How to Get a Drug Licence in India: State vs Central Approval Requirements Explained — 2026 Guide

Introduction

For any business in India that manufactures, imports, distributes, or sells pharmaceuticals, from a small retail medical store in a Tier-3 town to a global pharmaceutical manufacturer establishing a greenfield plant under the Production Linked Incentive scheme, obtaining a drug licence in India is the single most foundational regulatory clearance without which lawful operation cannot commence.

Anchored in the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, administered through a layered architecture of State Drug Licensing Authorities and the central regulator CDSCO (Central Drugs Standard Control Organization) under the Directorate General of Health Services in the Ministry of Health and Family Welfare, the framework governs every stage of the pharmaceutical value chain, manufacturing, import, wholesale distribution, and retail sale, across allopathic, biological, AYUSH, and homoeopathic categories.

The regulatory architecture has evolved materially over the last decade. A 2018 amendment to Rule 63 of the Drugs and Cosmetics Rules 1945 made drug licences perpetual (subject to a retention fee every 5 years), replacing the earlier 5-year renewal cycle, a substantial administrative simplification. The Drugs and Cosmetics (Draft Amendment) Rules, 2021 (introduced 23 September 2021) further refined the framework. The New Drugs and Clinical Trials Rules, 2019 streamlined the new-drug approval and clinical-trial pathway.

The Medical Devices Rules, 2017 separated medical devices from the parent drug framework. And the revised Schedule M of the Drugs and Cosmetics Rules, effective for large manufacturers from 28 June 2024, with an extension granted to SMEs through 31 December 2025, aligned Indian GMP standards substantially with WHO benchmarks. The cumulative effect: drug licence registration in India in 2026 operates under a more rigorous, more digital, more globally-aligned framework than at any previous point.

The state vs central split is a highly misunderstood aspect of the drug licensing framework. State Drug Licensing Authorities (typically the State Drugs Controller) issue licences for retail and wholesale activities within the state, and for manufacturing of allopathic drugs (other than biologicals) at facilities located in the state. CDSCO operates at the central level for new drug approvals, clinical trials, import of drugs, biologicals and Schedule C/C1 products, and certain notified categories that require national approval.

Crucially, several activities require sequential coordination between the two, a state drug licence for a manufacturing facility, for instance, may need to be supplemented by CDSCO approval for specific product categories. Understanding state vs central drug licence in India correctly at the outset is essential to a clean, efficient compliance programme.

Drawing on IMARC Engineering's experience supporting pharmaceutical and life-sciences regulatory advisory, manufacturing facility setup, retail and wholesale licensing, import facilitation, and integrated compliance programmes for Indian and international pharmaceutical companies, this guide lays out a structured, step-by-step approach to the drug licence application process in 2026 India.

You will find a clear view on why drug licensing matters, the legal framework anchored in the D&C Act 1940 and Rules 1945, the state vs CDSCO division, the types of drug licences (manufacturing, retail, wholesale, import, loan licence, test licence), the documents required, the step-by-step application process for each licence type, sector-specific overlays, common pitfalls, a checklist, and a frequently-asked-questions section. The objective is to make pharmaceutical licence in India practical and predictable for your regulatory, operations, and project teams.

Table of Contents

• Introduction
• Why Drug Licensing Is Mission-Critical in 2026
• The Legal Framework - Drugs and Cosmetics Act 1940 and Rules 1945
• State Drug Authorities vs CDSCO - Who Approves What
• Types of Drug Licences in India
• Documents Required for Drug Licence Application
• Step-by-Step Application Process
• Sector-Specific Considerations
• Common Mistakes and How to Avoid Them
• Drug Licence Application Checklist
• Conclusion

1. Why Drug Licensing Is Mission-Critical in 2026

Understanding why a drug licence in India has become more consequential than ever in 2026 starts with five structural drivers that have raised the regulatory, financial, and reputational stakes of drug-licensing compliance.

1.1 The Legal Mandate Is Absolute

The Drugs and Cosmetics Act, 1940 prohibits the manufacture, distribution, sale, or import of any drug in India without a valid licence under the Act. Operating without one is not a procedural lapse - it is a substantive violation that exposes the operator to penalty proceedings, seizure of stock, sealing of premises, prosecution, and (in serious cases) imprisonment under Sections 27 and 28 of the Act.

The mandate applies across allopathic, biological, AYUSH, and homoeopathic categories, and across the value chain from manufacturing through wholesale to retail. There is no de minimis exception - even small retail pharmacies, mid-size wholesalers, and small-batch manufacturers require fkyormal licensing.

1.2 Enforcement Has Intensified Across Categories

Post-2020, drug-licence enforcement has materially tightened across multiple fronts. Periodic CDSCO and State Drug Controller inspection drives target unlicensed retail outlets, expired licences, and substandard premises. Customs and import enforcement has tightened on unlicensed drug imports. The revised Schedule M roll-out has driven manufacturing-site inspections to verify GMP compliance.

The Drugs and Cosmetics Rules require statutory inspections of licensed premises not less than once in every 3 years, in addition to surveillance and complaint-driven inspections. Quality concerns following several high-profile NSQ (Not of Standard Quality) events have driven sample testing intensification across the supply chain.

1.3 The Compliance Bar Has Risen With Revised Schedule M

The revised Schedule M, effective for large manufacturers from 28 June 2024 (with SMEs granted extension to 31 December 2025), substantially raised the GMP bar for Indian pharma manufacturing - introducing Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), and comprehensive qualification and validation requirements aligned with WHO GMP.

Manufacturers seeking new licences under Form 25 or Form 28, or renewing existing facilities, must demonstrate compliance with the revised Schedule M standards - a substantially higher bar than the pre-2024 framework.

1.4 Digital Workflows Have Raised Documentation Standards

Most State Drug Control departments and CDSCO now operate online portals - CDSCO's SUGAM portal for central applications, state-specific drug control portals for state-level retail, wholesale, and manufacturing licences. The digital workflow has materially compressed processing times for clean applications but raised the documentation discipline bar - incomplete or inconsistent submissions are flagged automatically rather than corrected informally. The audit-readiness expectations applied to drug licence filings are materially higher than they were five years ago.

1.5 Commercial and Insurance Gating

A drug licence in India is no longer just a regulatory requirement—it has become an important commercial qualification. Banks and NBFCs often require valid licensing before extending credit to pharmaceutical businesses, while landlords, insurers, and online healthcare platforms commonly verify licence status during onboarding and due diligence.

B2B customers in regulated pharmaceutical supply chains also treat licensing as a standard vendor qualification criterion. As a result, any gap in licensing status, whether due to non-application, lapse, or non-compliance, can disrupt financing, commercial partnerships, insurance coverage, and market access well beyond the immediate regulatory implications.

2. The Legal Framework - Drugs and Cosmetics Act 1940 and Rules 1945

Mapping the legal architecture correctly is the foundation of any drug licensing programme. The framework is layered - parent statutes, operational rules, schedules with technical specifics, sector-specific overlays, and adjacent regulators.

2.1 The Parent Statutes

Statute / Rule	Year	Scope
Drugs and Cosmetics Act	1940	Parent statute governing manufacture, sale, import of drugs and cosmetics
Drugs and Cosmetics Rules	1945	Operational rules - forms, fees, schedules, GMP, licensing procedure
Pharmacy Act	1948	Regulation of the pharmacy profession; State Pharmacy Council registration
Drugs and Magic Remedies (Objectionable Advertisements) Act	1954	Prohibits objectionable advertisements claiming cures
Drugs (Prices Control) Order	2013	Price control of essential drugs; NPPA administration
Medical Devices Rules	2017	Separated medical devices into a distinct regulatory framework (effective 1 January 2018)
New Drugs and Clinical Trials Rules	2019	Streamlined new-drug approval and clinical-trial pathway

2.2 Key Schedules Under the D&C Rules 1945

Schedule	Coverage
Schedule C / C1	Biological products, sera, vaccines, hormones, insulin, blood products
Schedule H	Prescription drugs - require valid prescription for sale
Schedule H1	More tightly controlled prescription drugs (added 2013); record-keeping mandatory
Schedule X	Certain psychotropic substances, habit-forming drugs, specified narcotic-related preparations
Schedule M	Good Manufacturing Practices (GMP) - revised version effective from 1 July 2024 for large manufacturers, 31 December 2025 for SMEs
Schedule T	GMP for Ayurvedic, Siddha, and Unani drugs
Schedule J	Diseases for which no drug claim is permitted (e.g., AIDS, cancer)
Schedule K	Drugs exempt from certain provisions of the Rules
Schedule F / F1	Standards for biological products
Schedule Y	Clinical trial protocols (largely subsumed by the 2019 Rules)

2.3 Perpetual Licences - The 2018 Rule 63 Amendment

A 2018 amendment to Rule 63 of the Drugs and Cosmetics Rules 1945 replaced the traditional renewal regime with a perpetual licence system. Under the current framework, once granted, the licence does not expire on a fixed cycle. The licensee must, however, pay a licence retention fee every 5 years to maintain validity, and statutory inspections of licensed premises must be conducted not less than once in 3 years. Failure to pay retention fees or maintain compliance can trigger suspension or cancellation. The perpetual-with-retention model has substantially reduced administrative burden compared to the pre-2018 renewal regime.

2.4 Adjacent Regulators

Drug licensing does not operate in isolation. Several parallel approvals may be required from regulators such as the Pharmacy Council of India (PCI) and State Pharmacy Councils for pharmacist eligibility, the NPPA for price-controlled drugs, the Department of AYUSH for traditional medicine products, and State Pollution Control Boards and Fire Services for manufacturing-site compliance.

For pharmaceutical manufacturing facilities, environmental, hazardous waste, and fire-safety approvals often run alongside the drug licence application process. In the case of new drugs and clinical trials, additional approvals from bodies such as the DTAB, Subject Expert Committees, and Institutional Ethics Committees may also be required.

2.5 The Penalty Architecture

Penalties for operating without a valid drug licence, or in violation of licence conditions, range from significant fines under Sections 27 and 28 of the D&C Act 1940 to imprisonment for serious violations (especially those involving adulterated, spurious, misbranded, or Schedule X / narcotic drugs). Repeated offences attract progressively higher penalties.

Beyond statutory penalties, business consequences include licence suspension or cancellation, sealing of premises, stock seizure, and reputational damage that affects all future regulatory submissions. Pharmacy chains and corporate operators face director-level accountability for compliance lapses.

3. State Drug Authorities vs CDSCO - Who Approves What

The single most frequently misunderstood aspect of the framework is the division of regulatory authority between State Drug Licensing Authorities (issuing the state drug licence in India for retail, wholesale, and general manufacturing) and CDSCO (governing central drug approval in India for new drugs, biologicals, imports, and clinical trials).

Knowing which authority issues which licence type is the first practical question in any drug licence application process, and getting this wrong adds months of avoidable delay. The framework below clarifies the division with current 2026 detail.

3.1 What State Drug Authorities Do

State Drug Licensing Authorities, led by the State Drugs Controller and supported by district-level Drug Inspectors, are responsible for most day-to-day pharmaceutical regulation. Their scope includes retail drug licence India approvals, wholesale licences, manufacturing licences for most allopathic drugs, loan licences for contract manufacturing, and routine inspections of pharmacies, distributors, and manufacturing facilities.

They also oversee storage and sale conditions, enforce the Drugs and Cosmetics Act at the state level, and collect samples for quality testing. For most retail pharmacies, wholesalers, and formulation manufacturers, the primary regulatory relationship is with the State Drug Licensing Authority rather than CDSCO.

3.2 What CDSCO Does

CDSCO, headed by the Drug Controller General of India (DCGI), is the central regulatory authority responsible for activities requiring national oversight. The CDSCO approval process covers new drug approvals, clinical trial permissions, drug and cosmetic imports, biological products, certain medical devices, and national drug-quality standards.

CDSCO also coordinates drug recalls, adverse drug reaction monitoring, and regulatory oversight of specific pharmaceutical categories in collaboration with state authorities. For businesses requiring central drug approval in India, applications are typically managed through the CDSCO SUGAM portal in accordance with applicable CDSCO approval requirements in India.

3.3 The Activity-to-Authority Map

Activity	Issuing Authority	Key Form
Retail pharmacy / medical store	State Drug Authority	Form 20 (general) / Form 21 (Schedule C/C1)
Wholesale distribution	State Drug Authority	Form 20B / Form 21B
Manufacturing of allopathic drugs (excl. biologicals)	State Drug Authority	Form 25
Loan licence (contract manufacturing)	State Drug Authority	Form 25A
Manufacturing of biologicals / Schedule C/C1	CDSCO (with state coordination)	Form 28
Blood banks and blood-product manufacturing	State Drug Authority with CDSCO approval	Form 28-C (CLA approval)
Import of drugs	CDSCO	Form 10 / Form 10A
New drug approval	CDSCO (DCGI)	Form CT-21 (new drug)
Clinical trial permission	CDSCO with Ethics Committee approval	Form CT-04
Manufacture for test / examination	State Drug Authority	Form 29
Ayurvedic, Siddha, Unani manufacture	Department of AYUSH / State AYUSH licensing authority	State-specific forms
Homoeopathic manufacture	State Drug Authority	State-specific forms

3.4 The Coordination Requirement

Several activities require coordination between state and central authorities. Blood banks, for instance, are licensed by the State Drug Authority but with approval from the Central Licence Approving Authority (CLA) under CDSCO - the licence is operationally state-administered but substantively requires central concurrence.

New drug manufacturing typically requires CDSCO product approval (for the new drug) followed by state manufacturing licensing (Form 25 or Form 28). Imports require CDSCO licensing (Form 10) and then state-level wholesale or distribution licensing for the in-country handling. The coordination is well-established but requires careful sequencing to avoid one approval lapsing while the other is being pursued.

3.5 Practical Implications for Applicants

Three practical implications emerge from the state-central division. First, identify the correct authority at the very first stage of planning - filing a retail application with CDSCO, or an import application with State Drug Authority, simply does not work. Second, sequence parallel approvals correctly when both are needed - typically central new-drug approval before state manufacturing licence; central import licence before state wholesale licence for imported products. Third, maintain compliance with both authorities simultaneously once licensed - state inspections (every 3 years statutory minimum) and any applicable CDSCO surveillance run on separate cycles.

4. Types of Drug Licences in India

The D&C Rules 1945 distinguish several distinct licence types, each with its own form, scope, eligibility, and infrastructure requirements. Identifying the right type at the outset is essential to scoping the application correctly.

4.1 Retail Drug Licence

A retail drug licence in India authorises the operation of a medical store, chemist shop, or pharmacy selling drugs directly to consumers. The drug licence in India framework distinguishes between Form 20, which covers the retail sale of general drugs, and Form 21, which applies to Schedule C and C1 products such as biologicals. Both licences are issued by the State Drug Licensing Authority.

Key requirements include the presence of a registered pharmacist, adequate premises (typically around 10 sq. m.), prescribed storage conditions, refrigeration for temperature-sensitive medicines, and proper record-keeping systems. Some states may also require air conditioning and additional infrastructure standards. The drug licence for medical store in India is the most common drug licence type in the country, issued to retail pharmacies operating across India's roughly 12 lakh registered medical stores.

4.2 Wholesale Drug Licence

A wholesale drug licence authorises bulk distribution to retailers, hospitals, stockists, institutional buyers, and other wholesalers. The framework distinguishes: Form 20B (general wholesale licence); Form 21B (wholesale licence for Schedule C and C1 biologicals). The wholesale drug licence application process in India requires a competent person on premises, typically a graduate with at least 1 year of experience in dealing with drugs, or an undergraduate with at least 4 years of experience (Rule 64 of the D&C Rules 1945).

Premises must include adequate storage capacity, segregated cold storage for thermo-sensitive products, segregated narcotics storage (for Schedule X), record-keeping, and dispatch facilities. The wholesale licence is the gateway to B2B pharmaceutical distribution at scale.

4.3 Manufacturing Licence

A drug manufacturing licence in India authorises the production of pharmaceutical products. Multiple sub-types apply by product category and product mix: Form 25 for manufacturing of allopathic drugs other than Schedule C and C1; Form 28 for Schedule C and C1 biologicals; Form 25A (loan licence) for entities that manufacture at another licensee's premises under a contract arrangement; Form 29 for manufacture for examination, test, or analysis only (test licence).

All manufacturing licences require compliance with the revised Schedule M, qualified technical staff (Production Head, Quality Control Head, Quality Assurance Head with prescribed qualifications and experience), dedicated production facility configured by dosage form, validated equipment, comprehensive Standard Operating Procedures, in-house Quality Control laboratory, and full GMP documentation discipline.

4.4 Import Licence

A drug import licence application in India is processed through CDSCO. Key forms: Form 10 (import licence for sale and distribution); Form 10A (import licence for clinical trial use); Form 11 (personal use); Form 12 (examination, test, analysis). Imports of new drugs (drugs being introduced in India for the first time) require prior CDSCO new-drug approval through the SUGAM portal before the import licence can be considered.

Imports must be channelled through a registered Indian importer; foreign manufacturers cannot directly import without an Indian counterparty. Import-licensed drugs must then move through wholesale and retail channels with the appropriate state-level wholesale and retail licences for distribution and sale within India.

4.5 Loan Licence and Repacking Licence

A loan licence (Form 25A for allopathic, Form 28A for biologicals) allows an entity that does not own its own manufacturing facility to manufacture using another licensed manufacturer's premises and equipment under a contractual arrangement. The loan licensee is the principal for product registration, branding, and regulatory accountability; the host manufacturer provides the physical infrastructure.

A repacking licence covers repackaging of already-manufactured drugs into smaller pack sizes or relabelled packs, with separate licensing requirements. Both forms are widely used by small and mid-size brand owners that want to commercialise products without owning fixed-asset manufacturing capacity.

4.6 Specialised Licences

Several specialised licence types apply to specific activities: blood bank licence for blood collection, processing, and storage; manufacturing licence for cosmetics; manufacturing licence for AYUSH products under the Department of AYUSH framework; restricted licences- these restricted variants are increasingly rare but still operative in some states. Each specialised category has its own form, eligibility, and infrastructure expectations.

5. Documents Required for Drug Licence Application

Document discipline is the single most common cause of avoidable delay in drug licence applications. The working baseline list below covers the documents required for drug licence registration across major State Drug Authorities and CDSCO. The exact set varies by licence type, state, and applicant type — retail applications focus on premises and pharmacist; wholesale on competent person and storage; manufacturing on facility, qualified staff, and GMP; import on the foreign manufacturer documentation.

5.1 Identity and Entity Documents (All Licence Types)

• PAN card and Aadhaar of the applicant / proprietor / directors
• Photograph of applicant (passport-size)
• Partnership deed (for partnership firms)
• Certificate of Incorporation, MoA, and AoA (for companies)
• Board resolution or Power of Attorney appointing authorised signatory
• Affidavit of non-conviction under D&C Act 1940 (notarised)

5.2 Premises Documents

• Proof of premises - sale deed / lease deed / rent agreement with NOC from owner
• Site plan showing layout, dimensions, and storage zones
• Photographs of premises (interior and exterior)
• Municipal trade licence or Shops and Establishments registration
• Property tax receipt of the premises

5.3 Qualified Person Documents

• For retail: Registered Pharmacist's qualification certificates and State Pharmacy Council registration
• Registered Pharmacist's appointment letter and undertaking
• For wholesale: Competent Person's qualification certificate (graduate with 1+ years drug experience, or undergraduate with 4+ years)
• Competent Person's appointment letter, experience certificate, and undertaking
• Aadhaar and PAN of pharmacist / competent person

5.4 Retail / Wholesale Specific

• Refrigerator make and model (for thermo-sensitive drug storage)
• Air-conditioning system details (where required)
• Storage rack layout
• Sale and purchase register format / billing system
• Schedule H1 register format (for retail handling Schedule H1 drugs)

5.5 Manufacturing Specific (Form 25 / Form 28)

• Detailed site master file covering site, layout, and process flow
• Equipment list with capacities, models, and calibration status
• Quality Control laboratory infrastructure list and analytical equipment
• HVAC system design and validation documents
• Water system (purified water, water for injection where applicable) design and validation
• Standard Operating Procedures (SOPs) covering manufacturing, QC, QA, warehousing
• Master batch records and validation protocols
• Qualifications and experience of Production Head, Quality Control Head, Quality Assurance Head
• Schedule M compliance declaration with gap analysis (where applicable)
• Pollution Control Board CTE / CTO
• Factory licence under Factories Act 1948
• Fire NOC from State Fire Service
• Building stability certificate from registered structural engineer

5.6 Import Specific (Form 10)

• Manufacturer's licence from country of origin
• Free Sale Certificate (FSC) / Certificate of Pharmaceutical Product (CoPP) issued by the regulatory authority of the country of origin
• Notarised and apostilled Power of Attorney to the Indian Authorised Agent
• Product details, composition, specifications, and packing information
• Indian Authorised Agent's wholesale drug licence (Form 20B / 21B)
• Test reports from the manufacturer with accreditation
• Indian-language label artwork compliant with D&C Rules 1945 labelling provisions
• Where the drug is a new drug - prior CDSCO new-drug approval

5.7 Document Discipline - High-Leverage Practices

Three practices can significantly improve first-pass success in the drug licence application process. First, ensure complete consistency across all documents, including applicant details, premises information, drug categories, and qualified-person credentials. Even minor discrepancies can trigger regulatory queries.

Second, verify that all registrations, qualifications, and experience certificates are current and easily verifiable. Third, review the latest documents required for drug licence registration checklist published by the relevant State Drug Authority, as requirements are updated periodically and outdated submissions often face avoidable delays.

6. Step-by-Step Application Process

The practical workflow varies materially by licence type. Below we cover the four most-common pathways, retail, wholesale, manufacturing, and import, with the structured step-by-step process for each. The flow for how to apply for retail drug licence in India is similar in shape to the wholesale flow but differs in qualified-person requirements; manufacturing and import follow more complex multi-stage pathways.

6.1 Retail Drug Licence - Step-by-Step

Step	Activity	Typical Timeline
1. Pre-application diagnostic	Identify state, premises, pharmacist availability, document checklist	1-2 weeks
2. Premises preparation	Lease premises; arrange minimum area, height, refrigerator, racks, AC	2-6 weeks
3. Pharmacist engagement	Appoint Registered Pharmacist with valid State Pharmacy Council registration	1-3 weeks
4. Application filing	File Form 19 application on state portal with Form 20 / 21 specified	1 week
5. Document upload and fees	Upload all documents; pay state-specific fee (typically around INR 1,500)	1-2 days
6. Drug Inspector verification	Drug Inspector visits premises; verifies pharmacist; checks infrastructure	2-4 weeks
7. Licence grant	Form 20 / 21 issued; display at premises; commence operations	1-2 weeks

6.2 Practical Retail Application Notes

The how to get drug licence in India online process is broadly similar across states. Applicants must register on the State Drug Control portal, complete authentication, select the appropriate licence category, fill the application form, upload the required documents, and pay the prescribed fee online.

After submission, the application is reviewed and a Drug Inspector typically conducts a premises inspection within a few weeks. For a clean drug licence registration in India application, the overall process generally takes 25–45 days, although first-time applicants should allow additional time for queries and inspections.

6.3 Wholesale Drug Licence - Step-by-Step

The wholesale process largely mirrors retail but with different qualified-person requirements (Competent Person rather than Registered Pharmacist), larger premises (typically meeting state-specific minimum area for wholesale storage), and more substantial storage and dispatch infrastructure. Application is filed through the State Drug Control portal with Form 19 indicating Form 20B (general wholesale) or Form 21B (Schedule C/C1 wholesale). Government fees are typically higher than retail (~INR 6,000+). Drug Inspector verification is similarly conducted within 2-4 weeks. The wholesale licence enables B2B distribution to retailers, hospitals, institutions, and other wholesalers.

6.4 Manufacturing Licence (Form 25 / Form 28) - Step-by-Step

Step	Activity	Typical Timeline
1. Pre-application diagnostic	Confirm authority (state for Form 25 / CDSCO involvement for Form 28); product categories; Schedule M readiness	2-4 weeks
2. Site and infrastructure	Acquire premises; complete construction; install equipment; implement HVAC, water, QC infrastructure	12-36 months (project-dependent)
3. GMP and SOP development	Develop SOPs, master batch records, validation protocols; train staff; implement QMS	8-26 weeks
4. Pre-application gap analysis	Internal gap analysis against Schedule M; close gaps before filing	4-8 weeks
5. Application filing	File Form 24 (allopathic) or Form 27 (biologicals) with state authority	1-2 weeks
6. Inspector review and queries	Drug Inspector / CDSCO inspector reviews documentation; queries	8-16 weeks
7. Site inspection	Multi-day site inspection covering GMP, equipment, QC, documentation, personnel	4-8 weeks
8. Licence grant	Form 25 / Form 28 issued; commercial production can commence	2-4 weeks

6.5 Manufacturing Application Key Considerations

Obtaining a drug manufacturing licence in India is significantly more complex than securing a retail or wholesale licence due to Schedule M GMP requirements. Manufacturers should complete facility construction, utilities, and compliance infrastructure before filing, as applications submitted during construction often face inspection observations.

Success depends on having qualified technical personnel, a functioning Quality Management System, validated processes, SOPs, and complete documentation in place before inspection. Internal mock audits are highly recommended. For a greenfield facility, the journey from investment approval to commercial production typically takes 18–36 months.

6.6 Import Licence (Form 10) - Step-by-Step

The CDSCO approval process for drug imports begins with appointing an Indian Authorised Agent (IAA) holding the required wholesale licence. If the product is classified as a new drug, central drug approval in India must be obtained before the import application can proceed.

Applicants then submit the import dossier through the SUGAM portal, including manufacturer approvals, Free Sale Certificates, product specifications, and labeling documents. After CDSCO review and query resolution, a Form 10 import licence is issued, allowing imports and distribution through licensed wholesale and retail channels. For clean applications, the process typically takes 4–9 months.

6.7 CDSCO New Drug Approval - Brief Workflow

The CDSCO new drug approval process in India applies to drugs being introduced in India for the first time. The CDSCO approval process for a new drug typically begins with pre-submission consultations, followed by a Clinical Trial Application through the SUGAM portal. The application is reviewed by expert committees, after which clinical trials are conducted with Ethics Committee approvals and registered investigators.

Following successful safety and efficacy evaluation, the sponsor submits a new drug application for regulatory review. Depending on the product and clinical requirements, the process can take 18–36 months or longer. Once central drug approval in India is obtained, the applicant can proceed with a drug manufacturing licence in India or import licence application, as applicable.

7. Sector-Specific Considerations

Although the broad framework is common, the practical content of drug licence applications differs by business model. The sections below highlight the most common patterns across the segments where licensing is most frequently sought - and where sector-specific overlays add complexity.

7.1 Retail Pharmacy / Medical Stores

A retail drug licence in India is the most common category of drug licence in India, covering pharmacies and medical stores. Key compliance requirements include the continuous presence of a registered pharmacist, proper maintenance of Schedule H, H1, and X registers, functioning refrigeration for temperature-sensitive medicines, and clear segregation of controlled drug categories.

Drug Inspectors increasingly conduct surprise inspections to verify compliance. Pharmacies must also maintain processes for expired-drug handling and returns. For e-pharmacy businesses, additional requirements such as prescription verification, digital record management, and platform-specific compliance obligations apply.

7.2 Wholesale Distribution

Wholesale operations under a drug licence in India face stricter oversight than retail businesses due to larger inventory volumes and wider distribution responsibility. Key requirements include the presence of a qualified Competent Person, proper cold-chain and temperature-controlled storage, secure handling of Schedule X products, and accurate inventory records.

Wholesalers must also maintain SOPs for storage, dispatch, recalls, and traceability. Increasingly, hospitals, institutions, and large buyers conduct supplier audits, making operational and compliance readiness an essential part of wholesale pharmaceutical distribution.

7.3 Pharmaceutical Manufacturing

A drug manufacturing licence in India carries the highest compliance burden among all pharmaceutical licence categories. Beyond obtaining Form 25 or Form 28 approval, manufacturers must maintain compliance with revised Schedule M requirements, GMP documentation, quality systems, equipment qualification, laboratory controls, training records, and validation programmes.

Manufacturing facilities must also remain inspection-ready for State Drug Authorities, customer audits, and, where applicable, international regulators such as USFDA, EMA, and WHO. Many Indian pharmaceutical companies serve both domestic and export markets, making multi-regime regulatory compliance a core operational requirement.

7.4 Drug Importers and Foreign Manufacturers

Foreign pharmaceutical companies cannot directly hold Indian import licences and must appoint an Indian Authorised Agent (IAA) with a valid wholesale drug licence. The IAA manages the CDSCO approval process, holds the Form 10 import licence, coordinates with regulators through the SUGAM portal, and handles customs clearance and regulatory compliance within India.

Selecting the right IAA is critical. Factors such as regulatory experience, product-handling capacity, compliance track record, and support for pharmacovigilance and product recalls can significantly affect the success of central drug approval in India and ongoing market operations. Many foreign manufacturers eventually establish Indian subsidiaries to internalize these functions as business volumes grow.

7.5 New Drug Innovators

Companies developing or introducing new drugs in India face the most complex CDSCO approval process, with approvals under the New Drugs and Clinical Trials Rules 2019 often taking 18–36 months or longer. The pathway involves multiple stages of review by Subject Expert Committees, the DTAB, and other regulatory bodies.

Success depends on strong clinical-trial design, proactive engagement with CDSCO, robust pharmacovigilance systems, and timely safety reporting. While pursuing central drug approval in India, companies typically plan manufacturing, import licensing, distribution, and commercialization strategies in parallel to accelerate market launch after approval.

7.6 AYUSH (Ayurvedic, Siddha, Unani) Manufacturing

AYUSH drug manufacturing follows a separate regulatory framework administered by the Ministry of AYUSH and state AYUSH authorities. Unlike allopathic products, which require a drug manufacturing licence in India under the Drugs and Cosmetics Rules, AYUSH manufacturers must comply with Schedule T GMP requirements and sector-specific licensing provisions.

The qualification, labeling, and compliance requirements also differ, with AYUSH facilities typically requiring qualified Ayurvedic or traditional medicine professionals rather than pharmacy graduates. Many pharmaceutical companies operate both allopathic and AYUSH facilities, managing parallel licensing and compliance frameworks simultaneously.

8. Common Mistakes and How to Avoid Them

The mistakes below are the recurring patterns we see across drug licence engagements - and the ones most likely to delay approval, trigger post-grant compliance findings, or expose the operator to regulatory action. Each is paired with the discipline that prevents it.

8.1 Misidentifying State vs Central Authority

The most common avoidable failure is filing with the wrong authority - filing for retail / wholesale with CDSCO instead of the State Drug Authority, or filing for biologicals manufacturing (Form 28) with the state authority without engaging CDSCO. The pattern: application is rejected on jurisdiction grounds and must be refiled, adding 3-6 months to the timeline. Discipline: complete the state-vs-central authority diagnostic before any filing; map the activity, product categories, and applicant type carefully; for borderline cases involving multiple authorities, sequence the central approvals first (where required) before state filings.

8.2 Filing Without Pharmacist or Competent Person In Place

Retail licence applications filed without a registered pharmacist genuinely available on the premises - or wholesale licences filed without a qualified competent person - routinely fail at Drug Inspector verification. The pattern: the application is technically complete, but the inspector finds no pharmacist on-site at the verification visit. Discipline: appoint the pharmacist or competent person before filing; document the appointment, salary, and reporting structure; ensure the pharmacist's current State Pharmacy Council registration is valid; have an evidence-of-presence protocol for inspections.

8.3 Premises Not Meeting Minimum Specifications

Retail and wholesale licence applications filed for premises that do not meet the state-specific minimum area, ceiling height, refrigeration, or air-conditioning standards routinely fail inspection. Common gaps: minimum 10 sqm area not achieved (state-specific variations apply); ceiling height below 2.75m; refrigerator absent or not operational; storage racks inadequate; no segregated cold-chain area for thermo-sensitive drugs. Discipline: verify state-specific premises specifications before lease signing; ensure all infrastructure is installed and functional before filing; conduct pre-inspection internal verification.

8.4 Inadequate Schedule M Readiness for Manufacturing

Manufacturing licence applications filed before the facility is genuinely Schedule M-compliant routinely face inspection findings on QC laboratory infrastructure, HVAC validation, water system, equipment qualification, SOPs, or qualified technical staff. The pattern: capital is committed; inspection happens; major deficiencies identified; 6-18 months of remediation work before licence can be granted. Discipline: complete full Schedule M-compliant facility construction and validation before filing; conduct internal gap analysis against the revised Schedule M provisions; engage GMP consultants for pre-application diagnostic; ensure Production Head, QC Head, QA Head are appointed with prescribed qualifications and demonstrably in place.

8.5 Missing Schedule H, H1, X Compliance

Retail and wholesale licences granted on the basis of standard premises and pharmacist setup sometimes operate without proper Schedule H, Schedule H1, or Schedule X compliance - Schedule H1 register not maintained, Schedule X narcotic register absent, expired-drug segregation not implemented. Drug Inspector surveillance visits typically catch these gaps and can result in suspension or penalty proceedings. Discipline: implement full Schedule H / H1 / X compliance from Day 1 of operations; maintain registers in prescribed format with daily entries; conduct quarterly internal audits to verify continuing compliance.

8.6 Underestimating Document Consistency Requirements

Inconsistencies across application form, premises documents, pharmacist credentials, partnership / company documents, and supporting affidavits routinely trigger query notices that add 2-4 weeks per round. Common pattern: business name spelled differently on different documents; address variations; pharmacist registration number inconsistencies; partner / director details mismatched. Discipline: maintain a master document index ensuring consistency across the entire application package; cross-verify before final submission; reconcile any historical inconsistencies before filing.

8.7 Letting Retention Fee Lapse

Although drug licences are now perpetual (Rule 63 amendment, 2018), they require retention fee payment every 5 years. Lapse of the retention fee can result in suspension of the licence - and a suspended licence is operationally equivalent to no licence. Discipline: institutionalise the 5-year retention fee calendar at the original grant; appoint a named compliance owner; build a 90-day pre-due-date alert; maintain payment evidence for audit. Pharmacy chains and multi-location wholesalers should consolidate retention-fee tracking across all licenses centrally.

8.8 Operating Beyond Licensed Scope

Retail outlets granted Form 20 (general retail) sometimes attempt to handle Schedule C / C1 biologicals without securing Form 21; wholesalers operating under Form 20B sometimes handle biologicals without Form 21B. Manufacturers granted Form 25 sometimes add product categories outside the licensed scope without formal amendment. The pattern: operations grow organically beyond the licensed scope; surveillance or audit discovers the gap; show-cause and penalty proceedings follow. Discipline: any expansion of product categories, scope, or operations goes through formal licence amendment before commencement; never assume the original licence automatically covers new categories.

9. Drug Licence Application Checklist

The checklist below consolidates the operational decision points into a structured framework that pharma operations, regulatory, and project teams can apply directly to their next drug licence application, covering the full lifecycle from drug licence registration in India scoping through to post-grant compliance.

9.1 Pre-Application Phase

• Activity-to-authority diagnostic completed (State Drug Authority vs CDSCO)
• Licence type identified
• Schedule applicability mapped (Schedule C/C1, H, H1, X applicability)
• State-specific document checklist obtained from the State Drug Authority portal
• CDSCO SUGAM portal access (for central applications) registered
• Project timeline and resource plan documented

9.2 Premises and Infrastructure Phase

• Premises lease / ownership documents in place with NOC from owner
• For retail: minimum area (typically 10 sqm), ceiling height (2.75m), refrigerator, storage racks, AC
• For wholesale: larger storage area, segregated cold storage, narcotics storage, dispatch infrastructure
• For manufacturing: Schedule M-compliant facility with HVAC, water system, dedicated production areas, QC laboratory
• Site plan and photographs prepared for the application
• Adjacent approvals - municipal trade licence, Shops and Establishments, Fire NOC, building occupancy

9.3 Qualified Person Phase

• For retail: Registered Pharmacist appointed with valid State Pharmacy Council registration
• For wholesale: Competent Person appointed with qualification and experience evidence
• For manufacturing: Production Head, Quality Control Head, Quality Assurance Head appointed with Schedule M-compliant qualifications and experience
• Appointment letters, salary records, undertakings in place
• All qualifications, registrations, certifications current and verifiable

9.4 Documentation Phase

• Identity and entity documents complete with internal consistency
• Premises documents with all required attachments
• Qualified person credentials and undertakings
• For manufacturing: site master file, equipment list, SOPs, validation protocols, QC infrastructure
• For import: foreign manufacturer's licence, FSC, Power of Attorney, IAA wholesale licence
• Adjacent approvals (Fire NOC, factory licence, PCB consent) where applicable
• Master document index with version control and consistency verification

9.5 Application Phase

• Online portal account created (state portal or CDSCO SUGAM)
• Application form completed with consistent applicant, premises, and qualified-person details
• All required documents uploaded in prescribed formats
• Application fee paid through portal; receipt retained
• Application reference number received and recorded

9.6 Inspection and Grant Phase

• Drug Inspector visit accommodated; queries responded to comprehensively
• Pharmacist / Competent Person / qualified technical staff present and demonstrable at inspection
• Schedule H, H1, X registers ready; storage segregation verified
• Inspection observations closed before licence grant
• Licence (Form 20 / 21 / 20B / 21B / 25 / 28 / 10) granted
• Licence displayed conspicuously at premises per Rule provisions

9.7 Post-Grant Compliance Phase

• 5-year retention fee calendar set up with named compliance owner
• Statutory 3-year inspection cycle anticipated with continuing-compliance readiness
• Schedule H, H1, X registers maintained with current entries
• For manufacturing: Schedule M compliance maintained; CAPA, change control, deviation logs current
• Pharmacist / Competent Person availability maintained continuously
• Any change in scope, premises, or qualified person processed through formal amendment
• Adjacent approvals (Fire NOC, factory licence, PCB consent) renewed on their own cycles

Conclusion

Obtaining a drug licence in India is a structured process governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945, supported by recent reforms such as perpetual licences, the NDCT Rules 2019, revised Schedule M requirements, and digital application systems through CDSCO and state portals. While the regulatory framework is clear, success depends on proper planning, infrastructure readiness, and correct licence categorization.

Three practices are critical: identifying the correct licensing authority before filing, ensuring all personnel and facility requirements are in place prior to inspection, and establishing a strong post-approval compliance system. Ongoing compliance, including inspections, record maintenance, and statutory fee obligations, is essential to maintain the licence and avoid regulatory disruptions.

Whether you are opening your first retail pharmacy, scaling a wholesale distribution business, setting up a new pharmaceutical manufacturing facility under the revised Schedule M, navigating CDSCO import licensing from abroad, or pursuing new drug approval through the 2019 Rules pathway, IMARC Engineering provides end-to-end pharmaceutical regulatory and drug licensing advisory and execution.