The Ministry of Health and Family Welfare has expanded the designated entry points for pharmaceutical consignments to 42 ports by enabling drug imports through the newly inaugurated Navi Mumbai Airport in Maharashtra. This move, made through an amendment to Rule 43A of the Drugs Rules, 1945, includes Navi Mumbai in the list of airports for drug importation, aiming to bolster the pharmaceutical supply chain and streamline trade processes.
According to a statement from the Ministry of Health and Family Welfare, this amendment, following consultation with the Drugs Technical Advisory Board under the Drugs and Cosmetics Act, 1940, is expected to enhance the movement of pharmaceutical consignments, reinforce logistics infrastructure, and offer importers more flexibility by introducing a new import option for medicines into India.
The initiative aligns with the government’s ongoing efforts to fortify the regulatory framework, enhance trade facilitation, and promote business ease while ensuring effective regulatory oversight of imported drugs. In June, the Union Ministry of Health and Family Welfare had proposed amendments to the Drugs Rules, 1945, simplifying the process for obtaining permission to import drugs for examination, test, or analysis, commonly referred to as through Form 11.
The proposed amendment introduces an acknowledgment-based system for importing all drugs in small quantities for analytical and non-clinical testing purposes. This change is anticipated to alleviate the compliance burden on applicants by removing licensing requirements for importing small quantities of drugs for testing or research and development purposes, fostering research, innovation, and business ease in the pharmaceutical sector, enabling swift testing or analysis initiation for start-ups and industries.
