Karnataka embarks on inspections to ensure quality of four cough syrups that led to death of 66 children in Gambia
The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, 1945.
Further, it mandates a certificate of analysis of glycerin and propylene glycol procured in the last one year to be submitted in a time-bound manner. All this comes after the Gambian tragedy where 66 kids succumbed to death after consumption of the cough syrup early this month.
In a communication to the 321 pharma manufacturers in the state, Karnataka drugs controller BT Khanapure said as an increased precaution pharma companies will need to sample, test and analyse all individual container packs of glycerin and propylene.
The department’s enforcement team is also engaged in surprise inspections to ensure the quality of the four cough syrups that led to the fatality of 66 Gambia children: Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip N cold syrup which were all found to contain unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG).
The state drugs control department embarked on inspections after reports of tests conducted in Gambia indicated that , diethylene glycol found in drugs was about 19 percent when it should not be above 0.1 per cent. This led the children who consumed few sips to succumb to death. These drugs were manufactured by the Haryana-based Maiden Pharmaceuticals.
The World Health Organisation on October 5 issued a global advisory on the contaminated pediatric medicines. Further it is stated that it contains unacceptable limits of ethylene glycol and diethylene glycol.
Also Karnataka is an exporter of bulk drug, formulations of solid dosage forms like capsules and tablets, liquids, semi-solids and injectables to combat all diseases. The state is known for its 12 US FDA approved plants, 8 TGA and MHRA audited facilities, besides 82 WHO-GMP certified units. In addition, there are also a number of international approvals from UNICEF, MOH South Africa, ANIVSA of Brazil and PIC/S. There is also considerable quantum of contract manufacturing taking place as 7 of the top 10 global companies get their products manufactured from Karnataka.
The need of the hour is to ensure high quality and approved products which is possible by surprise inspections across the 28,000 pharmacy outlets in the 31 districts in the state. “Products containing contaminants are adulterated and a violation of the Drugs and Cosmetics Act. Hence we insists on Certificate of Analysis of glycerin from pharma manufacturers of ethylene glycol and diethylene glycol,” said Khanapure.
Source : 1
AuroBlog | Clinical Research Blog | Aurous HealthCare CRO, India 