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- The Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulatory authority, has instructed all states and Union Territories to halt the production, sale, and distribution of 35 unapproved Fixed-Dose Combination (FDC) drugs. This directive follows violations of the New Drugs and Clinical Trials (NDCT) Rules, 2019, outlined under the Drugs & Cosmetics Act, 1940.
- FDC drugs consist of two or more active ingredients combined for a specific therapeutic purpose. The active ingredient is the component that provides the intended medical effect. FDCs are categorized into four broad types and are treated as new drugs under the NDCT Rules when they combine previously approved drugs in a fixed ratio or modify existing combinations with claim changes.
- FDCs are often favored for their improved therapeutic outcomes due to synergistic effects, better patient compliance by reducing the number of pills, and cost-effective treatment by combining medications into a single formulation.
- India’s trade deficit with China has widened in the fiscal year 2024-25, mainly due to a surge in imports of electronic goods like EV batteries and solar cells, as well as consumer durables. In contrast, India’s exports to China declined to $14.3 billion during the same period.
- This growing imbalance raises several concerns. Cheap Chinese imports threaten India’s domestic manufacturing, especially in sectors like steel, chemicals, and electronics. The increasing reliance on Chinese goods also poses strategic risks, potentially compromising national security and supply chain resilience. There's concern that China could exploit this dependence during border tensions or emergencies. Additionally, India might become a channel for Chinese goods to enter the U.S. market, affecting India–U.S. trade relations. Dumping of cheap goods and foreign exchange outflow are further risks.
- To address this, India has introduced initiatives like the PLI scheme, Bulk Drug Parks, RoSCTL, Interest Equalization Scheme, and trade remedies like anti-dumping duties to strengthen local manufacturing and reduce dependency.
- The Minister emphasized that the India-Middle East-Europe Economic Corridor (IMEC) is set to significantly lower logistics costs by up to 30% and cut transportation time by 40%, creating efficient trade linkages across continents. To ensure effective implementation, he proposed inclusive collaboration involving industry, academia, and think tanks, along with innovative financing mechanisms like long-term IMEC Bonds.
- IMEC is a multi-modal connectivity initiative formalized through a Memorandum of Understanding during the G20 Summit 2023 in New Delhi. It involves India, the EU, France, Germany, Italy, Saudi Arabia, UAE, and the US. The corridor aims to develop key infrastructure—ports, railways, roads, sea routes, and pipelines—to boost trade between India, the Arabian Peninsula, and Europe.
- Strategically, IMEC offers an alternative to critical sea routes like the Suez Canal, enhancing global trade resilience. Economically, it strengthens ties between India, the Middle East, and Europe, while also serving as a counterweight to China’s Belt and Road Initiative.