Now, epilepsy drug fails quality test

Sodium Valproate, an antiepileptic medication that controls seizures or fits, has reportedly “not met the standard quality” in an examination done at RDTL in Chandigarh.
Image used for representational purpose.
Image used for representational purpose.

NEW DELHI: Days, after samples of multiple drugs available at major government hospitals and Aam Aadmi Mohalla clinics failed the quality test, prompting L-G VK Saxena to recommend a CBI investigation into the matter, samples of a medicine used for treating epilepsy, are spurious.

Sodium Valproate, an antiepileptic medication that controls seizures or fits, has reportedly “not met the standard quality” in an examination done at the Regional Drug Testing Laboratory, Chandigarh (RDTL). One-third of the samples sent for testing failed the quality examination, the report revealed.

“In dissolution test, out of 24 units seven units were found less than Q-15 and one unit was found less than Q-25, as per IP 2022 the limit of Q is NLT 75%,” the report said. “In the opinion of the undersigned, the sample referred to above is not of standard quality as defined in the Drugs and Cosmetics Act, 1940.

The samples do not conform to the claim as per IP 2022 concerning the dissolution of Sodium Valproate,” Hitesh Kumar Khare, government analyst at RDTL said in the report. Sources said that samples of Sodium valproate were collected from IHBAS hospital.

On Sunday, Saxena recommended a CBI investigation into the procurement and supply of allegedly spurious drugs at Delhi government-run hospitals and the AAP-led city government’s mohalla clinics after a large number of samples from five certain drugs failed the quality check.

The drugs allegedly found spurious include Cephalexin, a life-saving antibiotic for the treatment of lung and urinary tract infections; Dexamethasone, a steroid for curing life-threatening inflammation in lungs, joints and swelling in the body.

Pantoprazole, a proton pump inhibitor used for the treatment of stomach ulcers; Levetiracetam, an anti-epilepsy and anti-anxiety psychiatric drug; and Amlodipine administered for hypertension, are also under scanner. The Drug Controller randomly collected 86 drug samples from IHBAS, Lok Nayak and Deen Dayal Upadhyay and sent 43 each to the approved govt and private labs for testing.

According to the vigilance department, over 10% of samples of the drugs collected for quality assessment failed the test. “Out of 43 samples that were sent to government labs, 3 samples failed the test and 12 reports are still pending. Further, out of another 43 samples sent to private labs, 5 samples failed,” the report filed by the department to the L-G stated.

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