IDMA urges IPC not to consider implementing revising of DT time for soft gelatin capsules to avoid supply disruption

Mumbai, March 11, 2023 :

The Indian Drug Manufacturers’ Association (IDMA) has made various representations to the Indian Pharmacopoeia Commission (IPC) to refrain from the implementation of the British Pharmacopoeia (BP) standards with reference to the Disintegration Testing (DT) time 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 (SGCMAI) has said that the change in DT time should be gradually implemented with proper study and proof-of-concept. 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 BP are valid for controlled temperature and humidity and that too in bottled packs to prevent moisture permeation during the course of its shelf life. 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 time 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 time 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 substantiated merits, but has made an ardent plea to allow time for gradual transformation. However, 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.

“We are recommending to persist with the current Not More Than (NMT) 60 minutes time rather than NMT 30 minutes which has now been decided upon for soft gelatin capsules and needing to be implemented in due course. Most of the products already available will fail the DT time standards and this will impact the market of all multi-vitamins and multi-mineral formulations - both ethical and the nutraceutical products. The recommendation is, therefore, not to implement the changeover to NMT 30 minutes considering that manufacturers might not be able to suitably change even if given a one year timespan allotted for the same,” according to industry sources.

The industry urged the IPC to limit the NMT 30 minutes for soft gelatin capsules having single drug ingredient and incorporating the same in specific monographs when justified and substantiated. IDMA and other concerned stakeholders’, including related associations, has represented to the IPC not to make this NMT 30 minutes a mandatory limit for all soft gelatin capsules by incorporating in the general test limits.

According to an official associated with the development, “Our concern specifically is the across-the-board revision of the DT time, which may not be feasible or even desired for all the products specifically for the multimineral and multivitamin products. This change is very difficult and even impossible to implement and will lead to serious market disruption.”“The industry understands the IPC basis for proposing a revision in the DT time for soft gelatin capsules from NMT 60 to NMT 30 minutes. It is agreeable for certain drug products where it is required and pending conducting feasibility of this exercise,” the official added.

“The industry’s true challenges with reference to the vitamin-mineral, including extract-containing, soft gelatin capsule products’ DT time revision to NMT 30 minutes (from the current NMT 60 minutes) will be favourably considered, especially since it would otherwise impact consumer and patient’s well-being on account of looming possibility of discontinuance of especially vitamin-mineral-nutraceutical, including extract-containing products,” he further added.

As per the discussions, industry experts reiterate that it may not be feasible for the stakeholders to revise the DT time for vitamin-mineral with/without extracts - drug or nutraceutical products, from NMT 60 minutes at present to NMT 30 minutes as proposed. There are several technical issues with this, for example, the limitations of temperature or humidity in the storage condition in the supply chain within India coupled by the technical feasibility due to multiple ingredients in case of multi-mineral/multi-vitamin formulations, among others.

In view of the above positive approach of IPC, the Industry appreciated their agreeing to postpone their decision regarding reducing DT time for soft gelatin products pending their submission of evaluation done on the samples of vitamin-mineral-nutraceutical extract products. However, even before the said results could be forwarded, IPC issued a mandate for soft gelatin capsules to have a DT time of NMT 30 minutes and the same to be implemented in immediate due course. The Industry has thus appealed once again to the regulators to reconsider their stand and revert to the already in practice DT time of NMT 60 minutes for soft gelatin capsules in general barring the few justifiable single-ingredient exceptions in drug product category. Pharmabiz