Excipient manufacturers and traders of Karnataka have demanded that spurious excipients should also be included under the purview of the new bill awarding death sentence to spurious drug makers as these products are also equally hazardous as they are used in every drug formulation.
Excipients such as povidone, (PVP), cellulosics, modified starchers and others used as binders disintegrants and diluents constitute 85 per cent of the contents in formulations (tablets, capsules, injectibles and oral suspensions) as against about 15 per cent of the bulk actives composition. When inferior quality excipients are used, it can alter the therapeutic activity of active ingredients especially during storage on the shelves due to the impurity that may be present in the spurious excipients.
Reliable sources here said that several fly-by-night excipient suppliers have emerged in the country of late. Pharma companies are aware that these suppliers claim to source the excipients from China and other unregulated markets, but refuse to disclose names of the manufacturers in their documents. They repack and re-label with an Indian Pharmacopoeia (IP) tag the old drums of leading global excipients manufacturers.
It is not uncommon for many pharma companies to prefer cheap excipients for domestic products because of the price control and source branded excipients from reputed international suppliers only for exports to the regulated markets. There are however, companies that strictly adhere to usage of top quality international excipients for both the domestic and international markets, Nagarajan Kailasm, general manager, Anshul Agencies told pharmabiz.com
Although pharma ingredients including excipients are governed by Indian and international Pharmacopoeia norms, excipients even if they are inert substances are governed by stringent production and quality standards. But the reality is that there are gross violations such as use of industrial grade excipients for pharmaceutical products.
Although efforts are on to increase the customer awareness about spurious excipients, the biggest deterrent to punish spurious excipient suppliers according to Nagarajan is that IP standards are less rigorous compared to the US Pharmacopoeia, Japanese Pharmacopoeia and European Pharmacopoeia requirements.
When manufacturers are concerned about their brand image, they cannot ignore quality of excipients. More often they are up in arms against excipient suppliers only when the drugs are rejected for poor quality, pointed out Nagarajan.
Companies particularly Anshul Agencies, which are the distributors and global sourcing agents for Speciality Chemicals and Fine Chemicals from ISP Technologies, USA and others are at the receiving end after they found that anonymous and fake suppliers in the country use recycled ISP drums to refill cheap and spurious excipients which are sold to many pharma companies.
The paradox is that Chinese pharmaceutical companies source all their excipients only from reputed international manufacturers, while the excipients produced in China find a ready made market in India, stated the sources.