NEW DELHI: The deaths of 12 children in northern India between December 2019 and January 2020, police allege, were caused by adulterated cough syrup made by drugmaker Digital Vision. It was not the first time the company's medicines have come under scrutiny.

Indian drugs regulators found quality shortfalls in drugs made by Digital and its unit Orison Pharmaceuticals at least 22 times between 2012 and July this year, according to a Reuters review of records from five states and India's federal drugs regulator CDSCO.

The medicines either did not contain the claimed volume of ingredients or failed to dissolve quickly enough for absorption by the body, according to the records.

Digital Vision founder Parshottam Goyal downplayed the shortfalls. "Drug samples of every company fail on some criteria every now and then: small mismatches in the quantity of medicines and things like that," he told Reuters, when asked about the regulators' warnings.

Tests by government laboratories in 2020 found that a batch of Digital Vision's COLDBEST-PC cough syrup taken by the children in the northern region of Jammu and Kashmir contained high levels of toxic chemicals. The company has denied this and said its syrup was not to blame for the wave of poisonings, without providing proof.

Maiden Pharmaceuticals - whose cough syrups have been linked to deaths of at least 70 children in Gambia last year – had also been alerted by regulators to quality shortfalls in some of its drugs.

Regulators found at least 10 medicines produced in India by Maiden were "not of standard quality," according to records shared by India's Department of Pharmaceuticals with parliament in March. The eastern state of Bihar in 2011 banned the company for five years for selling substandard medicines there.

India's health ministry and the CDSCO did not respond to requests for comment.

Maiden, which has denied its cough syrup was responsible for the deaths in Gambia, did not respond to requests for comment for this story.

When Maiden produced the syrups exported to Gambia in late 2021, its founder, Naresh Kumar Goyal, and Technical Director Mahender Kumar Sharma were already on bail since March 2018 in a separate case on charges of illegally storing substandard medicines, according to documents from a court in Haryana state.

Goyal did not respond to requests for comment; Sharma could not be reached.

The court documents show that inspectors visited Maiden's factory in 2014 after Vietnam had banned the company the previous year for allegedly selling another heartburn drug there that did not meet specifications.

Maiden's lawyers told the court in Haryana its own testing had shown the drugs discovered by the Indian inspectors fell short and it had not intended to sell them.

But the court in February this year found "substandard quality medicines were kept for the purpose of its sale to derive undue gain" and that "such types of sub-standard quality drugs were also exported" to Vietnam.

It sentenced Goyal and Sharma to two and half years in jail. They pleaded not guilty, appealed in a higher court, and have been on bail again since March while their petition is heard.