Otc Drugs Sale Sans Licence Seen

The government is considering a proposal to allow certain commonly used over-the-counter (OTC) drugs to be sold without a sale licence under the Drugs & Cosmetics Rules, 1945.

The matter came up for discussion at the recent meeting of the Drugs Technical Advisory Board (DTAB), ministry of health and family welfare.

According to the proposal, certain commonly used drugs which are considered safe and are needed for symptomatic relief should not be limited for sale through the licensed outlets only and should be made available to the consumers at other sale outlets also. Such a practice is prevalent in many countries where the OTC drugs are further classified as pharmacy and non-pharmacy drugs.

 

The proposal was also considered by the Drugs Consultative Committee (DCC) and a sub-committee was formed to consider the issue. The committee had recommended that various drugs that have been exempted under Schedule K from time to time should be clubbed together and the list should be enlarged to include more drugs which could be permitted to be sold without the condition of the sale licence under the rules.

The DCC in its subsequent meeting agreed, in principle, for review of Schedule K on the lines suggested by the sub-committee. For instance, Schedule K also lists certain household remedies that are permitted to be sold without a licence in a village having a population of not more than 1,000 persons. The committee suggested that some of the drugs covered under this entry could also be included in the list of total exemption from the sale licence.

The DTAB has suggested that the list of drugs which could be exempted from the sale licences should be examined by the expert committee and its report submitted for consideration of the board.