Mumbai: In a bid to bring drug quality norms in India on a par with global standards, the Central Drugs Standard Control Organization’s (CDSCO) engagement with global regulators has increased significantly over the last two years.
“We are constantly engaging with global regulators. We are participating in plant inspections conducted by US FDA (Food and Drug Administration as well as European regulators to observe and learn what are their expectations and skills,” Drugs Controller General of India G.N. Singh said on Thursday on the sidelines of a quality excellence conference organised by the Indian Pharmaceutical Alliance (IPA) in Mumbai.
He said Indian regulators have been a part of 30% of about 150 inspections conducted by the US FDA in the last one year.
On its part, the US FDA has been informing the CDSCO at least seven days in advance about their routine inspections of drug manufacturing facilities in India.
Sharing of information between US FDA and CDSCO has increased and both the regulators are interacting almost on a weekly basis, Mathew Thomas, director of US FDA’s India office said in a presentation at the conference.
Meanwhile, the UK Medicines and Healthcare Products Authority (MHRA) has signed an Memorandum of Understanding (MoU) with CDSCO for collaboration on quality management.
The increasing dialogue between regulators is important as it helps Indian pharma industry to understand the expectations of global inspectors when they visit their manufacturing facilities and also helps in upgrading Indian quality norms.
India is one of the largest supplier of generic drugs globally.
In recent years, a number of domestic companies have reported violations of good manufacturing practices at their plants, which has hit their earnings and also dented image of the sector.
Industry lobby group IPA, along with knowledge partner Mckinsey & Co. formed a Quality Forum in March 2015 and initiated activities to address the key issues leading to lapses in quality.
The group has also been engaging with global regulators.
Data reliability, non-adherence to standard operating procedures, batch failures, contamination, and insufficient investigation of problems identified in the quality process are some of the key non-compliance issues observed at manufacturing plants.
Apart from the quality issues at manufacturing facilities, US FDA’s Thomas highlighted the need to improve quality of applications filed by Indian companies for product approvals as that will quicken the review process.
