCQ, azithromycin has gained prominence because of US President Donald Trump.  

On March 21, Trump had tweeted, “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents………be put in use IMMEDIATELY. PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE!”

HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)…..

— Donald J. Trump (@realDonaldTrump) March 21, 2020

A Croatian drug

Also known as world’s best selling antibiotic, azithromycin was discovered in the 1970s by a team of researchers at Pliva, a Croatian pharmaceutical company.  

“From early trials, Azithromycin proved to be extremely efficient and capable of remaining in the body tissue of animals longer than other similar antibiotics,” according to the World Intellectual Property Organisation (WIPO).  

In 1981, the company filed a patent application for azithromycin and patented it worldwide, including in the United States. However, in 1986, Pfizer under a licensing agreement acquired the right to sell Azithromycin worldwide. “Pliva, however, maintained the right to sell the product in Central and Eastern Europe and would earn royalties on Pfizer’s sales,” WIPO states. 

In 2008, Pliva became part of the Israel-based Teva Pharmaceuticals.  

At present, Pfizer sells the drug under the brand name Zithromax and Zitromax in more than 30 countries across the globe including Malaysia, Italy, Belgium, Spain, Canada, Ireland and Denmark.

Status of drug in India

According to data with the  research firm IQVIA, India sold 12 crore strips of the drug last year, which is around 60 crore tablets (an average of 5 tablets a strip). The top brand here is the Vadodara-based Alembic’s Azithral.  

It is the largest player in the azithromycin market, estimated Rs 550 crore a month. 

Alembic, which also claims to be the largest player in selling active pharmaceutical ingredients (APIs) of azithromycin to the world, holds 30 per cent market share in selling the finished tablets of the antibiotic in India.  

“Our three manufacturing plants for the azithromycin APIs produce 20 tonnes every month, which can be expanded to 40 tonnes. Generally, one crore tablets are manufactured using 5 tonnes of API,” Rajkumar Kumar Baheti, Chief Financial Officer, Alembic Pharmaceuticals, told ThePrint.  

Alembic exports all of its APIs. For finished tablets, the company, going by the estimates, can manufacture around 10 crore tablets per month.  

According to the data given by industry to the health ministry, Indian requirement is 75-80 metric tonnes of the drug, which is around 12-20 crore tablets monthly.  The other players in the market include Cipla, Mankind, Ipca Laboratories, Sun Pharma, Wockhardt and Micro labs among others.  

Gurgaon-based Mankind Pharma produces around 25 lakh tablets every month but does not export. “We produce 2-3 crore pills for the drug annually using 30-40 percent capacity of our plant,” R.C. Juneja, CEO of Mankind Pharma, said. 

Growing Demand 

Baheti from Alembic said that the company is receiving orders from the majority of its API clients from foreign countries, which in turn sell formulations (finished medicines) to other nations. “Majority of orders are coming from the United States, especially South America and Europe. But I don’t want to reveal the details of their locations,” Baheti said.    

“Of the total production, only 5-12 tonnes is the domestic requirement. We are, however, keeping buffer stock with us as India’s requirements are the first priority and exports are secondary,” he said. 

Dependence on Chinese imports is a challenge 

Unlike HCQ, where India is self-sufficient in production of the drug, for azithromycin, the majority of companies import the APIs from China, especially Wuhan, the initial epicentre of the coronavirus outbreak. 

While Alembic leads in the production of APIs in the world, as the company claims, it also imports the intermediates and key starting material from China and other parts of the world. “The only challenge is the inputs for APIs come from China and other parts… Coordinating the supply chain can be a task at times. However, we have enough buffer stock,” Baheti said. 

Juneja from Mankind added, “In anticipation of shortages (due to Covid-19 pandemic in China), we are fully stock as of now and there is no shortage. If the demand picks up, we will be able to match it.”