The office of the Drugs Controller General of India's stand supporting the action of the Karnataka state drug control department in sanctioning market approval for GSK Consumer Healthcare's Crocin quik could set a bad precedence in allowing introduction of more brands not conforming to the Indian pharmacopoeia and rules under the Drugs and Cosmetics Act, according to Dr. S.P. Adeshera, Commissioner, Gujarat Food and Drugs Control Administration.

Reacting to the Pharmabiz report 'DCGI finds no fault with Crocin quik, terms Gujarat and Maharashtra Commissioners' action unprofessional,' Adeshera said that Gujarat FDA'S decision to prohibit Crocin quik in the state was based on the rules under the Drug and Cosmetics Act.

"If the DCGI is endorsing to add colouring agents in a patent and proprietary drug, then this would throw open a Pandora's Box for the manufacturers. Numerous manufacturers will produce several new brands in the same fashion adding to the 80,000 odd brands already available in the market. We were comfortable with colourless paracetamol tablets for the last 45 - 50 years. Then why should we suddenly allow a company to manufacture paracetamol with colour and film coating, clearly violating the rules?" questioned Adeshera.

The Commissioner told Pharmabiz from Ahmedabad that if the DCGI was of the view to allow colouring agents and film coating in patent and proprietary medicines, then this should be communicated to the state drug controllers with clear-cut details and compositions.

He said, "The Gujarat FDA never objected or tried to counter the views of the apex drug regulatory authority. In several cases, Gujarat has allowed drugs based on the NOC from the DCGI's office. The NOC submitted by GSK in the case of Crocin quik has no mention of colouring agents and film coating in the drug."

Commenting on DCGI's opinion that the Maharashtra and Gujarat drug authorities should have consulted the Karnataka drug controller before effecting prohibition, Adeshera said that he had written to the Karnataka drug controller on the issue.

"Karnataka did not even bother to reply to my letter. State drug controllers having knowledge of the rules should not have licensed that product. It was a grave blunder," he said.

Adeshera noted that as per the Rule 144(C) under the Drug and Cosmetics Act, colouring agents are not permitted even in cosmetics, which are used externally. Gujarat did not allow the company to market the drug because the product was found not conforming to the Indian pharmacopoeia. Gujarat never questioned the efficacy and safety of the drug.

Ramesh Kumar, commissioner, Maharashtra FDA said that he would respond to the DCGI's views when the apex authority contacts him officially on the issue.