Following on from in-PharmaTechnologist.com’s article on growing shortages of the excipient – commonly used in capsule production and tablet coating – Beroe senior research analyst, Sandeep Chandra, dug further into the issues behind the crisis.
He found that the demand for ossein-based gelatine from cow bone has increased significantly in recent years with up to 13,000 tons consumed in 2011 and an expected growth rate 10 – 15 per cent on top of that every year.
But with 80 per cent of the Indian population declaring themselves Hindu – a religion which reveres the cow as holy – the already considerable challenge of sourcing sufficient gelatine to meet this demand is becoming even harder according to Chandra.
“The cow slaughter rates have only gone up by 0.8 per cent in India over the last 5 years, while the demand for gelatine is growing fast,” he told us, predicting that “an increase in cow slaughter seems very unlikely. This marks the root of the raw material scarcity in India.”
The export issue
Chandra also told us that shortages are being accelerated because a large chunk of the already insufficient amounts of gelatine produced in the country is exported to companies looking for the cheap deals provided by the declining rupee.
Three of the top manufacturers of the product – Sterling Biotech Limited, Nitta Gelatin and Narmada Gelatins – export about half of their produce, he said.
He added that the demand to source the excipient from India has risen even further since 2010, when the European Commission marked India a country with low BSE risk.
“So severe has been the shortage, that the Indian pharmaceutical industry has requested government intervention on the exports of bone and ossein, since they have been forced to import gelatin to meet their requirements,” he said.
Importing gelatine is not a viable option, he added, because while the raw materials for making are charged a 7.5 per cent duty for import, there is a 20 per cent duty charged on the import of the finished product.
Agreeing with IPEC Federation, who spoke to in-PharmaTechnologist.com about the issues in May, Chandra said more foreign gelatine makers establishing businesses in the area could be a solution.
However, he added the proviso “that the foreign players team up with GMP certified Indian gelatine makers.”
As for shortages of the raw materials used to produce gelatin, Chandra admitted it is unrealistic to expect people to go against their religious views, adding that “bones and ossein might have to be imported at some point if the Indian gelatine industry is to meet the rising demand.”