Three more drugs made in Haryana ‘not of standard quality’

Bhartesh Singh Thakur

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Chandigarh, October 17

The Central Drugs Standard Control Organisation (CDSCO) has declared three drugs manufactured in Haryana as “Not of standard quality” owing to the failure in the quality tests at the Regional Drug Testing Laboratory (RDTL), Guwahati.

From January to September this year, 16 drugs manufactured in Haryana have failed in quality testing at the RDTLs in the country.

According to the monthly drug alert for the September issued by the CDSCO today, Pantoprazole Sodium Gastro Resistant Tablets

IP, manufactured by Wamika Pharmaceuticals Pvt Ltd of Saha (Ambala), failed in the dissolution test. The Drug Control Department of Jharkhand had drawn the sample.

Ocean®-OZ (Ofloxacin & Ornidazole Tablets), manufactured by SMBJ Pharmaceuticals Pvt Ltd, Barhi (Sonepat), too, failed in the dissolution test. The sample was drawn by the Drug Control Department of Bihar.

Telmisartan Tablets of Nestor Pharmaceuticals, Faridabad, too, failed this test. The Drug Control Department of Jharkhand had taken the sample. In February, April, May and July too, Telmisartan tablets of Nestor Pharmaceuticals had failed in Jharkhand.

Earlier in August, Paracetamol tablets of Alco Formulation, Faridabad, had failed in the dissolution test at the RDTL, Guwahati. The Drug Control Department of Assam had drawn the sample.

In June, Ibuprofen tablets of Faridabad-based Hindustan Antibiotics had failed in the assay and dissolution test at the Central Drugs Laboratory (CDL), Kolkata. The CDSCO North Zone, Ghaziabad, had drawn the samples. Paracetamol of Alco Formulation, too, had failed in the dissolution test at the RDTL, Guwahati. The Drug Control Department of Assam had drawn the sample. The same month, iron and folic acid tablets of Nestor Pharmaceuticals failed at the RDTL, Chandigarh, in uniformity of the content test. The CDSCO North Zone had taken the sample.

In these cases, legal action is taken by the states where the sample has been drawn. However, on information to the state regulator, the Food and Drug Administration, Haryana, will issue a notice and suspend the production of the particular product till it is ensured that the quality is maintained.