New Delhi: Even as the central government has initiated several efforts to reduce dependence on imports of active pharmaceutical ingredients (APIs) and drug intermediates from the neighbouring country, imports of bulk drugs and intermediates from China out of the overall imports has registered a growth in the last five years, according to official data.
The country has registered a growth of 4.12 per cent in overall imports of bulk drugs and intermediates at Rs. 37,721.88 crore during the fiscal year 2023-24, as compared to Rs. 36,229.15 crore during the previous fiscal year.
Imports from China stood at Rs. 27,055.22 crore during 2023-24, as compared to Rs. 25,550.91 crore during the previous fiscal year, with a growth of 5.89 per cent, according to data from Directorate General of Commercial Intelligence and Statistics (DGCI&S).
Import from China was almost 71.72 per cent of the overall bulk drug imports during the fiscal year. The share of China in India’s overall bulk drugs and intermediates import over the last five years has seen a growth from 68.02 per cent in 2019-20 to 71.72 per cent now, shows data from DCGIS and Department of Pharmaceuticals (DoP).
In terms of quantity, the share has increased from 60.61 per cent in 2019-20 to 76 per cent in 2023-24. India imported almost 3,44,053.2 MT out of the total 4,51,894.3 MT of overall pharma raw material imports, from China, in the year 2023-24.
The overall growth of imports in value terms during the five years ended 2023-24 was 56.1 per cent, from Rs. 24,171.78 crore in 2019-20. Imports from China, during the same period registered growth of 64.5 per cent, from Rs. 16,443.1 crore in 2019-20.
In the last five years, the imports of bulk drugs and intermediates to India, in terms of value went up during the two fiscal years 2020-21 and 2021-22, owing to the Covid-19 pandemic and the increase in overall costs. Overall bulk drug imports in terms of value grew 18.02 per cent and 23.55 per cent during 202-21 and 2021-22, respectively. While it came down to 2.78 per cent in 2022-23, this was on a higher base in the previous year.
Import from China, however, has been witnessing a decline in growth momentum in terms of value, after registering a 19.95 per cent growth in 2021-22, to 9.79 per cent growth in 2022-23 and to 5.89 per cent in 2023-24, shows the data.
The centre has been adapting various measures to make the country self-sustaining in APIs and drug intermediates, with schemes and support spearheaded by the DoP. This include the production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs) and active pharmaceutical ingredients (APIs) in India, with a financial outlay of Rs. 6,940 crore and the tenure from FY 2020-2021 to FY 2029-30, financial incentive is given for manufacturing of 41 identified products. A total of 48 applications have been selected under the scheme.
Production linked incentive scheme for Pharmaceuticals, with a financial outlay Rs. 15,000 crore and the tenure from FY 2020- 2021 to FY 2028-29, provides for financial incentive to 55 selected applicants for manufacturing of identified products under three categories for a period of six years. The product category two covers the APIs/KSMs/DIs except for the 41 eligible products already covered under the “Production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs)/active pharmaceutical ingredients (APIs) in India”.
The Scheme for Promotion of Bulk Drug Parks, with a financial outlay of Rs. 3,000 crore and the tenure from FY 2020-2021 to FY 2024-25, provides for financial assistance to three States for establishing Bulk Drug Parks. The Department had received proposals from 13 States. After evaluation of the proposals as per prescribed criteria, the approval to the proposal of setting up Bulk Drug Parks in the states of Andhra Pradesh, Gujarat and Himachal Pradesh were issued and these projects are in progress, according to the DoP.
The DoP in December, 2023, said that so far as regulatory measures are concerned, the ministry of health and family welfare and the Central Drugs Standard Control Organisation has taken various steps to encourage indigenous manufacturing of drugs, including amendment in the Drugs Rules,1945 on October 27, 2017 providing that drugs manufacturing license, sale license and approval of drug testing laboratory shall remain valid, if licensee deposits a license retention fee as prescribed, before the expiry of a period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority. The Drugs Rules, 1945 were amended through a notification in the year 2018 wherein application fees were increased for grant of import Registration Certificate as well as fees for overseas inspection, it said.
