REGULATORY & COMPLIANCE PRACTICE

The Government of India is bringing in changes to the regulatory environment with respect to sensitive products like food and drugs, nutraceuticals, medical devices, biotech products, tobacco, wines and spirits. While some of these changes are mandated by international conventions and rules (like WHO regulations on tobacco), many other developments are in response to growing industry needs and increased interest in investments in India in certain fields like drug clinical trial. Such are the dynamics in these sectors that hitherto unregulated industries like medical devices have been brought under the ambit of regulatory mechanism as a result of certain adverse events. Some such examples are allegations of unsafe ingredients used in baby oil thus ‘misbranding’ the product. The other incidents widely reported are contamination of bottled drinking water, presence of pesticides in bottled soft drinks etc. 
India has a federal structure of Government and different subject matters for legislation come under legislative competencies of either the Centre or the twenty-eight (28) States or at times both. Further, India has a staggering number of legislation (some dated), at the central, state and municipal levels and legal compliance of all aspects of an entities operations is essential.