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THREE INDIAN STATES TO CLOSE NON-GMP-COMPLIANT PLANTS

July 31, 2006

The drug control departments of India's northeastern states will soon begin to enforce more strict good manufacturing practices (GMP) in pharmaceutical plants. Three states, Assam, Mizoram and Manipur, have already issued circulars banning the manufacture and sale of drugs produced from noncompliant facilities, and others are expected to follow suit.

The decision will affect hundreds of pharmaceutical companies that are not yet fully compliant with the Schedule M norms under the Drugs and Cosmetics Act. Schedule M implementation is not uniform across the country, and some state drug manufacturers associations have obtained a stay on the government order. Regulatory authorities in the affected states will revoke the licenses of noncompliant manufacturers and halt the manufacture of drugs.

Drug regulatory agencies in the southern and western parts of the country have already started issuing closure notices to noncompliant companies. Northern states are the only ones with state governments that have taken a lenient attitude toward companies that are not Schedule M-compliant.