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Haryana Court Convicts Maiden Pharma Directors In Substandard Medicines Case

A local Sonepat court sentenced the directors of Maiden Pharmaceuticals to jail, along with a Rs 1 lakh fine.

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A local Sonepat court, on 22 February, sentenced the director and technical director of Maiden Pharmaceuticals to two-and-a-half years of jail, along with a Rs 1 lakh fine to each, for supplying substandard medicines to Vietnam in 2013.

Maiden Pharmaceuticals has also been in the news since last year after cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – made by the company were linked to the deaths of 66 children in the Gambia in October.

Here’s all you need to know about the case.

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The Case In Question: Back in 2013, after Vietnam blacklisted 46 Indian companies for supplying “substandard drugs,” the Indian Consul General in Vietnam, Deepak Mittal, wrote to the health ministry to run a background check on these companies and “penalise them for bringing (a) bad name to the Indian pharma industries abroad.”

Following this, drug control officers from Chandigarh’s Regional Drug Testing Laboratory ran tests on Ranitidine 150 mg (Mantek-150) tablets produced by the company and declared them to be “Not of Standard Quality.”

Since the drugs lacked “uniformity of active ingredients,” the company was asked to cease their sale, reported The Wire. However, the company responded that the batch in concern was not sold anyway since an internal inquiry had also ascertained that they were not of the standard quality. 

The company was found violating clause 2.6 of the Drugs and Cosmetics Rules 1945 since they had not segregated the rejected material (the 61,000 tablets of ranitidine) from the material that was fit for sale.

Ultimately, the company directors were sentenced under Section 27 (d) of the Drugs and Cosmetic Act 1940.

Time For Jail, Then? Not yet. According to news reports, the directors could appeal against the quantum of the sentence in a higher court till the stipulated time period on or before 23 March.

In News Since Last Year: The World Health Organization had issued an alert against the sale of the company's four cough syrups after the Gambia held Maiden responsible for the deaths.

They stated that these cough syrups contained excessive amounts of diethylene and ethylene glycol which were contaminants. 

After this, while the Haryana government had stopped operations at Maiden Pharma’s Sonipat unit, the Drugs Controller General of India, VG Somani, had gone on record to say that the cough syrups did not contain any contaminants.

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