Several civil society organisations claimed that Johnson & Johnson's move of giving donations for the National Tuberculosis Control Program is aimed at inducing leniency from the government in a probe initiated against its products.
They have urged Union Health Minister J P Nadda to discontinue receiving donations from the company.
In a letter to Nadda, the organisations and patient groups stated that such ad-hoc donations threaten the sustainability and predictability of the government's MDR-TB treatment programme.
Recently, Johnson & Johnson had announced to provide an additional 10,000 courses of tuberculosis drug bedaquiline (BDQ) to the Indian government.
The pharmaceutical company had previously donated 10,000 courses of BDQ to India's TB programme in 2016, as part of a global donation programme operated in partnership with the US Agency for International Development (USAID).
"The announcement of the new donation comes a full three years later in the backdrop of multiple regulatory actions and investigations by the Union Health Ministry into harmful medical devices and cosmetic products marketed by J&J in India," the letter stated.
According to the civil society organisations, the donations of BDQ to India not only create dependence on donations from a single supplier but also stifle the government's willingness to promote local production of BDQ by generic manufacturers.
"It is therefore extremely disappointing to see the government's continued reliance on donations from J&J for MDR-TB treatment. This is an unsustainable approach to running India's TB programme that is meant to serve and treat the world's highest burden of TB and MDR-TB cases. This is also antithetical to the government's goal to eliminate TB in India by 2025," they said.
They said given the string of regulatory actions and investigations into J&J's products recently, the announcement of the BDQ drug donations has led to apprehensions that the donations are an attempt to "whitewash its image and induce leniency" by the government for the company's "transgressions", particularly "in relation to refusal to compensate Indian patients of ASR hip implants, which the government is pursuing actively both in and outside the courts".
The ministry had initiated a process to compensate the victims of faulty hip implants.
However, J&J approached the Delhi High Court against a Central Drugs Standard Control Organisation (CDSCO) order asking it to pay Rs 65 lakh and Rs 74 lakh to two of the victims of faulty Articular Surface Replacement (ASR) hip implants.
"Therefore, we urge the government to put in place clear guidelines in accepting donations from pharmaceutical companies, to safeguard against potential conflicts of interest that can undermine the role of the health ministry and any of its agencies/committees, to regulate companies and take actions necessary for protecting patient safety," the letter stated.
Some of the civil society organisations and patient groups include All India Drug Action Network (AIDAN), Delhi Harm Reduction and Advocacy Forum, Delhi Network of Positive People (DNP+), Social activist Francis Joseph, TB survivor and TB/HIV Activist Ganesh Acharya, Hip Implant Patients Support Group (HIPS) and Lawyers Collective among others.
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