Gujarat FDCA Commissioner Subhodh P Adeshara told Business Standard that the Crocin variant, called Crocin Quick, had been prohibited in the state on the grounds that the product did not meet the accepted standards of drug dissolution specified for paracetamol and it had a prohibitive colouring agent, Titanium Dioxide.
"Since the FDCA does not have the power to ban the product, we have prohibited it in our territory and has informed DCGI and also the Drug Controller of Karnataka, where the drug is manufactured," he said.
He added that the prohibition made the company withdraw the product from the market. The state did not allow the product to reach the market place, Adeshara added.
He also said the company could not give a satisfactory explanation on its claims such as quick dissolution and colour additives. "Since the Crocin Quick formulation is outside existing pharmacopoeial standards, it should be considered as a new product and needs clearance from the DCGI. But the company did not do that," he added.
GSK Consumer Healthcare managing director Nick Massey was not available for comments.
When contacted, Leanne Cutts, vice-president (marketing) of the company, said, "GSK applied to DCGI for approval of this formulation and after obtaining this clearance, as per the process, GSK applied to the Drugs Controller, Karnataka, and received the licence for manufacture and marketing of this formulations."
The drugs controller, Karnataka, has also replied to the FDA commissioner, Gujarat, on his queries and reaffirmed that the licence for the formulation had been granted on the basis of DCGI's clearance.
Titatmium dioxide is an approved colourant for any coated tablet. This is patent and proprietary medicine, and had been cleared by DCGI as a coated paracetamol tablet.
GSK Consumer Healthcare is a 100 per cent subsidiary of GSK Asia. The company is focussing on the over the counter healthcare and nutritional products in the country.
Crocin 500 is the flagship OTC brand of the GSK Consumer Healthcare. The company has recently launched two more variant of this brands - Crocin Pain relief and Crocin Quick.
The company had withdrawn another variant of Crocin, Crocin 1000, a couple of years ago due to 'strategic reasons'.
