NHRC issues notice to 3 states in cough syrup related death case

• The National Human Rights Commission (NHRC) issued notices to Madhya Pradesh, Rajasthan and Uttar Pradesh governments, directing them to probe allegations of children’s deaths due to contaminated cough syrup and immediately ban the sale of spurious medicines.

• It has also directed the Ministry of Health and Family Welfare, the Drugs Controller General of India (DCGI), the Central Drugs Standard Control Organisation (CDSCO) and the Directorate General of Health Services (DGHS) to order an investigation into the supply of spurious drugs and instruct all regional labs in states to collect the samples of spurious drugs and submit test reports.

• The Coldrif cough syrup, manufactured by Sresan Pharmaceutical, Kancheepuram (Tamil Nadu), has been blamed for the deaths of the children.

• Madhya Pradesh government has banned the sale of Coldrif cough syrup following the death of 14 children in Chhindwara due to suspected renal failure, with officials stating the drug samples were found to contain a highly toxic substance. 

What action has been taken by the govt?

• Various clinical, environmental, entomological and drug samples were collected and sent to NIV Pune, Central Drug Laboratory (CDL) Mumbai, and National Environmental Engineering Research Institute (NEERI) Nagpur for laboratory testing.

• Preliminary findings ruled out common infectious diseases except for one positive case of leptospirosis.

• It said 19 samples of medicines which were consumed by children were collected from treating private practitioners and nearby retail stores. The chemical analysis so far indicates that of the 10 samples analysed till date, nine meet quality standards.

• However, one of them, cough syrup Coldrif, contains DEG beyond the permissible limit. Subsequently, regulatory action has been taken by Tamil Nadu FDA on the medicine manufacturing unit located in Kancheepuram.

• Cancellation of the manufacturing licence has been recommended by the CDSCO based on the inspection findings. Criminal proceedings have also been initiated.

• Indian Medical Association (IMA) said pharmaceutical-grade glycerin and propylene glycol required for manufacturing cough syrups are expensive.

• Toxic substances such as industrial-grade DEG and ethylene glycol (EG) are cheaper and visually indistinguishable. If quality control fails at the level of both the manufacturer and the regulator, cough syrups produced by a few companies may end up containing toxic substances capable of causing kidney failure and death in young children, the IMA said.

Other measures by the Union government

• The Ministry of Health and Family Welfare convened a high-level meeting, under the chairmanship of the Union Health Secretary Punya Salila Srivastava,  with all states and Union Territories to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric populations.

• It underlined the need for all drug manufacturers to comply with the Revised Schedule M (Good Manufacturing Practices provision) and said that strict action will be taken against violators.

• Manufacturers of drugs are required to comply with the requirements of Good Manufacturing Practices (GMP) as prescribed under Schedule M of the Drugs Rules, 1945.

• The government had notified revised Schedule M requirements in December 2023 wherein “good manufacturing practices” was upgraded to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products”. 

• States were advised to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment.