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Finally, Indian pharma companies are finding a way to enter the world’s second largest pharmaceutical market which is attractive and profitable market of China. Usually it takes 5 years to get n approval but the Indian drug regulators get the approval for the drug product within 3-6 months.
“They (the China Food and Drug Administration, or CFDA) are very clear about expediting entry of Indian generic pharmaceuticals,” said Dinesh Dua, Chairman of Pharmaceuticals Export Promotion Council (Pharmexcil) “They will follow the dossier whatever written in the Drug Master File (DMF), and if everything is found alright they will then expedite approval without ifs and buts,” Dua said.
Dua also said that Pharmexcil had meeting with the CFDA, Chinese Chamber of Commerce and other industrial bodies.Whereas soon a Delegation from CFDA will visit India for providing more clarification and educating us that what Chinese drug regulator expects. “The ground work has started, China is our top focus for exports,” Dua added.
