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India’s Draft Plan To End API Reliance On China ‘Needs Work’

 
• By Penelope MacRae

India has come up with a draft policy proposal to end the dependence of the country’s generic drug industry on Chinese bulk drug imports but it’s sketchy on measures, at least so far, to promote domestic production and “needs work.”

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INDIA AIMS TO LOWER ITS DEPENDENCE ON CHINESE APIs

Back in January 2016, the government set a 2020 deadline to end the country's heavy dependence on neighboring China for raw materials to make medicines, especially key antibiotics and painkillers, and it announced ambitious plans to ramp up production of bulk drugs.

Since then, though, India’s progress toward achieving self-reliance has been minimal and chances of meeting the 2020 target look increasingly elusive. Now, the government of Prime Minister Narendra Modi has...

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Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

More from Asia

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
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India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.