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Haryana shuts Maiden Pharma production, issues notice for 12 violations — details here

Haryana shuts Maiden Pharma production, issues notice for 12 violations — details here

Haryana shuts Maiden Pharma production, issues notice for 12 violations — details here
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By Timsy Jaipuria  Oct 12, 2022 1:01:46 PM IST (Updated)

Maiden Pharma has seven days to reply to the show cause notice issued by Haryana's Food & Drugs Administration. Read about the violations mentioned in the notice here.

Haryana has shut production of drugs at Maiden Pharmaceuticals, and the state Food & Drugs Administration has issued a show cause notice for 12 violations found at its plants. This company has been under the scanner over cough syrup-linked deaths of more than 60 children in the Gambia, West Africa.

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Haryana Home Minister Anil Vij has confirmed the state stopped the production of cough syrups and that around 12 flaws were found after the central and Haryana state drug departments conducted a joint inspection.
"Samples of three drugs mentioned by the WHO (World Health Organization) of Sonipat's pharmaceuticals company were sent to the Central Drug Lab in Kolkata. The reports are not in yet. Action will be taken after that," he was quoted by ANI as saying.
The four cough syrups linked to the deaths are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
The firm now has seven days to reply to the show cause notice, "failing which ex-parte action shall be liable to be taken against you as per the Drugs and Cosmetics Act 1940 & Rules, 1945," the notice accessed by CNBC-TV18 read.
During the probe, the team of the state drug controller found that the entire factory was under renovation. They also listed 12 violations by the plant in the show cause notice.
About the violations
1. According to sources, Maiden Pharma failed to produce the log books of equipment and instruments regarding manufacturing and testing for cough syrups.
2. Quality testing of propylene glycol for diethylene glycol and ethylene glycol was missing. Maiden Pharma didn’t perform the quality testing of Propylene Glycol for Diethylene Glycol and Ethylene Glycol. The notice said that Propylene glycol (batch number E1007/UP, E1105149) had failed as per the certificate of analysis for the test in respect of water but was declared as of standard quality.
3. Maiden Pharma did not even perform process validation and analytical method validation for the four cough syrups.
4. The firm has submitted the six-month real-time and accelerated stability data of four cough syrups. However, at the time of investigation, none of the cough and cold syrups was found to be charged (monitored) in the stability chamber.
5. In the notice, the State Drug Controller said the batch numbers, manufacturer name, and manufacturing and expiry dates were not found on purchase invoices of items used, including propylene glycol.
“As per report no. MPLR22031105 batch number, manufacturing date and expiry date of propylene glycol were not found mentioned. The said batch also failed in respect of water,” the notice added.
The Propylene glycol (batch number E009844), having a manufacturing date of September 2021 and an expiry date of September 2023, was used in the manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n Cold Syrup.
These products had a product expiry of November 2024, demonstrating that the shelf life of the product was more than that of raw material.
Also, batch numbers of propylene glycol and sorbitol solution used in manufacturing the controversial cough syrups were not found in the certificate of analysis (CoA) report.
Similarly, the batch number of sodium methylparaben, which was also used in the cough syrup, was also missing from the Council of Architecture (CoA) report.
DGFT keeping a close eye on Maiden Pharma
The Directorate General of Foreign Trade (DGFT) is in touch with Haryana State Drug regulatory authority for a detailed update on Maiden Pharma. The firm is also under the scanner of the Importer-Exporter Code (IEC).
IEC is the business identification number which mandatory for export from India or Import to India
Based on a detailed report filed by Haryana state Drug regulatory authority, the DGFT will act on Maiden Pharma IEC. In case of a negative report by the Haryana drug controller, Maiden's IEC will be suspended.
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