§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇮🇳India	🇺🇸United States
Authority & dossier
Regulatory authority	CDSCO	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, Health Canada +2	—
Lead pathway (timeline & fees) — New Drug Approval — Form CT-21 (Imported) · New Drug Application — 505(b)(1)
Pathway name	New Drug Approval — Form CT-21 (Imported)	New Drug Application — 505(b)(1)
Approval timeline	180–270 days	304–365 days
Application fee	USD 50,000	USD 4,310,002
Annual renewal	USD 0	USD 416,734
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	No
Local responsible person	Yes	Yes
RP role	A qualified Indian-resident pharmacist or technically qualified person must be designated as Responsible Pharmacist for the Indian agent/manufacturer. A separate Pharmacovigilance Officer is required under PvPI (Pharmacovigilance Programme of India) under IPC Ghaziabad.	US Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.
Accelerated pathways
Designations available	4 designations	6 designations
Examples	Reliance Pathway (Rule 101), Orphan Drug Designation, Public Health Emergency / Pandemic Pathway +1	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Post-approval variations governed by NDCTR 2019 and CDSCO guidance on post-approval changes (2018, updated). Tiered into Major (prior-approval), Moderate (notification with implementation), and Minor (annual reporting) — broadly aligned with ICH Q12 principles. Major variations include API source change, manufacturing site change for sterile products, indication addition.	FDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.
Renewal cycle	Marketing authorisations valid for 5 years; renewal application required at least 3 months before expiry under Rule 30. Renewal includes updated PSUR, sales/distribution data, and pharmacovigilance summary.	FDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.
Pharmacovigilance	Pharmacovigilance Programme of India (PvPI) coordinated by Indian Pharmacopoeia Commission (IPC) Ghaziabad. PSURs every 6 months for first 2 years, annually thereafter. Mandatory ICSR reporting via VigiFlow. PvPI is a WHO-UMC official member.	Mandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	90–180 days	30–30 days
GCP standard	Indian GCP (CDSCO 2001) + ICH-GCP	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	No	No
HTA required	No	No
HTA body	Health Technology Assessment in India (HTAIn) — advisory; Department of Health Research	ICER (Institute for Clinical and Economic Review) — independent, non-binding

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

IndiaCDSCO
United StatesFDA

English submissions

IndiaYes
United StatesYes

CTD accepted

IndiaYes
United StatesYes

eCTD accepted

IndiaNo
United StatesYes

Reliance pathway

IndiaAvailable
United StatesNone

Reference agencies

IndiaFDA, EMA, MHRA, Health Canada +2
United States—

Lead pathway (timeline & fees) — New Drug Approval — Form CT-21 (Imported) · New Drug Application — 505(b)(1)

Pathway name

IndiaNew Drug Approval — Form CT-21 (Imported)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

India180–270 days
United States304–365 days

Application fee

IndiaUSD 50,000
United StatesUSD 4,310,002

Annual renewal

IndiaUSD 0
United StatesUSD 416,734

Local representative

IndiaRequired
United StatesNot required

Local manufacturing

IndiaNot required
United StatesNot required

GMP inspection

IndiaRequired
United StatesRequired

MAH & local presence

Local entity required

IndiaYes
United StatesNo

Local responsible person

IndiaYes
United StatesYes

RP role

IndiaA qualified Indian-resident pharmacist or technically qualified person must be designated as Responsible Pharmacist for the Indian agent/manufacturer. A separate Pharmacovigilance Officer is required under PvPI (Pharmacovigilance Programme of India) under IPC Ghaziabad.
United StatesUS Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.

Accelerated pathways

Designations available

India4 designations
United States6 designations

Examples

IndiaReliance Pathway (Rule 101), Orphan Drug Designation, Public Health Emergency / Pandemic Pathway +1
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

IndiaPost-approval variations governed by NDCTR 2019 and CDSCO guidance on post-approval changes (2018, updated). Tiered into Major (prior-approval), Moderate (notification with implementation), and Minor (annual reporting) — broadly aligned with ICH Q12 principles. Major variations include API source change, manufacturing site change for sterile products, indication addition.
United StatesFDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.

Renewal cycle

IndiaMarketing authorisations valid for 5 years; renewal application required at least 3 months before expiry under Rule 30. Renewal includes updated PSUR, sales/distribution data, and pharmacovigilance summary.
United StatesFDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.

Pharmacovigilance

IndiaPharmacovigilance Programme of India (PvPI) coordinated by Indian Pharmacopoeia Commission (IPC) Ghaziabad. PSURs every 6 months for first 2 years, annually thereafter. Mandatory ICSR reporting via VigiFlow. PvPI is a WHO-UMC official member.
United StatesMandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.

Unlicensed access

Named Patient Supply

IndiaAvailable
United StatesAvailable

Compassionate Use

IndiaAvailable
United StatesAvailable

Emergency Import

IndiaAvailable
United StatesAvailable

Parallel Import

IndiaNot permitted
United StatesNot permitted

Clinical trials

CTA approval

IndiaRequired
United StatesRequired

Ethics approval

IndiaYes
United StatesYes

CTA timeline

India90–180 days
United States30–30 days

GCP standard

IndiaIndian GCP (CDSCO 2001) + ICH-GCP
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

IndiaRegulated
United StatesFree pricing

Reference pricing

IndiaNo
United StatesNo

HTA required

IndiaNo
United StatesNo

HTA body

IndiaHealth Technology Assessment in India (HTAIn) — advisory; Department of Health Research
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding