Illegal China drugs seized in Chennai

The import of bulk drugs requires a registration certificate and import license.

Indian drug regulators have seized more than 2,300 kg of illegal Chinese bulk drugs awaiting dispatch to the pharmaceutical industry for use in formulating drugs sold in retail medicine shops.

If used in formulation, such unauthorised bulk drugs — raw material for tablets, capsules and syrups — pose health risks to patients as their quality remains suspect.

Import of bulk drugs requires registration certificate and import license. An importer has to provide information like manufacturing process, validation data, analytical procedure, bio-equivalence data, stability data and certificate of analysis to the regulator to ensure that only certified quality bulk drugs enter the country.

After receiving a tip-off, officials of the Central Drug Standards Control Organisation and Tamil Nadu Drugs Control Department raided the office and premises of Kawarlal and Co, Madhavaram, Chennai, and recovered 2,354 kg of illegal bulk drugs earlier this week.

The drugs recovered included Erythromycin Stearate (235 kg), Verapamil Hydrochloride (155 kg), Megestrol Acetate (70 kg), Trimetazidine dihydrochloride (1,344 kg), Folic Acid (125 kg), Silymarin (175 kg) and Calcium D Pantothenate (250 kg).

As some of these drugs are antibiotics, they pose additional challenge to the regulators. If bulk quantities of unauthorised antibiotics found their way to retail markets for human and veterinary medicines, it will add to the growing problem of antibiotic resistance.

These drugs were manufactured in China by Zhejiang Medicines and Health Products, Ningbo Hitech Biochemicals, Jingjing Pharmaceuticals and Shandong Sinder Technology.

“Import of unregistered drugs without quality evaluation is a major health hazard to the patients using formulation made from these bulk drugs. The cost of the seized material is estimated to be about Rs 1.5 crore, which may be much more in the open market. It is suspected that the total value of illegal transactions may run into several crores,” the CDSCO said in a statement.

While the CDSCO continues with the investigation, regulators have also informed the Directorate of Revenue Intelligence, which will take appropriate action under the law.

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