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 The Telangana Drugs Control Administration (DCA) has intensified its regulatory oversight by issuing ‘Stop Production’ orders to several liquid manufacturing firms across the state.
This decisive action follows a series of comprehensive, risk-based inspections aimed at ensuring the safety and efficacy of pharmaceutical products. The move reflects growing national concern regarding the quality of liquid orals, particularly in the wake of recent health crises linked to contaminated cough syrups that have surfaced in various parts of the country.
The crackdown was initiated after multiple samples collected during routine and surprise inspections failed to meet required quality standards. According to regulatory officials, these manufacturing units were found to be in violation of the revised good manufacturing practices (GMP). Most significantly, sources within the DCA confirmed that the companies were not complying with the revised Schedule M norms. These updated standards mandate more stringent quality control, upgraded infrastructure, and improved self-audit mechanisms to align Indian manufacturing with global benchmarks.
Speaking to Pharmabiz, Dr M Ramdhan, joint director of the DCA, confirmed that the administration has taken a stern stance against non-compliance. He emphasized that the stop production orders are part of a broader effort to sanitize the pharmaceutical manufacturing landscape in the state. The inspections focused heavily on the infrastructure and protocols maintained by these units, specifically looking for lapses that could lead to contamination or sub-therapeutic dosage in paediatric formulations.
One of the primary reasons for the suspension of licenses and production activities was the lack of adequate testing facilities within the manufacturing premises. Regulatory norms mandate that every batch of liquid medicine must undergo rigorous testing, including checks for toxins like diethylene glycol (DEG) and ethylene glycol (EG), before being released. However, Dr. Ramdhan noted that several units were operating without the necessary laboratory equipment or personnel to conduct these vital safety checks, which is a grave violation of the Drugs and Cosmetics Act.
While the joint director was transparent about the nature of the violations and the ongoing regulatory heat, he did not divulge the specific names of the companies served with these notices for lacking testing facilities. This confidentiality is often maintained during the initial stages of adjudication to allow for further investigation and legal proceedings. However, the message from the department is clear that any manufacturer failing to uphold the safety bridge between production and patient consumption will face immediate shut-down.
This development in Telangana is part of a larger, multi-state ripple effect following the tragic ‘Coldrif’ cough syrup incident in Madhya Pradesh, where contaminated medicine led to the deaths of several children and left survivors with permanent organ damage. That tragedy sparked a nationwide audit of liquid manufacturing plants.
In response to these regulatory actions, P Rambabu, president of the Telangana Drug Manufacturers Association, stated that he has convened a meeting of all members to address these issues and the broader challenges facing the local industry. Acknowledging the gravity of the situation, he affirmed that all drug manufacturing units in the state are committed to attaining full compliance with the Central Drugs Standard Control Organization (CDSCO) regulations. This proactive stance from the industry association signals a collaborative effort to restore confidence in the quality and safety of medicines manufactured in the region.
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