Every product backed by documented quality.
Keroli Healthcare sources products exclusively from WHO-GMP and Schedule M certified manufacturers. Our quality framework covers manufacturer qualification, product documentation, storage compliance, and active pharmacovigilance.
Certifications & Licences
All certifications listed below are current. Copies available to qualified business partners upon request.
Drug Licence 20B
Drug Licence 21B
FSSAI Registration
Drug Marketing Licence
Keroli Healthcare Pvt. Ltd. holds a valid Drug Licence under the Drugs and Cosmetics Act, 1940:
Licence Number
20B: MH-PL1-630311 | 21B: MH-PL1-630312
Issuing Authority
State Drug Control Department
CIN
U24232XX2024PTC000000
Quality Assurance Framework
A six-stage quality framework governs every product we market — from manufacturer qualification to post-market pharmacovigilance.
Manufacturer Qualification
Every manufacturing partner is assessed against WHO-GMP and Schedule M requirements before onboarding. Facility audits and documentation review are mandatory.
Product Approval
Each product is approved for marketing only after verification of the manufacturing licence, product approval, and batch release documentation from the facility.
Certificate of Analysis
A valid COA from the manufacturer's in-house QC laboratory accompanies every product batch supplied by Keroli Healthcare.
Storage & Cold Chain
Products are stored and transported under conditions specified in the approved labelling. Temperature-sensitive products handled under cold chain protocols.
Regulatory Compliance
All marketing activities comply with the Drugs & Cosmetics Act 1940, DCGI guidelines, and the Drugs and Magic Remedies Act 1954. No prohibited claims are made.
Pharmacovigilance
Active post-market surveillance. Adverse event reports collected and submitted to CDSCO PvPI programme. Quality complaints investigated within 30 days.
Regulatory Framework
Keroli Healthcare's operations are governed by the following key statutes and guidelines:
| Regulation / Standard | Relevance to Keroli Healthcare |
|---|---|
| Drugs and Cosmetics Act, 1940 | Drug licence, product approval, marketing compliance |
| Drugs and Cosmetics Rules, 1945 — Schedule M | GMP standard applied to all manufacturing partners |
| Drugs and Magic Remedies Act, 1954 | Advertising compliance — no curative/magical claims |
| DPCO — Drug Price Control Order, 2013 | Pricing compliance for scheduled formulations |
| Pharmacovigilance Programme (PvPI) | ADR reporting obligations |
| DPDP Act, 2023 / IT Act, 2000 | Digital operations and data protection |
| WHO Technical Report 986 (GMP) | International standard applied to manufacturing partners |
Quality Statement PDF
Full certification list with certificate numbers, issuing authorities, and validity dates.
Request DownloadCertificate Copies
Qualified distributors and export buyers can request certified copies of WHO-GMP and ISO certificates.
Request CertificatesDrug Lic. No. 20B: MH-PL1-630311 | 21B: MH-PL1-630312 · Issued by State Drug Control Department · CIN: U24232XX2024PTC000000