Revising DT limit for Soft Gelatin Capsules: Pharma Industry seek solutions

May 17, 2023

The IPC has proposed a reduction of the DT from 60 minutes to 30 minutes for all product categories.

However, the industry highlights an important distinction between Indian regulations and the United State Pharmacopoeia (USP).

While the USP does not subject nutraceuticals, multivitamins, and health supplements to this test, they fall under the purview of the Food Safety and Standards Authority of India (FSSAI) in India and adhere to different standards.

The industry opposes these changes without a comprehensive assessment of their impact on the availability of essential medicines for patients.

The Soft Gelatin Capsules Manufacturers Association of India (SGCMAI) has engaged in serious discussions with the health ministry and the FSSAI, urging the IPC to reconsider implementing unexamined changes that could disrupt the smooth supply of soft gelatin capsules in the market.

The Indian Drug Manufacturers’ Association (IDMA) has also voiced its concerns to the IPC, requesting a refrain from implementing USP standards for DT in soft gelatin capsules to prevent product shortages in the market.

According to an industry expert, altering the DT requirement would necessitate formulation changes that could impact clinical efficacy, bioequivalence, and stability.

The IPC does not currently consider these factors as requirements under Schedule M and Y, which are statutory and mandate 6 to 12 months of study and evaluation.

Rushing the reformulation process or making abrupt changes to existing marketed products may have detrimental effects on patient health, including dose dumping, side effects, and compromised quality.

It is worth noting that the climatic conditions specified in the USP monographs are applicable to controlled temperature and humidity settings, typically in bottled packs to prevent moisture permeation throughout the product’s shelf life.

Collaborative efforts between the IPC and industry leaders and associations are recommended to ensure harmonious changes.

Given the prevailing climatic conditions in India, which differ from those in the United States, soft gelatin capsules undergo several changes during transportation. This makes it undesirable to maintain a DT limit of Not More Than (NMT) 30 minutes.

In the majority of soft gelatin capsule formulations, the DT needs to exceed 30 minutes to ensure compliance with quality standards and regulations due to the extreme temperature and humidity variations experienced by products in the Indian market.

While the industry is open to faster DT time limits for single-ingredient drug products that demonstrate clear benefits, they strongly advocate for a gradual transition.

Additionally, the industry urges the IPC to engage in in-depth discussions regarding the potential ramifications of any changes on other soft gelatin capsule products in the market, as their availability and consumer health could be adversely affected.

An industry expert noted that the industry has suggested several additions to the DT test, such as using gastric media instead of water and employing simulated enzymes for certain products in alignment with BP/EP/USP guidelines. However, the IPC has rejected these suggestions despite repeated reminders.

It is crucial for industry associations, regulatory bodies, and the IPC to collaborate effectively, considering the diverse perspectives and potential impacts on the availability and quality of soft gelatin capsules.

A thorough evaluation and a gradual implementation approach will promote patient safety and ensure compliance with relevant standards.

The Health Master