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Book Free Consultation →End-to-end support for drug registration under the Drugs & Cosmetics Act, 1940 — from Retail & Wholesale licences to New Drug Applications, Import Licences, NOCs and more.
India's drug regulation is governed by a multi-layered legal framework. Click each act to explore scope, schedules, and compliance obligations.
From simple retail drug licences to complex new drug approvals — we manage the full spectrum of drug licensing in India.
Required for retail sale of allopathic drugs to consumers. Issued by the State Drug Control Authority. A qualified pharmacist must be present during business hours.
For wholesale distribution of drugs to retailers, hospitals and institutions. Requires dedicated storage area, cold chain facilities and a qualified person-in-charge.
For manufacture of allopathic drugs. Requires GMP-compliant factory, approved premises, qualified staff, and QC laboratory. Issued by State Drug Controller for domestic; CDSCO for certain categories.
Foreign manufacturers must obtain a Central Import Licence (Form 41) from CDSCO before commercially importing any drug into India. Comprehensive dossier and Indian agent required.
No Objection Certificates required for export of drugs from India and for drugs transported via airports. ADC NOC is issued by the Airport Drug Controller for drugs in passenger baggage or courier.
Test Licences allow import of drug samples for testing/analysis without full commercial registration. New Drug Applications (NDA) are for NCEs, fixed dose combinations, biologicals and new indications under NDCT Rules 2019.
Our structured 6-step approach ensures your drug licence application is complete, compliant and processed without unnecessary delays.
The first step is determining which drug licence is applicable to your specific situation — retail, wholesale, manufacturing or import — and whether it's a state-level or central (CDSCO) licence. Getting this right avoids wasted time and fees.
Required documents vary significantly by licence type. Below is a comprehensive breakdown for the most common drug licence categories.
Fees vary by state, authority level and licence category. Timelines are statutory but actual durations depend on query resolution and inspection scheduling.
| Licence Type | Authority | Approx. Govt. Fee | Validity | Statutory Timeline | Key Form |
|---|---|---|---|---|---|
| Retail Drug Licence | State Drug Controller | ₹ 500 – ₹ 3,000 | 1–5 years | 30–60 days | Form 20 / 21 |
| Wholesale Drug Licence | State Drug Controller | ₹ 1,000 – ₹ 5,000 | 1–5 years | 45–90 days | Form 20B / 21B |
| Manufacturing Licence | State / CDSCO | ₹ 5,000 – ₹ 50,000 | 5 years | 3–9 months | Form 25 / 28 |
| CDSCO Import Licence | CDSCO Central | USD 1,000 – 5,000 | 3–5 years | 3–12 months | Form 41 |
| New Drug NDA | CDSCO Central | ₹ 50,000 – ₹ 5,00,000 | Permanent | 12–24 months | NDA-1 / CT-04 |
| Drug Export NOC | CDSCO Central | ₹ 1,000 – ₹ 5,000 | Per shipment | 15–30 days | Export NOC Form |
| ADC NOC | Airport Drug Controller | ₹ 500 – ₹ 2,000 | Single use | 7–15 days | ADC Application |
| CDSCO Test Licence | CDSCO Central | ₹ 2,000 – ₹ 10,000 | 1–2 years | 30–60 days | Test Licence Form |
Understanding which schedule your drug falls under is critical — it determines prescription requirements, storage, sales records and penalties for non-compliance.
Drugs that can only be sold on a valid prescription from a registered medical practitioner. Must be stored separately; sale records maintained for 2 years.
Stricter than Schedule H. Requires prescription with doctor's registration number. Sales must be recorded in a separate register with patient and prescriber details.
Habit-forming or psychotropic substances. Requires separate storage, special prescription with doctor details, and 2-year record retention. Separate licence often required.
Regulated under the NDPS Act, 1985 (not D&C Act). Requires special NDPS licence from NCB / State authority. Extremely strict storage, reporting and record requirements.
Drugs requiring a caution label on the package: "Caution: To be sold by retail on the prescription of a Registered Medical Practitioner only." Less restrictive than Schedule H.
Biological and special products such as vaccines, sera, and blood products. Require special storage (cold chain, 2–8°C), separate records and testing before release.
15+ years of navigating India's complex drug licensing framework — across all states and central CDSCO — means faster approvals and fewer rejections.
We handle drug licences across all Indian states — understanding each state authority's specific requirements, inspectors' expectations and timelines.
CDSCO-compliant CTD / ACTD dossier templates for import licences and new drug applications reduce preparation time by up to 50%.
Extensive experience helping USA, EU, Japanese, and Korean pharma companies obtain Indian import licences — familiar with bridging foreign CTDs to Indian requirements.
Handled complex NDAs for new chemical entities, fixed dose combinations, biologicals and biosimilars under NDCT Rules 2019 with ex-CDSCO experts on our team.
"RegPath helped us obtain our CDSCO Form 41 Import Licence in 8 months — their knowledge of dossier requirements and CDSCO procedures was exceptional."
Answers to the most common questions from pharmaceutical companies, importers and retailers about drug licensing in India.
Book a free 30-minute consultation with our drug regulatory experts. We'll assess your licence requirements, prepare a roadmap and provide a transparent fee estimate.