29/11/2024
Spurious’ Drugs In Delhi Hospitals: Panel Gives Clean Chit
New Delhi, 29 Nov 2024: Nearly a year after Lieutenant-Governor (L-G) V K Saxena recommended a CBI probe into the procurement and supply of allegedly “spurious” and “substandard” drugs in Delhi’s government hospitals and mohalla clinics, an internal inquiry committee of the Directorate General of Health Services (DGHS) has found “no wrongdoing” under the provision of Drugs and Cosmetics Act, 1940, on the part of Central Procurement Agency (CPA) and DGHS officials, government officials, vendors and firms.
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As per a report submitted by Rajiv Bhargava, Assistant Drug Controller, Drugs Control Department, to the DGHS committee, teams from the Vigilance and Drug Control Departments had visited government hospitals across Delhi between July 24 and 26 this year to collect 43 samples, which were sent to government and private laboratories for testing. The report states that these drug samples were not found to be “substandard” or “spurious”, as alleged in a complaint to the Delhi government’s Vigilance Department.
A Delhi Health Department official told The Indian Express, “The DGHS report shows that there was no technical fault with the medicine samples.”
"An anonymous complaint to the CBI against “substandard” or “spurious” medicines had hit the supply of drugs like Amlodipine (for blood pressure), Sodium Valproate (for epilepsy and bipolar disorders), Levetiracetam (for seizures), Pantoprazole (for acid reflux and heartburn), Cephalexin (for respiratory infections) and Dexamethasone (inflammation) at Delhi government hospitals and mohalla clinics.
Spurious drugs are products that imitate others, mostly popular brands, and may not contain the active ingredient or the correct chemical composition required to treat a disease. Vendors supplying these drugs were also blacklisted following the complaint.
According to the DGHS inquiry committee report:
Of 43 samples (including those of Amlodipine, Sodium Valproate, Levetiracetam, Pantoprazole, Cephalexin and Dexamethasone) collected by it, six were found to be “not of standard quality” by either private or government laboratories, or both. The DGHS report states that “as per Section IV, general and special conditions of the tender reference, ‘not of standard quality’ is not a criminal act as per the tender conditions as well as the Drugs and Cosmetics Act 1940”
Reports from government laboratories found issues with related substances in Amlodipine and Levetiracetam. Sources in the Delhi Health Department said, “In the purification stage of manufacturing of active pharmaceutical ingredients, impurities are removed or it is ensured that they are either minimised and within permissible limits, so that they are not harmful or not present at all.”
Pantoprazole, Sodium Valproate, Dexamethasone and Cephalexin tablets did not comply with the standards for dissolution (the time taken by a drug to dissolve in the body). A Delhi Health Department official said, “Each tablet and formulation (like coated, uncoated, chewable and capsules) has a different dissolution time. Prescribed standards for each tablet and formulation is passed by the Drug Control Department every time it gives a nod to a medicine.”
The DGHS had submitted its inquiry report to the L-G, Delhi Chief Secretary and Principal Secretary, Health, on October 10. The report will now be sent to the Vigilance Department and the CBI.
During its investigation, the Vigilance Department had conducted interviews with three former heads of the CPA (which procures drugs and surgical items for all Delhi government hospitals, mohalla clinics and dispensaries), the DGHS head and vendors.
The internal inquiry committee report states that the former CPA heads had said during their interviews that none of the firms were ever blacklisted as per tender conditions, as was alleged earlier. The report said, “One of the vendors has not supplied any drugs to the CPA in the last 10 years.”
Recommending the acceptance of the closure report against the blacklisted vendor firms, the report submitted that the anonymous complaint to the CBI was “purely based on either professional rivalry or vested interests to falsely implicate vendor firms for reasons best known to them”.
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In his letter to the Vigilance Department on August 28 this year, CBI’s Superintendent of Police Rajiv Kumar had sought an action taken report from the Delhi Health Department. The letter had also stated that a high-level board set up by the Delhi government had raided hospitals and the CPA, and found a supply of “substandard” surgical items and “spurious” drugs. In its reply, the Vigilance Department had stated that it was unaware of such a raid by a high-level board.
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