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




Medicines (representative image) |
Medicines (Representational image )| Pexels

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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.

Also read: After HCQ, countries begin to call India for the humble pain and fever tablet paracetamol

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!”

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.

Also read: India is testing for Covid-19 antibodies, but unlikely to let recovered patients move freely

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. 

Also read: ICMR studying BCG vaccine for Covid-19, won’t advise without enough evidence: Top scientist

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.”

Also read: Doctors, IAS officers & a scientist — the 5 women leading India’s fight against Covid-19


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Andhra doctor, suspended for alleging PPE shortage, now beaten by cops for ‘creating nuisance’




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A doctor with a stethoscope (Representative image) | Pixabay

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Bengaluru: A doctor with a government hospital in Andhra Pradesh, who was suspended for questioning the shortage of PPE kits, was admitted to a mental health facility Sunday, a day after he was allegedly manhandled by the police and arrested for creating nuisance in Visakhapatnam.

Dr Sudhakar Rao, a government civil surgeon, was beaten, his hands tied behind his back and dragged by police officers Sunday. During the incident, Sudhakar allegedly verbally abused the Jagan Mohan Reddy government in an inebriated state. Videos of the incident have since been widely shared online.

“The police control room received a call about a person creating nuisance on Beach Road Hospital in Visakhapatnam. The Fourth Town police was rushed there and found that the person was the suspended doctor, Sudhakar.

“When the police tried to control him, he snatched the mobile phone of an officer and threw it away. He is suffering from mental disorder and he was drunk. He was sent for a medical examination,” Vishakapatnam Police Commissioner R.K. Meena told the media Sunday.

Sudhakar was admitted to a mental hospital Sunday after doctors at the King George Hospital in Vishakapatnam said he suffered from anxiety.

“Since the doctor is in anxiety and talking irrelevant things, I have referred him to a mental care hospital in Visakhapatnam,” said Dr Radha Rani, medical superintendent, King George Hospital.

A statement released by the hospital said: “Dr Sudhakar was brought to the KGH casualty ward at 6.30 pm. From the smell, it was found that he was in a drunk condition. Under the influence of alcohol, he did not cooperate with anybody there and kept abusing all. Still, his pulse, BP were checked. Pulse was 98, BP 140/100. Blood samples were sent to forensic lab to ascertain alcohol content in his blood.”

Also read: 6 toilets for 20 houses, inadequate testing: Why Mumbai’s Worli chawls are a Covid hotspot

‘Treatment towards Sudhakar was inhuman’

Sudhakar, who spent more than 10 years at the Narsipatnam Government Hospital in Andhra Pradesh, was suspended from his duties in March after he openly criticised the Reddy government for failing to provide PPE kits and N95 masks to doctors treating Covid-19 patients.

He had alleged that the state government was giving N95 masks and PPE kits meant for doctors to politicians and the police.

A video of Sudhakar criticising the government was also shared widely. In the clip, he can be heard saying: “We are putting our lives at risk here. We are asked to use the same mask for 15 days and a fresh mask will be provided only twice a month.”

Speaking to ThePrint, Dr P. Gangadhar Rao, member of the National COVID Committee of the Indian Medical Association, said the manner in which Sudhakar was manhandled by the police was “inhuman” and “violated” human rights.

“We strongly condemn the way he was taken into custody. He was not carrying a weapon, he was alone, the number of policemen outnumbered him. Why treat him like that? We also saw a video where a policeman beats him with a lathi,” said Dr Gangadhar.

He added that Rao was one of the most experienced anaesthetists the Andhra Pradesh government had.

“Our next step of action is to get Sudhakar to write an unconditional apology for having used filthy language, abusing the chief minister and the government. We will then take our appeal to the CM seeking that he be reinstated,” Gangadhar said.

Also read: Face shields, gowns, masks — the new attire for cabin crew post lockdown


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