Large quantities of spurious and substandard drugs, originating from various international sources are understood to be entering the country through imports by units in Special Economic Zones and by way of Advance License Scheme.
Since the imports through these routes are not required to be registered under the existing import registration procedure, the materials under these schemes are entering the country with no monitoring and quality testing.
Alarmingly most of the suppliers in China, Korea and Taiwan and many other countries who failed to register their manufacturing sites and products with Indian authority under import registration prefer to come through these routes. This practice is increasingly encouraged by the local importers too as they get the material cheaper, admits key officials in the Central Drug Standard Control Organisation (CDSCO).
However, the most dangerous practice is that majority of the APIs coming through these routes are being diverted to the local market by the domestic companies instead of using it for exports. "Thus, the importers through these so-called export promotion schemes are benefited in many ways as they make undesirable profits in addition to the duty exemption and other tax incentives. At the same time harming the industry and the public by pumping the substandard drug material in the country."
It may be recalled that Pharmabiz had earlier reported that despite the seemingly stringent import registration system for drugs in India, large quantities of inferior quality drugs are flowing into the country mainly from China and other sources.
The state drug control departments in the country have also seized a number of inferior quality products after testing the samples by the state drug testing laboratory. It was found that most of the materials originated from a few suppliers from China. The state officials had revealed that in several cases of formulation sample tests, it was found that the active ingredients in the samples were substantially inferior in quality or the stability factor is notably low.
In Gujarat alone 11 such cases have been detected following routine sample tests and also after complaints from patients and other state departments. Recently, 10 cases of spurious/inferior products, wherein loperamide hydrochloride and jentamycin formulations, were seized from the markets. In all the ten cases, it is found that the active ingredients were either of low quality or nil.