Sub-standard drugs are a major issue for the health system and, thus, any violations and deviations cannot be ignored, the Court emphasised.
The Allahabad High Court recently declined to quash proceedings under the Drugs and Cosmetics Act against the directors of a company accused of manufacturing sub-standard cough syrup that caused deaths in Uzbekistan [M/S Marion Biotech Pvt Ltd and 5 others v. Union of India and another]
The World Health Organization (WHO) in 2023 had issued a warning related to two cough syrups manufactured by Marion Biotech. One of the cough syrups allegedly led to the death of more than 18 children in Uzbekistan, according to the Government of India.
The company along with five of its directors and officials in 2024 moved the High Court seeking quashing of a summoning order passed against them by the Chief Judicial Magistrate at Gautam Budh Nagar on a complaint moved by the Drug Inspector in Uttar Pradesh.
Declining to interfere with the proceedings, Justice Harvir Singh opined that the Drug Inspector operated well within his statutory mandate, collecting samples and initiating prosecution based on objective lab analysis.
“The complaint lays out the basis for prosecution, and the analytical report constitutes adequate prima facie evidence for the case to proceed in accordance with law. It is further noted that, having a license to manufacture the certain drugs is not sufficient and absolute. However, the company has to comply with the conditions of license, is equally important and, if there is any violation in respect of the conditions, given in the license itself, an appropriate case can be made out against the revisionists, as such the revisionists have violated the conditions of license, as enumerated in Section 78 of the Act,” the Court added.
Counsel appearing for the company argued that the Drugs Inspector’s complaint did show any direct involvement of the directors or other functionaries in the alleged offences.
It was also argued that examination for diethylene glycol and ethylene glycol in this case was not mandated, but it was done only upon a special request by the Drug Inspector.
However, the Court noted that the use of ethylene glycol in manufacturing the cough syrup was completely prohibited under the British pharmacopoeia, which was applicable at the time of manufacturing the drugs in 2021.
It added that as per the findings of the Central Drugs Standard Control Organisation (CDSCO) and State Drugs Control, Uttar Pradesh, the company failed to produce the manufacturer/supplier certificate of analysis of propylene glycol, in violation of Section 18-B of the Act.
Further, the Court found that the propylene glycol was purchased from a company which did not hold any drug licence required to sell or distribute it.
“The DOK-I Max syrup manufactured by the revisionists, was found poisonous in Uzbekistan, which resulted in death of more than 18 children,” the Bench recorded in the order.
Justice Singh also remarked that enforcement of public health laws cannot be thwarted by mere technical objections. Sub-standard drugs are a major issue for the health system and, thus, any violations and deviations cannot be ignored, the Court emphasised.
