Innovative drug R&D in India and China

India is the third largest producer of high quality generic drugs in the world, far ahead of china. However, innovative drug R&D in India doesn’t look so good. Here are two papers[1, 2] on drug discovery in India.

In order to comply with the requirements of TRIPS Agreement, India introduced a new patent law in 2005, which granted full patent protection to drugs. China enacted a similar amendment in 1993, a little earlier than India. For previous decades, patent laws were not established or protected only the production process.

The CFDA has approved several new chemical entities (NCEs) since 2009, including antofloxacin, imrecoxib, icotinib, allisartan isoproxil, dicycloplatin, hemporfin, conbercept and morinidazole. Most of domestically developed NCEs are me-too drugs, structurally similar to already known drugs.

In April 2012, Ranbaxy launched Synriam (arterolane maleate/piperaquine phosphate) for the treatment of Plasmodium falciparum malaria. That is the first domestically developed drug of India.

Later, Fulyzaq (crofelemer), co-developed by Glenmark Pharmaceuticals (licensed from Napo Pharmaceuticals) and Salix Pharmaceuticals, was approved by the FDA in December 2012 for the treatment of diarrhea associated with anti-HIV drugs. Crofelemer is a purified oligomeric proanthocyanidin isolated from the latex of the South American tree Croton lechleri.

In June 2013, Zydus Cadila launched Lipaglyn (saroglitazar), the first drug discovered and developed by an Indian pharmaceutical company. This drug is the first dual PPARα/γ agonist (known as glitazars) in the world to be approved for the treatment of dyslipidemia or hypertriglyceridemia in patients with type 2 diabetes.

India and China are standing on the starting line of innovative drug R&D; however, it is not unreasonable to speculate that they will be the emerging forces in the future.

[1] ChemMedChem. 2014, 9(1), 43-60.

[2] ACS Med Chem Lett. 2014, 5(7), 724-726.

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