The office of the CDSCO circulated a notice to the pharmaceutical industry last April indicating its intention to replace gelatin capsules with vegetable capsules. After the issue of the notice, the Drug Controller General of India has been seeking suggestions and comments from the industry bodies and experts before taking a final decision in this regard. As expected, the reactions from the pharmaceutical industry on the matter has been largely negative. Two major industry bodies namely Indian Drug Manufacturers Association and Confederation of Indian Pharmaceutical Industry have raised serious objections to the proposed change by the CDSCO. These industry bodies have pointed out that the usage of gelatin capsules has been in practice for more than 100 years and it has stood the test of time. Global pharmaceutical products worldwide including the leading brands and products are delivered in gelatin capsules and are approved by the regulatory bodies like the US FDA, UK MHRA, TGA, etc. Gelatine capsules have also gone through extensive clinical trials and have been consumed for decades with no adverse reactions. The Associations pointed out that the production and consumption of vegetable capsules in India form less than 2 per cent of total capsules and are mostly used in herbal applications. The specifications of gelatin based capsules for use in drug formulations are included in the US Pharmacopoeia and Indian Pharmacopoeia and they have undergone stability testing, bioequivalence and bioavailability testing at various stages of regulatory approvals. Whereas, none of the pharmacopoeias have published monographs or standards for vegetable capsules. Besides, the safety and efficacy of gelatin based capsules has been proved scientifically with the gelatin having a higher shelf life than vegetable capsules.
Vegetable capsules are cellulose based and are of plant origin. Hydroxypropyl Methycellulose (HPMC) is a form of cellulose that is used in manufacturing vegetable capsules. HPMC is derived from plant fiber such as wood from tree trunks and then treated with a number of chemicals to get synthetic gelatin. One of the chemicals used is propylene oxide which is considered to be a category 2 carcinogenic material. According to some researchers, a key benefit of vegetable capsules is that they are chemically stable even at low humidity levels and do not foster bacteria unlike gelatin capsules. Vegetable capsules have low moisture content, light protection, no reaction with fillings and low static charge. And it is a fact that these capsules are being used by food and nutraceutical industry in a big way for several years. However, two major issues to be considered before deciding to shift to the use of cellulose based capsules are the current availability of the product and the additional costs to be incurred by the pharmaceutical industry by the switch. With shifting to cellulose based capsules, the companies will have to certainly incur huge additional costs by way of making vital changes in the filling and packaging lines. The companies will also have to conduct accelerated and long term stability and other tests as per regulatory requirements. In the case of exporters of drug formulations, they may have to seek re-registration of their products in the importing countries requiring data for accelerated and long term stability, in-vivo and in-vitro dissolution studies. The process may take about 3 years to be completed and re-registration will be granted on payment of hefty re-registration fee in hard currency. Considering these factors, a drastic step to replace gelatin based capsules with cellulose based capsules does not seem necessary at present. Therefore, the proposal need to be considered after seriously studying the scientific, techno-commercial, availability, affordability issues as that can impact the patient community in India and all countries depending on Indian medicines.