The Union Health Ministry has invited suggestions and comments from all the stakeholders including NGOs, consumers and the pharmaceutical industry to a proposal of the ministry to replace gelatin capsules with cellulose-based capsules which are of plant origin and are safe for use as compared to animal-based gelatin capsules.
The Ministry in March this year had constituted an Expert Committee to address all the technical issues pertaining to replacing of gelatin capsules with cellulose-based capsules for encapsulation of drugs. The Expert Committee has desired that views of stakeholders including manufacturers and marketeers of HPMC capsules as well as NGOs who are working in this area or involved in this subject may also be obtained so that a considered view can be taken in this matter. The Committee has asked the NGOs, consumers and all other stakeholders to send their suggestions and comments within 21 days.
The issue of replacing gelatin capsules with cellulose-based capsules has been there for the last more than two years. Way back in April 2016, the Drug Controller General of India (DCGI) had circulated a notice to the pharmaceutical companies inviting suggestions on the proposal to replace gelatin capsules with cellulose-based capsules in the pharmaceutical industry. In the notice, DCGI Dr. G.N. Singh said, “In order to provide the pros and cons of the proposal to use vegetable capsules, the regulatory authority is looking for science-based suggestions and comments within six weeks which is before the second week of May from the pharma industry for taking a considered decision in the matter.”
Since then the industry has been opposing the government’s move on the plea that cellulose based capsules of plant origin do not have time tested data whereas gelatin based capsules continue to be the mainstay of drug delivery systems for its safety, convenience, patient acceptance, economy and pharmacokinetic parameters.
The industry is of the view that usage of gelatin capsules has been in practice for more than 185 years and thereby has stood the test of time. Global pharmaceutical products worldwide including the leading brands and products are delivered in gelatin capsules and are approved by the US FDA, MHRA, EU, TGA and DCGI. These products have gone through extensive clinical trial, BA/BE studies etc. and have been consumed for decades with no adverse reaction. On the contrary, the number of products approved in cellulose capsules are a fraction in number.
Read the original notice HERE