Mumbai : Drug maker Abbott on September 14 said it is implementing corrective actions at its Goa-based facility from where it had produced antacid Digene Gel that was recalled from the market due to non-compliance with manufacturing norms. Earlier this month, regulator DCGI cautioned against the consumption of Digene Gel citing safety concerns even as the drug maker recalled several batches of the medicine manufactured at the Goa facility.
The drug regulatory body also advised doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the medicine’s use and for reporting of any adverse drug reactions arising due to consumption of the said product. Goa FDA officials had conducted multiple inspections of the plant after the drug maker announced the recall of the antacid produced at the site and found various lapses of manufacturing norms, including hygiene issues, industry sources said.
“We voluntarily stopped Digene manufacturing at our Goa site upon the receipt of the first complaint, recalled all of the Digene Gel manufactured at the site and immediately began implementing corrective actions,” the drug maker said in a statement. The letter issued by the Goa FDA and their recent visit to the company’s site is part of the regulatory procedure, it added.
The drug maker is in the process of responding to the drug regulator.
Reuters reported that “India’s Goa state has warned the local unit of Abbott Laboratories (ABT.N) it plans to suspend the manufacturing licence of its antacid medicine after inspectors flagged contamination risks and sanitization issues at its factory, government documents show.
The U.S. based drugmaker is locked in a tussle with drug regulators in the tourist state of Goa in western India after the company, starting in August, voluntarily recalled many batches of its Digene Gel syrup produced there after it received customer complaints on taste and odor.
The Goa plant is one of Abbott’s two factories in India, where Digene has a 7% share of the market for so-called antiflatulent medicines, according to healthcare data platform Pharmarack, which estimated annual Digene syrup sales at $11 million, with 8 million units sold.
Following the recall, inspectors conducted four inspections at Abbott’s Goa factory between Aug. 24 and Sept. 2 and flagged issues such as water stagnation in tanks and pipes, saying: “This may lead to the contamination and microbial growth,” confidential inspection reports reviewed by Reuters showed.
Following that, the state director of the Goa Food and Drugs department, Jyoti J. Sardesai, wrote a warning notice to Abbott on Sept. 11, saying: “I intend to cancel the product permission for all variants of Digene Gel/suspend the licenses held by you for a period deemed fit.”
The state authorities have given Abbott seven days to respond to the notice to defend its position.
Abbott India told Reuters in a statement it was in the process of responding to the notice by the Goa state regulator, adding the “letter issued by the Goa FDA and their recent visit to our site is part of the regulatory process.”
“Whatever protocol has been laid down for the state government to follow when it comes to handling such issues, that has been followed,” Goa Health Minister Vishwajit Rane told Reuters.
Inspection reports said they found sanitization was not done at the Goa factory as per standard operating procedures, and records showed batches in question were kept for 21 days after manufacturing in a holding tank without mixing, “which may be the possible reason for contamination or growth of bacteria.”
the warning notice was issued even as Abbott, in a letter to Goa regulators on Aug. 28 seen by Reuters, stated it will take “corrective and preventive measures” to address concerns, including those related to cleaning processes.
Digene syrups in mint, orange and mixed fruit flavours are popular across India. The medicine continues to be manufactured by Abbott at its other Indian factory in Himachal Pradesh state, though the drug’s manufacturing in Goa has been halted by the company.
Inspection documents said the Digene recall affected 179 batches of 7.6 million bottles, many of which would have been consumed. By the end of August, 486,439 bottles were yet to be recalled.
Goa authorities have also ordered Abbott to stop the manufacturing or filling of liquid products which used “common facilities” as those for Digene, leading to a halt in making laxative syrups Cremaffin and Duphalac at the plant.”
