Indian non-compliance triggers joint industry-regulator awareness drive
This article was originally published in Clinica
Executive Summary
The Confederation of Indian Industries and the Central Drugs Standard Control Organisation (CDSCO) are to conduct India-wide regulatory awareness and educational seminars, in a bid to improve compliance. The majority of companies that make the 10 regulated devices are still failing to comply with the regulations that came into force in 2005, according to Pharmabiz. Non-compliance is due to not knowing that the regulations are mandatory and a lack of clarity about specific requirements involved it suggests. The CDSCO recently warned that punitive action would be taken against companies failing to comply (see Clinica No 1319, p 10).