Udhampur Infant Deaths: Cough Syrup Maker Failed Drug Tests 5 Times In 5 Years

Chandigarh, 8 March 2020:

Having failed drug quality tests at least five times in the last five years, Himachal Pradesh’s Kala Amb-based drug manufacturer, whose adulterated cough syrup killed 12 children in Jammu & Kashmir’s Udhampur district, seems to be a habitual offender.

First in 2015, samples of amoxicillin and clavulanate potassium tablets produced by Digital Vision Pharma Pvt Ltd failed the test, stated a report issued by the state drugs control department. Then between 2014 and 2019, other drug samples — including rabeprozole sodium (sold under the name Rebz 20); domperidone, diclofenac potassium, paracetamol voxmic-D and Rabizole DSR — too failed to meet the quality standards, it mentioned.

Though the state drug controller claimed that action was taken against the firm, it didn’t appear to have stopped it from making sub-standard, and even deadly drugs, for five years in a row.

“Action was taken against the pharma company from time-to-time,” said state drug controller Navneet Marwah, adding, “Its drug samples were procured from various chemist shops across the state, but the adulteration found in the medicines was not life-threatening.”

Marwah, however, agreed that the cough syrup goof up was of serious nature as it resulted in the deaths of a dozen infants. “Cases under different sections of the Drugs and Cosmetics Act have been registered against the manufacturer. An FIR has also been filed under Section 308 of the Indian Penal Code,” he said.

Meanwhile, the regional drugs testing laboratory has also confirmed that ColdBest-PC syrup, which caused the deaths of nine infants in Ramnagar area of Udhampur, was contaminated with diethylene glycol (DEG) — a chemical used to make polymers. In its report of March 2, the regional lab noted that the syrup was “not of standard quality” as prescribed by the Drugs and Cosmetics Act. The tested sample contained 38.87% of DEG, it said.

On March 3, an FIR was filed under Sections 17-A and 27 (a) of the Drugs and Cosmetic Act, making it a non – billable offence.

In February, PGIMER Chandigarh had also collected 33 samples from batch number DL 5201 of the cough syrup during their team visit to Ramnagar. These samples too were found to contain DEG, which reportedly led to kidney failures among the children resulting in their deaths.

Of the 17 children who fell ill after consuming the cough syrup, nine had died between December end last year and January 17, 2020. All of them had been hospitalised with acute kidney failure.

The drug manufacturing unit was set up in 2009. There are nearly 650 units of pharma companies in Himachal Pradesh. Majority of them are situated in Solan, Sirmaur, Mandi and Kangra districts. Hindustan Times