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Setback: Himachal HC junks Digital Vision Pharma plea on cough syrup Coldbest PC testing
Shimla: Upholding the Sirmaur Chief Judicial Magistrate (CJM) order allowing the drug inspector to take additional samples of the seized syrup, the Himachal High court has rejected Digital Vision pharma's plea in a case of failure of samples of Coldbest PC cough syrup that claimed the lives of a dozen children.
The drugmaker along with its partner Parshottam Lal Goyal moved a couple of petitions with the court challenging the order given by Sirmaur Chief Judicial Magistrate (CJM).
The order permitted the Drug Inspector to draw additional samples of drug from the bulk seized by and in the custody of the Drug Inspector, for demand received from Government Analyst to send an additional sample for testing the drug for Diethylene Glycol, as the quantity sent earlier was found to be insufficient by Government Analyst to conduct test/analysis asked for.
This came in wake of the contaminated cough and cold medicine, Coldbest being flagged in various states, wherein, the Himachal government had in February booked the company, Digital Vision, for selling the "contaminated cough syrup".
Medical Dialogues had reported that Narendra Ahooja, State Drug Controller, Haryana had stated that "The same firm and supply chain was found indulging in the activity of manufacturing adulterated drugs called Coldbest, which allegedly costed the lives of many children at Udhampur, Jammu. After that various FIRs were filed against Digital Vision and Orison Pharma at Kala-amb, Himachal Pradesh, Ambala, and Panipat, and their licenses of manufacturing and marketing were suspended by the concerned competent authority i.e., state drug controller of Himachal Pradesh."
Also Read: DCGI Slams Drugmaker Digital Vision Over Contaminated Cofset AT Syrup, Issues Stop-Sale Order
According to the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, the children died due to a substance called ethylene glycol, a dye present in the cough syrup.
In the instant case, the petitioners challenged the orders of the Sirmaur chief judicial magistrate (CJM) of March 11 and May 2 in the court. The petitioners pleaded not to send 20 bottles of samples taken on March 11 for testing but only four bottles, taken on February 26, for testing.
However, the court rejected the objections of the applicant. It noted;
"At the first instance only four bottles drawn as a sample at the initial stage should be sent and an additional sample of twenty bottles should be sent only in case the demand is raised by CDL, Kolkata, is also rejected on the ground that the firm itself is claiming that delay in the process is causing harm to its business whereas by sending four bottles of the initial sample at first instance and sending of another twenty bottles of the additional sample, later on, would definitely consume more time in comparison to the manner in which learned CMJ, has ordered to send the samples to CDL, Kolkata i.e. both initial and additional sample together with a direction to CDL, Kolkata, to open four bottles first to conduct requisite tests and in case quantity is found insufficient, then to open additional sample of twenty bottles.
Although the magistrate allowed only four bottles to be opened for examination, he also made it clear that if the sample was inadequate, another 20 bottles will be tested.
Subsequently, Justice Vivek Singh Thakur dismissed the batch of petitions moved by the firm and observed;
"In aforesaid circumstances, request of Government Analyst for sending additional sample and action in sequel thereto, taken by the Drug Inspector and also order passed by learned CJM, is in consonance with the spirit of provisions of the Drugs and Cosmetics Act, 1940 and it cannot be termed as a step of framing new Regulations or creating law and procedure beyond the Statute or contrary to provisions and spirit of Statute."
It held;
"In view of the aforesaid discussion impugned orders dated 11.03.2020 and 02.05.2020 passed by learned CJM are upheld and petition(s) are dismissed, in aforesaid terms. Pending application(s), if any, also stand disposed of."
To access the judgment click on the link given below-
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751