The Union Ministry of Health and Family Welfare has proposed amending Rule 43A of the Drugs Rules, 1945, to expand the network of authorised entry points for the import of drugs, medical devices and cosmetics into India.
The proposed amendment aims to streamline import operations, improve logistics efficiency and strengthen the supply chain for healthcare products by adding new Inland Container Depots (ICDs), a Special Economic Zone (SEZ) and an international airport to the list of authorised import locations.
Rule 43A specifies the authorised ports, airports, railway stations, road crossings and other entry points through which drugs may be imported into the country.
Under the draft amendment, the Ministry has proposed adding the following locations to the existing network:
- Haryana: ICD Sonipat, Piyala and Harsaru
- Uttar Pradesh: ICD Dadri and Noida International Airport, for the import of drugs by air.
- Gujarat: ICD Gandhidham/Mundra
- Telangana: ICD Sanath Nagar and Thimmapur in Hyderabad
- Karnataka: ICD Whitefield, Bengaluru, and SEZ Bommasandra
These locations would supplement the existing authorised import gateways, which include ICDs at Dhannad and Tihi in Indore, Madhya Pradesh, and the airports already notified for drug imports.
The proposed expansion is expected to enable importers to clear consignments closer to manufacturing facilities, warehouses and distribution centres. This could reduce inland transportation distances, optimise logistics costs and minimise delays in the movement of imported consignments.
The measure is also expected to improve operational convenience for importers and ease movement of medicines, medical devices and cosmetics across different regions of the country.
Through the proposed amendment, the Ministry seeks to strengthen import infrastructure, promote ease of doing business and support a more efficient and responsive healthcare supply chain, thereby facilitating timely availability of essential healthcare products.
Stakeholders invited to submit comments
The Ministry has invited objections and suggestions on the draft amendment. Submissions may be sent to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall, C Wing, First Floor, Kartavya Bhawan-1, New Delhi – 110001, or by email to drugsdiv-mohfw[at]gov[dot]in.
The draft notification proposing amendments to the Drugs Rules, 1945, is available through the Official Gazette.
