Children died from cough syrup formulas banned two years ago; states and companies ignored the central government's warning.:

News Topical, Digital Desk : The cough syrup that killed more than 16 children in Madhya Pradesh had been used in the United States for several years. The central government had issued a warning two years ago regarding the formula and even banned the formula. However, the negligence of states and the irresponsibility of companies led to the deaths of children.

The Center had issued this warning to the states

A letter containing a central government order sent to all states on December 18, 2023, has also surfaced. It clearly states that syrups containing chlorpheniramine maleate 2 mg and phenylephrine HCl 5 mg should not be given to children under four years of age. Investigations found these syrups to have more harm than good. Warnings were also mandated on the labels.

Neither state governments nor pharmaceutical companies followed this central order and changed the labels. State governments also did not ban the product. Furthermore, no awareness campaigns were launched. As a result, more than 16 children in Madhya Pradesh died from "Coldrif" syrup. This syrup contained the same banned formula (paracetamol + chlorpheniramine + phenylephrine). There was no warning on the bottle.

The Centre had put a ban on the cough syrup formula.

The Center had already banned the use of this formula in children under file number 04-01/2022-DC. Investigations revealed that the drug lacked a warning label, which surprised the team. Following the Gambia cough syrup incident, the Center had mandated that every company must obtain a WHO-GMP certification (quality certification).

Pharmaceutical companies did not listen to the Centre

According to information, there are a total of 5,308 MSME pharmaceutical companies in the country. Of these, 3,838 companies have obtained certification. 1,470 companies have not yet applied. Srisan Pharma, a cough syrup company in Madhya Pradesh, also lacks a GMP certification. Yet, the company continues to manufacture and sell generic medicines.

A CDSCO investigation found unbilled containers of DEG at Srisan Pharma's factory. This chemical is highly toxic. Regulations limit the amount of DEG to 0.1%, but the company was adding up to 46-48%. Phenylephrine HCL is an expensive chemical, while chlorpheniramine is much cheaper. The company was using DEG to save on phenylephrine.

States also showed negligence

The Centre has created the Online National Drug Licensing System (ONDLS), a single-window platform for processing licence applications related to drugs, cosmetics and medical products.

This system was jointly developed by the Centre for Development of Advanced Computing (CDAC) and CDSCO. The CAPA portal was also created to facilitate corrective action in the pharmaceutical industry. However, only 18 states have joined it so far, with the remaining states remaining inactive. It's worth noting that while all states have gone online for blood bank licensing, drug licensing has not.

Overall, the central government issued warnings and bans two years ago, but negligence by states and irresponsibility by companies led to child deaths. More than 1,400 pharmaceutical factories in the country still operate without quality certification.