The samples of sodium valproate, critical for managing epilepsy and seizures, were found spurious during the ongoing examination of drugs undertaken after Lieutenant Governor VK Saxena recommended a CBI inquiry into the alleged supply of non-standard drugs—including some live-saving medicines—to Delhi government hospitals and the AAP’s flagship Mohalla Clinics.
According to sources, the epilepsy drug samples were found to have failed the tests at the Regional Drug Testing Laboratory (RDTL), Chandigarh. A series of medicines being provided to patients at hospitals under the Delhi government and Mohalla Clinics were “not meeting the standards”, they added.
“Sodium Valproate was found to be not meeting the standards…The drug is being supplied in Delhi government hospitals and was found to be of ‘not of standard quality’ in a report issued by the government analyst, that is the RDTL, on 22nd December 2023,” a source said.
According to the sources, the test report stated that the sample was “not of standard quality as defined in the Drugs and Cosmetics Act, 1940…” as it did not conform to the “claim as per IP 2022 in respect to the Dissolution of Sodium Valproate.” “In the 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%…,” according to the report.
Hitting back after Saxena’s allegations last week, Health Minister Saurabh Bharadwaj sought the suspension of the health secretary and other officials, claiming that no action was taken on his direction to conduct an audit of the medicines procured.
Raising the issue in a note to Chief Secretary Naresh Kumar, Saxena had attached a Directorate of Vigilance report on the matter.
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Following complaints of “substandard medicines” being supplied to Delhi government hospitals, the drugs controller under the health department had sent samples for testing. The lab reports were then sent to the vigilance department for necessary action.
According to officials, samples were collected from three major hospitals—IHBAS (Institute of Human Behaviour and Allied Sciences), Lok Nayak Hospital and Deen Dayal Upadhyay Hospital.
The allegedly spurious drugs 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; levetiracetam, an anti-epilepsy and anti-anxiety psychiatric drug; and amlodipine for hypertension.
The Vigilance report, reviewed by The Indian Express, says the lab reports found that over 10 per cent of the samples were found to be “not of standard quality”. Of the 43 samples that were sent to government labs, three samples failed the test while reports on 12 samples are pending. Of another 43 samples sent to private labs, five failed the test.
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The vigilance department recommended that since over 10 per cent samples had failed, distribution of such medicines should be stopped immediately and the scope of sampling should be increased. It also sought to investigate the role of suppliers under the health department, other than the Central Procurement Agency, that had procured the drugs.
Addressing a press conference, Bharadwaj had asked why the central government was not taking action against Health Secretary SB Deepak, who he said was responsible for drug procurement.
“I have issued several directions about the audit of these drugs but no action-taken report has been submitted by the officials… The Centre has ended the accountability of officials to the health minister, so what more can we do? The officials do not listen to our orders at the meetings,” Bharadwaj said.
On Wednesday, the Delhi BJP held a protest near the AAP headquarters over the issue. Addressing protesters, Delhi BJP president Virendra Sachdeva said, “Today, another sample report has arrived and that was also found to be fake. The tender for the medicines whose samples were found to be fake had ended.”
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The AAP, in turn, accused the BJP of “spreading blatant lies” on the matter by calling the said drug sample spurious. “Basically, the test report being shared by BJP says it has got all genuine ingredients (salt formulation). The only thing which is not standard is the dissolution of this drug. This in layman terms means a standard drug may dissolve in 30 seconds in the body while this sample may take 40 seconds,” it stated.
