"A proposal has been received for plant cellulose-based capsules which are also safer for use than animal-based gelatin ones," drug controller
general of India G N Singh said. Gelatin is manufactured from processed bones, skin and tissue of cattle, pigs and other animals.
The regulator sought suggestions from stakeholders, including the pharmaceutical industry and consumers, to take what it says is a
considered decision on the proposal. Regulatory sources said a final decision is likely by end of May. The proposal has the support of
various quarters in government. Besides, it is also considered safer than gelatin because it's plants sourced. However, more scientific
evaluation is needed before taking a final call," an official source said.
As of now the Bureau of Indian Standards has already framed standards, norms and guidelines for manufacturing vegetarian capsules based on
cellulose. Gelatin, a key element in capsules, is also widely used in food products as a gelling agent and in toiletries.
The over Rs 1 lakh crore Indian pharmaceutical industry extensively depends on gelatin. According to a senior industry executive, almost
80% of any pharmaceutical company's products are either capsules or tablets. Though tablets are a bigger share, capsules make up at least
40% of the total.
While some in the industry and medical fraternity feel switching to cellulose may impact the cost of medicines as cellulose coating is more
expensive than gelatin, many believe the difference may not be significant with easily available technology and expertise. Also, it
would be adding to the choice available for consumers.
A proposal to switch to cellulose was discussed in the past as well.
However, regulatory agencies and the government have so far failed to provide vegetarians with this option, primarily because of opposition
from the industry.
"There are also issues about religious, cultural and personal preferences of patients. If there is an alternative available which is
more natural or plant based and is preferred by vegetarians then it must be evaluated," the source said.