After a terrible event in Madhya Pradesh where 20 children died after taking the cough syrup “Coldrif,” the Drugs Controller General of India (DCGI) has sent a strict order to all States and Union Territories (UTs). The decree says that everyone must follow the Drugs Rules of 1945, especially when it comes to checking raw materials and finished products for drugs.
In a letter dated October 7, DCGI Dr. Rajeev Singh Raghuvanshi pointed out the main reason for the regulatory action: “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 DCGI stressed how important it is to test new materials, such excipients, before they are used to make pharmaceutical formulations.
Exposed Systemic Failures in Testing
The latest order is a direct result of inspections and investigations that found widespread problems with compliance at some manufacturing plants. The DCGI said that some manufacturers were skipping important testing steps, which directly affects the quality of the drugs.
The letter said, “During the inspections of the manufacturing facilities and the investigations of the drug that was declared Not of Standard Quality, the reports showed that the manufacturers are not testing each batch of the excipients/inactive and active pharmaceutical ingredients to make sure they meet the required standards before using them to make formulations and finished products.”
New Rules for Makers and Regulators
To fix this lack of regulation, the DCGI has made it plain what has to be done:
Mandatory Testing: Every licensed manufacturer must test all of their raw materials in their own lab or an approved lab before using them in production.
Record Keeping: As required by Schedule U of the Drugs Rules, detailed records of these tests must be kept up to date.
Vendor Qualification: Manufacturers must set up a strong system for vendor qualification and only buy raw materials, including excipients, from vendors that are trustworthy and approved.
State and UT drug controllers have been told to “take steps to make sure testing is done before the batch is made and released to the market by monitoring during inspections and sending out circulars to the manufacturers.”
Someone was arrested in the Coldrif Cough Syrup case.
The tragedy, which killed 20 children (17 from Chhindwara, two from Betul, and one from Pandhurna) and left five others in the hospital, has led to an arrest.
On Thursday, the Madhya Pradesh police said they had detained S. Ranganathan, the owner of the Tamil Nadu-based pharmaceutical company that makes the Coldrif cough syrup. The Chhindwara SP says that Ranganathan will appear in court in Chennai today and then be sent to Chhindwara after getting a transit remand.
On Wednesday, Rajendra Shukla, the Deputy Chief Minister and Health Minister of Madhya Pradesh, told the public about the deaths of the children.