In order to promote self care without compromising patient safety, the Central Drugs Standard Control Organisation (CDSCO) will soon notify list of over-the-counter (OTC) drugs and lay down specific provisions for its regulation in the country.
As per the recent drug consultative committee (DCC) recommendations, the definition for OTC drug must be laid down in the Drugs and Cosmetics (D&C) Rules, 1945.
The DCC recommendation comes in the wake of a subcommittee of experts proposal for adequate labeling in the drug packaging, so that consumers can “self-diagnose,” “self-elect,” “self-administer” and know when to stop using OTC drugs.
The CDSCO is also considering introducing a “unit dose packaging” for non-prescription medicines to lower chances of misuse or an overdose.
Contraceptive pills and analgesics such as paracetamol also qualify as over-the-counter medicines.
The subcommittee, which is looking into over-the-counter drugs, has suggested packaging for medicines that can be sold “without prescription, have a proven safety profile, therapeutic index and (are) used for common ailments”.
The experts have suggested two separate categories– OTC1 for those sold at retail outlets and OTC2 for those sold at pharmacies.
India does not have a definition for OTC drugs. The subcommittee has suggested that a formulation should have been sold for at least four years for it to be considered as an OTC medicine.
The experts have also proposed “labelling requirements”, which include a logo specifying whether a medicine is an OTC drug or an “OTC drug to be specified”.
DCC in its recent meet recommended that the suggestions of the sub-committee should be considered for suitable amendment in the Schedule K of the D&C Rules, 1945 to incorporate necessary provisions for such drugs for providing exemptions from requirements of sale license or prescription of RMP etc. subject to appropriate conditions. Accordingly, the DCC further recommended that the subcommittee should identify such list along with conditions and frame draft for amendments in the Rules.
Source : 1