The Union Ministry of Health and Family Welfare has proposed relaxing the shelf life requirement for imported medicines by replacing the existing rule of remaining shelf life of more than 60% with a minimum remaining shelf life of 12 months at the time of import.
The draft amendment to Rule 31 of the Drugs Rules, 1945, which aims to rationalize remaining shelf life requirements for imported medicines and further enhance ease of doing business in the pharmaceutical sector in the country, was published on June 22 for public consultation.
Currently, under the Drugs and Cosmetics Rules, 1945, a drug can be imported or distributed in India only if it has more than 60% of its usable shelf life remaining.
According to the Ministry of Health statement, the draft amendment proposes to review the current requirement of a minimum remaining shelf life of more than 60% for imported medicines to a minimum remaining shelf life of 12 months at the time of import.
However, due to their specialized nature and public health considerations, current requirements for a minimum remaining shelf life of more than 60% should continue to apply to biological products and radiopharmaceuticals, the notification said.
The changes were proposed after detailed consultations with the Medicines Technical Advisory Board.
The proposed amendment, according to the Ministry of Health, seeks to facilitate increased efficiency in the pharmaceutical supply chain while maintaining the availability of high-quality medicines for patients. By ensuring that imported medicines have a shelf life of at least 12 months upon entry into the country, the proposal provides sufficient time for distribution and consumption before expiration, thus ensuring that patients continue to receive medicines with a sufficient usable shelf life.
The amendment is also expected to improve the utilization of pharmaceutical stocks across the supply chain by reducing avoidable pharmaceutical waste arising from remaining restrictive shelf life requirements. This in turn is expected to improve supply management, reduce costs and enhance the availability of essential medicines in the country, according to the Ministry of Health statement.
The Ministry explained that the proposed amendment relates only to the remaining shelf life requirements applied when importing medicines. The proposal does not change any other regulatory requirements relating to the quality, safety or effectiveness of medicines under the Drugs and Cosmetics Act 1940 and the Drugs Rules 1945.
The Ministry has placed the draft notification in the public domain to receive objections and suggestions from all stakeholders, after which the final draft will be published in the Official Gazette.
“…it is hereby published for the information of all persons likely to be affected thereby and notice is hereby given that the said Draft Rules shall be taken into account on or after the expiration of a period of thirty days from the date on which copies of the Gazette of India containing such Draft Rules are made available to the public…” read the notification.
Those interested should submit their comments to the Undersecretary (Drugs) via email at drugdiv-mohfw[at]government[dot]in.
