Archive · 30 Jul 2026
Drug regulator overhauls export norms; tightens checks on unapproved medicines
India’s drug regulator has changed the rules for exporting medicines.
Now, medicines that haven’t been approved in India can only be sent abroad if the receiving country or a top regulator says it’s safe.
The new system uses a digital certificate that takes less than 10 days to approve.
The regulator also checks factories for quality and shares this info with government buyers.
For new medicines that are very good, India may skip local trials so patients can get them faster.
India’s drug regulator has overhauled export rules, banning export of unapproved medicines unless approved by the importing country or a stringent regulatory authority.
The new No Objection Certificate (NOC) system is fully digital, processing about 23,000 NOCs in a year with approval time under 10 days.
Export of drugs not approved in India now requires approval from one of six SRAs (US, UK, Canada, EU, Australia, Japan) if the importing country lacks robust regulators.
CDSCO has digitised 99% of regulatory processes and completed over 1,200 risk‑based audits in 3.5 years, sharing compliance data with procurement agencies.
Local clinical trial waivers are granted for 25‑30% of new drugs that are first‑in‑class or significantly better, speeding access to innovative medicines.
- Who
- Rajeev Raghuvanshi, Drugs Controller General of India
- What
- Overhauled drug export rules and tightened checks on unapproved medicines
- When
- 2026, at the Global Drug Regulatory Conclave
- Where
- India, Central Drugs Standard Control Organisation (CDSCO)
- Why
- To ensure safety and efficacy, maintain India’s reputation, and improve quality standards
- Regulator
- Central Drugs Standard Control Organisation (CDSCO)
- New Export Rule
- Unapproved drugs require import approval or SRA approval
- Digital NOC Processing
- 23,000 per year, approval time <10 days
- SRA List
- US, UK, Canada, EU, Australia, Japan
- Clinical Trial Waiver
- 25‑30% of new drugs