Pharma companies must adopt revised quality norms: Government
pharmaceutical companies to implement revised Good Manufacturing Practices (GMP) to improve quality in the face of children said to have died from toxic cough syrup and eye drops that allegedly caused infections.
The notification is likely this month, people in the know told ET.
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Offering CollegeCourseWebsiteIndian School of BusinessISB Healthcare ManagementVisitIIM KozhikodeIIMK Healthcare Management & Analytics ProgrammeVisit“The idea is to bring in quality and reduce manufacturing of those drugs which are not of standard quality. A need has been felt to revisit and implement GMP at par with global standards. A notification will be put up soon,” said a senior government official.
GMP standards ensure quality by way of controls on materials, methods, machines, processes, personnel as well as facilities and environment.
The World Health Organisation (WHO) said in October last year that the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer.
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In February, Chennai-based Global Pharma Healthcare recalled eye drops from the US market after that country’s regulator said several people had suffered from adverse events after the medicine was used.
Union health minister Mansukh Mandaviya had announced last month that companies with a turnover of Rs 250 crore and more will have to implement the revised GMP within six months. Medium and small-scale enterprises with a turnover of less than Rs 250 crore will have to implement it within a year. He also said that those
