Indian pharma industry

Indian pharma industry needs to arm itself to be in perpetual audit mode. This is because of the new stringent global regulatory norms that are being enforced and the frequent inspections by the international regulatory enforcement teams, said Dr Vinay G Nayak, president, technical operations, Alembic Pharmaceuticals.

Since 2008, the US FDA issued 483s warning letters and imposed ban on production plants of Indian pharma companies following non adherence to quality standards and have put the sector under surveillance. The only way to gain confidence of the regulator, clear doubts and relax scrutiny would be to put in place systems to document practices, prevent microbial contamination of drugs, bring in reliability and integrity in procedures across laboratory and manufacturing systems, he added.

The way forward for a confident regulatory compliance would be to automate process of manufacturing, computerise lab operations, install surveillance systems across the facility to bring in transparency and accountability at all levels. There should be review of standard operating procedures versus practice, said Dr Nayak in his presentation on ‘Quality audit case studies- major quality issues and trends’, presented at the recently concluded IPA Platinum jubilee event.