IPEC (International Pharmaceutical Excipients) Federation is calling on foreign gelatin makers to set up manufacturing plants in India in a bid to tackle an “acute” shortage of the excipient.
Speaking exclusively to in-PharmaTechnologist, IPEC Federation told us drugsmakers in the region – largely capsule and soft gel producers – could soon run into difficulties if the issue is not resolved.
It said a lack of the raw materials used to make gelatin – cow bone and ossein – is the biggest culprit.
“We are aware that a keyfactor in this situation is the shortage of bone and ossein from which gelatin is made,” she said. “If more ossein could be converted into gelatin in India the shortage would greatly ease.”
More than 80 per cent of the Indian population identify themselves as Hindu - a religion to which the cow is a sacred animal.
However when asked if this is a contributing factor to the shortfall, the Federation said it could not comment. " IPEC is a science base technical organisation. We do not comment on trade practices, business development, or religious practices," it said.
It also warned that gelatin manufacturers operating in India are exporting too much of ossein and finished product to Western countries.
Solving the puzzle
IPEC’s caution comes as the organisation prepares to launch its new Indian branch in June .
The Federation told in-PharmaTechnologist that the gap in the market is an opportunity for foreign gelatin producers to open operations in the area.
In a message to excipients makers pondering a move, the organisation said: “There is tremendous opportunity in India.”
But on the other hand, the association advised companies to be aware of GMP (good manufacturing practice) issues in India, saying: “The key thing is to make sure that any operation that you are involved with in India uses appropriate excipient GMPs in their manufacturing and properly qualifies all of their suppliers.”
IPEC added that the pharma and capsule industry must work through the current challenges together, and must “recognise and accept that some of the manufacturers have started importing gelatinwhich may have cost implications.”
IPEC Federation wish to make a correction that quotes did not come from its chair Janeen Skutnik-Wilkinson as it originally stated. The organisation apologises for any confusion caused.