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News about Regulation
AiMeD Urges Balanced Approach to GST Rates on Medical Devices
AiMeD noted that proposed GST changes—to either five percent or 18 percent—both present significant risks requiring nuanced consideration.
Regulation | 27/08/2025 | By Dineshwori | 218
Dr Reddy's Welcomes Unified GST Reform to Support Pharma Manufacturing
Reddy said he expects the reform to address these critical issues, improve medicine affordability, and enhance India’s competitiveness and innovation in the global pharmaceutical supply chain. He emphasised that a reformed GST system would not only benefit patients but also reinforce India’s role in global healthcare security.
Regulation | 27/08/2025 | By Darshana | 177
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 | 175
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 | 295
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 | 220
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 | 233
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 | 106
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 | 184
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 | 234
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 | 129
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