New Delhi, June 26 (IANS). The Central Government has proposed to relax the rules regarding the remaining shelf life for imported medicines. Under this, it has been proposed to change the existing rule, in which more than 60 percent of the total shelf life of the medicine is required at the time of import, to a minimum shelf life of 12 months. The government believes that this will make the drug supply chain more effective and make it easier to do business in the pharmaceutical sector.
The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification to amend Rule 31 of the Drugs Rules, 1945 and has invited suggestions and comments on the proposal from all concerned.
Under the proposed amendment, drugs imported into India will be required to have a remaining shelf life of at least 12 months at the time of import, compared to the current requirement of having more than 60 per cent of their total shelf life remaining.
However, the Government proposes to retain the existing rules for biological products and radiopharmaceutical drugs, as these are used in special circumstances and are considered to be of critical public health importance.
According to the ministry, the change aims to make import rules more practical, while also ensuring that patients continue to receive medicines with adequate shelf life.
The government says the minimum shelf life of 12 months will provide adequate time for distribution and utilization of medicines, making the medicine supply system more efficient and supply chain operations better.
The Ministry believes that the proposed amendment will reduce unnecessary wastage of medicines due to strict shelf life norms. Additionally, there will be better inventory management, reduced supply chain costs and strengthened availability of essential medicines across the country.
Additionally, the Government has clarified that this proposal pertains only to the condition of remaining shelf life applicable at the time of import. All other rules related to quality, safety and effectiveness of medicines under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 will remain in force as before.
–IANS
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