Low-cost Chinese APIs throng Indian market illegally, pose health risk to people
Low-cost
Chinese active pharmaceutical ingredients (APIs) continue to throng the Indian
market through illegal route, posing a health risk to the people. APIs such as
erythromycin stearate, used to treat a wide variety of bacterial infections,
are being imported by certain Indian drug companies /traders from China without
requisite registration certificates and the material is being sold at a very
low price in India.
A representation in this regard has already been made to
Drugs Controller General of India (DCGI) and the matter is being investigated
by regulatory authority.
Last month, it was brought to the notice of the DCGI that
erythromycin stearate of Shanong Sinder Technology, China was being openly sold
by Chennai-based drug companies/traders. It is understood that the importers
had lacked certificate of product registration of erythromycin stearate in
India thus casting suspicion on quality and efficacy of the product. The API
was being supplied by the importers in the domestic market at a very cheap
rate, nearly 25% less than the prevailing market rate.
Taking serious note of this, pharmaceutical industry has
requested the DCGI to conduct inquiry into alleged malpractice committed by the
importers and, if found guilty, strict action should be taken against the
wrongdoers and all materials which have been sold as API or as finished
formulation should be retrieved from the companies as the product originating
from unregistered source might harm the health of the people.
The industry had demanded that samples from batches of
pharmaceutical products being imported from ports should be checked by central
drugs laboratory to rein in circulation of substandard unregistered products in
the domestic market.
Earlier also, the pharmaceutical industry had raised concern
over substandard quality Chinese APIs supplied by the importers. The industry
had demanded setting up of an API Monitoring Cell which would help them get
genuine APIs from importers as well as domestic manufacturers.
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