‘Diligently following protocols’: Maiden Pharma breaks silence on the Gambia deaths
Maiden Pharma's director Vivek Goyal said on Saturday, said the company has been in the business for over three decades and their products are not sold in domestic market. The company said it has the requisite export approvals for the products that have come under the scanner of drug authorities.
Maiden Pharmaceuticals on Saturday said it has been “diligently following protocols” of health authorities including Drug Controller General of India (DCGI) and the Haryana drug controller, days after the World Health Organisation raised an alert linking deaths of 66 children in west Africa’s The Gambia to four syrups manufactured and exported by the company.
Haryana drug authorities, meanwhile, issued a show cause notice to the Delhi-based company with manufacturing unit in Sonepat district after deficiencies and inadequacies were discovered during a recent joint inspection by DCGI and state drug regulator. The notice was issued under Section 85(2) of the Drugs and Cosmetics Rules pertaining to cancellation and suspension of licence, officials familiar with the development said.
Maiden Pharmaceuticals’ director Vivek Goyal, in a statement issued on Saturday, said the company has been in the business for over three decades and their products are not sold in domestic market. The company said it has the requisite export approvals for the products that have come under the scanner of drug authorities.
“We are shocked to hear the media reports regarding the deaths and deeply saddened on this incident, but we received the official information from our agent in (The) Gambia on October 5, and on the subsequent date the WHO alert was issued against us,” read the statement.
“Government agencies visited our factory on October 1, October 3, October 6 and October 7, and samples were drawn by the CDSCO (Central Drugs Standard Control Organisation) along with all relevant documents in question in the presence of our directors,” it added.
On October 5, WHO director-general Tedros Adhanom Ghebreyesus said that four cough and cold syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — manufactured and exported by Maiden Pharmaceuticals were suspected to have caused the death of 66 children in The Gambia.
“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” the WHO alert said.
Tedros told reporters that they were investigating with Indian drug regulators and the company.
A day later, the Union health ministry said that four of the 23 samples tested by the WHO were contaminated with diethylene glycol or ethylene glycol. According to health experts, diethylene glycol and ethylene glycol can be toxic to health and can trigger symptoms such as abdominal pain, vomiting, diarrhoea, headache, hallucinations, and acute kidney injury.
“Controlled samples of the same batch manufactured by Maiden Pharmaceuticals Limited for all the four drugs in question have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received from WHO,” the health ministry said in a statement on Saturday.
An official familiar with the development said the company has been in the news earlier also because of the substandard quality of its drugs. “In 2005, a drugs inspector from Kerala filed a prosecution against the company for which in 2017, a judicial first-class magistrate court in Kerala fined it; it was one of the 39 companies blacklisted by Vietnam for violation of quality control regulation and drug regulation; the Bihar government also black-listed it in 2011 for substandard drugs, etc. That’s the track record,” the official claimed.
Since the WHO alert, the pharma firm has refrained from making any statement. HT has earlier reported that the company’s corporate office in northwest Delhi’s Pitampura has been shut since Thursday.
“Samples have been drawn by the CDSCO officials and we are awaiting results. Since the matter is already pending investigation, we cannot comment on any other issue...” the company said.
(With inputs from Hitender Rao in Chandigarh)
