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ISO, BIS, Drug Licence & Other Certifications
Sector-specific certifications and regulatory licences — ISO 9001, BIS/ISI mark, drug licence, PCB NOC, factory licence, and more.
Depending on your business sector, various additional certifications and regulatory licences may be required or strongly advisable. These range from quality certifications that improve your market position to mandatory regulatory approvals without which you cannot legally operate.
ISO Certification
ISO (International Organization for Standardization) certifications demonstrate that your business meets international quality, safety, or environmental management standards. While not mandatory for most businesses, ISO certification is often required by large corporate buyers, government procurement, and export markets.
- ISO 9001:2015 Quality Management System — the most widely adopted ISO standard. Applicable to all businesses.
- ISO 14001:2015 Environmental Management System — for businesses with environmental impact.
- ISO 22000:2018 — Food Safety Management System — for food businesses (complements FSSAI compliance).
- ISO 27001:2022 — Information Security Management — for IT companies, data processors, and SaaS businesses.
- ISO 45001:2018 — Occupational Health and Safety Management — for manufacturing and industrial units.
BIS / ISI Mark Certification
- Products covered under mandatory BIS standards (household appliances, electrical goods, steel, cement, toys, etc.) cannot be sold in India without a BIS licence and ISI mark. Foreign manufacturers must obtain Compulsory Registration Scheme (CRS) certification for electronics
Drug Licence
- Any business manufacturing, storing, distributing, or selling pharmaceutical or allopathic drugs requires a drug licence under the Drugs and Cosmetics Act, 1940. This is issued by the State Drug Authority.
- Retail drug licence — For pharmacies and chemist shops — retail sale of Schedule H and Schedule X drugs
- Wholesale drug licence — Wholesale drug licence For wholesale distribution of pharmaceutical products
- Manufacturing licence — Manufacturing licence For pharmaceutical manufacturers — Form 25 and Form 28
- Cosmetics licence — For manufacturers of cosmetic products
Other Licences We Handle
Exporters using IEC must also ensure their GST compliance is aligned with export provisions:
- Pollution Control Board NOC — for manufacturing units with environmental impact
- Fire NOC — from State Fire Services for applicable commercial premises
- Factory Licence — for manufacturing units with 10+ workers under the Factories Act
- Liquor Licence — IMFL/beer retail and wholesale licence from State Excise Department
- Petroleum licence — for storage and handling of petroleum products
- Explosive licence — for storage and use of explosives under the Explosives Act
- PSARA Licence — for private security agencies under the Private Security Agencies Regulation Act
Frequently Asked Questions
01 Is ISO certification mandatory for government contracts?
ISO certification is not universally mandatory, but many government tenders — especially for IT services, construction, and manufacturing — require ISO 9001 certification. MSME-registered businesses may be exempt from this requirement in some tenders.
02 How long does ISO certification take?
The ISO certification process (documentation, gap analysis, internal audit, external audit, and certificate issuance) typically takes 2–4 months for first-time certifications.
03Does a medical store need a separate drug licence for each branch?
Yes — a separate retail drug licence is required for each pharmacy or medical store location. Each premises must also have a licensed pharmacist (registered with the State Pharmacy Council) present during business hours
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Contact Info
- +91 90150-53820
- info@aaaglobal.com