Haryana-based Maiden Pharmaceuticals, which had been linked to the deaths of 70 children in The Gambia in October due to its contaminated cough syrups, has now been convicted in a 2013 case of exporting substandard medicine to Vietnam, The Tribune reported on Saturday.
On February 22, a district court in Haryana’s Sonepat held the pharmaceutical company, its Director Naresh Kumar Goyal and Technical Director MK Sharma guilty of exporting poor quality ranitidine hydrochloride tablets under the brand name BP(Mantek-150). Ranitidine tablets are used to cure heartburn.
Both Goyal and Sharma have been sentenced to two-and-a-half years of rigorous imprisonment and fined Rs 1 lakh each under Section 27 (d) of the Drugs and Cosmetics Act, The Tribune reported.
What’s the case about?
The case dates back to December 2013, when Deepak Mittal, the Indian consul general at Vietnamese capital of Ho Chin Minh City had flagged to New Delhi’s health ministry that 46 Indian companies, including Maiden Pharmaceuticals, had been blacklisted by the east Asian country for supplying substandard drugs.
In a letter, Mittal had urged the health ministry to run background checks on the 46 companies and “penalise them for bringing bad name to the Indian pharma industries abroad”, The Wire reported.
In an inspection of samples of the ranitidine tablets from Maiden Pharmaceuticals in 2014, the Regional Drug Testing Laboratory in Chandigarh declared them as “Not of Standard Quality”.
The tablets did not have uniform active ingredients of the ranitidine drug, the government laboratory noted. In September 2014, the officials sent a notice to Maiden Pharmaceuticals, asking the company to stop the sale and distribution of the medicine and withdraw its stock from the markets immediately.
In its reply to the notice, Maiden Pharmeacuticals had informed the drug officials that 61,000 BP (Mantek-150) tablets had been stored along with another batch of the medicine. The Sonepat district court held that this was admission of guilt that Maiden Pharmaceuticals failed to comply with Clause 2.6 of Drugs and Cosmetics Rules, which mandate that “rejected materials” have to be stored separately.
The Gambia case
In October, the World Heath Organization had issued a global alert for contamination in the cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by Maiden Pharmaceuticals.
The world health body had said that its laboratory analysis of the syrups confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
In December, a parliamentary report submitted by The Gambia’s government confirmed that Maiden’s syrups were linked with acute kidney failure in children.
However, Drugs Controller General of India VG Somani wrote to Rogerio Gaspar, director (regulation and prequalification) at the World Health Organization, saying that the samples of the cough syrups tested in government laboratory were found to be complying with specifications.
Soon after the WHO alert issued in October, the Haryana government had suspended drug manufacturing at Maiden Pharmaceuticals’ Sonipat unit. The central and state drug departments had conducted a joint inspection and found 12 flaws in the medicines and their manufacturing process.