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Industry associations to discuss revision of DT limit for soft gelatin capsules at IPC virtual meet on May 23
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Shardul Nautiyal, Mumbai
May 17 , 2023
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Industry associations will be discussing issues and solutions on the decision taken by the Indian Pharmacopoeia Commission (IPC) for revision of the Disintegration Time (DT) limit in respect of soft gelatin capsules (SGC) at the IPC-hosted virtual meet on May 22, 2023. Soft gelatin capsules include ethical medicines, nutraceuticals, multivitamins and minerals and food supplements.
This is the fourth meeting of associations and industry experts on the same issue.
The IPC has proposed to reduce the DT from 60 minutes to 30 minutes across the board for all categories of products. The industry, however, pinpoints that it is important to note that US Pharmacopoeia (USP) does not apply this test for nutraceuticals, multivitamins and health supplements but in terms of Indian regulations, this category comes under FSSAI and has different standards for these products.
The industry has opposed changes without impact assessment on market short supply of essential medicines to patients.
There have been serious discussions with health ministry and the Food Safety and Standards Authority of India (FSSAI) by the Soft Gelatin Capsules Manufacturers Association of India (SGCMAI) persuading or compelling IPC to reconsider unevaluated changes which will impact smooth supply of soft gelatin capsules in the market.
The Indian Drug Manufacturers’ Association (IDMA) has also made various representations to the IPC to refrain from the implementation of the USP standards with reference to the DT for soft gelatin capsules to avoid short supply of products in the market.
This is because various soft gelatin capsule products have been approved and/or marketed after bioequivalence and other regulatory compliance studies. The Soft Gelatin Capsules Manufacturers Association of India has said that the change in DT time should be gradually implemented with proper study and proof-of-concept.
According to an industry expert, “This change would require changes to the formulation which would impact clinical efficacy, bioequivalence and stability which IPC does not consider as requirements under Schedule M and Y which is statutory and requires 6 to 12 months of study and evaluation.”
Any change in the existing marketed products can be detrimental to the patient's health in terms of dose dumping or other side effects apart from quality concerns if required to be hurriedly reformulated. It is important to note that the climatic conditions of the monographs in USP are valid for controlled temperature and humidity and that too in bottled packs to prevent moisture permeation during the course of its shelf life. It is preferable IPC works in collaboration with industry leaders and associations to make changes harmoniously.
Due to prevalent climatic conditions in India, unlike in the United States of America (USA), the soft gelatin capsule undergoes several changes during the transportation due to which it is not desirable to maintain DT of Not More Than (NMT) 30 minutes. Thus, the products in the Indian market being always subjected to extremes of temperature and humidity, the DT will always need to exceed 30 minutes in majority of the soft gelatin capsule formulations to ensure quality and regulatory compliances.
For specific drug products, industry is agreeable in principle for changeover to a faster DT time limit for a single-ingredient drug product, if it substantiates merits, but has made an ardent plea to allow time for gradual transformation. However, the industry urges IPC to have a detailed discussion on the ramifications of any changes in the other soft gelatin capsule products in the market since it could otherwise impact availability and thereby consumer health adversely.
“Industry has also suggested few additions to the DT test like use of gastric media in place of water and also use of simulated enzymes for some products in line with BP/EP/USP but IPC has rejected the suggestion even after repeat reminders,” an industry expert said.
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