New Delhi, May 30: Amid controversy over the safety of its use, nyse-listed Dr Reddy`s Laboratories has discontinued Fixed Dosage Combinations (FDCs) of Nimesulide even as it continues to market all single ingredient formulations. In a letter dated May 21, 2003, addressed to the Drug Controller General of India, the company said it had "stopped manufacturing fixed dosage combinations of Nimesulide."
The brand names of fixed dosage combinations include Nise Spas & Nise Spas DS, Novigan N, Niap and Nise Mr.
When contacted, the company spokesperson confirmed that the fixed dosage combinations had been discontinued last year. This was a part of its product portfolio rationalisation strategy, he said.
He said as part of the move, the company had stopped manufacturing combinations of non-steriodal anti-inflammatory drug Nimesulide with tizanidine, dicyclomine, paracetamol and ketone plus amide.

However, he said that the company continued to market all its single ingredient formulations of Nimesulide including tablets and paediatric suspensions.

The Drug Controller General of India had earlier said manufacturers had been asked to discontinue paediatric drops even as Union Health Minister Sushma Swaraj had told Parliament in a written reply in February that "no serious adverse drug reaction was noted in the children in the country.”

Ruling out a ban on the drug, she had said 20 leading paediatric experts and Indian Academy of Paediatrics were consulted and "majority of experts confirmed reliability of Nimesulide.”
Bureau Report