Drug regulator steps up oversight on product changes after approval

Drug makers now need government approval for any quality changes to medicines. This applies to alterations affecting a drug's identity, strength, quality, purity, or potency. The regulator is strengthening manufacturing standards through risk-based audits and more inspections. This ensures only safe and effective medicines reach consumers. Manufacturers must inform the drug regulator about changes in manufacturing, packaging, or shelf life.

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Sun Pharma to pump in Rs 500 cr in Assam manufacturing unit

Sun Pharmaceutical will invest Rs 500 crore to establish a new manufacturing plant in Assam. This significant project will create over 500 direct employment opportunities. The company plans to implement the investment in two phases. Discussions covered land, water, power, and skilled manpower. Sun Pharmaceutical will focus on sustainable manufacturing practices.

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Biopharma Shakti: India targets China dependence, patent cliff

India is launching a major initiative to boost its biopharmaceutical manufacturing. This plan aims to reduce reliance on China for crucial drug components. It also seeks to capitalize on upcoming patent expirations of major global drugs. India will focus on becoming a hub for biosimilars and emerging biologics. This strategy will strengthen the nation's pharmaceutical industry on the global stage.

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AstraZeneca gets CDSCO approval for Durvalumab in gastric cancer treatment

AstraZeneca Pharma India has secured approval for Durvalumab. This drug, combined with chemotherapy, will treat gastric and gastroesophageal junction cancer. The approval comes from the Central Drugs Standard Control Organisation. This new treatment offers a perioperative immunotherapy approach for adult patients. It aims to improve survival rates for those with resectable forms of the disease.

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Medical gear firms told to 'promptly' flag adverse cases

Indian medical device firms must now promptly report all adverse events, both serious and non-serious, to the government's Materiovigilance Programme. This directive aims to boost patient safety and address concerns over underreporting of issues linked to locally manufactured equipment. Timely reporting is crucial for identifying risks and implementing necessary safety measures.

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US tariff cut to 18% to boost India’s medical device exports

India's medical device exports to the US will surge following a tariff cut. This move makes Indian products more competitive against China. Lower import duties will also benefit India's healthcare system by reducing costs for high-value equipment. Industry leaders hail the deal as transformative, unlocking significant market potential and fostering investment.

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Budget relief on the label: Govt proposes to drop duty on rare disease drugs

The Indian budget proposes exempting seven rare disease drugs from import duties. This move aims to lower costs for expensive life-saving medicines. Patient groups welcome the relief for out-of-pocket expenses. However, some believe duty cuts alone will not make these drugs affordable for most Indians. The proposal also includes duty waivers on anti-cancer drugs.

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