homehealthcare NewsGovt set to modify solatium clause in clinical trials; Sun Pharma, Biocon likely to benefit: report

Govt set to modify solatium clause in clinical trials; Sun Pharma, Biocon likely to benefit: report

In a major relief to pharmaceutical companies, the government has decided to do away with a clause in the draft clinical trial rules that binds the entity initiating trial to pay 60 percent of the compensation upfront in case of death or permanent physical disability of the patient, Mint reported.

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By CNBC-TV18 Jan 11, 2019 8:58:58 AM IST (Published)

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Govt set to modify solatium clause in clinical trials; Sun Pharma, Biocon likely to benefit: report
In a major relief to pharmaceutical companies, the government has decided to do away with a clause in the draft clinical trial rules that binds the entity initiating trial to pay 60 percent of the compensation upfront in case of death or permanent physical disability of the patient, Mint reported.

However, the companies must adhere to a timeline and cannot take forever to pay the compensation, the report said citing a person privy to the discussions.
The earlier proposal made by the Union health ministry included a mandate to pay 60 percent of the compensation within 15 days if a person dies or suffers a permanent disability, said the report.
According to India’s drugs regulatory authority Central Drugs Standard Control Organisation (CDSCO), major pharmaceutical companies conducting medical trials in India include global giants such as Novartis, Pfizer, Merck KGaA, and AstraZeneca, as well as Indian drug firms such as Torrent Pharmaceuticals Ltd, Sun Pharmaceuticals Industries Ltd, and Biocon Ltd, said the report.
 
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