New Delhi: The Himachal Pradesh government plans to file an FIR against the maker of Coldbest-PC cough syrup, which has allegedly led to the death of nine infants in Rampur, Udhampur district, Jammu & Kashmir, and one death in Haryana, ThePrint has learnt.
Brand Coldbest-PC is manufactured by Himachal Pradesh-based pharmaceutical company, Digital Vision, which has a history of selling products of inferior quality.
A team of doctors from Postgraduate Institute of Medical Education & Research, Chandigarh had detected a poisonous substance ‘diethylene glycol’ in the syrup. To re-check the report, the state and central government are awaiting the second report for the same samples sent to the Regional Drug Testing Laboratory (RDTL), Chandigarh.
“We are awaiting the results of samples sent to RDTL, Chandigarh, for verification of the allegations. If the fresh report also establishes similar findings, we will file the FIR against the drug firm,” Navneet Marwah, state drug controller, Himachal Pradesh, told ThePrint.
The punishment for distributing spurious drugs that can cause death includes 10 years to life imprisonment and a fine of Rs 10 lakh or three times the value of drugs confiscated, according to Drugs and Cosmetics Act, 1940.
So far, the government has cancelled the manufacturing license of the company along with seizing the available stock.
On 15 February, the Jammu-based state drug controller had sent a letter to Marwah to inspect the manufacturing unit and implement drug recall in “the larger public interest”.
“As soon as we received the letter, within half an hour, we suspended the license of Digital Vision, stopped manufacturing and sent samples for testing to RDTL for further testing,” said Marwah.
Govt yet to trace 3400 bottles with possible contamination
Authorities, however, are yet to trace at least 3,400 bottles of the cough syrup that could be possibly contaminated.
“A September 2019 batch of cold syrup was found to contain the poisonous impurity. Around 1,400 bottles of the batch have been seized and 600 have been taken by various agencies for sampling,” Marwah said.
“About 3400 bottles have been sold and possibly consumed,” he added. “We have information from CDSCO (Central Drugs Standard Control Organisation) that they have tried to reach the end users in Saharanpur, Kanpur etc.”
Manufacturers are responsible for ensuring drug recall by contacting the drug distribution network including individual chemists. “This was a small manufacturer; it is not difficult to manage the drug recall in such cases,” said an official from CDSCO.
The CDSCO had, in 2017, also published guidelines on recalls and a “rapid alert system” for such drugs but it hasn’t been converted into rules and enforcement is ineffective.
“In this case, they (state and central drug authorities) have to actually identify the patients and people who it has been sold to and the government may also need to order a mandatory recall to take back the bottle especially if it contains a substance that can potentially cause death,” said Malini Aisola, co-convenor, All India Drug Action Network.
No arrests yet, inconsistent implementation of law
According to Xtended Licencing Laboratory and Legal Node, a database that tracks instances of substandard medicines, there have been seven cases from 2014 to 2019 when drugs manufactured by Digital Vision were found to be “not of standard quality”.
“The fact that we put these young lives at risk despite the history of this exact set of events says something about accountability of our drug regulation and its implementation” said Dinesh Thakur, public health activist who works on the issue of drug safety.
“The question now is what is different in this case? The answer largely rests on whether there is a transparent investigation and people who were responsible are held accountable. Only time will tell,” he told ThePrint.
However, in the case of deaths caused by contamination of drugs, the government has in the recent past made arrests immediately after the preliminary investigations.
For instance, in 2018, the Drugs Controller General of India — the apex body to regulate the quality of medicines in India — had filed an FIR against the Ghaziabad based vaccine maker, Biomed.
In this case, as many as 30 lakh children were believed to have received oral polio vaccine (OPV) contaminated with the type 2 polio virus manufactured by the firm.
While the preliminary investigation report had ruled out the chances of the adulteration happening at the company’s facility, the government had immediately arrested the company’s managing director, S.P. Garg.