India’s Rising Pharma Import Concerns: A Closer Look at API and KSM Dependency
In recent years, India’s dependence on other countries, particularly China, for Active Pharmaceutical Ingredients (API) and Key Starting Materials (KSM) has raised eyebrows, leading to concerns about the nation’s self-sufficiency in the pharmaceutical sector. According to data released by the Ministry of Chemicals and Fertilizers to the Parliament, the import of bulk drug and drug intermediates, notably from China, witnessed a significant surge in the financial year 2022-23.
The numbers are striking, with imports from China alone escalating from 264,582 metric tons, valued at ₹23,273 crore in 2021-22, to a staggering 300,120 metric tons, amounting to ₹25,551 crore in 2022-23. This alarming increase has triggered questions and discussions among Members of Parliament, highlighting the need for strategic measures to address India’s growing reliance on foreign nations for essential pharmaceutical components.
Importance of API
API, or Active Pharmaceutical Ingredient, is a crucial component in drug manufacturing. It is the biologically active part of a drug, responsible for its therapeutic effects. KSM, or Key Starting Material, is the primary raw material used in the synthesis of APIs. India’s reliance on imports for these essential components stems from economic considerations, as articulated by the Minister of State for Chemicals and Fertilizers in response to parliamentary inquiries.
Factors behind the big statistics of Imports
The Minister acknowledged that a substantial portion of these imports is due to economic considerations. Furthermore, China’s status as one of the world’s largest producers of KSM and APIs contributes significantly to India’s sourcing strategy. While economic considerations are imperative, the heightened dependence on a single country for such critical pharmaceutical components raises concerns about the stability and security of the pharmaceutical supply chain.
In response to parliamentary inquiries, the Ministry of Chemicals and Fertilizers emphasized that India has also been an exporter of bulk drugs and drug intermediates, amounting to ₹37,853 crore in the fiscal year 2022-23. This signals a complex scenario where India is both a significant importer and exporter in the global pharmaceutical landscape.
Measures taken by govt. to curb rising imports
To address the concerns surrounding import dependency, the government has taken several measures to boost indigenous manufacturing of bulk drugs and APIs. One such initiative is the “Scheme for Promotion of Bulk Drug Parks,” which has a financial outlay of ₹3,000 crores and spans from FY 2020-2021 to FY 2024-25. The scheme aims to provide financial assistance to three states—Andhra Pradesh, Gujarat, and Himachal Pradesh—for establishing Bulk Drug Parks.
The Ministry outlined that it had received proposals from 13 states, and after careful evaluation based on prescribed criteria, approval was granted for setting up Bulk Drug Parks in the aforementioned states. This move aligns with the government’s broader vision to reduce dependence on imports and strengthen the domestic pharmaceutical manufacturing ecosystem.
In addition to these initiatives, the Health Ministry has also been actively encouraging indigenous manufacturing of drugs. These efforts are essential not only for achieving self-sufficiency but also for ensuring the availability of critical medicines during unforeseen global disruptions or crises, as witnessed during the COVID-19 pandemic.
Steps that govt can taken for this medical-cum-geopolitical issue
While these measures are steps in the right direction, the challenge remains multifaceted. The government needs to continue fostering an environment conducive to pharmaceutical innovation, research, and development. This includes providing incentives for research and development in the pharmaceutical sector, supporting smaller pharmaceutical companies, and streamlining regulatory processes to facilitate faster approval for new drugs and manufacturing facilities.
In conclusion, India’s escalating reliance on Chinese imports for Active Pharmaceutical Ingredients and Key Starting Materials underscores the need for a comprehensive and sustainable strategy to ensure the country’s pharmaceutical self-sufficiency. Government initiatives, such as the Bulk Drug Parks scheme, are pivotal in this regard, but a holistic approach involving industry collaboration, research and development incentives, and a resilient regulatory framework is crucial to secure India’s position in the global pharmaceutical landscape.
