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Last Updated : May 02, 2019 10:41 PM IST | Source:

Donation of TB drug bedaquiline based on Indian govt's request to USAID: J&J

The specific India donation from J&J sparked questions from public health groups and activists about the timing and intent of J&J.

Viswanath Pilla @viswanath_pilla

Johnson & Johnson (J&J) said its decision to donate 10,000 courses of multi drug-resistant tuberculosis (MDR-TB) medicine bedaquiline free of cost to India was based on the Indian government’s request before the United States Agency for International Development (USAID).

“Johnson & Johnson did not solicit direct requests from governments as part of the bedaquiline donation program,” the company said in a statement.

“The Indian government independently approached USAID, which administered the donation program, to request an additional 10,000 courses of bedaquiline, bringing the total requested and agreed to 20,000,” the statement added.


Through its subsidiary Janssen, J&J had donated over 10,000 courses of bedaquiline in 2016 as part of a global donation programme, operated in partnership with the US Agency for International Development (USAID), which ended in March 2019.

J&J also refuted the allegations linking its donation with the patent opposition, and said that it is committed to ensure the drug reaches as many patients as possible.
 "The patent application in question – for the formulation of bedaquiline – was filed in 2007, and became publicly available in 2008, as part of standard procedures when developing new medicines," the company said.

"The application was first considered by the Indian Patent Office in 2012 and remains under review. A formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023," it added.

The specific donation to India from J&J sparked questions from public health groups and activists about the timing and intent of J&J.

The health groups have pointed out that the donation came from J&J came at a time when two tuberculosis survivors had opposed a secondary patent application filed in India by Janssen, on grounds that it could block generic versions of bedaquiline until 2027.

The donation also coincides with multiple controversies that raised questions over the safety of the products sold by the company in India.

A section of healthcare groups have alleged that the donations are aimed at undermining strict regulatory action by the Ministry of Health and Family Welfare (MOHFW) and extracting concessions or leniency from the government.

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First Published on May 2, 2019 08:30 pm
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