The notification is likely this month, people in the know told ET.
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“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.
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 companies that fail to follow the timeline may be penalised as per the provisions of the law.The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and was last amended in 2005. Schedule M sets out the requirements for drug plants.
India’s drug regulator recently carried out risk-based inspections and pointed to an urgent need to review the current GMP regulations and Quality Management Systems being followed by pharmaceutical companies.
The government is in the process of amending Schedule M of the Drugs and Cosmetics Rules, 1945, which will lead to an upgrade and tightening of the GMP norms for pharmaceutical firms. The regulator has been holding discussions with industry groupings as the process to revisit Schedule M starts.
The government had issued a draft notification in 2018 to upgrade Schedule M and synchronise it with international standards. However, the draft wasn’t finalised.
Considering the importance of GMP compliance in ensuring quality, the government has decided to finalise the draft rules, transiting from the existing Schedule M to a revised version.
