Although the numbers are not available, the economic impact of non-compliance of international regulatory by the life sciences sector in the last five years is very high.
The non-compliance due to various reasons is a serious challenge to growth of the sector and is going to hold growth of companies.
"Nobody has counted it in numbers but it was needed to be computed and the opportunity loss cannot be counted," said Rohit Mahajan, Senior Director, and Nitin Bidkar, Director, Deloitte Touche Tohmatsu India Private Limited, while releasing the survey report ‘Managing growth through better compliance management' here today.
Mahajan said about 50 plus companies were banned by the regulators from abroad for non-compliance so it can be very roughly guessed that the loss was somewhere around 5 to 7 % of the total revenue. The anonymous survey was done to assess the industry' preparedness for zero tolerance level of the regulators, to understand compliance culture and to capture behavior culture for compliance of the companies.
About 50 companies exporting products from among top life science 100 companies that included pharmaceuticals, medical devices, biotechnology, were approached for the survey and 33 responded. The survey was launched in August 2014. Deloitte concentrated on this area because of increasing monitoring by regulators abroad of Indian pharma sector and manufacturing facilities.