INDIAN DRUG approval process is still finding its feet, and news that nearly 300 Fixed Dose Combinations were launched without approval is perhaps a glimpse at the type of problem they face. That said, the regulatory authorities are also trying to create standards that not all other agencies elsewhere have adopted.
http://m.timesofindia.com/business/india-business/govt-cracks-down-on-harmful-drug-combos/articleshow/20903128.cms