New Delhi, June 26 (IANS). The Ministry of Health and Family Welfare is preparing important changes in the rules related to imported medicines. The Ministry has issued a draft of amendment to Rule 31 of the Drugs Rules, 1945 and has sought suggestions and objections from the general public and concerned parties. The objective of this proposal is to promote ‘Ease of Doing Business’ in the pharmaceutical sector and ensure availability of quality medicines to patients.
The draft, issued through a gazette notification on June 22, proposes to change the existing requirement of more than 60 per cent remaining shelf life for imported medicines. As per the new proposal, it will now be sufficient for the medicine to have a remaining shelf life of at least 12 months at the time of import.
Let us tell you that the shelf life of medicines is the time period during which a medicine remains safe and completely effective. This period starts from the date of manufacture of the medicine till the expiry date printed on it.
However, the Ministry has clarified that in the case of biological products and radiopharmaceuticals, the existing rules will remain applicable. That is, there will be no change in the requirement of more than 60 percent remaining shelf life at the time of import for these special category medicines. This is because of the special nature of these medicines and the public health requirements.
The ministry says that this amendment will make the pharmaceutical supply chain more effective. Imported medicines having at least 12 months of remaining validity at the time of arrival in the country will provide sufficient time for them to reach the market and be made available to patients. This will ensure that patients continue to receive quality medicines with usable shelf life.
The government believes that this change will also reduce unnecessary wastage of medicines, as the existing strict shelf life rules often result in losses in medicine storage and distribution. This will improve supply management, reduce costs and also strengthen the availability of essential medicines in the country.
The Health Ministry has also clarified that this proposal pertains only to the condition of remaining shelf life applicable at the time of import. All other rules related to the quality, safety and effectiveness of medicines will remain in force as before under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
The ministry has invited suggestions and objections on this draft from all stakeholders. Interested people can send their suggestions on the official e-mail within the stipulated period.
–IANS
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