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With USFDA approval for generic Indian drugs, Indian pharma companies can now strengthen their presence in the US market

The COVID-19 has come as a blessing in disguise for Indian pharma companies that were earlier prohibited from entering US markets due to the stringent protective stance of US Food and Drug Administration.

With USFDA approval for generic Indian drugs, Indian pharma companies can now strengthen their presence in the US market

Kathir WebdeskBy : Kathir Webdesk

  |  11 April 2020 5:14 AM GMT

In a noteworthy sequence of events, the United States Food and Drug Administration (USFDA) has given the nod to Indian pharmaceutical companies to market their generic versions of essential and life-saving drugs in the United States of America. This comes after India's decision to ease export restrictions on hydroxychloroquine to the US. Hydroxychloroquine is an antimalarial drug which, in combination with the antibiotic azithromycin, has shown some efficacy in treating the COVID-19 disease.

Cipla, a leading drug manufacturer in the respiratory-illness segment, said that it had received final approval from the USFDA for its product – Albuterol Sulfate inhalation aerosol – on Thursday. The product is the generic version of Merck Sharp & Dohme Corp's Proventil HFA inhalation aerosol and is used in the treatment of bronchospasm and prevention of asthmatic symptoms. In a statement, Cipla said that it plans on shipping the product to the US in a staggered manner.

Lupin too has a filing for Albuterol pending with the US health regulator, and it is expected that the USFDA might prioritise the approval.

Granules India said, also on Thursday, that its foreign subsidiary had received approval from the USFDA for Butalbital, Acetaminophen and Caffeine capsules used to treat tension headaches. Granules India's products are the bioequivalents of Butalbital, Acetaminophen and Caffeine capsules of Nexgen Pharma.

Zydus Cadila on Thursday said in a statement that it had received final approval from the US regulatory body to market generic Perphenazine tablets, used in the treatment of schizophrenia, and in controlling severe nausea and vomiting in adults. On Friday, the firm got a tentative approval from the USFDA to market generic Empagliflozin tablets, used along with diet and exercise in controlling Type-2 Diabetes Mellitus and reducing the risk of cardiovascular death among adults. The pharma major is also a manufacturer of hydroxychloroquine.

Aurobindo Pharma also received an approval from the USFDA on Thursday to market Fluoxetine tablets in the US, which are generic versions of Eli Lilly's Prozac tablets. This anti-depressant medication is also used in the treatment of binge-eating and vomiting behaviours in adult patients with bulimia nervosa and obsessive-compulsive disorder (OCD) among pediatric patients.

US pharma sector dependent on China

The US pharmaceutical industry relies heavily on Chinese suppliers and manufacturers, and there were concerns that in the wake of the pandemic, China might seek to weaponize its dominance in the pharma supply chain.

Indian drug manufacturers now have a unique opportunity to become premier pharmaceutical suppliers to the US, the European Union and other nations. Will China's chokehold over the world's pharma sector be loosened? Will India play a part in this? Only Time will tell.

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