India: Over The Counter Drugs – Regulatory Clarity On The Horizon

Last Updated: 2 October 2019
Article by Ashwin Sapra, Biplab Lenin and Kartik Jain

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 drugs1.

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 Rules2, substances specified in certain schedules3 are required to be sold (by retail) in accordance with the prescription of an RMP and, in the case of substances specified in certain schedules4, 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 course5. 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.6

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 patients7.

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 exist8. 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:

  1. Definition of OTC drug.
  2. Basic characteristics of OTC drugs.
  3. Classification of OTC drugs.
  4. Preparation of initial list of OTC drugs.
  5. Regulation of Rx Drug to OTC Drug Switch Process.
  6. Regulation of new OTC drug approval.
  7. Manufacturing and labelling of OTC drugs.
  8. Distribution and sale of OTC drugs.
  9. Advertisement of OTC drugs.
  10. Pricing
  11. Miscellaneous

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:

  1. Promote self-care without compromising patient safety thereby reducing treatment costs.
  2. Lay down the definition for OTC drugs in the D&C Rules.
  3. Incorporate basic characteristics of OTC drugs.
  4. 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.
  5. Prepare initial list of OTC drugs.
  6. Regulate the switch of prescription drugs to OTC drugs.
  7. Regulate new OTC drug approval.
  8. Regulate the distribution and sale of OTC drugs.
  9. 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.

Footnotes

1 https://timesofindia.indiatimes.com/business/india-business/govt-to-come-up-with-list-of-otc-drugs-soon/articleshow/71268127.cms

2 Rule 65 of the D&C Rules.

3 Schedule H and H1 or Schedule X of D&C Rules.

4 Schedule X of the D&C Rules.

5 https://www.medicalbuyer.co.in/govt-to-come-up-with-list-of-over-the-counter-drugs-soon/

6 https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/india-may-soon-give-otc-drugs-definition/articleshow/60757040.cms

7 http://pharmabiz.com/ArticleDetails.aspx?aid=114394&sid=1

8 https://www.moneycontrol.com/news/health-and-fitness/why-india-needs-a-comprehensive-policy-on-otc-drugs-3043811.html

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions