Product approval will block sec 22 product, says IDMA


Indian Drug Manufacturers’ Association (IDMA) has pointed out to the Food Safety and Standards Authority of India (FSSAI) that its recent posting on the website inviting legal firms to assist framing suitable regulations, seemingly for introducing product approval system, is frightening and any attempt to do so will unleash a second attempt to block section 22 products’ availability as per prevalent global practices.

In a letter to the FSSAI chairman Ashish Bahuguna, the IDMA President S V Veeramani said, “The incorrect interpretation of the act led to enforcing the food product approval system through advisories, which had no force of law and it is not a global practice in general. It is well considered understanding of IDMA that it would be equally unlawful and wasteful attempt if FSSAI makes a concerted effort to bring the product approval through regulations.”

IDMA has forwarded the copy of the letter to the Prime Minister Narendra Modi mentioning that the proposed attempts of the FSSAI are contrary to the provisions of FSS Act, national interest and ‘make in India’ drive of the government. FSSAI was obsessed with introducing retrograde product approval system come what may, making it a prestige issue, it said in a covering letter addressed to the Prime Minister seeking his intervention to stall any such move by rejecting permission to publish a notification of draft regulation that seeks to bring back the PA system in any form.

In the original letter, Veeramani has pointed out that under section 22 products prohibitions are not permanent and total but only for a certain period and there is every indication that the prohibition shall be continued by further orders if the reasons for imposing the prohibition are not done away with within that period. Thus if any action was required require to be done with respect to prohibition under section 22 it is for the FBO who is affected by the prohibitory order to provide a remedy to remove the cause for such a notification.

Veermani has further said by its circular dated August 31, the FSSAI has virtually declared its motive to explore all avenues possible to bring back the PA system through regulation. But, as per the IDMA’s understanding of FSS Act, he pointed out, any such attempt would be would be contrary to the provisions of the section 18(2)(a)(ii). He has suggested that FSSAI should convene a conference of all food industries registered with FSSAI and FBOs to explore what could be the best ways to ensure quality products and safety of food products.

The IDMA has said that the letter should be considered in the spirit of harmonisation with transparency and in consultative manner. Bringing again the system would highlight the negative intent towards industry development and growth.

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