With the Indian pharma associations like IDMA and CIPI approaching the Drugs Control General of India (DCGI) not to substitute gelatin capsules with Hydroxypropyl methylcellulose (HPMC) or veg capsules, pharma industry and researchers have clarified that HPMC is not a carcinogenic material.
According to Jatish N Sheth, former president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and director Shrusti Pharma, both gelatin and veg capsules are safe. The only difference is that gelatin is an official product in Indian Pharmacopoeia. In the case of veg capsule, it is not yet officially listed in the IP.
“Veg capsules are in use for over 88 years in food and pharma. Specifically in pharma it is extensively used for coating of tablets and pellets. Further veg capsules are used for almost 50 per cent of the nutraceutical products in the US and Europe. These capsules have low moisture percentage and do not require air-conditioned storage. Therefore, veg capsules are proven to be extremely stable in all conditions. On the contrary gelatin capsules are prone to bacterial growth and require preservatives to manufacture them. These preservatives are totally banned in US and Europe as against the HPMC capsules which have no such issues, Prof PS Bisen, scientist emeritus, School of Studies in Biotechnology, Jowaji University, Gwalior and research director, Jaipur National University told Pharmabiz in a telecon.
HPMC mainly comes from wood pulp which is of plant origin, and quite safe, whereas gelatin which is derived from animal bones, and other animal matter, have been facing the issue of TSE/BSE for a long time, stated drug companies and scientists who have proven safety data on veg capsules, added Prof Bisen.
Sunil L Mundra, managing director, Natural Capsules, a pioneer in veg capsules in the country and started manufacturing in the year 2000, confirmed that gelatin capsule Industry can switchover to veg capsules if DCGI wants them to, but would need about 24-30 months to do so. They would also need financial support from government to convert their machines which are used for making gelatin capsules to veg capsules.
As a proactive initiative in 2008, the Union government unveiled the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) to help the pharma industry ensure compliance to WHO/ international GMPs by offering reasonable interest rates. Early this year, the government announced its intent to unveil a Rs. 500 crore pharma technology upgradation fund to facilitate cheaper loans to entities looking to upgrade their manufacturing facilities. Besides this, the department of pharmaceuticals is already working on a proposal to establish a venture capital fund with a same corpus to provide cheaper loans to small and marginal companies planning to set up new units. There is also the Ministry of Micro Small and Medium Enterprises’ (MSME’s) Credit Linked Capital Subsidy Scheme (CLCSS) for the SSI units.
“These funding initiatives will rejuvenate the domestic pharma sector comprising of 19,000 units of which over 90 per cent are SMEs. It would also definitely enable companies to transit smoothly from gelatin lines to veg cap production,” said Mundra.
Another major concern of formulation industry is about higher cost of veg capsules. This could be taken care by Government if it agrees to accommodate the market price of veg capsules in the approved costing by NPPA. Now the impact of this differential cost on the selling price of the finished formulation is very negligible. At the same time, once the mass production of veg capsules starts, these prices are bound to come down, said Mundra.