Haryana regulator raises red flag over glaring lapses at Maiden Pharma plant

The four cough syrups linked to the deaths in the West African nation are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

FDA’s show-cause notice

The state FDA, while giving seven days for filing a reply, has asked Maiden Pharma as to why their manufacturing licence may not be cancelled.

“Your reply to this show-cause notice must reach this office within 7 days of the receipt of this notice, failing which ex-parte action shall be liable to be taken against you as per the Drugs and Cosmetics Act, 1940 & Rules, 1945,” read the show-cause notice issued by Manmohan Taneja, the State Drugs Controller Cum Licensing Authority, FDA, Haryana.

Also read: Indian pharma company under fire for Gambia child deaths has a history of selling substandard drugs

Officials inspected the Maiden Pharma plant twice in the first week of October, and served the company a show-cause notice under Rule 85(2) of the Drug Rules, 1945.

Violations detected at Maiden’s factory

Missing log-book: The inspection team found that the entire plant was under renovation.

According to the show-cause notice, Maiden Pharma failed to produce the log-books of equipment and instruments, regarding the manufacturing and testing of cough syrups.

Also read: Exclusive | Early probe finds violation in drug manufacturing process by Maiden Pharma

Missing quality-testing of propylene glycol for diethylene glycol and ethylene glycol: The Haryana FDA, in the show-cause notice, said that Maiden Pharmaceuticals didn’t perform quality-testing of propylene glycol, diethylene glycol and ethylene glycol.

The WHO has claimed that laboratory analysis of samples of each of the four products by Maiden Pharmaceuticals confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

According to the WHO, diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death,” the WHO said in a Medical Product Alert on October 5.

Not performed process validation: The FDA officials, in the notice, said that Maiden Pharmaceuticals has not performed process validation and analytical method validation for the four cough syrups, which have been red flagged by the WHO.

Also read: Urgent probe launched into Gambia cough syrup deaths as fatalities report awaited from WHO

The United States Food and Drug Administration (USFDA) defines the process validation as the collection and evaluation of data for drugs, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Cough syrups not found in stability chamber: The Haryana drugs controller said that the firm has submitted the six-month real-time and accelerated stability data of the four cough syrups. However, at the time of investigation, none of the cough and cold syrups were found to be charged (monitored) in the stability chamber.

Manufacturing, expiry dates missing on CoA propylene glycol: The state authorities further said that the manufacturing and expiry dates were missing on the certificate of analysis (CoA) of certain batches of propylene glycol.

“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,” the notice said.

“As per report no. MPLR22031105 batch number, the manufacturing date and expiry date of propylene glycol were not found mentioned. The said batch also failed in respect of water,” it added.

Also read: Maiden Pharma’s factory wears a deserted look as its fate hangs in the balance

The state drugs controller, in the notice, said that the batch numbers, manufacturer’s name, and manufacturing and expiry dates were not found on the purchase invoices of items used, including propylene glycol.

Shelf-life of drugs fixed longer than raw material expiry: The Haryana FDA, in the notice, said that propylene glycol (batch number E009844), having the manufacturing date of September 2021 and expiry date of September 2023, was used in manufacturing Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n Cold Syrup, having a product expiry of November 2024, demonstrating that the shelf-life of the product was more than that of the raw material.

Missing batch numbers: The state FDA’s notice also shows that batch numbers of propylene glycol and sorbitol solution used in manufacturing the controversial cough syrups were not found in the CoA report.

Similarly, the batch number of sodium methyl paraben, which was also used in the cough syrup, was missing from the CoA report.

MoneyControl reached out to Taneja, the State Drugs Controller Cum Licensing Authority and Rakesh Dahiya, Senior Drug Control Officer, Sonipat, who was part of the inspection team for a comment, however, they didn't respond.

The calls to Naresh Goyal, Managing Director, Maiden Pharmaceuticals were not answered.