Selling drugs is not within the remit of the Food and Drug Organization

The head of the Raw Materials Department at the Food and Drug Organization said: Assessing investment levels, profitability, the sales market, and return on investment is the responsibility of the producer and investor, and is not within the Food and Drug Organization's remit.

The head of the Department of Raw Materials of the Food and Drug Organization said: Investigating the amount of investment, profitability, sales market and return on investment is the responsibility of the producer and investor, and is not the responsibility of the Food and Drug Organization.

According to Ambassador Arjan's report, quoted by Ifdana, Mehrdad Alami stated: The evaluation of pharmaceutical raw materials production plans is done based on technical and qualitative requirements, regulatory standards and strategic needs of the country, and the profitability and return on investment is the responsibility of the producer and investor.

He added: The Food and Drug Organization follows two main axes in the evaluation of medicinal raw materials, including the review of technical and quality requirements and the compliance of cases with regulatory standards and criteria, as well as the review of the country's therapeutic and strategic needs.

Alami continued: The ability of the producer, compliance with GMP principles, compliance of the technical file and the documentation provided with the regulations are among the indicators that are taken into consideration in the evaluation process of the Food and Drug Organization.

He added: In addition to the technical and quality requirements, the amount of consumption, the actual need of the country, the risk of shortage and the presence of the relevant drug in the list of essential and vital items are also important in decisions related to the production capacity and supply of raw materials.

The head of the Department of Raw Materials of the Food and Drug Organization stated: Investigating the amount of investment, profitability, sales market, business model, and return on investment is the responsibility of the producer and investor, and it is not the responsibility of the Food and Drug Organization.

He pointed out that the information related to the consumption volume and the actual need of the country is taken into account in the review of the capacity of the supply chain in order to avoid unrealistic estimates and the prediction of the production capacity exceeding the country's needs.