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NEW DELHI: Amid the controversy over deaths of children in parts of Madhya Pradesh, allegedly due to consumption of sub-standard cough syrup, Union health secretary Punya Salila Srivastava on Sunday asked states/UTs to ensure strict compliance with Revised Schedule M – updated Good Manufacturing Practices (GMP) — by all drug manufacturers.Srivastava, at a meeting with top health officials from all states/UTs, which was also attended by the chief of Indian Council for Medical Research and Drug Controller General of India (DCGI), directed rational use of cough syrups, particularly for children, as most coughs are self-limiting and do not require pharmacological treatment.Health ministry sources said the matter had been earlier reviewed by Union health minister J P Nadda, who had directed that the matter be discussed with states/UTs to ensure necessary action.Metropolitan Surveillance Unit (MSU), Nagpur, established under Pradhan Mantri-Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), had reported a cluster of cases and related deaths from a block in Chhindwara district of Madhya Pradesh a few days ago.The samples of 19 medicines which had been consumed by the children were collected from treating private practitioners and nearby retail stores. Health ministry said chemical analysis so far indicates that nine out of 10 samples meet quality standards. However, one of them, viz cough syrup ‘Coldrif’, contained Diethylene Glycol — contaminant known to cause serious kidney injury if used in higher proportions — beyond the permissible limit. “Cancellation of manufacturing licence of the unit that supplied the specific batch of the drug has been recommended by CDSCO based on inspection findings. Criminal proceedings have also been initiated,” the ministry said.DCGI Dr Rajeev Raghuvanshi reiterated the need for drug manufacturing units to strictly comply with Revised Schedule M for Good Manufacturing Practices (GMP). He noted that certain firms which had applied for the government’s infrastructure upgrade have been given an extension till December.
