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Healthcare & Pharma Compliance & Advisory Services in India – Drug Licensing (CDSCO), Medical Devices Rules 2017, Clinical Trials, NABH / NABL, GST Exemptions, Pharma FDI & IP Advisory

Healthcare and pharmaceuticals is among the most tightly licensed sectors in India — manufacturers, hospitals, diagnostic labs, device makers, and e-pharmacies operate under the Drugs and Cosmetics Act 1940 and the Drugs Rules 1945, the Central Drugs Standard Control Organisation (CDSCO) and state drug authorities, the Medical Devices Rules 2017, the New Drugs and Clinical Trials Rules 2019, clinical-establishment and NABH / NABL standards, the Bio-Medical Waste Rules, a special GST exemption structure, and a distinct FDI policy for greenfield and brownfield pharma. A single product can need a manufacturing licence, a sale licence, a device registration, and an import approval all at once.

Our healthcare and pharma practice gives manufacturers, hospitals, labs, device companies, and digital-health ventures one team for the whole regulatory and financial lifecycle — drug manufacturing and sale licensing, medical-device registration, clinical-trial and import approvals, clinical-establishment, NABH and NABL support, GST structuring on exempt and taxable supplies, pharma FDI structuring, patent and trademark protection, bio-medical-waste and pollution compliance, telemedicine and data-protection frameworks, and transaction and restructuring support. Whether you are setting up a plant, opening a hospital, importing a device, or running a trial, we keep you licensed, compliant, and investment-ready.

D&C Act 1940
Drug Licensing
MD Rules 2017
Device Classes A–D
CDSCO
Central Regulator
NABH / NABL
Accreditation
Laws & Frameworks We Work Under
Drugs & Cosmetics Act 1940
Drugs Rules 1945
CDSCO
Medical Devices Rules 2017
Clinical Trials Rules 2019
Cosmetics Rules 2020
Clinical Establishments Act
NABH / NABL
Bio-Medical Waste Rules 2016
GST (Healthcare Exemptions)
Patents Act (Sec 3(d))
Telemedicine Guidelines
DPDP Act 2023
Pharma FDI Policy

Healthcare & Pharma Engagements We Handle

Manufacturing

Drug Manufacturing Licensing

End-to-end licensing of a pharmaceutical plant — manufacturing licence, GMP / Schedule M readiness, and the supporting registration stack.

  • Manufacturing licence (Form 25 / 28)
  • Loan / contract-manufacturing
  • Schedule M (GMP) readiness
  • Product permissions
  • WHO-GMP / COPP support
  • State FDA liaison
Distribution

Drug Sale & Distribution Licences

Retail and wholesale drug licences for pharmacies, distributors, and online sellers, with the qualified-person and premises conditions.

  • Retail licence (Form 20 / 21)
  • Wholesale licence (Form 20B / 21B)
  • Pharmacist / competent person
  • Premises & storage norms
  • E-pharmacy structuring
  • Multi-state distribution
Devices

Medical-Device Registration

Risk-based registration of medical devices and in-vitro diagnostics under the 2017 Rules, for both domestic manufacture and import.

  • Risk classification (A / B / C / D)
  • Manufacturing licence (MD-5 / MD-9)
  • Import licence (MD-15)
  • Import registration (MD-14)
  • Quality-management system
  • Labelling & UDI compliance
Hospitals

Hospital & Lab Setup

Licensing and accreditation for hospitals, nursing homes, and diagnostic labs, including clinical-establishment registration.

  • Clinical-establishment registration
  • NABH / NABL support
  • Bio-medical-waste authorisation
  • AERB (radiology) approval
  • Blood-bank / pharmacy licences
  • Fire & building NOCs
Trials

Clinical Trials & Approvals

Regulatory approvals for clinical trials, new-drug permissions, and import of drugs for examination, test, or analysis.

  • Clinical-trial permission
  • Ethics-committee registration
  • New-drug approval
  • Test-licence imports
  • Subject-consent frameworks
  • Pharmacovigilance setup
Tax & FDI

Tax, GST & FDI Structuring

Indirect-tax treatment of exempt healthcare and taxable pharma supplies, plus foreign-investment structuring under the pharma FDI route.

  • Healthcare GST exemptions
  • Pharma GST & ITC
  • Inverted-duty refunds
  • Greenfield / brownfield FDI
  • FEMA / FC-GPR reporting
  • Transfer pricing

Key Healthcare & Pharma Concepts You Must Know

Manufacturing

Form 25 / 28 Licence

A drug manufacturing licence is granted by the state licensing authority — Form 25 for non-specified drugs and Form 28 for specified categories — subject to GMP and premises conditions.

State Authority GMP / Schedule M
Sale

Form 20 / 21 Licence

Selling drugs needs a licence — retail on Forms 20 and 21 and wholesale on Forms 20B and 21B — with a registered pharmacist or competent person and compliant storage.

Retail / Wholesale Pharmacist
Devices

Risk Classes A–D

Medical devices and diagnostics are classified by risk into Classes A, B, C, and D under the 2017 Rules, with the class deciding whether the state or the central authority licenses them.

A / B / C / D CDSCO / State
CDSCO

Central Regulator

The CDSCO, headed by the Drugs Controller General of India, approves new drugs, clinical trials, imports, and higher-risk devices, while state authorities handle most manufacturing and sale licences.

DCGI New Drugs / Imports
Trials

Clinical Trials Rules 2019

Clinical trials, ethics-committee registration, new-drug approval, and compensation for trial-related injury are governed by the New Drugs and Clinical Trials Rules 2019.

Ethics Committee Subject Consent
Accreditation

NABH / NABL

NABH accredits hospitals and clinics and NABL accredits testing and calibration laboratories — voluntary marks of quality that are increasingly required for empanelment and reimbursement.

Hospital / Lab Quality Mark
BMW

Bio-Medical Waste

Every healthcare facility generating bio-medical waste must obtain authorisation under the Bio-Medical Waste Management Rules 2016 and segregate, treat, and dispose of waste as prescribed.

SPCB Authorisation Segregation
GST

Healthcare Exemption

Healthcare services by a clinical establishment and certain related supplies are exempt from GST, while most pharmaceutical products and many devices are taxable — making input-credit and refund planning important.

Service Exempt Goods Taxable

Our Healthcare & Pharma Advisory Services

01

Drug Manufacturing Licensing

Manufacturing, loan, and contract-manufacturing licences, Schedule M / GMP readiness, product permissions, and WHO-GMP / COPP support.

02

Drug Sale & Distribution Licences

Retail and wholesale drug licences, e-pharmacy structuring, competent-person and premises compliance, and multi-state distribution setup.

03

Medical-Device Registration

Risk classification, manufacturing and import licences, import registration, quality-management systems, and labelling and UDI compliance.

04

Hospital & Lab Setup

Clinical-establishment registration, NABH / NABL support, AERB approvals, blood-bank and pharmacy licences, and fire and building NOCs.

05

Clinical Trials & New-Drug Approvals

Trial permissions, ethics-committee registration, new-drug approval, test-licence imports, and pharmacovigilance setup.

06

GST Advisory & Litigation

Exempt-versus-taxable mapping, input-credit and inverted-duty refunds, classification opinions, and representation in audits and appeals.

07

Direct Tax & Incentives

Corporate-tax planning, weighted deductions where available, tax audit, advance tax, and assessment representation for healthcare entities.

08

Pharma FDI & FEMA

Greenfield and brownfield FDI structuring, FC-GPR / FEMA reporting, ECB, and downstream-investment compliance.

09

Patents, IP & Regulatory

Patent and trademark protection, Section 3(d) strategy, data-exclusivity advice, and regulatory due-diligence on product portfolios.

10

Bio-Medical Waste & Pollution

Bio-medical-waste authorisation, pollution consents, and environmental compliance for hospitals, labs, and manufacturing units.

11

Telemedicine & Data Protection

Telemedicine-practice frameworks, e-pharmacy compliance, and DPDP-aligned handling of sensitive patient health data.

12

Transactions & Restructuring

Due diligence, licensing and supply agreements, mergers, slump sales, and group restructuring for healthcare and pharma businesses.

When a Healthcare or Pharma Business Needs an Advisor

Setting Up a Plant

A new pharmaceutical or device facility needs manufacturing licences, GMP-compliant premises, pollution and waste authorisations, and product permissions in sequence.

Opening a Hospital or Lab

Clinical-establishment registration, accreditation, bio-medical-waste authorisation, radiology approvals, and in-house pharmacy and blood-bank licences all apply.

Importing a Device or Drug

Imports require the correct registration and import licence, an authorised Indian agent, and labelling that meets the 2017 Rules or the Drugs Rules.

Launching an E-Pharmacy

Online medicine sale raises drug-licensing, prescription-validation, data-protection, and consumer-law questions that must be structured before launch.

Running a Clinical Trial

Trials need CDSCO permission, registered ethics committees, compliant consent and compensation, and a pharmacovigilance system.

Attracting Pharma FDI

Brownfield investment can cross from the automatic route into the government route and carries non-compete and production conditions to plan for.

GST Refund or Dispute

Inverted duty on pharma inputs and the exempt-taxable mix in hospitals frequently create refund claims and classification disputes.

Patent or Regulatory Challenge

Patent oppositions, Section 3(d) objections, and regulatory notices on a product portfolio need a coordinated legal and regulatory response.

Documents Needed for a Healthcare or Pharma Engagement

Corporate & Licensing

  • Certificate of Incorporation, MOA / AOA
  • Drug manufacturing / sale licences
  • Medical-device registrations & licences
  • Clinical-establishment registration
  • NABH / NABL certificates
  • Bio-medical-waste authorisation
  • GST & other registrations

Financial & Tax

  • Audited financials (3 years)
  • Income-tax returns & assessments
  • GST returns & reconciliations
  • Input-credit / refund records
  • FC-GPR & FEMA filings
  • Transfer-pricing documentation
  • Fixed-asset & capex register

Regulatory & Operational

  • Product permissions & approvals
  • GMP / Schedule M records
  • Clinical-trial & ethics approvals
  • Pharmacovigilance records
  • Patent & trademark filings
  • Supply / distribution agreements
  • Waste & pollution consents

Our Healthcare & Pharma Advisory Process

1

Assessment & Mapping

Reviewing the products, facility, and approvals, and a regulatory gap-analysis across licensing, devices, accreditation, tax, and FDI.

2

Licensing & Registration

Applying for manufacturing, sale, device, clinical-establishment, and import approvals, and registering the supporting statutory stack.

3

Structuring & Compliance

GST and tax structuring, FDI / FEMA design, GMP and quality-system readiness, and bio-medical-waste and pollution authorisation.

4

Filings & Representation

Periodic returns, pharmacovigilance and regulatory filings, and representation before CDSCO, state FDA, GST, and tax authorities.

5

Monitoring & Renewal

Compliance calendar, renewal tracking, internal audit, and periodic review to keep licences live and the business inspection-ready.

Why Choose Us for Healthcare & Pharma

✓
End-to-end drug & device licensing
✓
CDSCO & state-FDA liaison
✓
Hospital & lab accreditation
✓
Clinical-trial & pharmacovigilance
✓
GST exemption & refund expertise
✓
Pharma FDI & FEMA advisory
✓
Patent & IP protection
✓
Waste & data-protection compliance

FAQs on Healthcare & Pharma Compliance in India

What licences are needed to manufacture drugs in India?
Drug manufacture is licensed by the state licensing authority under the Drugs and Cosmetics Act 1940 and the Drugs Rules 1945 — typically a manufacturing licence in Form 25 for non-specified drugs and Form 28 for specified categories, supported by product permissions. The premises and processes must meet Good Manufacturing Practices under Schedule M, and a qualified technical staff is required. Exports may also need a WHO-GMP certificate and Certificate of Pharmaceutical Product (COPP). We manage the application, premises readiness, and product permissions end to end.
How are medical devices regulated in India?
Medical devices and in-vitro diagnostics are regulated under the Medical Devices Rules 2017 and are classified by risk into Class A (low), B (low-moderate), C (moderate-high), and D (high). Lower-risk Class A and B devices are generally licensed by the state authority, while higher-risk Class C and D devices, and all imports, are handled by the CDSCO — manufacture on licences such as MD-5 / MD-9 and import on MD-15, with import registration on MD-14. A quality-management system and compliant labelling are required. We classify the device and manage the licensing or import pathway.
What approvals are needed to open a hospital or diagnostic lab?
A hospital, nursing home, or diagnostic lab needs registration under the Clinical Establishments Act (or the equivalent state law), bio-medical-waste authorisation from the State Pollution Control Board, AERB approval for any radiology equipment, fire and building NOCs, and licences for any in-house pharmacy or blood bank. Accreditation by NABH (hospitals) or NABL (labs) is voluntary but increasingly required for insurer and government empanelment. We coordinate registration, accreditation, and the supporting approvals.
Is healthcare exempt from GST?
Healthcare services provided by a clinical establishment, an authorised medical practitioner, or paramedics are exempt from GST, as are certain related services. However, most pharmaceutical products and many medical devices are taxable, and some hospital supplies (such as certain room categories or non-clinical services) can attract GST. Because exempt outputs block input-tax credit, the exempt-taxable mix needs careful planning. We map your supplies, optimise input credit, and handle classification and refund issues.
How much foreign investment is allowed in pharma?
For greenfield pharma (new manufacturing), FDI is allowed up to 100% under the automatic route. For brownfield pharma (investment in existing companies), FDI is allowed up to 74% under the automatic route, and beyond that through the government-approval route, subject to conditions such as maintaining production of essential medicines and limits on non-compete clauses. Investment must follow the FEMA Non-Debt Instruments Rules with FC-GPR reporting. We structure the investment and manage the approvals and filings.
What does it take to run a clinical trial in India?
Clinical trials are governed by the New Drugs and Clinical Trials Rules 2019. A trial needs permission from the CDSCO / DCGI, conduct through a site overseen by a registered ethics committee, valid informed consent, and a framework for compensation for trial-related injury or death. Import of the investigational drug needs a test licence, and a pharmacovigilance system must capture and report adverse events. We obtain the approvals and put the consent, compensation, and safety-reporting systems in place.
Can medicines be sold online in India?
Online sale of medicines is possible but must rest on a valid drug licence — the seller or its fulfilment partner needs the appropriate retail or wholesale licence, and prescription medicines require a valid prescription. The platform must also meet data-protection obligations under the DPDP Act for sensitive health data, comply with consumer-protection and intermediary rules, and watch the evolving regulatory position on e-pharmacies. We structure the licensing, prescription-validation, and data-protection framework for a compliant e-pharmacy.

Licensed to Operate. Compliant to Scale. Ready to Inspect.

Partner with our healthcare and pharma experts for drug and device licensing, hospital and lab accreditation, clinical-trial approvals, GST and FDI structuring, and IP protection for FY 2026–27.

Talk to a Healthcare & Pharma Expert