Goa, where Abbott has one of its two India plants, asked the company to halt production of Cremaffin and Duphalac syrups last month. The request followed the recall of another Abbott drug which triggered factory inspections by health officials who found contamination risks and sanitisation issues.
Enhance Your Healthcare Expertise with High-Impact Courses
| Offering College | Course | Website |
|---|---|---|
| IIM Kozhikode | IIMK Healthcare Management & Analytics Programme | Visit |
| Indian School of Business | ISB Healthcare Management | Visit |
The two laxative brands together have estimated annual sales of $70 million in India, healthcare data firm Pharmarack says.
In a letter to Goa’s Directorate of Food and Drugs Administration dated Sept. 18, which is not public and has not previously been reported on, Abbott pushed state regulators to allow it to restart manufacturing the two medicines.
“The two products have a high consumption rate and are highly prescribed,” Abbott said in the letter seen by Reuters. “We are likely to face a supply shortage of these two products,” it warned.
Cremaffin, Abbott argued, is a “necessity to support hospitalised patients” while Duphalac is prescribed in serious disorders caused by liver failure. Abbott in India and the Goa FDA spokesperson did not immediately respond to requests for comment. India is a major market for Abbott. Its currently regulatory challenges in the country began in August with the recall of thousands of bottles of its popular Digene Gel antacid syrup following complaints about its taste and odour.
Abbott has since halted production of Digene but says there is no impact on patient health.
Drug inspectors who visited the Goa facility following the recall flagged issues such as water stagnation in tanks and pipes, saying it could lead to contamination and microbial growth.
They asked the company to fix the problems and the FDA warned it could revoke the manufacturing licence for Digene syrup, Reuters reported earlier this month.
In its latest letter, Abbott told Goa authorities it had taken corrective steps, segregating the manufacturing lines of different drugs and changing its cleaning protocols.
“We are committed to invest and upgrade the manufacturing site,” it said, asking that no action on the licence be taken.
