Over the Counter Drugs:
Over the counter drugs (OTC Drugs) are the drugs which can be available without prescription of medical practitioner. These are comparable safe drugs and don't produce any complications if used without doctor's recommendation or prescription.
In 2016, India’s Drug Consultative Committee (DCC) announced to establish a definition of OTC drugs that could be sold out without prescription in country.
Drug Consultative Committee now recommend suggestions regarding over the counter drugs.
The Sub-Committee is of the opinion that there is an urgent need for defining the Over-the Counter (OTC) drugs and to lay down specific provisions for the regulation of OTC drugs in the country. For these purposes following recommendations were suggested dated 12-09-2019:
Promote self-care without compromising patient safety thereby reducing the treatment cost.
- The definition for OTC drugs must be laid down in the Drugs & Cosmetics Rules 1945
- Basic Characteristics of OTC Drugs should be incorporated
- Classification of OTC drugs into OTC-1 and OTC-2 based on the extent of evidence of safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism, socioeconomic conditions of the country.
- Initial list of OTC Drugs should be prepared
- Regulation of switch of prescription Drugs to OTC Drug
- Regulation of New OTC Drug Approval
- Distribution & Sale of OTC Drugs
- Advertisement of OTC Drugs
After detailed deliberation, DCC recommended that the recommendations of the Subcommittee should be considered for suitable amendment in the Schedule K of the Drugs and Cosmetics Rules, 1945 to incorporate necessary provisions for such drugs for providing exemptions from requirements of Sale license/ 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.