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The Haryana drug control administration (DCA) is undertaking a major organizational overhaul focused on quality system upgrades and regulatory capacity building, particularly in response to the revised Schedule M norms.
State Drug Controller (SDC) Lalit Kumar Goel confirmed that while most of the large-scale manufacturers are nearing compliance, the department is intensely focused on helping the 118 allopathic manufacturing units, a significant portion of which are micro, small, and medium enterprises (MSMEs), to meet their extended deadline through guidance and rigorous new audit standards.
The most critical regulatory challenge facing the MSME sector remains the comprehensive financial and infrastructural commitment required to meet the revised Schedule M standards.
In an email chat with Pharmabiz, Lalit Goel stated that the department is conducting regular inspections and Risk-Based Audits (RBIs) to ensure compliance, which is actively progressing. Although the total percentage of MSMEs that have submitted a formal up-gradation plan was not specified, the regulatory focus has shifted to maintaining momentum and providing necessary oversight to the small-scale players who have time until December 2025 to comply with. To effectively monitor this transition, the department is rapidly training its drug inspectors and assistant drug controllers (ADCs) on the new audit requirements. He said the inspecting officers are well trained to effectively conduct inspections based on new Schedule M, which necessitates moving toward Risk-Based Audits (RBIs) and evaluating a unit’s Pharmaceutical Quality System (PQS), including its Quality Risk Management (QRM) process. Training sessions are conducted regularly, supplemented by deputing officers to specialized programs organized by the Central Drugs Standard Control Organisation (CDSCO).
According to the SDC, the capacity building extends beyond traditional drug manufacturing to specialized sectors. With the increasing focus on the Medical Devices Rules (MDR), 2017, the department’s inspectors who inspect medical devices are skilled and well trained in carrying out inspections at manufacturing units. Ongoing training sessions are specifically provided to help officers understand requirements related to standards like ISO 13485 and other device-specific regulations, reflecting the complexity of regulating the growing medical device industry.
To a technical query, Goel said, to maintain professional excellence across all regulatory functions, the DCA employs a strategy of continuous, advanced education. Beyond monthly operational meetings, officers are mandated to attend focused training modules on subjects like Gas Chromatography, specific sections of the NDPS Act (Narcotic Drugs and Psychotropic Substances Act), and Data Integrity at both the state and central levels. This continuous professional development aims to increase the overall professional skill and efficiency of the field officers.
When asked about the coordination of the DCGI office, he said the Haryana DCA is working in close coordination with the CDSCO to ensure a uniform and high standard of enforcement across the state. This coordination involves joint inspections and investigations that lead to quality audits and systematic monitoring of drugs, cosmetics, and medical devices being manufactured and marketed. This synergy between Central and state authorities is critical for maintaining the quality and efficacy of products in the market, he said.
To a question on technology-driven enforcement strategy, the SDC said the department is leveraging technology to secure the retail supply chain and prevent illegal drug trade. The primary enforcement strategy involves making the installation of CCTV cameras mandatory in all medical shops. Further, regular raids and inspections are conducted to ensure not only the installation of CCTVs and the presence of registered pharmacists but also to meticulously check sale and purchase records.
“This approach is designed to prevent medical shops from becoming conduits for the illegal, interstate trade of psychotropic and controlled substances,” Goel told Pharmabiz.
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