The Botswana Medicines Regulatory Authority (BOMRA) has licensed an Indian drug manufacturer believed to be exporting “toxic” medical products.
Maiden Pharmaceuticals which has been flagged by the World Health Organisation after its cough syrup killed 66 children in Gambia lists Botswana among a half a dozen African countries that import its products.
WHO Director General Tedros Adhanom Ghebreyesus, informed in a press briefing on Wednesday that the World Health Organisation positioned a medical product alert on Maiden pharma’s cough syrups for its connections with the kidney accidents and 66 deaths of kids in Gamibia.
WHO has called on regulators, among them the Botswana Medicines Regulatory Authority (BOMRA) to remove Maiden Pharmaceuticals’ products from the Botswana market.
A statement from the Indian government state that the cough syrups found to have dangerously high levels of ethylene glycol and deithylene glycol that led to kidney injuries were only licensed for export. At the time of going to press, the Sunday Standard could not establish if Botswana has imported the toxic cough syrups.
Botswana is one of six African countries which import drugs from Maiden Pharmaceuticals. The other five are Liberia, Burkina Faso, Sudan, Nigeria, and Sierra Leon.
Maiden Pharmaceuticals is also embroiled in a controversy in its home country as the Indian media questions why India’s Central Drugs Standard Control Organisation (CDSCO) has not yet barred the company from operating in India when many of its medical products made for Indian use have also been found to be of substandard quality, often flagged by authorities.
It has emerged from media reports that the company has been flagged in many Indian states over the years after their medicines failed the quality and safety standards.
An investigation by India Today newspaper revealed that, “reports suggest that the company has been a serial offender on quality control standards in the past as many state governments, and authorities have flagged it. Dinesh thakur, a public health activist based in St Petersburg has published a long Tweet thread on the matter and has also raised questions over the functioning of the Central Drugs Standard Control Organisation (CDSCO) in India as well as the pre-qualification process of the WHO.
Usually the CDSCO simply passes the buck in these cases to the state drug controller who issues the manufacturing licence. Except in this case Maiden Pharmaceuticals was certified by the CDSCO through the CoPP process. The national drug regulator, CDSCO provides assurance via the CoPP (Certificate of Pharmaceutical Product) to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards. A pharma manufacturer has to provide this certificate (and the certification is not worth the paper it is written on) to the buyer overseas. Given the wonderful track record above of this company, does it not beg the question on what basis does the CDSCO issue this piece of paper, Dinesh Thakur tweeted.”
At the time of going to press, The Sunday Standard could not establish with Botswana Medicines Regulatory Authority (BOMRA) on whether they conducted a due diligence on the Indian drug manufacturer company before licensing its medical products for use in Botswana.
It has emerged that the company has a chequered history:
In 2011, the government of Bihar also blacklisted Maiden Pharmaceuticals for supplying substandard drugs. A drug named Methylergometrine tablets which were provided to the civil surgeon in Munger was found to be spurious. Another batch of drugs, Erythromycin Sterate Syrup 125mg/5 ml was found to be of unsatisfactory quality.
In states like Kerala, in 2017, a Judicial First-Class Magistrate Court in Kerala fined this company a small ransom of Rs 1,000 in a prosecution filed by a Drug Inspector in Kerala in 2005. EVEN Jammu and Kashmir has raised an alarm over substandard products.
A central government drug inspector prosecuted the company in Sonipat, Haryana for quality violations under the Drugs & Cosmetics Act. The company was charged under sections of the drugs and cosmetics act, for offenses related to adulteration.
According to the extended licensing, Laboratory and Legal Node (XLN) database maintained by the Government of India, at least two state governments Kerala and Gujarat have repeatedly warned of the company’s illegal practices.
