UP FDA bars IPCA Lab from supplying drugs to hospitals

A drug maker is required to get permission from the state drugs controller under section 104A of D&C Rules, 1945 to put ‘only hospital supply’ stamp on drugs meant for hospitals and physicians.

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FDA

Last Updated on March 10, 2021 by The Health Master

The Food Safety and Drug Administration (FSDA), Uttar Pradesh has barred Ipca Laboratories, Lucknow from supplying pharmaceutical products to hospitals and medical practitioners in the absence of permission from state drugs controller under Section 104A of Drugs and Cosmetics Rules, 1945.

A drug maker is required to get permission from the state drugs controller under section 104A of D&C Rules, 1945 to put ‘only hospital supply’ stamp on drugs meant for hospitals and physicians.

But Ipca drugs supplied to healthcare facilities lacked a stamp of ‘only hospital supply’ as the drug firm has not taken approval from the drugs controller for the same, said assistant commissioner (drugs), FSDA, Manoj Kumar.

Medicine
Picture: Pixabay

This came to light when a FSDA team conducted raids at premises of Ipca CFA, Lucknow and its authorised hospital supply distributor in Lucknow, Sainath Enterprises on January 11, 2021 following a complaint by Nadie Jauhari.


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Jauhari in a letter to the drugs controller, Uttar Pradesh stated that Ipca goods are supplied to Sainath Enterprises which is authorised by the company for hospital supply at special rate and Sainath in turn raises bills in the name of hospitals and physicians but goods are never sent to them.

The products meant for hospitals are actually sold to drug retailers at discounted rates. The difference in market rate and discounted price is shared between the sales team and Sainath, the letter added.

“The FSDA team collected samples of six suspicious medicines during the raids and sent it to the laboratory for testing. The report is awaited Based on the record seized during the raid at Sainath, we sent notices to 23 private medical practitioners, hospitals, institutions asking them whether they have received supplies from Sainath.

The notices had sale invoice number of Ipca instead of sale invoice number of Sainath which was later corrected by FSDA. We further sent notices to seven healthcare facilities and doctors. So far seven healthcare facilities confirmed that they have received supplies from Sainath,” said assistant commissioner (drugs).

Based on their responses, FSDA concluded that neither Ipca CFA nor Sainath Enterprises complied with provisions of D&C Rules, 1945 with respect to hospital supplies.

It issued a notice to Ipca CFA Lucknow prohibiting it from supplying drugs to Sainath and other government and private healthcare facilities from March 1, 2021 till further order.

The FSDA also suspended licence of Sainath from March 1, 2021 till further order in absence of stamping of ‘only hospital supply/institutional supply’, thus the firm was barred from supplying medicines to hospitals and doctors.

The action was taken against Ipca CFA and Sainath under section 22(1)(d) of D&C Rules, said assistant commissioner (drugs), adding that the investigation is going on and responses of 23 doctors and hospitals are awaited.

Kumar communicated this to the commissioner, FSDA in a letter on March 5, 2021.

Earlier on February 23, 2021 Sanjay Prasad, principal secretary to chief minister had also ordered secretary, FSDA department to conduct an inquiry into Nadie Jauhari’s complaint against malpractices of Sainath Enterprises.

The secretary, FSDA directed the assistant commissioner (drugs) to look into the matter. When contacted Sunil Ghai, president (marketing), Ipca Lab, he did not turn up for comment.

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