The Drug Technical Advisory Board (DTAB) has recommended inclusion of all drugs that have been approved for marketing with a restriction to be sold against prescription under the Schedule H. This includes drugs which have been given permission to be sold against prescription at the time of first approval by DCGI but are not been formally brought under Schedule H. The reason behind the move is to correct the existing anomaly, which curtails the authority's power to take action against drug retailers even if such medicines are sold over the counter sans prescription. Strictly speaking, inclusion of prescription drugs under Schedule H is a prerequisite to ensure appropriate checks on the OTC sales of these drugs.

While nimesulide would be the first drug to be included in Schedule H, the DTAB has entrusted a sub-committee to prepare a list of drugs required to be brought under Schedule H. The first meeting of the sub-committee was held on May 19, 2003. The list brought out by the committee will be published as draft rules for obtaining comments as required under section 33 of Drugs and Cosmetics Act 1940 before finalization of the amendment to Schedule H.

With regard to the inclusion of nimesulide in Schedule H, DTAB had noted that at the time of approval of the drug, it was a condition of approval that it would be sold only against prescription of a registered medical practitioner. Though this condition is still in force, lack of legal support had spoiled the spirit.

DTAB also noted that fixed dose combinations of nimesulide with paracetamol, muscle relaxants etc are like other similar combinations of non steroidal anti inflammatory drugs (NSAIDS) for short term use and are considered rational, and may be permitted to continue to be marketed. It has however asked the sub-committee to examine other formulations expeditiously so that the combinations that lack adequate justfication are withdrawn from the market. DTAB sub-committee is to submit a report within three months.