The Haryana government on Wednesday suspended drug manufacturing at Maiden Pharmaceuticals’ Sonipat unit immediately after its cough syrups were linked to the deaths of 66 children in The Gambia.
“The production activity of Maiden Pharmaceuticals has been stopped till further notice,” an unidentified official from Haryana Food and Drugs Administration told Scroll.in. “We found major lapses in their manufacturing process.”
Authorities in the west African country have linked the deaths, most of them due to acute kidney failure, to four medicines – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by Haryana-based drugmaker Maiden Pharmaceuticals.
The Gambia took the decision after the World Health Organization issued an alert against the four contaminated medicines on October 5.
On Wednesday, Haryana Health Minister Anil Vij said the central and state drug departments conducted a joint inspection and found 12 flaws in the medicines and their manufacturing process.
These include not maintaining a log book of equipment, instruments and some of the chemicals used in manufacturing the four cough syrups, according to NDTV. The company has been asked to reply to a notice issued by the Haryana government by Friday.
Maiden Pharmaceuticals also did not perform quality testing of propylene glycol, the raw material used for making one of the formulations.
“During inspection many contraventions were detected,” the notice said. “You are hereby served with the show cause notice rule 85(2) of drug rules, 1945 as to why your manufacturing license may not be suspended or cancelled.”
Vij said that he is yet to receive a report on samples from the Central Drugs Laboratory in Kolkata. “Depending on what it says, we will take further action,” he added.
India’s Pharmaceutical Export Promotion Council has suspended the membership of Maiden Pharmaceuticals after the deaths. The suspension cuts the firm off from the Market Access initiative under which incentives up to Rs 2 crore are given to a company that registers their products with a drug or health regulator abroad.
Meanwhile, the Central government announced the formation of a four-member panel to look into the case. The panel includes Dr YK Gupta, Dr Pragya Yadav, Dr Arti Bahl and AK Pradhan.
On October 8, Maiden Pharmaceuticals had said that it was shocked and saddened to hear about the deaths.
“We are in the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General [of India] and the State Drugs Controllers, Haryana,” the company’s director Vivek Goyal said.