The Union Government, vide GSR no 393 (E) dated May 25, 2022, for the first time, proposed to introduce over-the-counter (OTC) drugs in India through an amendment in the Drugs and Cosmetics Rules, 1945 (D&C Rules) to allow their sale in the retail market without the prescription of a Registered Medical Professional (RMP).[1] To increase the accessibility the notification proposed 16 drugs.[2] This notification amends Rule 123 and Schedule K of D&C Rules.


OTC Drugs:

OTC drugs are those that may be purchased from pharmacists without a prescription from an RMP. The regulatory framework remains grey in this regard, primarily because the term OTC has nowhere been expressly defined under the D&C Act and Rules.

In many countries, OTC drugs are regulated as a separate category. Considering the low doctor-patient ratio in India, developing a regulatory framework for OTC drugs, and defining them will improve access to such drugs.

Schedule K and Rule 123 of the Drug & Cosmetics Rules, 1945:

Schedule K[3] contains 33 items that are described as exempted drugs like aspirin, paracetamol tablets, analgesics, antacids, etc.

Rule 123 mentions that the drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder.

The different entries in the Schedule indicate that a few drugs are exempt from obtaining a sale license and a few drugs are exempt from obtaining a sale and distribution license as well as a manufacturing license. The Second Schedule to the Drugs Act[4] prescribes the standard to be complied with in respect of drugs stocked or exhibited for sale.

The Recent Amendment:

  1. The notification included 16 drugs comprising Paracetamol 500mg, Povidone Iodine solution, and Clotrimazole among others.
  1. The specified drugs can be sold by retail over the counter without the prescription of a registered medical practitioner subject to the following conditions:
  • The maximum duration of treatment/use does not exceed five days,
  • If the symptoms do not resolve, the patient must consult a doctor.
  • Pack size of the drug does not exceed the maximum doses recommended for five days.
  • Each pack of the drug must be accompanied by Patient Information Leaflet (PIL).
  • The indication claimed should be the same as already approved by the Licensing Authority under Rule 21(b)[5] for the categories mentioned.

Extent and Conditions for Exemption under Schedule K:

The extent and conditions for exemption are defined under Schedule K. Some of the drugs do not need a selling license under Form 19, 20, 20A as required by Chapter IV of the Act and the Rules. However, this is subject to the following conditions specified in Schedule K which may include particular conditions relating to a drug, these conditions are drafted according to the nature of the drug and various other factors.

Judicial Decisions:

There have been various judgments on the exemption of Part IV of the Act on schedule K drugs wherein drug authorities prosecuted seller /manufacturer for violating Section 18 (1) (c) of the Act[6].

  • Reckitt and Benckiser (India) Ltd. Versus the State of Andhra Pradesh[7], it was held that disinfectant as a drug does not require a sale license subject to complying with Condition (17) of Rule 65 of the Rules[8]. Since some Schedule ‘K’ drugs are excluded from the restrictions of Chapter IV under the conditions set out in the Schedule, the petitioner’s argument that the production of the disinfectant ‘Lizol’ is similarly exempt under Rule 123 cannot be accepted. Section 12[9], covers pesticides and disinfectants.


  • Qualified Private Medical Practitioners’ Association & Ors vs the State of Kerala[10], it was held that all drugs specified in Schedule K; shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder, to the extent and subject to the conditions specified in that schedule.
  • S.Healthcare Pvt. Ltd vs Commissioner Of Customs[11], it was held that the imported goods can be used for more than one stated purpose, and depending on the use, the license for exemption is to be obtained. As in this case, if the import substance is used for manufacturing a drug, the import requires a license and does not qualify for exemption as provided for under Rule 123 and Schedule K of the Rule.
  • Shailendra Prasad Singh v State of Jharkhand[12], it was held that both Oxygen 99% and Oxygen 93% are Drugs as defined in Section 3(b)(ii) of the Act[13] However since entry no. 34 in Schedule ‘K’ of the Drugs & Cosmetics Rules, 1945 includes Oxygen 93% generated from the air using the molecular sieve technique, it is exempt from the restrictions of Chapter IV of the Act and under Rule 123 of the Rules, 1945. Therefore, no drug license is necessary for the production of Oxygen (93%) from the air using the molecular sieve method since it falls outside the scope of Chapter IV of the Act.


  • Reckitt Benckiser (India) Ltd. vs the State of Kerala[14], it was held that Dettol (item 12, Schedule K) contains some chemicals which are antiseptic but does not lose its character as a disinfectant for the said reason or that it can be used to treat skin and other body membranes and cavities.


It is to be noted that the term “Over The Counter” has been used for the first time in the Drug laws.  Although the term has not been defined in the proposed amendment yet, the legislature intends to recognize this commercially widely used term for retail sales without a sale license. All other drugs mentioned under schedule K do not find a similar explanation.

The CDSCO’s Drugs Consultative Committee looked into whether the D&C Rules need to be updated to include provisions exempting OTC drugs from the need for a sale license or a doctor’s prescription. The Sub-Committee emphasized the critical need for a clear definition of OTC drugs and the establishment of detailed procedures for OTC drug regulation in the nation.  Following are the recommendations:

  • OTC drugs must be defined to avoid misinterpretations.
  • The specifications regarding how the switch shall be regulated and implemented must be laid out.
  • The specifications regarding distribution & sale of OTC Drugs must be enumerated to avoid any difficulties in its implementation.
  • Regulations regarding the advertisement of OTC Drugs must also be laid out.

[1] GSR no 393 (E), Gazette Notification, Central Drugs Standard Control Organization.

[2] Ibid.

[3] Schedule K, The Drug & Cosmetics Rules, 1945.

[4] Second Schedule, The Drugs and Cosmetics Act, 1940.

[5] Rule 21(b), The Drug & Cosmetics Rules, 1945.

[6] Section 18 (c), The Drugs and Cosmetics Act, 1940.

[7] Reckitt and Benckiser (India) Ltd. Versus State of Andhra Pradesh 2008 SCC Online AP 871

[8] Rule 65 (17), The Drug & Cosmetics Rules, 1945.

[9] Section 12, The Drugs and Cosmetics Act, 1940.

[10] Shailendra Prasad Singh v State of Jharkhand 2019 SCC On-line Jhar 2344

[11] M.S.Healthcare Pvt. Ltd vs Commissioner of Customs Appeal No. C/756/11

[12] Shailendra Prasad Singh v State of Jharkhand 2019 SCC On-line Jhar 2344

[13] Section 3(b)(ii), The Drugs and Cosmetics Act, 1940.

[14] Reckit Benckiser (India) Ltd.  vs State of Kerala 2011 SCC On-line Ker 3943