COVID-19: HCQ A Historical Game-Changer

Dr Basab Ghosh

April 11, 2020, 03:20:10   

India is the world's biggest manufacturer of Hydroxychloroquine (HCQ), an anti-malarial drug that US President Trump is pushing as a "Game-Changer" in the fight against COVID-19. The whole world is looking for HCQ to fight coronavirus causing COVID-19. In medical science it is alsoused successfully to patients other than malaria with rheumatoid arthritis, lupus, the blood disorder porphyria cutanea tarda, etc.                                                                                                                              
Indian Council of Medical Research (ICMR) has recommended the use of HCQ for treatment of severe COVID-19 cases. They also recommended HCQ as prophylaxis for those health workers who are involved in the care and treatment of suspected or confirmed cases of COVID-19 and for household contacts of laboratory confirmed persons who has no symptom of active disease. In both treatment and prophylaxis the drug will be only used by registered medical practitioners. It may have serious consequences if not used under medical care. ICMR never recommends this drug for self treatment or for everyone`s protection from COVID-19.
The man who has important contribution in India's lead taking malaria history is Acharya Prafulla Chandra Roy. He is known as "The father of Indian Chemistry", who was a well-known Indian Scientist, teacher and the first modern Indian chemical researcher. He had the revolutionary discovery of the stable compound mercurous nitrate in 1896.
In 12th April 1901 Bengal Chemicals was formed by him in a rented house in Kolkata. It is the first pharmaceutical company in India. Presently it is a public sector undertaking (PSU) and since decades Bengal Chemicals & Pharmaceuticals Ltd. (BCPL) is the only PSU that produces the anti-malarial drug in the country Chloroquine phosphate, from which HCQ can be produced easily. HCQ is an analog of Chloroquine, meaning the two have similar structures but different chemical and biological properties. HCQ is considered the less toxic derivative, according to studies.
India manufactures 70% of the world supply of HCQ. Ipca laboratories, Zydus Cadila and Wallace Pharmaceuticals are top manufacturing companies in India. This drug is not manufactured by USA because of non-existent of malaria. 
As most of us are already aware, HCQ has taken the world by storm in COVID-19 battle. Every newspaper is talking about it, and all countries are requesting India to supply it. An interested person might wonder how this anti malarial chemical has emerged and is there any history behind it?
Beautiful flowering tree Cinchona is the native of South America and its medicinal value is used for many years. The bark extracts have been used to treat malaria since at least 1632. Later on Quinine was isolated from the bark of the cinchona tree by French chemists in 1820 to employ it to treat fever. After more than a century Chloroquine was first discovered in 1943as a derivative of quinine and in medical science first used for prophylactic treatment of malaria in 1947, subsequently it has established its important role in both prevention and treatment of malaria.                                                               
Hydroxychloroquine (HCQ) is a different formulation of Chloroquine and it was approved for medical use in the USA in 1955. It is popularly used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine. It is taken by mouth preferably immediately after meal to minimize it's stomach irritation and acidity. 
Now, a curious person might wonder apart from proud 70% production of this drug by India, is there any other history in its association to pride in India? 
Well, there is an interesting history behind this drug which goes all the way to 1799. When Tipu Sultan was defeated by the British, the whole of Mysore Kingdom came under British control. But within weeks, many got sick due to Malaria, because that was a highly moist and damp area with severe mosquito trouble. The local Indian population developed self immunity over the centuries, what British were lacking for sudden exposure.
To quickly overcome the mosquito menace, the British Army immediately shifted their station from Mysore to Bangalore, which was a welcome change, especially due to cool weather. But the malaria problem still persisted because Bangalore was also no exception to mosquitoes.
Around the same time, European scientists were working on a chemical composition which in 1820 French discovered as Quinine. Scientists thought that could be used to treat malaria, but it was yet to be extensively tested at large scale. This malaria crisis among British Army came at a favorable time, and thus Quinine was imported by the Army and distributed to all their soldiers. All were instructed to take regular dosages so that they could build immunity. This was followed up in all other British stations throughout India.
But there was a small problem. Many soldiers were continued to become sick and it was later found that they were not taking dosages of Quinine as because it was very bitter!! British officers and scientists started experimenting ways to convince their soldiers to firmly take these dosages, and during their experiments, they found that the bitter Quinine when mixed with Juniper berry based liquor, actually turned somewhat into a sweet and flavored drink.
That Juniper berry based liquor was Gin. And the Gin mixed with Quinine was called "Gin & Tonic", which immediately became an instant hit among British soldiers. In fact, the Army even started issuing few bottles of Gin along with "tonic water" (Quinine) as part of their monthly ration, so that soldiers could themselves prepare Gin & Tonic and consume them every day to build immunity.
Couple of century back Quinine had gone against India and helped the British to establish their emperor in Indian soil, but now a descendent of Quinine, called Hydroxychloroquine, has given India the opportunity to be the savior around the globe in COVID-19 battle! This drug behaves like a true Game-Changer!
India is the leading player across the globe in the manufacturing of HCQ with almost 70% of total global manufacturing capacity. The country's largest manufacturers of HCQ, Ipca laboratories and Zydus Cadila, have bagged orders from the Ministry of Health and Family Welfare to supply around 10 crore tablets. 
The Centre has placed the order after the country's apex health research body, ICMR recommended HCQ for both treatment and prophylaxis. However, health officials around the world highlight that there is no evidence that any drug, including HCQ, can cure or prevent a COVID-19 infection. But this hasn't stopped countries around the world asking India for shipments. 
Presently, the country's production capacity of HCQ is 20 crore tablets every month. As far as production of Chloroquine phosphate was concerned, the BCPL usually produces three to four lakh tablets annually. "Considering the raw material we have, we can manufacture about 10 lakh tablets in a week's time," Managing Director P.M. Chandraiah told The Hindu. Both Chloroquine phosphate and HCQ have similar structures but different chemical and biological properties, so accordingly HCQ production is possible as per the requirements, he admitted.

However, as only a few clinical trials have shown limited success of the drug, scientists are warning against the mass-prescribing of HCQ to battle the COVID-19 pandemic. Despite early success in trials in China and France, the European Medicine Agency (EMA) emphasized that the efficacy of HCQ in treating COVID-19 has yet to be shown in studies.
Currently, two large trials are underway to study the effectiveness of HCQ, and Chloroquine, in COVID-19 treatment. One is a "Solidarity Trail" run by the World Health Organization (WHO) to test HCQ or Chloroquine treatment protocol along with other three protocol drugs separately in four different set of COVID-19 patients. This trial is to confirm efficacy of the selected drugs including HCQ or Chloroquine. Another is called the "Chloroquine Accelerator Trial" looking instead at prophylaxis of HCQ and the trail is run by Wellcome Trust, the Bill and Melinda Gates Foundation and Mastercard of US and UK. Here up to 2000 asymptomatic men and women who are close contacts of confirmed COVID-19 patient or suspected COVID-19 patients whose sample has already taken for diagnosis are enrolled to see the effect of HCQ in disease prevention.
The government of India had put a blanket ban on all these medicines, including hydroxychloroquine, on 4 April 2020, on which US President Donald Trump is now banking heavily for the treatment of COVID-19 patients. India has received similar requests from several other countries including its immediate neighbors Sri Lanka and Nepal. 
India had said that it is reviewing its export ban order and with coronavirus  spreading at a rapid pace in the country and the neighbourhood, now India has partially eased restrictions on export of Hydroxychloroquine to clear "all existing orders". Also it has decided to permit in appropriate quantities to all our neighboring countries that are dependent on India's capabilities as per the official announcement of Ministry of External Affairs. We are proud that our country is playing a big role in the present COVID-19 battle to save the mankind and hope India would have been the real Game-Changer like HCQ in the history of pandemic control!


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