CDSCO has circulated a notice to the pharmaceutical companies inviting suggestions on the proposal to replace gelatin capsules with vegetable capsules in the pharmaceutical industry. Vegetable capsules are cellulose-based and are of plant origin.
In the notice, DCGI/MISC/2016, 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.”
Natural Capsules from Karnataka which was the first manufacturer of veg capsules in the country, is stated to be in a position to quickly step up its production over the next 6 months and can cater to local demand. Associated Capsule Group, which is the other manufacturer of these capsules, can also scale up its production.
The move to consider vegetable capsules over gelatin based version is a welcome step. But the pharma industry will require some time to change over to this packaging option. “While we have 19 lines for gelatin capsules and only one dedicated line for veg capsules, we can convert quickly gelatin lines if required by market, Sunil Mundra, managing director, Natural Capsules told Pharmabiz.
The company is already marketing its products in 28 countries globally where there is a visible trend to move towards veg capsules especially in non-pharma segments. “We are confident to return to this space at time when the market holds promising prospects and having successfully completed our ongoing gelatin projects early this year,” he added.
It is gathered that both ACG and Bengaluru-based Natural Capsules have a sizable production capacity for veg capsules. Present domestic market size for veg capsules is approximately at 1.2 billion capsules, however with the changes being proposed by DCGI, this is likely to increase substantially.
In the meanwhile, in December 2015 Natural Capsules invested Rs. 3 crore to augment its research and install new equipment, which will manufacture about 400 million vegetable capsules per annum. We have put in systems to make a come-back with veg capsules which are of pure plant origin, said Mundra which has been a pioneer in the manufacture these cellulose based versions since 2001.
However, based on the muted market demand, Natural Capsules did not vigourously pursue marketing of veg capsules as Indian market was not ready for this capsule. This led the company to focus on gelatin versions. Now it has made a re-entry driven by global demand and promising domestic market opportunities and is euphoric as the DCGI office is looking at the vegetable capsules as a safer alternative.
The key benefit is that veg caps are chemically stable even at low humidity levels and do not foster bacteria unlike gelatin versions. Further, veg capsules have very low shell moisture, light protection, no reaction with fillings and low static charge. Moreover these capsules are being used by food, dietary supplements, herbal and nutraceutical industry in a big way, explained Mundra.