New Delhi, Oct 8: The Drugs Controller General of India (DCGI) has urged all drug controllers of the states and Union Territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing them in the market in the wake of children’s deaths allegedly due to the consumption of contaminated cough syrup in Madhya Pradesh and Rajasthan.
Five children from Madhya Pradesh are in a critical condition, while 20 have died due to kidney infections caused by the consumption of the “contaminated” cough syrup, containing Diethylene Glycol (DEG) and Ethylene Glycol (EG).
Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state.
In an advisory, the DCGI said that during recent inspections at manufacturing facilities and in the investigations of the drugs declared as ‘Not of Standard Quality’, it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.
The DCGI said that the directorate has, from time to time, emphasised the critical importance of testing of raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.
There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups, the advisory said.
“During the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products,” the advisory dated October 7 said.
The advisory highlighted that according to Drugs Rules, including rule 74 (c) and rule 78 (c) (ii), the licensee shall, either in his own laboratory or in any laboratory approved by the licensing authority, test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product, and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U.
“All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.
“Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, from reliable approved vendors only,” the advisory said. (PTI)
