The industry response to the draft notification revising the list of prescription drugs (Schedule H) has been very poor. According to drugs control officials there has been hardly any response from the industry after the notification issued on February 24. The lack of interest among the industry with regard to Schedule H has been attributed to the typical Indian situation where all the drugs, irrespective of Schedule H or not, are available without prescription from most of the chemist shops.

Industry sources say that it hardly make any difference whether a drug is included in Schedule H list or not.

Eventhough the time allotted by the Union Ministry of Health to comment on the draft notification is long over, the office of the Drugs Controller General of India (DCGI) invited the industry to come out with its suggestions before the list is finalised through another notification. As per the draft, there are 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.

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.

Another interesting reason for the lack of response from the Industry is that almost all these drugs had been "prescription drugs" all these years. So a mere inclusion in the list makes no difference to them. 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."

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.