The Drugs Controller General of India is understood to have informed the state drug control authorities in Kerala and Andhra Pradesh that they can allow the manufacturing and marketing of fixed dose combination of paracetamol and nimesulide.

Although various state drug authorities have been issuing manufacturing licenses for this combination for some years, the office of the DCGI had taken a stand that the combination was irrational and should be phased out or restricted. In 2000, the DCGI directed the state drug authorities to 'restrict' the issue of manufacturing licenses and marketing of combination of paracetamol with nimesulide in the wake of reports of harmful side effects.

According to informed sources, the DCGI note circulated to the DCs a few weeks ago is based on a recent recommendation clearing the combination by the DTAB.

The latest intimation of DCGI has pushed Kerala and Andhra state drug control administrations into a dilemma, as these were the only states, which had not allowed manufacturing or marketing of paracetamol and nimesulide combinations as per the earlier directive. Now both the state drug authorities have to allow the combination in their states.

An embarrassed Kerala DC had to issue a public notice last week highlighting the 'side effects due to overuse of paracetamol and its combinations' sources said. Though Kerala did not have any manufacturers of this combination, about 15 brands were freely available in the market before the DCGI directive in 2000.

There are a total of 50 combinations of nimesulide and paracetamol out of 200 odd nimesulide formulations (70 nimesulide suspensions and 130 fixed dose combinations with other drugs) in the country today as reported by Pharmabiz earlier.

Some of the prominent medical experts and industry sources said that the decision to allow nimesulide and paracetamol combinations is strange and deserved further scrutiny. "The decision is surprising. While intense debates and legal proceedings are on to totally ban nimesulide and its combinations for its side effects, the DCGI move now should be interpreted as an effort to help the existing manufacturers of nimesulide and to create a precedent to allow other irrational combinations" remarked an industry source. At present at least two cases, filed by NGOs, are to be heard in the Delhi and Chennai High Courts for a total ban of nimesulide in India. The Delhi High Court is expected to come up with its judgment within a few months.

"Paracetamol is safe. I will never prefer a combination of paracetamol and nimesulide as nimesulide has been proven beyond doubt for its hepatotoxic side effects. I don't want to comment beyond this" Dr MA Phadke, a senior pediatrician and advisor for Maharashtra government and consultant for UNICEF told Pharmabiz in Chennai, while reacting to the development. A Swiss study also indicated nimesulide has the highest rate of side effects amongst non-steroidal anti-inflammatory drugs (NSAIDs).