§ 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 Kingdom
Authority & dossier
Regulatory authority	CDSCO	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Health Canada +2	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Approval — Form CT-21 (Imported) · International Recognition Procedure (IRP)
Pathway name	New Drug Approval — Form CT-21 (Imported)	International Recognition Procedure (IRP)
Approval timeline	180–270 days	60–110 days
Application fee	USD 50,000	GBP 35,305
Annual renewal	USD 0	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	Yes	Yes
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.	Qualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	4 designations	4 designations
Examples	Reliance Pathway (Rule 101), Orphan Drug Designation, Public Health Emergency / Pandemic Pathway +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.
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.	Initial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	90–180 days	30–60 days
GCP standard	Indian GCP (CDSCO 2001) + ICH-GCP	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	No	No
HTA required	No	Yes
HTA body	Health Technology Assessment in India (HTAIn) — advisory; Department of Health Research	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

Authority & dossier

Regulatory authority

IndiaCDSCO
United KingdomMHRA

English submissions

IndiaYes
United KingdomYes

CTD accepted

IndiaYes
United KingdomYes

eCTD accepted

IndiaNo
United KingdomYes

Reliance pathway

IndiaAvailable
United KingdomAvailable

Reference agencies

IndiaFDA, EMA, MHRA, Health Canada +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Drug Approval — Form CT-21 (Imported) · International Recognition Procedure (IRP)

Pathway name

IndiaNew Drug Approval — Form CT-21 (Imported)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

India180–270 days
United Kingdom60–110 days

Application fee

IndiaUSD 50,000
United KingdomGBP 35,305

Annual renewal

IndiaUSD 0
United KingdomGBP 0

Local representative

IndiaRequired
United KingdomNot required

Local manufacturing

IndiaNot required
United KingdomNot required

GMP inspection

IndiaRequired
United KingdomNot required

MAH & local presence

Local entity required

IndiaYes
United KingdomYes

Local responsible person

IndiaYes
United KingdomYes

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 KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

India4 designations
United Kingdom4 designations

Examples

IndiaReliance Pathway (Rule 101), Orphan Drug Designation, Public Health Emergency / Pandemic Pathway +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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 KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.

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 KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

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 KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

IndiaAvailable
United KingdomAvailable

Compassionate Use

IndiaAvailable
United KingdomAvailable

Emergency Import

IndiaAvailable
United KingdomAvailable

Parallel Import

IndiaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

IndiaRequired
United KingdomRequired

Ethics approval

IndiaYes
United KingdomYes

CTA timeline

India90–180 days
United Kingdom30–60 days

GCP standard

IndiaIndian GCP (CDSCO 2001) + ICH-GCP
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

IndiaRegulated
United KingdomRegulated

Reference pricing

IndiaNo
United KingdomNo

HTA required

IndiaNo
United KingdomYes

HTA body

IndiaHealth Technology Assessment in India (HTAIn) — advisory; Department of Health Research
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)