News about Regulation

Centre Revises Drugs Rules for Cell and Gene Therapies

The Centre has amended the Drugs Rules, 1945 to bring advanced cell and gene therapies under the Centrally License Approving Authority (CLAA), to include cell and stem cell-derived products, gene therapeutics and xenografts.

Regulation | 03/07/2026 | By News Bureau

Glenmark Pharma Receives Six Procedural Observations Following US FDA Inspection of Goa Facility

Glenmark Pharmaceuticals has received six procedural observations in a Form 483 following a US FDA GMP inspection of its Goa manufacturing facility. The company said there were no data integrity or repeat observations and expects no impact on the supply of its commercial products while it works with the regulator to address the findings.

Regulation | 02/07/2026 | By News Bureau |  388

Health Ministry Seeks Comments on Draft National Pharmacy Commission Bill 2026

The Union Health Ministry has released the revised Draft National Pharmacy Commission Bill, 2026 for public consultation, seeking stakeholder feedback.

Regulation | 02/07/2026 | By News Bureau |  619

WuXi Biologics Receives Brazil GMP Certification for Cancer Therapy Manufacturing

WuXi Biologics has received Brazil ANVISA GMP certification with zero inspection findings, enabling global commercial manufacturing of its innovative cancer immunotherapy.

Regulation | 02/07/2026 | By News Bureau

Health Minister Nadda Launches National Drug Registry

Union Health Minister JP Nadda has launched the National Drug Registry to standardise medicine information, enhancing transparency, trust, and seamless access to drug data across India.

Regulation | 01/07/2026 | By News Bureau

EMA Panel Recommends Revoking EU Authorisation for Tavneos Over Data Integrity Concerns

CHMP concludes pivotal clinical trial data cannot reliably demonstrate the drug’s efficacy, advises discontinuation for new patients and enhances liver monitoring for existing users.<br />

Regulation | 29/06/2026 | By News Bureau

Alembic Pharmaceuticals Receives US FDA Approval for Dapsone Gel 5 Percent

Alembic Pharmaceuticals has received US FDA approval for Dapsone Gel 5 percent, a topical treatment for acne vulgaris.

Regulation | 29/06/2026 | By News Bureau

Sobi Receives FDA Complete Response Letter for Experimental Gout Therapy NASP

Sobi has received a Complete Response Letter from the US FDA for its investigational gout therapy NASP, with the regulator requesting additional manufacturing data and facility-related information before considering approval. The company plans to work with the FDA and its manufacturing partners toward resubmitting the application.

Regulation | 29/06/2026 | By News Bureau

Government Simplifies Drug Import Rules for Testing and Analysis

The Government has proposed amendments to the Drugs Rules, 1945, introducing an acknowledgement-based system to simplify the import of drugs for examination, testing, analysis, and non-clinical research.

Regulation | 29/06/2026 | By News Bureau

Lupin Receives US FDA Tentative Approval for Enzalutamide Tablets

Lupin has received tentative US Food and Drug Administration (FDA) approval for Enzalutamide tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths.

Regulation | 29/06/2026 | By News Bureau