Concerned over the quality, safety and high cost of cellulose based capsules, the Confederation of Indian Pharmaceutical Industry (CIPI) has urged the Drugs Controller General of India (DCGI) and the Union ministry of health and family welfare not to go ahead with implementation of cellulose based capsules replacing the gelatin based capsules. The CIPI has recently submitted a memorandum in this regard.

Gelatin based capsules are cost effective, time tested, safe and recognised by regulatory bodies across the world. It has been used by pharma industries over a century, said CIPI executive secretary Sudesh Kumar.

He said in countries like USA and EU, 95 per cent of the capsules used for drug formulations are gelatin based. In India the ratio is around 98 per cent. The specifications of gelatin based capsules for use in drug formulations are included in USP, E.Ph, IP etc and they have undergone stability testing, bioequivalence and bioavailability testing at various stages of regulatory approvals.

In highly regulated markets such as US, its FDA accepts and grants approvals of drug formulations in gelatin based capsules under ANDAs without any restriction. So far there are no reports indicating side effects of gelatin based capsules in people, hence it is unnecessary to shift to cellulose based capsules, he opined.

Raising concern over the safety of cellulose based capsules, CIPI executive secretary said the Hydroxypropyl Methycellulose (HPMC), a form of cellulose is used in manufacturing cellulose based capsules. HPMC is derived from plant fiber such as wood from tree trunks and then treated with a number of harsh chemicals to get synthetic gelatin. One of the chemicals being used is propylene oxide which is considered to be category 2 carcinogenic. K-Carrageenan, another chemical is used as a gelling agent to manufacture cellulose based capsules. Carrageenan is highly inflammatory and toxic to the digestive track and may be responsible for colitis and colon cancer.

Pointing out low durability of cellulose based capsules, he said cellulose based capsules are having shelf life of 3 years as compared to shelf life of five years for gelatin based capsules.

In shifting to cellulose based capsules, some vital parameters like safety, quality, in vitro disintegration and dissolution time as against gelatin based capsules need to be considered, he added.

He said HPMC which is used for the manufacture of cellulose based capsules is imported from China. In order to meet the demand of the pharmaceutical industry either the capsules or HPMC will have to be imported resulting in shortage of medicines in the country.

The cost of cellulose based capsules will be three times higher as compared to gelatin based capsules due to high cost of imported raw material, manufacturing cost, poor yield and higher wastage and high investment in plant and machinery, Kumar said.

In a bid to shift to cellulose based capsules, the manufacturers of drug formulations will have to make vital changes in the filling and packaging lines and also in the packaging materials. The manufacturers also need to conduct accelerated and long term stability and other tests as per regulatory requirements including PMS to switch to cellulose based capsules, he said.

In the case of drug formulations being exported in gelatin based capsules, the manufacturers may have to seek re-registration of their products in the importing country requiring data for accelerated and long term stability, in-vivo and in-vitro dissolution studies and shelf life claimed for the drug formulation in cellulose based capsules. 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, he added.

Considering the given situation, the regulator should conduct such studies in government laboratories and also based on available data and published papers about the safety of cellulose based capsules, shall declare that drug formulations in cellulose based capsules meet the requirement of stability, disintegration and dissolution including bioavailability as compared with the formulations in gelatin based capsules and are safe for use for oral dosages forms of drug formulations, he concluded.