by Manushvi Chadha, BPharm, RA Cert
Regulatory Affairs Associate, dicentra

The past year had the NHPD re-evaluate their strategy for enzyme and probiotic-containing products, which had been on hold for years. With the exception of compendial applications, the assessment of all other submissions containing enzymes and probiotics were suspended by the directorate, though they continued to receive submission numbers.

However, in mid September, mass Information Request Notices (IRNs) and Section 16 Notices were received by industry. Essentially, the notices asked to either reformulate or revise the presentation of the product to match the new standards for enzymes and probiotics, or provide evidence for doing otherwise.

“New standards” included a revised monograph for Probiotics, revised abbreviated labelling standard (AbLS) for Live Microorganisms and new AbLSs for the following enzymes:

Alpha – Amylase
Bromelain, Fruit
Bromelain, Stem
Cellulase
Chymotrypsin
alpha-Galactosidase
Lipase
Pancreatic Enzymes
Papain
Protease, Fungal
Trypsin

After months of waiting for NHPD’s revised standards, these changes did catch the industry off guard because some of the changes that came about were unexpected.

Major issues that left the industry grappling were 1) the fact that the term ‘probiotic’ was applicable to only a few select strains, 2) claims for many products were cut down, and 3) that previously issued NPNs were called into question, essentially tainting the standard of all licenced products.

Industry felt that after considerable time and effort spent on educating consumers on the benefits of probiotics, they were now being barred from using this term on their products and instead must label and advertise as “Live Microorganisms”. The claims available for a majority of products previously identified as “Probiotics” (now “Live microorganisms”) were substantially cut down, while many enzyme AbLS’ do not list set uses, but require submission of evidence to get any type of claim. All products attesting to an AbLS now required submission of an FPS.

After considerable backlash from stakeholders, the NHPD substantially extended the due date for the responses to give companies some time to reformulate / comply. However, the deadline for these notices is almost up now, and all enzyme products will soon officially be off-hold.

For consumers though, this may be considered a good thing. Many deficient submissions and products will have been identified in this exercise, and weeded out, or updated to current standards, which means better products.

As the time frame for the expiry of UPLAR is fast approaching (February 2013), it appears that the NHPD is trying to clear their backlog as fast as they can. The enzymes represent a significant portion of the backlog, and these notices may have helped clear the NHPD’s files and also provided a standard for all future enzyme products.

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