Manufacturing
Drug Licence
in India
Complete regulatory support for obtaining a Manufacturing Drug Licence from the State Drug Controller — mandatory for every pharmaceutical company manufacturing allopathic, biological or AYUSH drugs for the Indian market.
What is a Manufacturing Drug Licence?
A Manufacturing Drug Licence is a statutory authorisation from the State Drug Control Authority permitting a company to manufacture allopathic drugs for sale in India. No pharmaceutical company can legally produce drugs without it.
Legal Obligation
Manufacturing without a valid licence is a criminal offence under Section 27 of the D&C Act — punishable with imprisonment up to 3 years. Directors are personally liable for prosecution.
Schedule M GMP Compliance
The factory must fully comply with Schedule M — covering premises design, equipment qualification, cleanroom classification, HVAC, water systems and QC laboratory.
Separate Qualified Personnel
HOD Manufacturing and HOD QC must be different people, both holding B.Pharm/M.Pharm or equivalent degrees. A single person cannot hold both positions.
Per Dosage Form Endorsements
Tablets, capsules, liquids, injectables and ointments each require a separate endorsement on Form 25. Sterile injectables need dedicated cleanroom infrastructure.
Types of Manufacturing Drug Licences
The right licence depends on your drug category, manufacturing setup and ownership structure. Most pharma companies need multiple endorsements on a single Form 25.
Form 25⏱ 3–9 monthsPrimary licence for all allopathic drug manufacturers. Covers tablets, capsules, liquids, ointments, topicals. Each dosage form needs a separate endorsement from the State Drug Controller after GMP inspection.
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Form 27⏱ 9–18 monthsSterile injectables require ISO Class 5–7 cleanrooms, validated HVAC and environmental monitoring. Biologicals (vaccines, sera) under Form 27 also need CDSCO central approval in addition to state licence.
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Loan Licence⏱ 3–6 monthsManufacture in another licensed factory without owning your own facility. The Loan Licensee holds Form 25. Ideal for new entrants and brand owners launching products without building their own plant.
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AYUSH⏱ 4–9 monthsSeparate state AYUSH licence for Ayurvedic, Unani, Siddha and Homoeopathic drugs — issued by the State AYUSH Department. Cannot use Form 25 for AYUSH products. Separate qualified person required.
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Repacking⏱ 3–6 monthsFor companies importing bulk drugs and repacking into consumer units or relabelling for the Indian market. Requires a separate Form 25 endorsement with dedicated repacking area and equipment.
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Form 28⏱ 30–60 daysRenewal via Form 28 before expiry. Amendments for HOD change, new drug category, premises expansion or process changes. A lapsed licence requires fresh inspection — we track all deadlines proactively.
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"Schedule M compliance is the minimum standard every licensed pharmaceutical manufacturer in India must meet — it is non-negotiable."
— Drugs Rules, 1945 · Govt. of IndiaWhat the Drug Inspector Checks
Every requirement below is verified during the factory inspection. Deficiencies become Non-Conformity Reports (NCRs) that must be closed before the licence is issued.
Premises & Layout
Dedicated zones for manufacturing, QC, quarantine, warehouse and utilities. Airlock systems, controlled access, defined personnel flow and pest control to prevent contamination.
Equipment Qualification
All manufacturing and testing equipment must be qualified (IQ/OQ/PQ), calibrated with valid in-date certificates and maintained under a preventive maintenance programme.
Qualified Personnel
Separate HOD Manufacturing and HOD QC, both holding B.Pharm/M.Pharm degrees. GMP training programme with documented training records mandatory for all staff.
SOPs & Batch Records
Current approved SOPs for every critical operation. Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) completed in real-time for every batch — no post-hoc entries.
How to Get a Manufacturing Drug Licence
Our 7-step process takes your factory from gap analysis through GMP inspection to licence grant — with mock audits, SOP library and full NCR response support included.
A thorough pre-application review of your factory against all Schedule M GMP requirements — identifying infrastructure, equipment, personnel and documentation gaps before any filing. This prevents rejection at the inspection stage.
Documents Required
Manufacturing licence applications require comprehensive documentation. Click each section to expand the complete checklist.
Company & Legal Documents
Business registration, NOCs and premises proof
Factory & Premises Documents
Layout plans, equipment lists and infrastructure
Qualified Personnel Documents
HOD Manufacturing, HOD QC degrees and experience
Technical & Product Documents
Drug categories, master formulae and SOPs
Application Forms & Declarations
Statutory forms, fees and signed undertakings
Govt. Fees & Approval Timelines
Manufacturing licence fees vary by state, drug category and production scale. Below is an indicative guide — we provide exact quotes after assessment.
| Licence / Service | Authority | Approx. Govt. Fee | Validity | Timeline | Form |
|---|---|---|---|---|---|
| Form 25 — Allopathic | State Drug Controller | ₹ 5,000 – ₹ 50,000 | 5 years | 3–9 months | Form 25 |
| Form 27 — Biologicals | State + CDSCO | ₹ 25,000 – ₹ 1,00,000 | 5 years | 9–18 months | Form 27 |
| Loan Licence | State Drug Controller | ₹ 3,000 – ₹ 25,000 | 5 years | 3–6 months | Form 25 |
| AYUSH Manufacturing | State AYUSH Dept. | ₹ 3,000 – ₹ 20,000 | 5 years | 4–9 months | State Form |
| Annual Renewal — Form 28 | State Drug Controller | ₹ 2,000 – ₹ 20,000 | 5 years | 30–60 days | Form 28 |
| Additional Category | State Drug Controller | ₹ 2,000 – ₹ 15,000 | Balance | 2–4 months | Amendment |
| Repacking / Relabelling | State Drug Controller | ₹ 3,000 – ₹ 15,000 | 5 years | 3–6 months | Form 25 |
Critical GMP Compliance Areas
Drug Inspectors conduct surprise inspections. These 8 areas are most frequently cited in NCRs — keep them in perfect order at all times.
All SOPs must be current, approved by HOD QC and reviewed every 2 years. Expired or unsigned SOPs are the single most common NCR finding during inspections.
Every batch needs a complete BMR and BPR, filled in real-time. No post-hoc entries. Incomplete batch records attract regulatory action including product recall.
Cleanrooms must be monitored for temperature, humidity, particle counts and microbial contamination per approved protocols. Log all excursions with CAPA.
All instruments and gauges must be calibrated on schedule. An expired calibration certificate found during inspection leads to an immediate NCR.
Any change to suppliers, equipment, processes or formulas must go through formal change control with risk assessment and revalidation where required.
APQR must be conducted for every product annually to assess batch consistency, identify trends and evaluate whether revalidation is needed.
Out-of-Specification results must be investigated through a formal OOS procedure before product disposition. No batch release until root cause is documented.
All complaints must be recorded and investigated. A formal, tested recall procedure must be maintained and ready for immediate activation if a defect is detected.
Why Choose RegPath for Your Manufacturing Licence?
200+ manufacturing licences obtained across all Indian states — from small tablet manufacturers in Himachal Pradesh to sterile injectable companies in Maharashtra.
Schedule M Mock Audit & GMP Readiness
We conduct a thorough pre-inspection audit and full mock Drug Inspector visit — closing every gap before the real inspection. Our 91% first-attempt inspection pass rate is the result.
80+ SOP Templates — Ready to Customise
Our Schedule M SOP library covers manufacturing, QC, warehouse and utilities. Dramatically reduces your documentation preparation time and ensures inspector-ready SOPs from day one.
All-State Drug Controller Knowledge
Maharashtra, Karnataka, Himachal Pradesh, Gujarat, Rajasthan, Uttarakhand and 22+ more states — each state's specific requirements and inspector preferences are built into our process.
NCR Response — First Attempt Closure
We prepare technically precise, evidence-backed NCR responses. Our first-attempt NCR closure rate is over 90% — preventing costly re-inspections that delay your start.
Manufacturing Drug Licence — FAQs
Common questions from pharma entrepreneurs, contract manufacturers and established companies about the manufacturing drug licence process in India.
Get Your Manufacturing
Drug Licence — Fast
Book a free consultation. We'll assess your factory readiness, identify all Schedule M gaps and give you a transparent licence roadmap — at zero cost to you.