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India convicts Maiden Pharma over substandard tablets

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Maiden Pharmaceutical, the Indian company with syrups associated with the death of over seventy children in the Gambia, has been convicted by a local court in Sonepat, India.

The company, along with its director Naresh Kumar Goyal and technical director MK Sharma were convicted over a substandard Ranitidine hydrochloride tablets BP (Mantek-150) case.

Both Goyal and Sharma have been sentenced to two years and six months of rigorous imprisonment and fined Rs 1 lakh each under Section 27 (d) of the Drugs and Cosmetics Act, 1940.

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During the trial, the prosecution submitted that due to the export of substandard quality drugs (to Vietnam) by the accused, the image of India had been adversely impacted.

Ranitidine tablet is used for treating heartburn.

The case against Maiden Pharmaceuticals dates back to 2013. The Consulate General of India in Vietnam informed the Drugs Controller General of India (DCGI) in December, 2013, that 46 Indian companies had been blacklisted for quality violation by the Drugs Administration of Vietnam. Maiden Pharmaceuticals was fourth on the list of blacklisted firms.

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The DCGI sent letters to all zonal and sub-zonal offices of the Central Drugs Standard Control Organization (CDSCO) on February 6, 2014, seeking a probe into the matter.

Dinesh Kumar, drug inspector at CDSCO’s sub-zone in Baddi, and Parveen Kumar, drug control officer, Sonepat, visited the firm’s premises in Sonepat on March 13, 2014. They sent samples of Ranitidine drug from the company’s “finished goods store” to Regional Drug Testing Laboratory (RDTL), Chandigarh.

The report from the RDTL, dated August 8, 2014, specified that the sample was not of standard quality as defined in the Drugs and Cosmetics Act, 1940, as “the sample does not conform to claim as per BP (British Pharmacopoeia) 2013 in respect of uniformity of weight and assay”.

A show-cause notice was issued to the firm on September 1, 2014. The CDSCO’s drug inspector asked the firm to stop the sale and distribution of drugs and withdraw the stock from the market immediately. The firm replied on September 19, 2014, that they had not sold the specific batch and admitted it was not of standard quality as per their internal quality control department. It further said that it couldn’t destroy the goods before the expiry date as per the excise rules and regulations.

After getting the prosecution sanction from the DCGI, a Sonepat court summoned the firm and its two directors on March 15, 2017, and thereafter the court proceedings started.

The court of Additional District and Sessions Judge Sanjeev Arya observed that the firm’s reply made it ample clear that 61,000 tablets of Ranitidine BP (Mantek-150) were not of standard quality, even then Goyal and Sharma did not adhere to Clause 2.6 of the Drugs and Cosmetics Rule, 1945, which calls for segregation of rejected products at the storage unit.

“Such areas, materials, or products should be suitably marked and secured,” said the court in its order dated February 22.

The court added that substandard drugs in the finished goods store made it clear that they were kept for the purpose of sale to derive undue gain and such substandard drugs were also exported, as a consequence Maiden Pharma was blacklisted.

On the filing of separate applications, the sentence of both directors was suspended for filing appeals before a higher court.

Source: The Tribune

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