The union ministry of health is expected to come out with a revised Schedule H list bringing 517 drugs under the prescription category. Drugs like Nimesulide, Letrozole, Celecoxib, anti-retrovirals etc have all found place in the new list.

There are about 300 new drugs that would find way into the revised Schedule H. While some of the existing drugs are to move to over the counter category, about 200 drugs in the existing list would continue as prescription drugs.

The government has prepared the draft notification, which substitutes the existing Schedule H and is to come out with the final notification soon.

Since the Schedule H was last revised in 1996, hundreds of drugs that were introduced into the market as prescription drugs during the last nine years were not present in the existing list. With the revision, the backlog is to get cleared.

However, the inclusion in the Schedule H list is not to make any difference in their marketing prospects, as they have been "prescription drugs" all these years. These drugs were dispensed by retail chemists only on the production of the prescription of a registered medical practitioner. The drugs had been carrying the statutory information that "it has to be sold against prescription." After the inclusion in Schedule H, the same formulations would have to carry "Rx" symbol conspicuously displayed on the left hand top corner of the label and should carry the following sentence "Schedule H drug - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only."

The issue of Schedule H revision was first taken up at the DTAB meeting held on April 10, 2003. The DTAB had then recommended that all drugs, which are restricted to be sold against prescription at the time of first approval by the office of DCGI as a new drug, may also be simultaneously considered for inclusion under Schedule H. The matter was referred to a sub-committee of DTAB, which came out with a list of 219 drugs few months ago. The revised draft of Schedule H was finalised after refining this list.

In order to avoid such backlogs in future, the Central Drugs Standard Control Organisation (CDSCO) is known to be in the process of streamlining the inclusion of prescription drugs under Schedule H on an automatic basis. As per the plan, all new drugs approved for marketing as prescription drugs by the regulatory authority should automatically get included in the Schedule H list. The CDSCO plans to circulate the details of such drugs, as and when approved, among the members of the Drugs Technical Advisory Board (DTAB) on a regular basis, and come out with a notification announcing the inclusion of the drug under Schedule H.