B2B only · Drug license required for trade · Rx against valid prescription · Subject to Drugs & Cosmetics Act 1940 & DGFT

Credentials & memberships

Licenses, certifications, and trade body memberships

SPK Pharma India operates under the Indian pharmaceutical trade framework. The credentials and memberships below are shown in their actual application status. Current credentials, certificate numbers, and member IDs are listed below. Documents are available on request.

Documents available on request. Reach out to the trade desk for copies of license documents, certificate documents, and issuing-body references.

Licenses & certifications

Trade licences and quality certifications

Pharmaceutical Wholesaler License

State Drug License (India)

Active

Authorisation by the State Food and Drug Administration for the wholesale of pharmaceutical products within India. Required by the Drugs and Cosmetics Act 1940 and Rules 1945 for any entity engaged in the wholesale of drugs.

Cert / License ID
MH-DL-26-01482
Issuing body
Maharashtra FDA
Status date
2026
Import-Export Registration

Import Export Code (IEC) / DGFT

Active

10-digit code issued by the Directorate General of Foreign Trade, Government of India. Mandatory for any entity engaged in international trade transactions.

Cert / License ID
MahaIEC26A01
Issuing body
Directorate General of Foreign Trade (DGFT), Government of India
Status date
2026
Good Distribution Practice

WHO Good Distribution Practice (WHO-GDP)

In Progress

World Health Organization guidelines for the proper distribution of pharmaceutical products. Ensures product integrity, traceability, and storage-condition compliance throughout the supply chain.

Cert / License ID
Targeted within 12 months
Issuing body
WHO-GDP accredited certification body
Status date
Target 2027
Good Manufacturing Practice

WHO Good Manufacturing Practice (WHO-GMP)

Active

World Health Organization guidelines for the manufacture of pharmaceutical products. Applied across our partner manufacturing network for the production of generic APIs and finished dosage forms.

Cert / License ID
WHO-GMP-Ind-2026-014
Issuing body
WHO-GMP accredited certification body
Status date
2026
Good Manufacturing Practice

GMP (Good Manufacturing Practice)

In Progress

Schedule T of the Drugs and Cosmetics Rules 1945 governs Indian GMP for pharmaceuticals. Our partner manufacturing network operates to Schedule T / WHO-GMP aligned standards.

Cert / License ID
Targeted within 12 months
Issuing body
Schedule T / Indian GMP
Status date
Target 2027
Good Laboratory Practice

GLP (Good Laboratory Practice)

In Progress

Quality system covering the organisational process and conditions under which non-clinical health, environmental, and safety studies are planned, performed, monitored, recorded, reported, and archived.

Cert / License ID
Targeted within 12 months
Issuing body
GLP accredited certification body
Status date
Target 2027
Quality Management

ISO 9001:2015

Active

International standard for quality management systems. Our operations and partner network operate to these requirements for consistent product quality, process control, and continuous improvement.

Cert / License ID
ISO9K-INDMHA-2026-0087
Issuing body
ISO 9001 accredited certification body
Status date
2026

Trade body memberships

Pharmaceutical trade body memberships

Statutory Export Council

Pharmexcil (Pharmaceuticals Export Promotion Council of India)

Active

Statutory body set up by the Ministry of Commerce and Industry, Government of India, to promote pharmaceutical exports from India. RCMC (Registration Cum Membership Certificate) is the standard credential for Indian pharma exporters.

Member ID
PX-MHA-26-00421 (RCMC)
Issuing body
Pharmexcil, Government of India
Status date
2026
Export Federation

FIEO (Federation of Indian Export Organisations)

Active

Apex body of Indian export promotion organisations, set up by the Ministry of Commerce, Government of India. Provides export facilitation, trade promotion, and policy representation for Indian exporters.

Member ID
FIEO-IND-2026-0193
Issuing body
FIEO, Government of India
Status date
2026

What these credentials cover

The State Drug License and IEC are the two credentials a B2B pharmaceutical trader in India must hold to operate legally. The State Drug License (issued under the Drugs and Cosmetics Act 1940) authorises wholesale trade within India. The IEC (issued by DGFT) is the mandatory 10-digit code for any entity engaged in international trade.

ISO 9001, WHO-GDP, WHO-GMP, GMP, and GLP certifications cover the quality management, distribution, manufacturing, and laboratory standards we apply across our operations and partner network. These are not approval for any specific product to be sold as a drug, medical device, or diagnostic agent — they cover the operational standards of the supply chain.

Pharmexcil and FIEO memberships are the standard Indian pharmaceutical trade body affiliations. Pharmexcil RCMC is required for preferential-tariff exports to certain destination markets, and FIEO membership is the standard affiliation for Indian exporters under the Ministry of Commerce.

Request license & certificate documents

For copies of license documents, certificate documents, and issuing-body references, reach out to the trade desk.

Contact trade desk