The Drug Controller General of India (DCGI) is likely to ask explanation from the state drug controllers who have issued manufacturing licences for formulations of nimesulide in single as well as in combination. The DCGI action comes in the wake of increased instances of the state drug control offices issuing licences for manufacturers who come out with nimesulide single and combination formulations.

Nimesulide, being a drug that was approved only in 1999 by the DCGI, should be treated as a new drug for four years after the approval as per the current rule, so as the combinations with this drug. Hence, the manufacturing licences for these formulations are supposed to be issued by the DCGI only. However, there are a number of manufacturing licences have already been issued by various state level drug controllers in the country without consulting the DCGI or the Drug Consultative Committee (DCC).

Moreover, since the Nimusulide-Paraecetamol formulations are still not been cleared as an established rational combination, the state drug controllers are supposed to consult the DCGI before issuing manufacturing licences, says Dr Venkateshwarlu, Deputy Drug Controller (India) west zone. "So we are going to ask the drug controllers who has issued the licences to these formulations that on what basis they have granted manufacturing licences for this new drug formulation as well as this doubtfully irrational combination," he said.

However, we can seek explanations only on the cases that we have already come across, otherwise it is difficult to intervene in the functions of the state level departments to keep a track on the complete applications and clearances. And, we can't even directly withdraw the licences issued by the state FDAs. So, we can only initiate enquiries on a case-to-case basis with the State authorities and can warn them to follow the DCGI guidelines in respect of the new drugs and irrational combinations, the DDC said.

There are currently around 60 brands of nimesulide (single) formulation and about ten brands of the combination with paracetamol available in the market manufactured in the country.

The combination, which is currently prescribed for all types of musculoskeletal inflammatory conditions with pyrexia and pain, post-operative inflammation and pain, rheumatoid arthritis, osteoarthritis, etc. have already been listed in the doubtfully irrational combinations and the DCGI has already issued a guideline to inform state DCs not to issue licences for the manufacturing. But since the DCGI circular was only a guideline, several state drug licensing authorities chose to ignore it and continued to issue manufacturing licences for the combination. However, drug licensing authorities of Karnataka and Kerala have not been issuing the manufacturing licences for this combination. But as the reports of adverse effects of the combination continue to come, the Drug Technical Advisory Board has directed all the companies marketing the combination to conduct clinical trials of the combination, informed sources says.

The combination has also been listed among the banned combinations by the prestigious Monthly Index of Medical Specialities, a reference book of all major ethical preparations available for prescription in India.

The leading brands of nimesulide -paracetamol combination available in the market includes Sumo (Alkem Laboratories), Dolomide (Ranbaxy Laboratories Ltd), Emsulide ( Emcure Pharmaceuticals Ltd), Noflam P suspension and Noflam P tablet (Euphoric Pharmaceuticals (Pvt.) Ltd.), Niap (American Remedies Ltd), SN-15 (Serum Institute of India Ltd) , Nicip Plus (Cipla Ltd), Nimsaid (Medley Pharmaceuticals Private Ltd), Nimeson_P (Unison Pharma), Nimetic Plus (Talents Laboratories), Parazolandin (Sarabhai Piramal Pharmaceuticals Ltd), and Remudol of Recon Healthcare Ltd.