The Drug Controller General of India (DCGI) had cleared Crocin quik in April 2004 as a coated drug containing a single active, paracetamol and had denied new drug status to the drug, and therefore GSK produces the drug as a patent and proprietary medicine, according to GSK Consumer Healthcare.

In two different e-written communications to Pharmabiz, Pradeep Chaudhry, vice president, R&D and regulatory affairs, and Partha Mukherjee, director, legal and corporate affairs, GSK Consumer Healthcare revealed the application of approval for Crocin quik as a coated paracetamol 500 mg tablet, which was submitted to the DCGI on July 18, 2003. The DCGI issued a letter on April 27, 2004 (reference F. No. 4-89/2003 DC) clearing Crocin quik as a drug containing a single active i.e., paracetamol 500 mg.

Based on the letter, the company approached the Karnataka Drug Controller and he granted the license to manufacture Crocin quik on August 2, 2004 (ref no: DCD/CR-232/MFG/2004-05) as a patent and proprietary medicine. Having complied with the mandated procedure, Crocin quik was introduced in the market in January 2005, as an innovative new formula that enables paracetamol to be absorbed at least twice as fast as conventional paracetamol tablets.

"Crocin quik is a 'patent and proprietary medicine' that is distinctive in its formulation from paracetamol tablets IP," said Pradeep Chawdhary.

Partha Mukherjee noted that any medicine that exists within officially recognised pharmacopoeia such as IP, BP, USP, is called a pharmacopoeial product. Any product not specified within any of the officially recognised pharmacopoeia is called a patent and proprietary (P&P) product. Any innovation outside the formulations currently specified in the official pharmacopoeia will be a P&P drug until it is adopted in the pharmacopoeia. A P&P drug may or may not be a new drug depending on whether it complies with the definition of 'new drug' as stated in the Drugs and Cosmetics Act and the rules there under. DCGI's clearance of Crocin quik is as a coated paracetamol tablet 500 mg, which is not covered under IP and thus it is a P&P drug. DCGI has not given a new drug status to Crocin quik. GSKAP has complied with all mandated procedures for the approval to manufacture and market Crocin quik in India, said the official.

He said that the company markets Crocin quik in the states of Orissa, Assam, West Bengal, Jharkhand, Chandigarh, Uttar Pradesh, Rajasthan, Delhi, Haryana, Punjab, Uttaranchal, Karnataka, Kerala, Tamil Nadu, Andhra Pradesh, Gujarat, Goa, Maharashtra, Chattisgarh and Madhya Pradesh. However, the official declined to reveal the market size of the product in the market.

Commenting on the controversy related to the presence of sodium bicarbonate in the paracetamol tablet, he said that sodium was important for maintaining proper electrolyte balance within the human body for normal functioning of cells. Sodium bicarbonate is a common kitchen ingredient; baking soda is non-toxic and is used for cooking and baking in homes across India. Average sodium consumption per day in India is about 4000 mg to 6000 mg. Advice for people with 'restricted sodium diet' is a maximum of 2300 mg /day and that for people on 'low sodium diet' is a maximum of 1500 mg/day. The level of sodium in a tablet of Crocin quik is less than 1/10th of sodium from a teaspoon of salt, and is within permissible dietary intake. As per US FDA 21 CFR Part 331.11, 3 the usage of sodium bicarbonate in OTC antacids in the US is 16.8 g of sodium bicarbonate per day. Therefore it will take 26 tablets of Crocin quik to equal this level.

(Interestingly, US do not figure in the list of countries where GSK markets the product, as per the data provided by the company).

"Crocin quik is suitable for a vast majority of the population but we still advise a small section of the population on low sodium diet to consult their doctors before consuming Crocin quik. These features have been given in our pack communication as well," said Partha Mukherjee.

The company said that the formulation of Crocin quik has been clinically researched and proven for its safety and efficacy and is available in around 70 countries across the world as an OTC drug, including UK, South Africa, Australia, New Zealand, Singapore, Hong Kong, Sri Lanka etc.

Commenting on the prohibition of the drug in Maharashtra and Gujarat, the official said that the issue really was one of a difference in regulatory interpretation, over the clearance given by the DCGI for the manufacture and marketing of the product.

"We are very surprised at the developments and are in close consultation with both the DCGI and the Maharashtra FDA Commissioner to understand and resolve the matter quickly," said Pradeep Chaudhry.