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 Lalit Kumar Goel, State Drug Controller (SDC) of Haryana, outlines his comprehensive vision and the transformative projects he has undertaken since his appointment in August this year.
In an interview with Peethaambaran Kunnathoor, he said his initial priority is to establish the department as a hub of efficiency and transparency, evidenced by the launch of accelerated digital approvals in dual-mode for MSMEs and the implementation of a new, mandatory digital monitoring system for high-risk solvents like propylene glycol to ensure robust quality control.
He also highlighted the proactive steps he has taken to form an inter-state co-ordination committee to enhance enforcement against spurious and psychotropic drugs.
His future plans are focused on driving all manufacturing units, particularly the MSME sector, towards 100 per cent compliance with the stringent, revised Schedule M (GMP) standards through continuous training and risk-based audits.
You were appointed as the SDC of Haryana in August this year. What key administrative and procedural changes have you initiated since your appointment to make the department more efficient and transparent for the industry, especially MSMEs? What are your next major organizational goals?
After joining as SDC, approvals of additional items of drugs and cosmetics have been started in dual mode and the approval is granted within seven days of receipt of application. Firms can apply for additional items for cosmetics products and allopathic drugs online as well as in offline mode. We are trying our best to deliver quality and timely services to MSMEs.
In the wake of the toxic cough syrup incident in Madhya Pradesh, Haryana launched a new digital monitoring system for high-risk solvents like propylene glycol and glycerine. How is this system achieving real-time oversight, and how has the industry responded to the new mandate of uploading batch and vendor details for these solvents?
Yes, Haryana has started a monitoring system on the ONDLS portal where the firms have been directed to upload batch and vendor details of solvents like PG and glycerine etc. Firms are uploading requisite data which is helpful in ascertaining the authenticity of vendors and products.
You spearheaded the initiative to form an interstate coordination committee with neighbouring states like Punjab, Himachal Pradesh, J&K, and Uttarakhand to tackle spurious and psychotropic drugs. What are the immediate, actionable outcomes of this collaboration, and how do joint raids specifically target cross-border drug trafficking networks?
Two interstate meetings of this coordination committee have been convened in Chandigarh. The first was initiated by Himachal Pradesh, and the second was recently convened by FDA Haryana. Officers of the Drugs Department, CID, and Police Department of seven states participated in this meeting on 21.11.2025. Now we are in the process of developing an online portal on which data of NDPS drugs will be uploaded and this data will be very useful for other states and for the monitoring of NDPS drugs.
Beyond allopathic drugs, the Haryana department extended the mandatory pre-use testing of propylene glycol to ayurvedic medicine manufacturers. What was the primary justification for extending this stringent quality measure to the Ayush sector, and what is the compliance status across the state?
Yes, the advisory for pre-use testing of PG was also sent to the Ayush Department. The Ayush Department circulated this advisory to the manufacturers of Ayurvedic medicines because these solvents, e.g., glycerine, PG, etc., are also used in ayurvedic cough syrups.
There are frequent instances of seizure of falsified, substandard, and psychotropic medications across the state, particularly in districts like Sirsa. Based on the department’s intensive crackdown, can you share the details on the number of offenders punished or convictions secured in major drug-related cases over the last one year?
In Haryana, there is an online randomisation system for inspections. Some raids have been conducted in Sirsa for monitoring of the sale of dual-use drugs and required action as per law has been taken.
While the Drugs & Cosmetics Act doesn't directly control MRP discounts, what action is your department taking to track the supply chain of NSQ drugs being sold by the discount retailers, and what measures are in place to ensure ethical trade practices?
Price Monitoring Resource Unit (PMRU, Central Govt.) of FDA Haryana is active in the state. Field Investigators of PMRU are regularly collecting data from the field, and if any violation of DPCO or discrepancy of MRP is detected, the same is intimated to NPPA for taking action against the defaulters.
Given that most large-scale manufacturers in Haryana are nearing or have achieved compliance with the revised Schedule M (GMP), what is the most critical challenge facing the MSME sector in meeting their extended compliance deadline? What specific, targeted support or incentives is your department providing to ensure 100% compliance among small-scale players?
Most of the firms in Haryana are complying with the revised Schedule M. Regular inspections and RBIs (Risk-Based Audits) are being conducted to ensure the implication of revised Schedule M and suitable actions are being taken.
For Micro, Small, and Medium Enterprises (MSMEs), which have a deadline extension, what is the current percentage of units in Haryana that have submitted a formal up-gradation plan to your department?
In Haryana, there are 118 allopathic manufacturing units.
The revised GMP necessitates moving to Risk-Based Audits and a Pharmaceutical Quality System (PQS). How are your Drug Inspectors and Assistant Drug Controllers (ADCs) being trained to effectively conduct inspections based on the new Schedule M requirements?
Our inspecting officers, drugs inspectors and ADCs, are well trained to effectively conduct inspections based on new Schedule M. Training sessions are conducted time to time for the same. Officers are also deputed to attend the trainings organized by CDSCO.
You are an expert in Medical Devices Rules (MDR). With the increasing focus on the MDR, 2017, how skilled are your department's officers in carrying out inspections at medical device manufacturing sites, and what specific training is being provided to help them understand ISO 13485 standards and other device-specific regulatory requirements?
Our Medical Device Officers are skilled and well trained in carrying out inspections of medical device manufacturing units. Time to time training sessions are being conducted and attended by the officers on state level and central level.
How is the Central Drugs Standard Control Organisation (CDSCO) coordinating with the Haryana DCA to ensure uniform enforcement of drug rules and maintain the quality and efficacy of drugs, cosmetics, and medical devices manufactured and marketed in the state?
In co-ordination with CDSCO, joint inspections and investigations are conducted in the state which leads to quality audit and monitoring of manufacturing and marketing of drugs, medical devices in the state.
What specific, technology-driven enforcement strategy is the Haryana DC Department employing to ensure that the large number of medical shops are not only managed by registered pharmacists, but are also actively prevented from becoming conduits for the illegal, interstate trade of psychotropic and controlled substances?
Installation of CCTV cameras in medical shops is mandatory in Haryana. Regular raids/inspections are being conducted to ensure the installation of CCTV cameras, and the presence of pharmacists in the medical shops. The sale and purchase records of drugs in medical stores are also checked during inspections/raids to check the illegal trade.
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