Over The Counter (OTC) drugs are drugs that can be sold by pharmacists without a prescription from a Registered Medical Practitioner (RMP). Many drugs are sold over the counter without prescription, but the regulatory regime is grey in this regard, primarily because the term OTC has not been expressly defined under the Drugs & Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). Regulatory ambiguity is set to change, however, as the Central Government is now actively considering regulating the sale and distribution of OTC drugs.
There is significant regulation in relation to ‘prescription drugs’ – which require a prescription from an RMP to be sold. In terms of the D&C Rules, substances specified in certain schedules are required to be sold (by retail) in accordance with the prescription of an RMP and, in the case of substances specified in certain schedules, the pharmacists are required to keep a copy of the prescription for a period of two years. In contrast, OTC drugs are not defined as a distinct category of drugs. However, certain media reports suggest that the Government is considering a change in this regard and is likely to identify a list of OTC drugs in due course. This development comes in light of certain recommendations made by the Drugs Consultative Committee (DCC). In the past, the Central Drugs Standard Control Organization (CDSCO) had proposed to clarify the ambit of the term OTC by including a separate schedule for OTC drugs in the D&C Act and D&C Rules. At the time of writing, however, that proposal has not yet been implemented as law.
In countries such as India, where the doctor-to-patient ratio is abysmally low, carving out a separate category of OTC drugs can improve access to safe medicines and bring clarity in the regulatory regime governing these drugs. This goal, however, must be tempered with the need to ensure that adequate safety measures are in place to ensure that such self-medication does not lead to any risk to the safety of patients.
Self-medication is a very common practice in India, especially in cases of minor ailments like headache, fever, body pain etc., and most times such medications are available easily across the counter from pharmacies. In obtaining such medications across the counter without a prescription, patients may not be aware of adverse reactions, contraindications, therapeutic value etc., which may be associated with such medications. The proposed regulations seem to focus on alleviating this patient safety issue.
Regulation of OTC drugs as a separate category of drugs is a common practice in many countries throughout the world. However, in India, OTC drugs, as a concept, does not even exist. The recent push from the regulators to rectify this anomaly, is certainly a move in the right direction.
Deliberations by the DCC
The DCC is the statutory advisory committee set up by Central Government under Section 7 of the D&C Act to advise Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending towards securing uniformity throughout India in the administration of the D&C Act. The DCC has been in the process of deliberating upon the creation of specific rules and regulations to govern OTC drugs.
52nd meeting of the DCC:
During the 52nd meeting of the DCC, held on September 18, 2017, the DCC deliberated upon the creation of separate provisions for OTC drugs to be sold in retail pharmacies. In this respect, the DCC had recommended the creation of a separate category of OTC drugs. Further, a subcommittee was created under the chairmanship of ‘Dr. Ravi Shankar IPS, Drugs Controller, Andhra Pradesh’ (Shankar Committee) to comprehensively examine drugs marketed in India vis-à-vis conditions for sale stipulated under various schedules, i.e. Schedules H, H1, G, X, and K, and recommend the list of drugs that may be considered for marketing as OTC along with conditions to be followed.
55th meeting of the DCC:
During the 55th meeting of the DCC, held on January 31, 2019 and February 1, 2019, the DCC noted that the Shankar Committee had examined the matter in detail and submitted its report, which inter alia contained its recommendations on the following aspects of OTC drugs:
- Definition of OTC drug.
- Basic characteristics of OTC drugs.
- Classification of OTC drugs.
- Preparation of initial list of OTC drugs.
- Regulation of Rx Drug to OTC Drug Switch Process.
- Regulation of new OTC drug approval.
- Manufacturing and labelling of OTC drugs.
- Distribution and sale of OTC drugs.
- Advertisement of OTC drugs.
The DCC, during this meeting, constituted a subcommittee under chairmanship of ‘Shri. N.K. Ahooja, Drugs Controller, Haryana’ (Ahooja Committee) to examine the report submitted by the Shankar Committee and submit its recommendations to the DCC for further consideration.
57th meeting of the DCC
During the 57th meeting of the DCC, held on August 20, 2019, the DCC noted that the Ahooja Committee was of the opinion that there is an urgent need for defining OTC drugs and to lay down specific provisions for the regulation of OTC drugs. The Ahooja Committee had given the following recommendations:
- Promote self-care without compromising patient safety thereby reducing treatment costs.
- Lay down the definition for OTC drugs in the D&C Rules.
- Incorporate basic characteristics of OTC drugs.
- Classify 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, and socioeconomic conditions of the country.
- Prepare initial list of OTC drugs.
- Regulate the switch of prescription drugs to OTC drugs.
- Regulate new OTC drug approval.
- Regulate the distribution and sale of OTC drugs.
- Regulate the advertisement of OTC drugs
Based on the recommendations of the Ahooja Committee, the DCC recommended that suitable amendment should be made in Schedule K (exemptions and conditions for exemption from the provisions of Chapter IV of the D&C Act and the Rules made thereunder) of the D&C Rules to incorporate necessary provisions for OTC drugs for providing exemptions from requirements of prescription and/or sale licence, subject to appropriate conditions. The DCC further recommended that the Ahooja Committee should identify the list of OTC drugs, along with conditions, and frame the draft for amending the D&C Rules.
While it appears that the DCC is firmly of the view that OTC drugs need to be regulated as a separate category of drugs, no regulatory changes in either the D&C Act or the D&C Rules have been made thus far. It is apparent from the minutes of the 57th meeting of the DCC that the Ahooja Committee would, at first, need to identify the OTC drugs and then frame the draft of amendment(s) to the D&C Rules accordingly. Thereafter, it will be up to the discretion of the Government to decide whether or not, and in what manner, it wants to actually amend the D&C Rules. We note that the Government has been actively making amendments to the D&C Rules rather than amending the D&C Act itself –the amendment of which is long overdue.
Though not regulated separately, OTC drugs are still categorised as a “drug” and, therefore, the manufacture, import and sale of OTC drugs is regulated under the D&C Act and D&C Rules. Any regulation in this sphere will have to stand true to two objectives: reduction in costs to achieve better access to healthcare and medication; and, ensure safety of patients who engage in self-medication and buy OTC drugs. How the Government balances these two, will ultimately decide the eventual characteristics of the final regulation. One thing is clear, the Government must strike a fair balance between patient safety and easy availability whilst bearing in mind the fact that any and all acts of regulation may be met with resistance, should the industry decide to raise a voice against what it sees as overtly far-reaching regulation.
 Rule 65 of the D&C Rules.
 Schedule H and H1 or Schedule X of D&C Rules.
 Schedule X of the D&C Rules.