India’s Biggest Pharma Audit: 700 Cough Syrup manufacturers face Heat After DEG crisis
After the DEG contamination controversy, India has taken its one of the biggest follow-up actions, the government india, has informed the rajyasabha that over 700 cough syrup manufacturers across India have now undergone intensive pharma audits. This huge inspection drive is a continuation of the steps taken after the reports of child death which is linked to toxic cough syrups that surfaced at the beginning of this year.
New Findings After the Earlier DEG incident
Anupriya Patel, Minister of State Health, informed the Rajya Sabha that the coldrif syrup batch that is associated with the child deaths in Chhindwara had a shocking of 46.28% Diethylene Glycol (DEG), which was manufactured by Sresan Pharmaceuticals in Kancheepuram, Tamil Nadu.
The confirmation of this incident has come after a central investigation team, comprising experts from NCDC, NIV and CDSCO visited Chhidwara and Nagpur to inquire about the child deaths.
During the investigation, it is found that the 19 samples of the medicines was reportedly consumed by the affected children, which was collected from the clinics and stores nearby. Among these 4 samples failed the quality tests, while the remaining were found to be in agreeable range.
Manufacturers under strict watch
Soon after the results were collected, the regulators inspected Sresan Pharmaceuticals manufacturing unit and the things they found out were serious. Officials reported the major violations of Good manufacturing practices (GMP) that includes poor hygiene and improper storage. The CDSCO has asked the Tamilnadu authorities to start the criminal proceedings.
The states that have received the supplies from the contaminated batch includes Madhya Pradesh, Odisha, TamilNadu and Puducherry, have been issued with the bans and recall orders immediately. Madhya Pradesh state has already registered the criminal case and made arrests.
Nationwide Regulatory Tightening
The government has stressed about this incident saying that they are not treating this just as an isolated case therefore a series of instructions have been issued countrywide since the incident, they are as follows:
- Oct 3 : Advisory to all the states/ UTs for rational use of the pediatric cough syrups
- Oct 7: Directive to make sure strict compliance with the testing norms
- Oct 21: Order to maintain increased vigilance against the substandard and spurious medicines
As part of this larger exercise, more than 700 syrup manufacturers have been audited and market surveillance for syrup formulations has been increased significantly.
New Rules To Prevent another tragedy
To close the gaps that are existing, the Indian Pharmacopoeia Commission (IPC) has amended IP 2022. The new requirements make it mandatory to test all the finished products and batches of all oral liquid medicines for DEG and Ethylene Glycol (EG) before they are released into the market. Before, checks used to primarily focus on the raw materials only.
This change is expected to substantially decrease the chance of contamination syrups that reach the consumers again.
