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New Chemical Entity (NCE)

A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development.
Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products.

The proposal of limiting of Acetaminophen (Paracetamol) in prescription combination products and giving Box Warning about its liver toxicity was considered by the DTAB in its 59th meeting held on 24th June, 2011 at New Delhi under the Chairmanship of Directorate General of Health Services.

The proposal was based on USFDA News Release dated 13.01.2011. It has directed the manufacturers of prescription combination products in USA containing Acetaminophen to limit the amount of Acetaminophen to no more than 325mg in each tablet or capsule. In addition to this, a box warning highlighting the potential for severe liver injury and a warning of potential for allergic reaction (e.g. swelling of face, mouth and throat, difficulty breathing, itching or rash) to be added to the label of all prescription drugs products that contain Acetaminophen. USFDA has taken this action to make prescription combination pain medications containing Acetaminophen safer for patients use.

It was further mentioned in the News Release that there is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care providers. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period. The elimination of higher dose prescription combination Acetaminophen products will be phased in over 3 year and should not create a shortage of pain medication. The DTAB after deliberations agreed that as the Paracetamol is known to have liver toxicity and in the light of the decision taken by US FDA, India should also limit the content of paracetamol to not more than 325 mg per tablet or capsule in the combination product in a phased manner in three years.

Manufacturers marketing fixed dose combinations of paracetamol may also be requested to limit the content of Paracetamol in such combinations to 325 mg and a box warning be printed on the label of such FDCs indicating that taking more than daily dose may cause serious liver damage or allergic reactions (e.g. swelling of the face, mouth and throat, difficulty in breathing, itching or rash) therefore requested that the State Licensing Authorities under your jurisdiction should be asked not grant fresh licences or renewals of the combinations products of Paracetamol containing more than 325 mg per tablet or capsule. The manufacturers marketing combination products having more than 325 mg of Paracetamol should be asked to limit the Paracetamol contents to 325 mg only in a period of three years. The manufacturers of Paracetamol combination products may also; be requested to provide a box warning on the label of such FDCs indicating-that taking more than daily dose may cause serious liver damage or allergic reactions (e.g. swelling of the face, mouth and throat, difficulty in breathing, itching or rash).