The PHD Chamber of Commerce & Industry has made a representation to the Drug Controller General of India detailing the benefits of using Gelatine capsules over HPMC capsules in medicines.
According to Mr Vivek Seigell, Director, Health Committee, PHD Chamber of Commerce and Industry, Gelatine capsules have technical advantage over HPMC capsules. Gelatin is a natural and safe product with Generally Recognized as Safe (GRAS) status in pharmaceutical and food applications by USA and other regulators. It is Genetically Modified Organism (GMO) free, completely natural, sustainable and non-allergic.
The safety aspect of capsule shells is very well defined by various Food and Drug Authorities, as well as different Pharmacopoeias. Gelatine capsules manufacturers and the Pharmaceutical companies rigorously test the shells on account of compliances to these norms only after which are the shells used in formulations said Mr. Vivek Seigell, Director of the Health Committee at PHD Chamber while commenting on the proposed ban on the gelatin capsules.
Technology of gelatin capsules manufacturing is an old age technology, standardized over the period of the last century and has presence all across the globe, with standard specification, defined by all approving authorities.
As gelatin capsules have robust and approved technology, the manufacturing cost of making these shells is low. In contrast the investment cost of the HPMC technology is very high and there are many complexities involved. Further, the investments required to be made for manufacturing HPMC capsules are also substantial and will require planning and time which may also impact accessibility of medicines.
Further, the cost required for the raw material is approximately four times that of Gelatin and the manufacturing cost is approximately three times the cost of Gelatin, considering the outputs from the current available technology. As the cost for HPMC is this high, its acceptance by the Pharmaceutical industry will be challenging esp in light of the price controls being implemented by the Govt.
Gelatine capsules are being used world over for the past 100 years without any health issues being reported by the virtue of capsule shell.
In highly regulated markets like USA, UK, Japan, Australia etc, gelatin based capsules are widely accepted in oral formulations for different ailments.
Gelatin as described in the Indian Pharmacopeia (IP 2014) “is a purified protein” obtained by partial hydrolysis of animal collagen and is translucent, colorless, brittle (when dry) and flavorless. It is an easily digestible pure protein providing its consumers with eight of the nine essential amino acids needed by the human body whereas HPMC Capsules (Hydroxypropyl methylcellulose) do not contain components of animal origin and has a synthetic base.
Gelatin is a protein which is essential component for human consumption and development and also the technology required in making of this is standardized over the last century and is safe for human consumption. This has been audited & approved by Pharmaceutical Industry & the controlling authorities like FDA & WHO whereas the technology used in the manufacturing of HPMC capsules is a very new concept to the industry and has not been thoroughly established & standardized in the industry.
In the aspect of availability of raw material , gelatin is readily available in the market to meet the demands of Pharmaceutical and Food Industries of India whereas there are only few manufacturers engaged in HPMC base material in India. The current annual installed capacity of HPMC is around 2.0 billion whereas for gelatin its is about 120 billion which is huge as compared to HPMC. Also for HPMC there is only one established manufacturer in India giving no choice to manufacturers to choose their vendor whereas for gelatin capsules there are number of established manufacturers giving a whole array of choices for pharma manufacturers to choose from.
As the gelatin capsule manufacturers are large in nos. and so is the turnover (in thousands of crores) it also plays a vital role in drug delivery to a large range of formulations, these Industries also generate large amount of employment opportunities.
HPMC Capsules are basically of Synthetic origin and the base in Chemical. This ecosystem of capsules made from gelatin had been existing for over 100 years now and has proved its technical importance hence every possible step must be taken to nurture and fortify this ecosystem of gelatin capsules.