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Regulation of OTC drugs : CDSCO to soon amend Schedule K of Drugs and Cosmetics Act


Regulation of OTC drugs : CDSCO to soon amend Schedule K of Drugs and Cosmetics Act

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. 

New Delhi: The Drugs and Cosmetics Act may soon see an amendment in order to define and regularise the sale of over-the-counter drugs (OTC drugs), as the Drugs Consultative Committee of the Central Drugs Standard Control Organisation (CDSCO) was recently seen highlighting the need to this effect

The Drugs Consultative Committee (DCC) functional under the apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) considered recommendations to incorporate necessary provisions in the Drugs and Cosmetics Rules, 1945 for exempting OTC drugs from requirements of sale license or prescription of doctors.

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The DCC suggestion came after a sub-committee under the chairmanship of N.K. Ahuja, Drugs Controller, Haryana submitted its recommendations to this effect to the DCC. The Sub-Committee highlighted 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:

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Promote self-care without compromising patient safety thereby reducing the treatment cost.

  • The definition of OTC drug 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.

In terms of Rule 123, drugs listed in Schedule K of the Drugs and Cosmetics Rules, 1945, do not need a licence for sale if sold by shop other than a chemist’s shop. Drugs in Schedule K include the following:

  • Drugs not intended for medicinal use

  • Quinine and other antimalarial drugs

  • Magnesium sulfate

  • Substances intended to be used for the destruction of vermin or insects, which cause disease in human beings or animals viz. Insecticides and Disinfectants.

  • Household remedies, namely:◊ Aspirin tablets◊ Paracetamol tablets◊ Analgesic balms◊ Antacid preparations◊ Gripe water for use of infants◊ Inhalers, containing drugs for the treatment of the cold and nasal congestion◊ Syrups, lozenges, pills and tablets for cough.◊ Liniments for external use◊ Skin ointments and ointments for burns◊ Absorbent cotton wool, bandages, absorbent gauze and adhesive plaster.◊ Castor oil, liquid Paraffin and Epsom salt.

“Accordingly, the sub-committee should identify such list along with conditions and frame draft for amendments in the Rules, ” DCC further recommended.

Medical Dialogues had earlier reported that the Delhi High Court directed the Centre to provide a “partial list” of over the counter (OTC) drugs to doctors and pharmacists.

Also Read: Delhi High Court directs Centre to provide a partial list of OTC drugs to doctors, pharmacists


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