 "Gelatine capsules technically better than HPMC, says PHD Chamber to DCGI")
Gelatine capsules, being used globally for more than 100 years, have technical advantage over HPMC (hydroxypropyl methylcellulose) capsules, which is relatively new technology, according to the PHD Chamber of Commerce & Industry (PHDCCI), which made a representation to the Drug Controller General of India (DCGI) detailing the benefits of gelatine capsules over HPMC capsules in medicines.
Last month, DCGI said that it has received a proposal to replace gelatine capsules (derived from animals) with cellulose-based capsules which are of plant origin. After this, the drug regulator had asked for suggestions from all stakeholders on this issues. Many of the pharmaceutical manufacturers and associations have strongly opposed the move.
According to Vivek Seigell, director, health committee, PHD Chamber of Commerce and Industry, gelatine capsules have technical advantage over HPMC capsules. Gelatine is a natural and safe product with Generally Recognized as Safe (GRAS) status in pharmaceutical and food applications by the drug regulators from the US and other countries. It is Genetically Modified Organism (GMO) free, completely natural, sustainable and non-allergic.
Technology of gelatine capsules manufacturing is an old age technology, standardised over the period of the last century and has presence all across the globe, with standard specification, defined by all approving authorities.
As gelatine 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 gelatine and the manufacturing cost is approximately three times the cost of gelatine, considering the outputs from the current available technology. As the cost for HPMC is high, its acceptance by the pharmaceutical industry will be challenging especially in light of the price controls being implemented by the government.
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 such as the US, UK, Japan, Australia etc, gelatine based capsules are widely accepted in oral formulations for different ailments. Gelatine 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 do not contain components of animal origin and has a synthetic base,” said PHDCCI.
Gelatine is a protein which is essential component for human consumption and development and also the technology required in making of this is standardised 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 & standardised in the industry.
In the aspect of availability of raw material, gelatine 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 billion whereas for gelatine it 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 gelatine capsules there are number of established manufacturers giving a whole array of choices for pharma manufacturers to choose from.
As the gelatine capsule manufacturers are large in number 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.
Last month, DCGI said that it has received a proposal to replace gelatine capsules (derived from animals) with cellulose-based capsules which are of plant origin. After this, the drug regulator had asked for suggestions from all stakeholders on this issues. Many of the pharmaceutical manufacturers and associations have strongly opposed the move.
According to Vivek Seigell, director, health committee, PHD Chamber of Commerce and Industry, gelatine capsules have technical advantage over HPMC capsules. Gelatine is a natural and safe product with Generally Recognized as Safe (GRAS) status in pharmaceutical and food applications by the drug regulators from the US and other countries. It is Genetically Modified Organism (GMO) free, completely natural, sustainable and non-allergic.
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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 Vivek Seigell, while commenting on the proposed ban on the gelatine capsules.
Technology of gelatine capsules manufacturing is an old age technology, standardised over the period of the last century and has presence all across the globe, with standard specification, defined by all approving authorities.
As gelatine 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 gelatine and the manufacturing cost is approximately three times the cost of gelatine, considering the outputs from the current available technology. As the cost for HPMC is high, its acceptance by the pharmaceutical industry will be challenging especially in light of the price controls being implemented by the government.
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 such as the US, UK, Japan, Australia etc, gelatine based capsules are widely accepted in oral formulations for different ailments. Gelatine 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 do not contain components of animal origin and has a synthetic base,” said PHDCCI.
Gelatine is a protein which is essential component for human consumption and development and also the technology required in making of this is standardised 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 & standardised in the industry.
In the aspect of availability of raw material, gelatine 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 billion whereas for gelatine it 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 gelatine capsules there are number of established manufacturers giving a whole array of choices for pharma manufacturers to choose from.
As the gelatine capsule manufacturers are large in number 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.