 "Medicines, Pharma")
A Haryana court has sentenced to two-and-a-half years in jail two executives of a pharmaceutical company, which was recently under the scanner for alleged cough syrup related deaths in Gambia, in another case of export of sub-standard drugs to Vietnam nearly a decade ago.
Additional Sessions Judge, Sonipat, Sanjeev Arya, sentenced Naresh Kumar Goel, Director of Maiden Pharmaceuticals, and Mahender Kumar Sharma, Technical Director, to jail and also imposed a fine of Rs one lakh each.
The complainant, a drug inspector of the Central Drugs Standard Control Organisation (CDSCO), North Zone, Ghaziabad, had inspected the manufacturing premises of the company here to investigate the matter regarding the export of medical products from India to Vietnam in 2014.
A sample of drugs was taken by the complainant during the investigation for testing and analysis.
One portion of the sample was sent to Government Analyst, for a test at Regional Drugs Testing Laboratory Chandigarh in March 2014. After analysis, the Government Analyst of Regional Drugs Testing Laboratory, Chandigarh, declared the sample as not of Standard Quality, according to the complainant.
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It was alleged that the company did not maintain the quality standard of drugs as required under the rules for exporting them to Vietnam.
The court, in its verdict delivered last week, held that the complainant has duly proved the charge against the accused.
"Looking into entire facts and circumstances either on the factual or legal front, this court has come to the conclusion that the complainant/ prosecution has duly proved the charge by leading substantial piece of oral evidence corroborated with documentary evidence under section 27 (d) for contravention of section 18 (aa) (i) of Drugs and Cosmetic Act, 1940, beyond a shadow of reasonable doubt," read the order.
In October, the WHO issued an alert saying cough syrups manufactured by the company could potentially be linked to the death of children in Gambia.
However, after an inquiry, India's drug regulator told the global health body that it drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe.
In a letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Drugs Controller General of India (DCGI) Dr V G Somani said a statement issued by the global health body in October in the wake of the deaths "was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products".
The DCGI said Gambia has informed, according to media, that there has been no direct causal relation established yet between the cough syrup consumption and the deaths, and that certain children who had died had not consumed the syrup in question.
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in a government laboratory here were found to be complying with specifications and not contaminated with diethylene glycol (DEG) and ethylene glycol (EG).
Cough syrup samples of Maiden Pharmaceuticals have been found to be of standard quality, the government had also told Parliament.
Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drug Controller, Haryana had carried out a joint investigation of Maiden Pharmaceuticals in Kundli, Sonepat to ascertain the facts.
During the investigation, it was revealed that the State Drug Controller, Haryana had given licences to the company for the manufacture of four drugs for export only, Minister of State for Chemicals and Fertilisers Bhagwanth Khuba said in a written reply in Rajya Sabha on December 13.
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