Maldives, India sign pact to boost drug regulation, cut costs
The Ministry noted that this agreement is expected to contribute to both regulatory efficiency and cost-effectiveness in the health sector.
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The governments of Maldives and India have signed an agreement on pharmacopoeia cooperation aimed at improving the quality and regulation of imported medicines, the Ministry of Health confirmed on Friday.
The agreement, signed between the Indian Pharmacopoeia Commission (IPC) and the Maldives Food and Drug Authority (MFDA), was one of eight trade-related memoranda signed during a ceremony at the President’s Office during the ongoing state visit of Indian Prime Minister Narendra Modi.
According to the Ministry of Health, the agreement marks a step in regulatory alignment between the two countries in the health sector. The Indian Pharmacopoeia will now be recognised as the official reference for setting standards for both imported and locally produced medicines in the Maldives.
“With this agreement, regulatory procedures will be streamlined, as Indian manufacturers’ certificates of analysis will be directly accepted by Maldivian authorities without the need for duplicate testing,” the ministry stated.
Under the agreement:
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Indian Pharmacopoeia Reference Standards (IPRS) and Impurity Standards will be used to conduct quality assurance analysis at controlled costs.
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It will support the development and availability of generic medicines in the Maldives.
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The availability of medicines that meet quality standards will be ensured.
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Regulatory processes will be simplified, potentially lowering the overall costs of drug imports.
The MFDA has previously restricted imports from certain pharmaceutical companies due to issues related to quality and toxicity. The authority has stated that improving the testing capacity of imported medicines is essential to preventing the entry of substandard drugs into the local market. According to the MFDA, proper testing of individual ingredients remains a key priority.
The Ministry noted that this agreement is expected to contribute to both regulatory efficiency and cost-effectiveness in the health sector.
