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India asks states to cancel licences for unauthorised fixed dose combinations

 
• By Anju Ghangurde

India's health ministry is clamping down on the country's burgeoning and increasingly confusing market for fixed dose combination drugs, limiting the tendency for manufacturers to formulate approved drugs in seemingly irrational combinations. The ministry is making it clear that the Drugs Controller General of India must have approved as 'new drugs' not only the components of combinations but also the combinations themselves.

India's health ministry is clamping down on the country's burgeoning and increasingly confusing market for fixed dose combination drugs, limiting the tendency for manufacturers to formulate approved drugs in seemingly irrational combinations. The ministry is making it clear that the Drugs Controller General of India must have approved as 'new drugs' not only the components of combinations but also the combinations themselves.

There have been several instances of state drug authorities issuing licences for new drugs including FDCs without the prior approval of the Drugs Controller according to a Parliamentary Committee report earlier this year

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OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 
• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Enzene Sees Tariff Exemptions For India, Front-Ends US Capacity

 
• By Vibha Ravi

Enzene's CEO Himanshu Gadgil anticipates exemptions for Indian products from US tariffs expected to be imposed on pharmaceuticals. In an interview ahead of the US Vice Premier's India visit, he also talks about front-loading capacity at Enzene's US plant and a change in its biosimilars strategy

More from Focus On Asia

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

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.

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

 
• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.