The office of the Drugs Controller General of India (DCGI) is investigating bulk pharmaceutical ingredients imported in from China. The DCGI has handed over 4 cases of “alleged” unregistered bulk drugs to the Central Bureau of Investigation (CBI) with an additional 3 cases to follow.The Directorate of Revenue Intelligence was alerted after the apex drug regulator noticed that such unregistered drugs accounted for almost half of the country’s recent bulk drugs import.
According to official sources, CBI has been asked to inquire into the import of drugs such as Roxithromycin ($81.5 per kg), Progesterone ($187.5 per kg) and Cimetidine ($14.5 per kg) by Gujarat-based Envee Drugs Pvt Ltd, and Mumbai-based firms J B Khokhani & Co and Sheetal Pharmaceuticals, respectively.
Samples of all three consignments are being tested for quality at Central Drugs Laboratory, Kolkata. The fourth case has been registered against Mumbai-based C J Shah & Co.
The products showed discrepancies in labeling, packaging and documentation. The documentation names Chinese manufacturers that have denied the products were sourced from them.
Many of the cases are labeled as chemicals, which do not undergo the same inspection as raw materials used in pharmaceuticals. This is of particular concern as these bulk drugs are used by local manufacturers to make the final medicine for domestic as well as export purposes.
The Indian drug industry is highly dependent on Chinese bulk drugs. “There is an urgent need to ensure the quality and authenticity of these drugs,” said a senior government official. India imported Rs 6,700 crore ($USD 144.23 Million) worth of mostly bulk drugs in 2007-08.
To view more on the investigation visit: www.business-standard.com.
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