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Another drug fails test, Sonepat firm faces ban

Firm already under scanner over contaminated cough syrups linked to death of more than 66 children in Gambia

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Geetanjali Gayatri & Bhartesh Singh Thakur

Tribune News Service

Chandigarh, November 4

Haryana Medical Services Corporation Limited (HMSCL) has issued a show-cause notice to Sonepat-based Maiden Pharmaceuticals after its 19 batches of albendazole tablets, used in the treatment of parasitic worm infections, failed the quality test.

We are in touch with the lab and the Centre, but there is no information about the report yet. Work at unit already halted. Anil Vij, Health Minister

The firm is already under the scanner over its four contaminated cough syrups linked to the death of more than 66 children in Gambia.

The firm has been told to reply to the notice, dated November 1, within seven days. Following this, an order for blacklisting the firm could be issued. If barred, the order would be sent to other states too.

The HMSCL had procured albendazole tablets from the firm for government hospitals and dispensaries. Sources said of 23 batches of the tablets, 19 failed the quality test. Earlier on November 1, The Tribune reported that several batches of albendazole tablets had failed the “dissolution test parameter of IP (Indian Pharmacopoeia) 2018” while one batch also failed to comply with the “uniformity of weight” and “assay test by UV”.

The sources said the report regarding the remaining batches was yet to come. For initiating a legal action, the state drug controller has taken samples of the tablets for testing at a government laboratory. The HMSCL has already blocked purchase orders from Maiden Pharmaceuticals, besides withdrawing medicines procured from it last year. Earlier, the Food and Drugs Administration (FDA), Haryana, had ordered Maiden Pharmaceuticals to stop manufacturing operations.

Test report of syrups awaited

  • After WHO flagged concern, a Central team collected samples of cough syrups from Sonepat firm for testing at CDL, Kolkata
  • The report was expected in a fortnight, but Haryana Health Department yet to get it

#sonepat

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