The office of the Drugs Controller General of India (DCGI) has defended the action of the Karnataka state drug control department in sanctioning market approval for GSK Consumer Healthcare's Crocin quik. The DCGI said that his office has not banned the drug and any directives on the contrary initiated by "unprofessional" government officials in few of the states, cannot be supported.

Speaking to pharmabiz.com, Ashwini Kumar, DCGI said, "The drug is absolutely safe and requires no ban as imposed in Gujarat and Maharashtra."

Agreeing that there is a technical issue pertaining to the labelling claims and composition of the drug, DCGI wanted the issue to be sorted out between the drug regulatory authorities without banning the drug.

"It is only the minor differences in the interpretation of the rules that has caused this confusion in some of the states. None of the states that have issued notices to stop the marketing of Crocin quik or made any prior consultations with the Karnataka State Drug Licensing Authority that issued the licenses. Nor have sought they our opinion. State departments should function as part of the whole system if they need to perform as a single drug regulatory authority. The agencies who are supposed to curb spurious drugs should not be seen engaged in banning safe drugs," said Kumar.

According to the DCGI, similar problems will continue to arise as long as state drug control authorities functions as detached bodies from the Central Drugs Standard Control Organisation. There has to be a co-ordination, qualified persons should be at the helm, and the drug regulatory system of the country should take informed decisions on technical matters and should not indulge in sensational activities, he opined.

The central authorities also blamed the media for blowing the issue out of proportion. They maintained that the company continues to market the drug in the country and the office of the DCGI does not intend to ban the drug on safety grounds. The actions of the state authorities are keenly watched and the central authority would intervene only if necessary.

This brand extension of Crocin is a combination containing 500 mg of paracetamol with sodium bicarbonate.

As pharmabiz had reported, the Gujarat Food and Drugs Control Administration was the first to ban Crocin quik in the state alleging it to be neither conforming to Indian pharmacopoeia nor with standard quality parameters.

The drug is marketed in India by GSK Asia and is manufactured by Remidex Pharmaceuticals Pvt. Ltd., Bangalore.