## Policy Analysis Report: Amendment to the Drugs Rules, 1945
**1. Executive Summary:**
This report analyzes a notification, G.S.R. 393(E), published in the Gazette of India on May 25, 2022, which proposes amendments to the Drugs Rules, 1945. The core purpose of this amendment is to expand the list of drugs that can be sold Over-The-Counter (OTC) by retail under a valid license, without requiring a prescription from a Registered Medical Practitioner (RMP). This report details the specific drugs added to the OTC list, the conditions attached to their sale, the affected stakeholders, and the anticipated impact of these changes.
**2. Introduction:**
This report aims to provide a comprehensive overview of the proposed amendments to the Drugs Rules, 1945, as outlined in notification G.S.R. 393(E) published on May 25, 2022. The analysis is based solely on the information provided within the notification text.
**3. Policy Overview:**
* The original policy being amended is the Drugs Rules, 1945.
* **Core Objective:** The core objective of this amendment, as inferred from the provided text, is to increase access to certain medications by allowing them to be sold Over-The-Counter (OTC) under specific conditions.
**4. Background and Rationale:**
This amendment likely aims to address the issue of accessibility to common medications for minor ailments. By expanding the OTC list, the government potentially intends to reduce the burden on healthcare professionals and provide consumers with more convenient access to treatments for conditions that can be self-managed. This move could also potentially reduce healthcare costs associated with seeking prescriptions for minor ailments.
**5. Key Provisions / Changes:**
This amendment focuses specifically on Schedule K of the Drugs Rules, 1945.
* **What is being changed:** After serial no. 39 in Schedule K, a new serial number 40 is inserted, which specifies a list of drugs to be sold Over-The-Counter (OTC) by retail under a valid license.
* **What the new rule/provision is:** The new rule allows the retail sale of the following drugs as OTC medications, *without a prescription from a Registered Medical Practitioner (RMP)*, subject to specific conditions:
* Povidone Iodine 5% w/v solution
* Chlorohexidine Mouth wash (Chlorohexidine Gluconate 0.2%)
* Clotrimazole cream (Clotrimazole 1% w/w)
* Clotrimazole dusting powder (Clotrimazole 1% w/w)
* Dextromethorphan Hydrobromide Lozenges 5mg
* Diclofenac ointment/cream/gel (Each gram contains 10 mg of diclofenac sodium equivalent to 11.6 mg of diclofenac diethylammonium)
* Diphenhydramine Capsules 25 mg
* Paracetamol tabs 500 mg
* Sodium Chloride Nasal spray 0.9%
* Oxymetazoline nasal solution 0.05%
* Ketoconazole shampoo 2% w/v
* Lactulose solution 10gm/15ml
* Benzoyl peroxide 2.5% w/w
* Calamine Lotion
* Xylometazoline hydrochloride 0.05% w/v
* Bisacodyl tablets 5mg
* **Conditions of Exemption:** The sale of these drugs OTC is subject to the following conditions:
* The provisions of Chapter IV of the Act and Rules thereunder apply, ensuring the drugs are sold under a valid retail license.
* The maximum duration of treatment with Chlorohexidine Mouthwash should not exceed five days.
* If symptoms do not resolve, the patient should consult a Registered Medical Practitioner (RMP).
* Pack size may not exceed the maximum doses recommended for five days.
* Each pack of the drug must be accompanied by a Patient Information Leaflet (PIL).
* The indication claimed must be the same as already approved by the Licensing Authority under Rule 21(b).
**6. Target Audience and Stakeholders:**
Based on the text, the primary target audience and stakeholders affected by these amendments include:
* **Pharmaceutical Manufacturers:** Who will need to adhere to the new labeling and packaging requirements (PILs).
* **Retail Pharmacies/Pharmacists:** Who can now sell these drugs OTC under a valid license but must comply with the specified conditions.
* **Consumers:** Who will have easier access to these medications without requiring a prescription.
* **Registered Medical Practitioners (RMPs):** Who may see a reduced number of consultations for minor ailments treatable with these OTC medications.
* **Licensing Authority:** Who need to ensure indication on the label is in compliance with Rule 21b.
**7. Implementation Aspects (Inferred):**
* **Responsible agency/bodies:** The Ministry of Health and Family Welfare, specifically the Department of Health and Family Welfare, is responsible for implementing and overseeing these amendments. The Drugs Technical Advisory Board was consulted in drafting the rules.
* **Timelines:** The rules will come into force on the date of their final publication in the Official Gazette, unless specified otherwise. There is a 30-day period for public comment before the draft rules are finalized.
* **Specific to Changes:** Retail pharmacies will need to ensure compliance with the packaging (PIL) and dosage limitations. Manufacturers will also need to update their product information to align with these changes.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of these amendments are:
* Increased accessibility and affordability of certain medications for common ailments.
* Reduced burden on healthcare providers for minor conditions.
* Empowered consumers to self-manage certain health issues.
* Potential cost savings for consumers due to the elimination of prescription fees for these specific drugs.
* Increased awareness among consumers regarding proper usage and potential risks associated with these drugs through the use of Patient Information Leaflets (PILs).
**9. Conclusion:**
The proposed amendments to the Drugs Rules, 1945, represent a significant shift in the accessibility of specific medications in India. By expanding the list of OTC drugs and implementing specific conditions for their sale, the government aims to improve access to essential medicines while ensuring patient safety. These changes will likely impact pharmaceutical manufacturers, retail pharmacies, consumers, and healthcare professionals. Further monitoring and evaluation will be crucial to assess the long-term impact of these amendments on public health and the pharmaceutical industry.
Key Entities Referenced
Drugs Rules, 1945: A set of rules related to drugs, which is being amended by this notification.
New Delhi: The city where the notification was issued.
Ministry of Health and Family Welfare: The Indian government ministry responsible for the notification.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
Drugs and Cosmetics Act, 1940: The Act under which the rules are being amended.
Drugs Technical Advisory Board: An advisory board consulted in the amendment of the rules.
Under Secretary Drugs: Position within the Ministry of Health and Family Welfare to whom objections and suggestions can be addressed.
Nirman Bhavan, New Delhi 110011: Address of the Ministry of Health and Family Welfare where objections and suggestions can be sent.
Drugs ..Amendment Rules, 2022: Title of the rules being introduced/amended
Schedule K: A schedule within the Drugs Rules, 1945 being amended.
Povidone Iodine: Drug to be sold Over-The-Counter
Chlorohexidine Mouth wash: Drug to be sold Over-The-Counter
Clotrimazole cream: Drug to be sold Over-The-Counter
Clotrimazole dusting powder: Drug to be sold Over-The-Counter
Dextromethorphan Hydrobromide Lozenges: Drug to be sold Over-The-Counter
Diclofenac ointmentcreamgel: Drug to be sold Over-The-Counter
Diphenhydramine Capsules: Drug to be sold Over-The-Counter
Paracetamol tabs: Drug to be sold Over-The-Counter
Sodium Chloride Nasal spray: Drug to be sold Over-The-Counter
Oxymetazoline nasal solution: Drug to be sold Over-The-Counter
Ketoconazole shampoo: Drug to be sold Over-The-Counter
Lactulose solution: Drug to be sold Over-The-Counter
Benzoyl peroxide: Drug to be sold Over-The-Counter
Calamine Lotion: Drug to be sold Over-The-Counter
Xylometazoline hydrochloride: Drug to be sold Over-The-Counter
Bisacodyl tablets: Drug to be sold Over-The-Counter
Dr. MANDEEP K. BHANDARI: Jt Secy.
Government of India Press, Ring Road, Mayapuri, New Delhi 110064: Details of printing press.
Delhi 110054: Location of Controller of Publications.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअID.-E2x5xx0 52022-236010
CG-DL-E-25052022-236010
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 372] नइ दद्ली, बयधवार, मइ 25, 2022/ज्य ष्े ठ 4, 1944
No. 372] NEW DELHI, WEDNESDAY, MAY 25, 2022/JYAISTHA 4, 1944
स्ट्व ास्ट्् य एव ं पिरवार क्य ाण मरं ालय
(स्ट्व ास्ट्् य एव ंपिरवार क्य ाण जवभाग)
ऄजधसचू ना
नइ दद् ली, 25 मइ, 2022
सा.का.जन. 393(ऄ).—औषजध जनयम, 1945 का और संिोधन करने के जलए कजतपय जनयमों के जनम्नजलजखत
प्रारूप, जजस े केंद्रीय सरकार औषजध तकनीकी सलाहकार बोडड के परामि ड स े औषजध और प्रसाधन सामग्री ऄजधजनयम,
1940 (23 के 1940) की धारा 12 की ईप-धारा (1) और धारा 33 की ईप-धारा (1) द्वारा प्रदत्त िजियों का प्रयोग करत े
हुए, आसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की जानकारी के जलए प्रकाजित दकया जाता ह ै और एतद ्
द्वारा सूचना दी जाती ह ै दक ईि प्रारूप जनयमों पर ईस तारीख स े तीस ददनों की ऄवजध समाप् त होने पर या ईसके पश्चात ्
जवचार दकया जाएगा जजस तारीख को आन प्रारूप जनयमों वाले भारत के राजपर की प्रजतयां जनता को ईपलब्ध कराइ
जाएगी;
केंद्रीय सरकार द्वारा ईपययडि जनर्ददष्ट ऄवजध के भीतर दकसी भी व्यजि स े प्राप्त होने वाली अपजत्तयों और सयझावों
पर जवचार दकया जाएगा;
अपजत्तयां और सयझाव, यदद कोइ हों, तो ऄवर सजचव (औषजध), स्ट्वास्ट््य और पिरवार क्याण मंरालय, भारत
सरकार, कमरा स.ं 434, सी ववग, जनमाडण भवन, नइ दद्ली - 110011 को ऄग्रेजषत दकया जाए ऄथवा drugsdiv-
mohfw@gov.in पर इ-मेल दकया जाए।
3485 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (1) आन जनयमों को औषजध (....संिोधन) जनयम, 2022 कहा जाएगा।
(2) जनयम राजपर में आनके ऄजं तम प्रकािन की तारीख को प्रभावी होंगे।
2. औषजध जनयम 1945 म,ें ऄनयसचू ी ट म,ें क्रम संखयांक 39 और ईससे संबंजधत प्रजवजष्टयों के पश्चात,् जनम्नजलजखत
क्रम संखयांक और प्रजवजष्ट ऄंतःस्ट्थाजपत की जाएगी, ऄथाडत:्—
औषजध का वग ड छूट की सीमा और ित ें
“40. जनम्नजलजखत औषजध की वैध ऄनज्ञय जप्त के ऄधीन ओवर-द-काईंटर ऄजधजनयम के ऄध्याय IV और आसके ऄधीन जनयमों
(ओटीसी) खदय रा जबक्री की जानी है: के ईपबंधों म ें प्रावधान ह ै दक आन औषजधयों की
जनम्नजलजखत ितों के ऄधीन एक रजजस्ट्रीकृत
(1) पोवीडोन अयोडीन 5% डब््य/ूजव सौलिू न संघटन: पोवीडोन
जचदकत्सक (अरएमपी) के नयस्ट्खे के जबना ओवर-द-
अयोडीन 5% डब््य/ूजव (एंटीसजे प्टक और कीटाणनय ािक एजटें )
काईंटर खयदरा जबक्री की जा सकती ह,ै ऄथाडत:्—
(2) क्लोरहजे क्सजडन माईथवॉि
(क) ईपचार / ईपयोग की ऄजधकतम ऄवजध पांच
सघं टन: क्लोरहजे क्सजडन ग्लूकोनटे 0.2% (मसूडे की सूजन के
ददनों स ेऄजधक नहीं होनी चाजहए ।
ईपचार के जलए)
(ख) यदद लक्षण हल नहीं होत े ह ैं तो रोगी को
(3) क्लोिरमजे ोल क्रीम
रजजस्ट्रीकृत जचदकत्सक से परामि ड लेना
सघं टन: क्लोिरमजे ोल 1% डब््य/ू डब््य ूक्रीम (एंटीफंगल)
चाजहए ।
(4) क्लोिरमजे ोल डवस्ट्टग पाईडर (ग) पैक साआज पांच ददनों के जलए ऄनयिंजसत
सघं टन: क्लोिरमजे ोल 1% डब््य ू/ डब््य ूपाईडर (एंटीफंगल) ऄजधकतम खयराक से ऄजधक नहीं हो ।
(5) डेक्स्ट्रोमथे ोफडन हाआड्रोब्रोमाआड लोजेंजसे (5एमजी) (खासं ी) (घ) औषजध के प्रत्येक पैक के साथ रोगी सूचना परक
(6) डाआक्लोफेनाक ऑआंटमटें / क्रीम / जेल (पीअइएल) संलग्न होना चाजहए ।
प्रत्यके ग्राम जेल म ें10 जमलीग्राम डाआक्लोफेनाक सोजडयम (11.6 (ड) दावा दकया गया संकेत वही होना चाजहए जो
जमलीग्राम डाआक्लोफेनाक डायआथाआलअमोजनयम के बराबर) ईज्लजखत श्रेजणयों के जलए जनयम 21(ख) के
होता है। (एना्जजे सक) ऄधीन ऄनयज्ञापन प्राजधकरण द्वारा पहले स े ही
ऄनयमोददत ह ै।”
(7) डाआफेनहाआड्रामाआन कैप्सलू 25 जमलीग्राम
(एंटीजहस्ट्टाजमजनक/एंटीएलर्जजक)
(8) पैराजसटामोल टैबलट्े स 500 जमलीग्राम (एंटीपायरेिटक)
(9) सोजडयम क्लोराआड नसे ल स्ट्प्र े- 0.9% (नसे ल डीकंजस्ट्टेन्ट)
(10) ऑक्सीमटे ाजोजलन नसे ल सौलिू न 0.05% (नसे ल डीकंजस्ट्टेन्ट)
(11) केटोकोनाजोल िम्ै प ू2% डब््य/ूजव (एंटी डैंड्रफ)
(12) लैक्टयलोज सौलिू न 10 ग्राम/15 जमली (लैक्सिे टव)
(13) बेंजोयल पेरोक्साआड 2.5 डब््य/ू डब््य ू (महयुँ ास े के जलए
जीवाणरय ोधी)
(14) कैलामाआन लोिन (एंटी सजे प्टक)
(15) जाआलोमटे ाजोजलन हाआड्रोक्लोराआड 0.05% डब््य/ूजव (नसे ल
डीकंजस्ट्टेन्ट)
(16) जबसाकोडील टैबलट्े स 5 जमलीग्राम (लैक्सिे टव)
[फा. सं. एक् स. 11014/27/2021–डीअर]
डॉ. मनदीप के भण्डारी, संययक् त सजचव
िटप्प ण: मलू जनयम ऄजधसूचना संख या एफ.2 -10/45-एच (1), तारीख 21 ददसम् बर, 1945 द्वारा भारत के राजपर म ें
प्रकाजित दकए गए थ े और ऄजधसूचना संख या सा.का.जन............(ऄ), तारीख ...................द्वारा ऄंजतम बार
संिोजधत दकए गए थे।[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 3
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 25th May, 2022
G.S.R. 393(E).—The following draft of certain rules further to amend the Drugs Rules, 1945, which the
Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-
section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs
Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is
hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days
from the date on which the copies of the Gazette of India containing these draft rules are made available to public;
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs (…..Amendment) Rules, 2022.
(2) These rules shall, unless specified otherwise, come into force on the date of their final publication in the
Official Gazette.
2. In the Drugs Rules, 1945, in Schedule K after serial no. 39 and entries relating thereto, the following serial
number and entries shall be inserted, namely:—
Class of Drugs Extent and conditions of Exemptions
―40. The following drugs to be sold Over-The-Counter (OTC) by The provisions of Chapter IV of the Act and
retail under the valid licence: Rules thereunder to provide that these drugs can
be sold by retail Over-The-Counter without
(1) Povidone Iodine 5% w/v solution Composition: Povidone prescription of a Registered Medical
Iodine 5% w/v (Antiseptic and disinfectant agent) Practitioner (RMP), subject to the following
conditions, namely:—
(2) Chlorohexidine Mouth wash Composition: (a) The maximum duration of
Chlorohexidine Gluconate 0.2% (For the treatment of treatment/use should not exceed five
gingivitis) days.
(3) Clotrimazole cream Composition: Clotrimazole 1% w/w (b) If the symptoms do not resolve the
cream (Antifungal) patient should consult Registered
(4) Clotrimazole dusting powder Composition: Clotrimazole Medical Practitioner.
1%w/w powder (Antifungal)
(c) Pack size may not exceed the
(5) Dextromethorphan Hydrobromide Lozenges (5mg) maximum doses recommended for five
(Cough) days.
(6) Diclofenac ointment/cream/gel Each gram of gel contains (d) Each pack of the drug may be
10 mg of diclofenac sodium (equivalent to 11.6 mg of accompanied with Patient Information
diclofenac diethylammonium) (Analgesic) Leaflet (PIL).
(7) Diphenhydramine Capsules 25 mg (e) The indication claimed should be same
(Antihistaminic/Antiallergic) as already approved by the Licensing
Authority under Rule 21(b) for the
(8) Paracetamol tabs 500 mg (Antipyretic) categories mentioned.‖
(9) Sodium Chloride Nasal spray – 0.9% (Nasal
Decongestant)
(10) Oxymetazoline nasal solution 0.05% (Nasal
Decongestant)
(11) Ketoconazole shampoo 2% w/v (Anti dandruff)
(12) Lactulose solution 10gm/15ml (Laxative)4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(13) Benzoyl peroxide 2.5 w/w (Antibacterial for acne)
(14) Calamine Lotion (Anti septic)
(15) Xylometazoline hydrochloride 0.05% w/v (Nasal
decongestant)
(16) Bisacodyl tablets 5mg (Laxative)
.
[F.No. X.11014/27/2021-DR]
Dr. MANDEEP K. BHANDARI, Jt Secy.
Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H (1), dated the
21st December, 1945 and last amended vide notification number G.S.R. ……(E), dated …….
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.