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India’s drug regulator has put on hold the opening of an office in China to inspect the quality of manufacturing units that supply the bulk of active pharmaceutical ingredients (APIs) required by Indian pharma firms.
The Central Drug Standard Control Organization (CDSCO) took the decision because of the lack of experienced staff, two officials familiar with the development said.
Besides, opening a dedicated office in China could negate plans by Indian drugmakers to ramp up domestic bulk drug manufacturing capabilities, the officials said on condition of anonymity.
APIs are the central, chemically active ingredients that produce the intended therapeutic effect on a patient.
With burgeoning growth in drug ingredients and intermediates being imported from China, which stood at Rs13,853 crore in 2015-16, CDSCO proposed to set up a permanent quality inspection office in Beijing three years ago. The proposal, however, has seen various impediments.
“The country’s central drug regulator domestically needs more competent drug inspectors and that takes time and effort. This lack of manpower is a major concern, so the plan for a dedicated office in China to check bulk-drug quality is on the back-burner for now,” said a senior health ministry official, one of the two cited in the first instance.
“Bulk-drug manufacturing capacities in China are heavily subsidized through the Chinese government’s policies while India has no such policy in place to subsidize API-manufacturing. So, even if India wants to increase domestic API capacity, the drug manufacturing costs would go up making it a financially uninviting proposal. However, we may have to come up with alternative arrangements,” said an official in the country’s drug regulatory body.
India’s reliance on China has reached such an extent that the National Security Advisor recently warned the government against over-dependence on the neighbouring country in the supply of essential drugs and APIs.
The country’s API imports from China stood at Rs12,757.96 crore in 2014-15 and Rs 12,061.53 crore in 2013-14, according to official figures.
The central government had declared 2015 as the “Year of API” to make India self-sufficient in bulk drugs and turn the country into a major manufacturer of bulk drugs. However, there has been little headway in this direction.