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Thu, Jul 10 2025
Shubham Bansal
A pharmacy license is the fundamental legal authorization required to operate any drug dispensing establishment in India. The Drugs and Cosmetics Act of 1940 and state rules govern this license. It keeps the public safe by enforcing strict standards for storing drugs, distributing them, and supervising these practices. The Central Drugs Standard Control Organisation (CDSCO) oversees national standards while State Drug Control Authorities implement local compliance.
Running a pharmacy without a valid license is a crime. It may result in a prison sentence of up to 3 years and fines exceeding ₹10 lakh. Besides being legal, the license shows consumers they can trust the pharmacy. It ensures that trained professionals provide good quality medicines in proper storage conditions.
Before applying, ensure compliance with infrastructure requirements:
Retail pharmacies must have at least 10 square meters of space. They need special areas for processing prescriptions. They also require temperature-controlled storage for vaccines, which should be between 2-8°C. Additionally, they must have good ventilation systems and be rodent-proof.
Wholesale establishments need larger warehouses. The minimum size is 15 square meters. They must have separate locked cabinets for Schedule X drugs. They also need climate monitoring systems and fire safety equipment.
Hospital Pharmacies need direct connectivity to inpatient wards and emergency departments, with separate access control for narcotics storage.
Full-time Registered Pharmacist (B.Pharm/D.Pharm with state council registration) physically present during operating hours
Supporting staff trained in inventory management and prescription handling
Property Documents: Registered lease agreement or ownership papers with municipal tax receipts
Pharmacist Credentials: Council registration certificate, employment agreement with notarized affidavit
Technical Documents:
Application Forms:
Submit complete applications through state drug control portals (ONDLS) • Pay application fees ranging from ₹3,000 to ₹15,000 via portal payment gateways • Receive inspection date within 15 working days • Drug inspectors verify: • Temperature logs and calibration certificates of refrigeration units • Mock prescription handling process • Security systems for narcotics storage • Staff qualification documents
Upon satisfactory inspection:
License issued within 60-90 days as per state timelines
Validity Period:
Mandatory Display Requirements:
Renewing a pharmacy license is a mandatory process that must be initiated at least 90 days before its expiry. You can submit renewal applications through state drug control portals. Examples include Kerala PRISM and the Delhi Drug Control portal.
Before applying for renewal, you should conduct a full compliance audit. Pharmacies must check their prescription registers for the last three years.
They should also verify purchase records against supplier licenses. Ensuring that someone disposes of expired drugs properly with valid certificates is important.
Additionally, pharmacies need to upgrade their infrastructure according to the latest rules. This includes installing or maintaining refrigeration systems, CCTV cameras, and fire safety equipment.
Applicants must submit the existing pharmacy license along with the renewal application form. You need to provide some other documents.
These include:
The renewal fee typically ranges between ₹3,000 to ₹10,000, depending on the state and the pharmacy’s turnover.
Inspectors primarily focus on verifying record integrity, ensuring sales entries match stock inventory. They also check sourcing documents to ensure drugs come from licensed suppliers.
Storage compliance is crucial too. This includes keeping temperature logs for sensitive drugs. It also means having separate storage areas for internal and external medications. Finally, someone must keep accurate records for Schedule H1 drugs.
If the license renewal is delayed by up to 6 months, a 50% surcharge is imposed on the renewal fee. If the delay exceeds 6 months, we will cancel the current license. The applicant must then apply again for a new license.
Renting or transferring a pharmacy license is strictly prohibited under Rule 65(2) of the Drugs and Cosmetics Rules. These licenses are non-transferable and linked to specific premises and owners.
Engaging in illegal licensing arrangements can result in severe penalties. For license owners, it may lead to license cancellation, blacklisting, and criminal charges under Section 27 of the Act.
Renters may face imprisonment and fines up to ₹5 lakh for unauthorized operations. Pharmacists involved in such schemes risk permanent cancellation of their registration certificates.
Governed under Rule 64, this license mandates the display of a “Registered Pharmacist on Duty” sign. Pharmacies must keep separate records for Schedule H, H1, and X drugs. They cannot sell antibiotics without a valid prescription.
Issued under Rule 63, this license requires pharmacies to have at least 3 meters of aisle space between storage racks. Storage areas must be humidity-controlled, especially for hygroscopic drugs. A digital logging system is essential for monitoring Schedule X drug distribution.
As per Rule 65, hospital pharmacies must offer 24/7 access to emergency medicines. They should have automated inventory systems in hospital wards. They must also keep a separate vault for narcotics. This vault should have dual-key security.
Pharmacies are expected to adhere to strict protocols regarding record maintenance, storage, and dispensing:
You must note the amount of drugs given. These documents should be retained for a minimum of three years.
Timely renewal of your pharmacy license is crucial to avoid penalties and ensure uninterrupted operations. Staying compliant with documentation, inspections, and legal requirements helps maintain your credibility. For a smooth and hassle-free renewal process, PSR Compliance is here to assist every step of the way.