[india-drug] Spurious excipients use rampant

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(Source:
http://www.pharmabiz.com/article/detnews.asp?articleid=19738&sectionid=
Thanks?SS)


Spurious excipients use rampant as regulators turn a blind eye
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Monday, January 05, 2004 08:00 IST 
Nandita Vijay, Bangalore

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.


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