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India almost out of stock of COVID-19 generic drugs




COVID-19 generic drugs demand surge in India


Naimatevir/ritonavir tablets (Paxlovid), a drug for the treatment of COVID-19, is currently facing "hard to find one drug" in pharmacies, hospitals and online platforms in India.


Due to the hit of new COVID-19 variant XBB in China, many Chinese are seeking medicines for COVID-19. A Chinese living in Mumbai, India, recently received an entrustment from a friend in China. He went to a nearby pharmacy to look for Paxlovid’s Indian generic drug but was told by the store that it was “sold out” and had to wait for the next shipment from the pharmaceutical factory.


Paxlovid, developed by Pfizer, was authorized by the U.S. Food and Drug Administration (FDA) for emergency use on December 22, 2021, for the treatment of COVID-19 patients aged 12 and over who are at higher risk of severe illness. It also became the first COVID-19 treatment drug approved in the U.S.


On February 11, 2022, the State Food and Drug Administration of China approved the import registration of Paxlovid with conditions.


In November 2021, before the emergency use authorization, the U.S. government stated that it had agreed with Pfizer to purchase 10 million courses of Paxlovid drugs at approximately US$5.3 billion. According to the calculation, the U.S. government needs to pay about $530 (about 3,690 yuan) for each 5-day course of treatment.


According to Pfizer's 2021 financial report, the drug brought the company $76 million in revenue, estimated that the revenue in 2022 will be around $22 billion.


For people in low-and-middle-income countries, such high drug costs are unaffordable. Moreover, it is inhumane to demand high prices from the destitute poor for life-saving medicine. Thus Pfizer had already made arrangements and said it did not want to make money in this way.


On November 16, 2021, Pfizer reached a licensing agreement with the non-profit "Medicines Patent Pool" (MPP), allowing it to authorize other drugmakers further to produce generics of Paxlovid.


The "Drug Patent Pool" is an international public health organization supported by the United Nations International Drug Purchase Mechanism. It was established in July 2010 and is headquartered in Geneva, Switzerland. It was found to improve access to essential medicines for low- and middle-income countries. According to the license agreement, the "drug patent pool" can authorize generic drugs to qualified generic drug companies in 95 countries and regions, and the authorization fee is exempted.


It is worth noting that five Chinese pharmaceutical companies, including Fosun Pharma, also obtained generic rights in this collective signing. However, since China is not on the list of low-and-middle-income countries, the generic drugs produced by these pharmaceutical companies cannot be listed in China.


Like Pfizer, on October 27, 2021, Merck also announced that it agreed to authorize the COVID-19 oral drug Molnupiravir to the "Drug Patent Pool", which will provide generic rights for pharmaceutical companies in low- and middle-income countries. At least two Indian pharmaceutical companies currently manufacture generic versions of Monuprevir.


India, Generic Drug Giant


India's generic drug exports accounted for 20% to 22% of the world's total. At the same time, India also meets 60% of the world's vaccine needs.


India's top five pharmaceutical export countries are the United States, the United Kingdom, South Africa, Russia, and Nigeria.


According to the "India 2021-2022 Economic Survey" issued by the Ministry of Finance of India, during the period 2020-2021, the total export of pharmaceuticals will be 24.4 billion US dollars, and the total import will be 7 billion US dollars, which is far greater than the import.


It's not just COVID-19 generics; India is already the world's largest exporter of generic drugs. India is often called the "pharmacy of the world" for its low-cost, high-quality medicines. India's generic drug exports accounted for 20% to 22% of the world's total. At the same time, India also meets 60% of the world's vaccine needs.


Large Indian pharmaceutical companies have attached great importance to the international market since their establishment. The company's management system and quality system have been established with reference to European and American standards, and a complete operation audit system has been provided. Obtaining certification from the US FDA and the European Medicines Agency is easier.


However, India has traditionally exported drugs to China on a small scale. According to the latest annual report of the Pharmaceuticals Export Promotion Council of India, India's pharmaceutical exports to China will only account for 1.4% of its overall exports in the fiscal year 2021-2022, and the United States is still the largest exporter of Indian pharmaceuticals.


 

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