NHRC issues notices to governments: Demands investigation into Coldriff syrup case; orders state labs to send reports

The National Human Rights Commission (NHRC) on Monday issued notices to the governments of Madhya Pradesh, Rajasthan, and Uttar Pradesh, directing them to investigate the deaths of children amid cough syrup row.

It is also directed an immediate ban on the sale of fake medicines. Additionally, the body has also directed state labs to take samples and send their report to NHRC. The NHRC has directed the Union Health Ministry, including the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), and Directorate General of Health Services (DGHS), to investigate the supply of fake medicines in the country.

The NHRC stated in its notice, "A complaint has been received demanding action in the case of 12 children who allegedly died after consuming cough syrup in some districts of MP and Rajasthan. All concerned departments should take prompt action and respond."

The Union Health Ministry issued a health advisory on October 3, stating that cough syrups (cough and cold medicines) should not be given to children under two years of age.

The DGHS, which comes under the Ministry of Health, stated in its advisory that cough syrup should generally not be given to children under 5 years of age. If cough syrup is given to older children, it should be used cautiously.

This means that the child to whom the medicine is being given should be kept under strict supervision. The correct dosage should be given. The medicine should be given for the shortest possible time. Cough syrup should not be given with multiple other medicines. Dr Sunita Sharma of DGHS has issued this advisory.

Deaths:

11 children have died in Chhindwara, MP, after consuming the cough syrup. The first suspected case came to light on August 24. The first death occurred on September 7. After this, 6 children died one by one due to kidney failure within 15 days.

MP State Food and Drug Controller Dinesh Kumar Maurya said on Saturday, "Coldrif syrup had diethylene glycol in excess of the prescribed amount. Due to this, the syrup was found to be poisonous." CM Mohan Yadav announced an assistance of 4-4 lakh rupees to the families of children who died after consuming Coldrif cough syrup.

Apart from MP, one death each has been reported in Bharatpur and Sikar in Rajasthan due to the consumption of another cough syrup. In the initial investigation, the name Dextromethorphan hydrobromide syrup IP came to light.

This medicine is manufactured by a private pharmaceutical company, Kessons Pharma. Here too, the reason for the children's death was stated to be kidney failure. On Saturday, the cause of death of a child in Churu is also being attributed to the consumption of cough syrup.

After this, the government took action on Saturday. The Rajasthan government has banned all 19 types of medicines from Kesen Pharma. The state's Drug Controller, Rajaram Sharma, has been suspended. Earlier, Sharma had given a clean chit to the company in the investigation.

Coldrife syrup (batch number SR-13) was seized from the unit of Srisan Pharmaceutical located in Sunguvarchatram, Kancheepuram district. Investigation revealed that non-pharmacopoeia grade propylene glycol was used in it, which was possibly contaminated with diethylene glycol (DEG) and ethylene glycol. Both chemicals are toxic substances that can damage the kidneys.

As soon as the samples were sent to the government drugs testing lab in Chennai, a report was provided within 24 hours. It was found that this batch of Coldrif syrup was toxic with 48.6% w/v DEG and 'Not of Standard Quality'. While the other four medicines (Respolite D, GL, ST and Hepsandin syrup) were found to be of Standard Quality.

Tamil Nadu Government's Action After Investigation Report

·         Sale and distribution of Coldrif syrup was immediately banned across the state.

·         All drug inspectors were ordered to freeze stock from wholesale and retail shops.

·         Officials in Odisha and Puducherry were also alerted.

·         A stop production order was issued to the company.

·         A show-cause notice was also sent to cancel the manufacturing license.

The Coldrif medicine is currently banned in three states of the country, Madhya Pradesh, Kerala, and Tamil Nadu. CDSCO, the institution that controls medicines across the country, will write to the Tamil Nadu Food and Drug Administration (FDA) to take strict action against the drug company.

An investigation by officials of Tamil Nadu's Drug Department revealed that Coldrif cough syrup contains 48.6% diethylene glycol adulteration. This is a poisonous chemical.

A bench of the NHRC headed by Priyank Kanoongo took action in the matter under the Protection of Human Rights Act, 1993. He informed that the complainant has demanded the formation of a special investigation committee.

Additionally, the NHRC has made a request to investigate the production and distruibution channels of the concerned medicine. Moreover the same has also demanded that a compensation must be given to the families that have been affected by the incident.

The complainant has pointed out serious lapses in drug safety, regulations, and monitoring, and has alleged that this is a violation of children's right to life, health, and safe medicines.