Repurposing Drugs During the COVID-19 Pandemic and Beyond

Ravi, Srividya; Jadhav, Sammita; Vaidya, Anuradha

doi:10.4155/ppa-2020-0031

Cited by 1 publication

(1 citation statement)

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“…The issue of infringement has been addressed by proposing an overt or covert feature in the label of a repurposed product enabling an immediate recognition of a repurposed product by a physician and a dispensing pharmacist. 29 Considering the substantial and numerous advantages repositioned molecules possess, it is evident that a strong protection mechanism and a method to detect infringement without ambiguity would benefit all the relevant stake holders in the system such as the academia, research institutions, pharmaceutical industry, regulatory authorities and most critically the patients. Solutions proposed through various mechanisms should be subject to periodic review to assure the fulfilment of objectives envisaged.…”

Section: How Can a Repurposing Programme Benefit India?mentioning

confidence: 99%

“Drug Repurposing” Policies and Statutes: Lessons from the COVID-19 Pandemic: A Review

Ravi¹,

Jadhav²

2023

Ind. J. Pharm. Edu. Res

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Introduction: Repurposed drugs are not eligible for patent protection in India vide Sec 3 (d) of the Indian Patent Act, 1970. The data generated to establish the therapeutic efficacy of the repurposed drugs for the new indication are not eligible for data exclusivity under the provisions of the Drugs and Cosmetic Act, 1940. However, repurposed drugs possess immense advantages, especially when compared to the traditional route of drug discovery. Marketing repurposed drugs is fraught with challenges, and means to overcome them need to be facilitated. Methodology: A review of literature regarding provisions available to protect repurposed candidates through various routes globally were studied including policies, special committee reports as well as case laws. Results: A brief tenure of data exclusivity for repurposed candidates as provided in statutes in the US and EU appears to be an attractive route of protection of such inventions. This will encourage and incentivize drug research by this route and eventually lead to a fulfillment of India being a preferred destination for not only pharma manufacturing, but also research.

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Section: How Can a Repurposing Programme Benefit India?mentioning

confidence: 99%