Gambian deaths: Maiden Pharma’s cough syrups were of standard quality, says Khuba

“The control samples of the aforementioned drugs were drawn and sent for test and analysis to Regional Drug Testing Laboratory, (RDTL) Chandigarh by the investigating team. As per report of the Government Analyst, the samples have been declared to be of standard quality. The said samples were also found negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG),” Bhagwanth Khuba, MoS, ministry of chemical and fertilizers stated in Rajya Sabha. 

It may be noted that in October the World Health Organisation issued an alert against four cough and cold syrups made by Maiden, saying that it might be linked to the Gambia deaths. As a result, Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drug Controller, Haryana carried out investigation at the firm to ascertain the facts that allegedly led to the death of 66 children in Gambia. 

During the investigation, it was revealed that the state drug controller had given licenses to the company for manufacture of four drugs namely Promethazine Oral Solution BP, KOFEXMALIN Baby Cough Syrup, MaKOFF Baby Cough syrup and MaGrip n Cold Syrup, for export purpose only. The Haryana drug regulator issued a show cause notice to the firm directing them to immediately stop all the manufacturing activities. 

“These 4 drugs are not licensed for manufacture and sale in India and the said drugs are not marketed or distributed in India. There is no observable impact on the Indian Pharma Export in the past few months, that can be attributed to this incident,” said Khuba in response to the questions made by Congress leader and Rajya Sabha member Jebi Mather Hisham on measures to ensure safety, quality, and standards in pharma manufacturing. 

Besides, this Khuba informed that CDSCO has taken various regulatory measures to ensure the quality of medicines manufactured in the country. According to the Drugs and Cosmetics Act, 1940 to provide stringent penalties for manufacture of spurious and adulterated drugs. 

“Certain offences have also been made cognizable and non-bailable. States/UTs were requested to set up special courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. So far, 33 States have already set up designated special Courts,” the minister said. 

On 17th November, the government directed all manufacturers of drug formulation products to shall print or affix Bar Code or Quick Response Code on its primary packaging label which should include–(a) unique product identification code, (b) proper and generic name of the drug, (c) brand name, (d) name and address of the manufacturer, (e) batch number, (f) date of manufacturing, (g) date of expiry, and (h) manufacturing licence number.