Admitting that all drug applications and dossiers filed by Ranbaxy Laboratories in the US will be examined by the authorities, Drug Controller General of India (DCGI) Dr G N Singh said that all approvals given to its drugs in India were in order and as per the laws with no indication of the company violating Indian laws.

Without going into the steps taken to scrutinise the dossiers and documents filed by Ranbaxy in the wake of the recent controversies, Dr Singh however admitted that all matters including approvals in the past would be examined. He asserted that all the needful as per the law would be taken including setting up special team to examine the case or sending officials  to the US as the situation demands.

“My most important concern is to assure the safety and efficacy of the drugs in India and action will be taken as per the Drugs and Cosmetics (D&C) Act, not just against Ranbaxy but other companies also if found guilty,” Dr Singh told Pharmabiz.

On the possibility of Indian regulator giving clearance to the dossiers and documents by any Indian company before filing them with another regulating agency abroad, Dr Singh expressed his inability as per the existing rules. “We cannot dictate the norms and requirements set by another country. Our task is to ensure the safety of our people and make sure that approvals to the drugs here are given as per the rules and stringent measures,” he said.

Ranbaxy last week agreed to pay $500 million to settle civil and criminal charges of making fraudulent statements to the US Food and Drug Administration (FDA) and selling adulterated drugs and the controversy got deeper further with its Japanese promoter Daiichi accusing former shareholders of concealing vital information about the case, before its take -over in 2008.

The DCGI said he wanted all companies to follow the rules in India and the D&C Act would be enforced strictly by the authorities.