DCGI to cap paracetamol content in combo drugs

The move could lead to a stir in the R1,700-crore domestic paracetamol-combination drugs market where most major brands have a strength of 500 mg of the drug, which is also widely used as single-drug formulations virtually as an over-the-counter product.

Taking a cue from the US FDA?s decision earlier this year, the Drugs Controller General of India (DCGI) is also set to make it mandatory for all manufacturers of these combination drugs to put a box-label on the formulation packs, warning the patient-consumer of potential liver toxicity if the drug is consumed more than the recommended daily dose. Popular brands in this category belonging to leading drug firms like Ranbaxy (Dolamide), Lupin (Lupisulide), Dr Reddy?s (Niap), Ipca Labs (Etomax P) , Alkem (Sumo) and Glenmark (Sibet P) will be impacted by the DCGI?s move.

The regulator reckons that taking more than the recommended daily dose of these drugs could cause serious liver damage or allergic reaction such as swelling of the face, mouth and throat, difficulty in breathing, itching or rashes.

However, the DCGI may allow drug firms a three-year transition time to phase out the existing lot of higher-dose paracetamol products from the market and shift to the new norms.

?The idea of giving a smooth transition period is to prevent any possible shortage of the drug in the market which are usually very high in demand among people for analgesic and other purpose,? a health ministry official told FE.

Of the total R2,016-crore paracetamol market in India (for the period of 12 months ended July), over R1,670 crore is estimated to be paracetamol-combination market, according to market research firm AIOCD AWACS. Both total paracetamol and combination paracetamol markets are growing in the range of 9% annually. There are at least six brands in the paracetamol combination market, which contribute annual revenues of over Rs 50 crore to the respective companies’ revenue.

?This is a good move and it was in the offing. However, unlike in US where it is mandatory that you cannot combine acetaminophen with anything other than codeine or narcotics, here we do not have such a law. It has led to formulations being marketed here, where acetaminophen has been combined with other classes of drugs that also cause liver toxicity, for instance NSAIDS. So, the effect on liver gets compounded and becomes additive,? points out drug regulatory expert CM Gulhati.

Government officials, said that they are first trying to bridge the time difference between evidence-based compelling decisions on side effects taken by international regulators and Indian regulator. For instance, in this case the Indian decision was taken within five months of the US FDA taking a call on the matter. Also, in a few years decisions on drugs causing adverse effects can be taken on the basis of data that is generated within the country, which could be more accurate considering that it would be based on the impact of drugs on the Indian population.

This is the time frame by when India’s own pharmacovigilance programme (to monitor adverse events of drugs nationally), initiated last year, is expected to gather full steam.

Paracetamol has analgesic and anti-pyretic properties. It is marketed as single dose formulations (which are not going to be impacted by the DCGI move) and also in combination with other drugs like Nimesulide, Nabumetone, Lornoxicam, Ibuprofen etc.