CHNADIGARH: The Sonipat firm which has been under the lens after its four cough syrups were flagged by the WHO allegedly violated multiple manufacturing and testing rules, potentially affecting "the quality, safety and efficacy of the drugs being produced" there, according to officials.
The Haryana government on Wednesday ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, days after the World Health Organization potentially linked the four syrups to the deaths of 66 children in the African nation of Gambia.
Officials here said that after the WHO alert, officers from the Central Drugs Standard Control Organisation (CDSCO) and Haryana Food and Drugs Administration inspected the firm's premises in Kundli industrial area of Sonipat on October 1, 3, 6 and 11.
They conducted necessary investigations related to the drugs manufactured by the firm and supplied to The Gambia, the officials said.
During the investigations, it was observed the firm had been manufacturing and testing drugs without adhering to and in contravention of various Good Manufacturing Practice requirements of Schedule M and Schedule U of the Drugs Rules, according to the officials.
"Firm has not maintained and not produced complete records of manufacturing and testing as per the rules. Various documents were examined by the investigating team, which clearly indicates that the firm is not meeting the requirements of Drugs Rules, 1945 under Drugs and Cosmetics Act, 1940 across its manufacturing and testing activities," according to an order issued by the State Drug Control Officer, Sonipat Zone.
"In view of the seriousness of the contraventions observed during the investigations and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm is being stopped with immediate effect under section 22 (1) (d) of Drugs and Cosmetics Act, 1940 and Rules framed thereunder, till further orders, in public interest, without prejudice to further action in the matter," read the order dated October 11.
Health Minister Anil said that during the investigation, the joint team of the state and the Centre found 12 violations or deficiencies.
"Taking cognisance of this, the state government has ordered to halt the drug production in this unit."
Meanwhile , official sources in Delhi said they have taken note of media reports that Atlanta-based Atlantic Pharmaceuticals Company Limited had procured the drugs from Maiden Pharmaceuticals for further export to The Gambia.
They also shared a communication dated October 4 in which the Medicines Control Agency of Gambia had written to the Managing Director of the Atlantic Pharmaceuticals, Westfield, notifying the temporary suspension of the importation of any Maiden Pharmaceuticals and asking it to immediately recall the contaminated, substandard and falsified medicinal products (syrups, tablets, capsules, injections etc) that it imported from Maiden Pharmaceuticals.