The Central Drugs Standard Control Organisation (CDSCO) has decided to streamline the inclusion of prescription drugs under Schedule H on an automatic basis. All new drugs approved for marketing as prescription drugs by the regulatory authority will hereafter, automatically get included in the Schedule H list. These details of such drugs, as and when approved, would be circulated among the members of the Drugs Technical Advisory Board (DTAB) on a regular basis, to be followed by a notification announcing the inclusion of the drug under Schedule H.
As a first step towards streamlining the entire process, CDSCO has cleared a list of 219 drugs that were approved as prescription drugs during the last eight years. Since the Schedule H was last amended in 1996, these drugs were not figuring under the list, though they were approved as prescription drugs.
However, the Schedule H status of the drugs is not to make any difference in their marketing prospects as they have been "prescription drugs" all these years. These drugs were allowed to be supplied 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 DCG(I) 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 the final list of 219 drugs recently.
Click here to view the complete list of 219 drugs included in Schedule-H in April 2004