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pharma: DCGI initiates review of pharma manufacturing standards to ensure drug quality and safety

India s drug regulator, the Drug Controller General of India (DCGI), plans to review pharmaceutical manufacturing standards in order to ensure the quality, safety, and efficacy of drugs. The DCGI will meet with pharma industry associations to discuss reviewing Good Manufacturing Practices (GMP) for pharma companies. The government aims to upgrade Schedule M, which lays down GMP, to international standards.

A Case of Slipping Quality

A Case of Slipping Quality
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Waiver for rare disease drugs brings little relief: Pharma sector

India s pharma sector on Wednesday said the Goods and Services Tax (GST) Council s decision to exempt tax on rare diseases drugs is unlikely to benefit the population unless the waiver is extended to drugs that are made commercially available in the country. The GST Council on Tuesday (July 11) said the Integrated Goods and Services Tax (IGST) on medicines and Food for Special Medical Purposes (FSMP) used for treating rare diseases enlisted under the National Policy for Rare Diseases, 2021, will be exempt when imported for personal use subject to existing conditions. We support the government s move to address the needs of patients suffering from rare diseases.

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