News about Regulation

Eris Lifesciences Secures ANVISA Approval for Sterile Injectable Facility in Ahmedabad

Eris Lifesciences Secures ANVISA Approval for Sterile Injectable Facility in Ahmedabad

Eris Lifesciences has received Anvisa approval for one of its sterile injectable manufacturing facilities in Ahmedabad, enabling entry into the Brazilian market.

Regulation | 26/08/2025 | By Mrinmoy Dey 330

CDSCO Cancels Import Registration of Mediderma Products Over Excess Salicylic Acid

CDSCO Cancels Import Registration of Mediderma Products Over Excess Salicylic Acid

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of certain skincare products from US-based Mediderma after finding salicylic acid levels far above the permissible limit.

Regulation | 26/08/2025 | By Dineshwori 479

Pharmexcil Calls for GST Parity on APIs and Formulations to Boost Pharma Efficiency

Pharmexcil Calls for GST Parity on APIs and Formulations to Boost Pharma Efficiency

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has called for harmonising GST rates on both active pharmaceutical ingredients (APIs) and finished formulations to streamline compliance and ease financial strain.

Regulation | 26/08/2025 | By Darshana 358

Eris Lifesciences Secures ANVISA Approval for its Manufacturing Unit in Ahmedabad

Eris Lifesciences Secures ANVISA Approval for its Manufacturing Unit in Ahmedabad

Eris Lifesciences has received ANVISA approval for a manufacturing unit at its Ahmedabad campus, paving the way for entry into Brazil, South America’s largest pharmaceutical market.

Regulation | 25/08/2025 | By Mrinmoy Dey 437

PLI Scheme Brings Down Rare Disease Treatment Costs from Crores to Lakhs: Pharma Secretary

PLI Scheme Brings Down Rare Disease Treatment Costs from Crores to Lakhs: Pharma Secretary

The Production Linked Incentive (PLI) Scheme for pharmaceuticals has significantly reduced the cost of treating rare diseases in India, bringing expenses down from crores to just a few lakhs, said Amit Agrawal, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.

Regulation | 22/08/2025 | By Dineshwori 175

Eli Lilly Opposes Tariffs on Medicines, Calls for Strategic Incentives to Strengthen US Manufacturing

Eli Lilly Opposes Tariffs on Medicines, Calls for Strategic Incentives to Strengthen US Manufacturing

Eli Lilly has voiced opposition to proposed tariffs on pharmaceutical products, cautioning that such measures could increase costs, limit patient access, and weaken US leadership in biopharmaceutical innovation.

Regulation | 16/08/2025 | By Dineshwori 234

India Launches SHRESTH to Strengthen State Drug Regulatory Systems

India Launches SHRESTH to Strengthen State Drug Regulatory Systems

The initiative, proposed by the Central Drugs Standard Control Organization (CDSCO), aims to drive improvements in the performance of state drug regulatory authorities across India, ensuring drug safety and quality standards are consistently met.
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Regulation | 13/08/2025 | By Dineshwori 348

Pharmexcil Urges Exporters to Comply with Zambia's New Pre-Shipment Requirements to Prevent Clearance Delays

Pharmexcil Urges Exporters to Comply with Zambia's New Pre-Shipment Requirements to Prevent Clearance Delays

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has called on all member companies exporting formulations to Zambia to comply with the country's new pre-shipment regulations aimed at curbing the import of counterfeit and substandard medicines.

Regulation | 12/08/2025 | By Dineshwori 229

Paracetamol Not Banned in India, Clarifies Union Minister Anupriya Patel

Paracetamol Not Banned in India, Clarifies Union Minister Anupriya Patel

Union Minister of State for Chemicals and Fertilizers Anupriya Patel has clarified on social media rumours regarding a ban on paracetamol and other common medicines.

Regulation | 06/08/2025 | By Dineshwori 511

CDSCO Launches Online Dual-Use NOC System via Sugam Portal to Ease Bulk Drug Imports for Non-Medicinal Use

CDSCO Launches Online Dual-Use NOC System via Sugam Portal to Ease Bulk Drug Imports for Non-Medicinal Use

In a bid to ease regulatory compliance and enhance the ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) will launch a new online system for issuing No Objection Certificates (NOCs) for bulk drug imports intended for non-medicinal use.

Regulation | 05/08/2025 | By Darshana 771

 
 

 

 

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