New Delhi, 26 June (H.S.): The Central Government has proposed amendments to the rules governing the import of medicines into India. The Ministry of Health and Family Welfare has notified a draft amendment to the Drugs Rules, 1945, and invited suggestions and objections from the public and other stakeholders.

Under the proposed amendments, most imported medicines will now be allowed to enter the country if they have at least 12 months of shelf life remaining at the time of import. At present, the rules require imported medicines to have more than 60 per cent of their total shelf life remaining.

However, the existing requirement of a minimum 60 per cent remaining shelf life will continue to apply to biological medicines and radiopharmaceuticals, with no changes proposed for these categories.

According to a statement issued by the Ministry of Health and Family Welfare on Friday, the proposed amendment is aimed at improving the efficiency of the pharmaceutical supply chain. It is expected to reduce wastage of medicines, enable companies to manage inventories more effectively, lower costs, and improve the availability of essential medicines.

The Ministry clarified that the proposed amendment relates only to the remaining shelf life of medicines at the time of import. All existing standards and regulations concerning the quality, safety, and efficacy of medicines will continue to remain in force without any change.

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Hindusthan Samachar / Jun Sarkar