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Drug regulators, industry body to conduct workshops on manufacturing norms

LiveMint logoLiveMint 15-09-2017 Isha Trivedi

Mumbai: At a time when the Indian pharmaceutical sector is drawing flak for non-adherence to quality norms, drug regulators and the industry association have come together to educate companies about improving their standards to meet global requirements.

Regulators like the US Food and Drug Administration’s (US FDA) India office, the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA), the European Medicines Agency (EMA) and India’s Central Drugs Standard Control Organisation (CDSCO) along with industry lobby group Indian Pharmaceutical Alliance (IPA) will conduct workshops on good manufacturing practices (GMP).

These two-day Advanced GMP workshops will be conducted in Chandigarh, Ahmedabad, Goa and Hyderabad between 6 and 17 November, IPA said in release on Friday. This is the second such series of workshops. The first was conducted in 2014.

The workshops are for supervisory and middle-level managers in manufacturing, quality control and regulatory functions in companies and nominees from CDSCO.

The topics covered will include data reliability, regulatory expectations, data quality and integrity investigation in laboratories, manufacturing and documentation practices, data integrity issues in inspections, risk-based approach to investigations, and data validation.

Over the last seven to eight years, many big and small Indian companies have been pulled up by global regulators, particularly the US FDA, for violation of current good manufacturing practices.

Sun Pharmaceutical Industries Ltd, Dr Reddy’s Laboratories Ltd, Wockhardt Ltd, Ipca Laboratories Ltd, and Divi’s Laboratories Ltd are among the companies that are currently facing quality compliance issues with US FDA. These issues have eroded earnings of the companies as product approvals in the US have been halted or delayed due to regulatory troubles.

The US is the biggest market for many Indian pharma companies and hence improving quality standards has become imperative to sustain growth.

Data unreliability, non-adherence to standard operating procedures, batch failures, contamination, and insufficient investigation of problems are some of the major non-compliance issues observed at Indian manufacturing facilities.

While companies have taken steps such as automation of processes in manufacturing units and laboratories to reduce human error and maintain data integrity, more needs to be done.

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