Last Updated on January 13, 2026 by The Health Master
MSMEs
The pharmaceutical sector is changing fundamentally in Northern India. Since taking office in August 2025, Lalit Kumar Goel, the State Drug Controller (SDC) of FDA Haryana, has taken rapid changes to strengthen the drug regulatory framework as well as MSMEs growth.
From regulating the entry of counterfeit drugs to facilitating a streamlined Schedule M compliance for MSMEs, he aims to make Haryana the most attractive place for pharmaceutical operations while serving as a national beacon of pharmaceutical quality.
Digitization: A Seven-Day Timeline for MSMEs
One of the biggest deterrents to the pharmaceutical sector over the years was access to items that required prolonged “red tape” for approvals.
SDC lalit Kumar Goel has proposed a dual-mode digitized approval system for business needs.
- Expedited Approvals: Additional approvals for drugs and cosmetics units are granted in seven days.
- Hybrid Application: Enterprises can apply for licenses/additional items through online and offline means to ensure all organizations are compliant.
- MSMEs in Focus: Micro, Small, and Medium Enterprises can facilitate growth without bureaucratic burden.
Smart Time-Tracking: Toxic Solvent Usage
When spurious cough syrup deaths hit Punjab and other regions, Haryana was more than ready to implement its comprehensive digital tracking application via the ONDLS portal.
High-risk solvents include Propylene Glycol (PG) and Glycerine.
- Data Uploads Required: Each batch/vendor of solvent must be uploaded to track where they came from.
- Legitimacy Tracking: This ensures that everything has legitimate sources.
- Ayush Recognition: Since Ayurveda cough syrups also use similar bases, the move applies to the Ayush sector as well to promote public safety.
Interstate Cooperation: Smuggling and Counterfeit Drugs
To combat psychotropic products and counterfeit substances, we need an inter-state approach.
Goel coordinated an Inter-state Coordinating Committee across seven states, including Punjab, Himachal Pradesh, J&K, and Uttarakhand.
On November 21, 2025, the FDA, CID and Police units met, and a final solution was determined: a centralized online portal listing NDPS information across all domains to share resources, conduct timely responses and implemented joint raids.
Compliance and Quality: Creating Revised Schedule M
As the state implements the revised Schedule M (Good Manufacturing Practices), more than 118 allopathic manufacturers are coming under scrutiny.
| Regulatory Focus | Strategy Employed |
| Risk-Based Audits (RBI) | Regular, unannounced inspections to ensure PQS compliance. |
| PMRU Activity | The Price Monitoring Resource Unit tracks MRP discrepancies and ethical trade. |
| Staff Training | ADCs and Drug Inspectors undergo specialized CDSCO-led training. |
| Medical Devices | Officers are specifically trained in ISO 13485 standards for MDR 2017. |
Technological Implements at Retailers: CCTV Cameras & Registration Requirements
Pharmacies cannot become hotspots for diversion/renting out necessary licenses to businesspersons attempting illegal sale without government intervention.
Therefore, the FDA Haryana has taken an external approach through technological implementations.
- CCTV Requirement: Any medical shop in Haryana must uphold a public-accessible CCTV system for sales activity.
- Pharmaceutical Evidence Required: Strict inspections must show that registered pharmacists are present; no “license-for-rent” systems can exist.
- Sale and Purchase Records: During check visits, if the sale and purchase records do not align with audit trails, diversion is confirmed.
What’s the timeframe for drug approvals?
Since SDC Lalit Kumar Goel took office, approvals for additional drugs and cosmetics have occurred within seven days.
How do you avoid contaminated solvents?
The state implements the ONDLS portal where customs must upload vendor/batch requirements to high-risk solvents like Propylene Glycol/Glycerine for timely confirmations.
What is Revised Schedule M?
The Revised Schedule M refers to Good Manufacturing Practices (GMP) where new focus areas include Pharmaceutical Quality System (PQS) versus Risk-Based Audits to confirm international-grade pharmaceuticals.
Which states meet in an interstate coordination committee?
The states include Haryana, Punjab, Himachal Pradesh, Jammu & Kashmir, along with Delhi/Chandigarh representatives.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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