## Policy Analysis Report: Amendment to the Drugs Rules, 1945
**1. Executive Summary:**
This report analyzes an amendment to the Drugs Rules, 1945, as notified by the Ministry of Health and Family Welfare on January 18, 2022. The amendment mandates the inclusion of a Quick Response (QR) code on the label of every active pharmaceutical ingredient (API) or bulk drug manufactured or imported in India, at each level of packaging. The code must contain specific data to facilitate tracking and tracing of the API. This amendment aims to enhance transparency, improve traceability, and potentially combat counterfeit drugs within the pharmaceutical supply chain. It will come into force on the first day of January, 2023.
**2. Introduction:**
This report provides an overview and analysis of the amendment to the Drugs Rules, 1945, as published in the Gazette of India on January 18, 2022. The analysis focuses on the content of the provided notification, outlining the key changes, target audience, and potential implications of this regulatory update.
**3. Policy Overview:**
* This is an amendment to the existing Drugs Rules, 1945.
* **Core Objective (inferred):** To enhance the traceability and accountability of active pharmaceutical ingredients (APIs) and bulk drugs manufactured or imported into India.
**4. Background and Rationale:**
The amendment likely addresses the need for improved supply chain security and authentication of APIs. By mandating QR codes with detailed information, the amendment aims to combat the proliferation of substandard or counterfeit drugs. This can be inferred from the text, as enhanced tracking and tracing capabilities inherently address concerns about product authenticity and origin.
**5. Key Provisions / Changes:**
This amendment introduces the following change to the Drugs Rules, 1945:
* **Specific Part of Original Policy Changed:** Rule 96 of the Drugs Rules, 1945 is being amended by inserting a *new* subrule (5) after subrule (4).
* **New Rule/Provision:** "Every active pharmaceutical ingredient bulk drug manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely: i Unique product identification code, ii Name of the API, iii Brand name if any, iv Name and address of the manufacturer, v Batch no., vi Batch size, vii Date of manufacturing, viii Date of expiry or retesting, ix Serial shipping container code, x Manufacturing licence no. or import licence no. xi Special storage conditions required if any."
* **Difference/Effect of Change:** The amendment introduces a *new requirement*. Previously, there was no explicit mandate for QR code labeling and tracking on APIs and bulk drugs. The new subrule enforces this requirement, compelling manufacturers and importers to adopt QR code technology for traceability purposes. It mandates *specific* data to be included in the code.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this amendment are:
* Manufacturers of active pharmaceutical ingredients (APIs) and bulk drugs in India.
* Importers of active pharmaceutical ingredients (APIs) and bulk drugs into India.
* Software application developers who may need to create solutions to read the QR codes.
**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 enforcing the amended Drugs Rules. The Drugs Technical Advisory Board was consulted.
* **Timelines:** The amendment will come into force on January 1, 2023.
* **Implementation Aspects related specifically to the changes:** Manufacturers and importers will need to invest in systems capable of generating and applying QR codes with the required data to all levels of packaging for APIs and bulk drugs. There will likely be an initial period of adjustment and potential compliance checks by regulatory authorities.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of this amendment is improved traceability and accountability within the pharmaceutical supply chain. The amendment is likely to:
* Enhance the ability to track and trace APIs and bulk drugs from manufacturer to consumer.
* Facilitate the detection and prevention of counterfeit or substandard drugs entering the market.
* Increase transparency in the pharmaceutical supply chain.
* Potentially improve patient safety through enhanced product authentication.
* Increase costs for manufacturers and importers due to the additional labeling requirements and technology investment.
**9. Conclusion:**
The amendment to the Drugs Rules, 1945, mandating QR code labeling for APIs and bulk drugs, represents a significant step towards bolstering supply chain security and ensuring the quality of pharmaceutical products in India. While potentially adding to the costs borne by manufacturers and importers, the amendment has the potential to improve drug traceability, combat counterfeiting, and ultimately enhance patient safety. Affected stakeholders should prepare for compliance by January 1, 2023.
Key Entities Referenced
NEW DELHI: Location of publication.
TUESDAY, JANUARY 18, 2022: Date of publication.
PAUSHA 28, 1943: Date in the Indian national calendar.
THE GAZETTE OF INDIA: Title of the official government publication.
MINISTRY OF HEALTH AND FAMILY WELFARE: The government ministry issuing the notification.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
NOTIFICATION: Type of document.
New Delhi, the 18th January, 2022: Location and date of the notification.
G.S.R. 20E: Notification number.
Drugs Rules, 1945: The rules being amended.
Drugs and Cosmetics Act, 1940: The act under which the rules are being amended.
23 of 1940: Act number and year.
Government of India: The governing body.
G.S.R. 567E: Previous notification number.
8th August, 2019: Date of the previous notification.
Gazette of India, Extraordinary, Part II, section 3, subsection i: Specific section of the Gazette of India.
Central Government: The governing authority.
Drugs Technical Advisory Board: Advisory board consulted by the Central Government.
Drugs Amendment Rules, 2022: Name of the amended rules.
January, 2023: Effective date of the rules.
rule 96: Rule number within the Drugs Rules, 1945 being amended.
India: Country where the rules apply.
Quick Response code: Type of code to be placed on label.
F.No.X.11014172019 DR: File number related to the notification.
Dr. MANDEEP K BHANDARI: Name of the Joint Secretary.
Jt. Secy.: Title of Dr. MANDEEP K BHANDARI.
F.281045H 1: Original notification number for the principal rules.
21st December, 1945: Date of the original notification.
G.S.R.848E: Last amended notification number.
9th December, 2021: Date of the last amended notification.
Government of India Press, Ring Road, Mayapuri, New Delhi110064: Location of the Government of India Press.
Controller of Publications, Delhi110054: Publisher of the document.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एxलx.x-GअID.-E1x9xx0 12022-232768
CG-DL-E-19012022-232768
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 20] नइ दद्ली, मगं लवार, िनवरी 18, 2022/पौष 28, 1943
No. 20] NEW DELHI, TUESDAY, JANUARY 18, 2022/PAUSHA 28, 1943
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरालं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
ऄजधसचू ना
नइ दद्ली, 18 िनवरी, 2022
सा.का.जन. 20(ऄ).—रषजध जनयम, 1945 का रर संिोधन करने के जलए कजतपय जनयमों का प्रारूप, रषजध
रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 की ईप-धारा (1) रर धारा 33 की ईप-धारा (1)
ऄधीन यथा ऄपेजित, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण मंरालालय (स्ट् वास्ट् ् य रर पिरवार क् याण जवभाग) की
ऄजधसूचना स.ं सा.का.जन. 567(ऄ), तारीख 8 ऄगस्ट्त, 2019 द्वारा भारत के रािपराल, ऄसाधारण, भाग II, खंड 3, ईपखंड
(i) में प्रकाजित दकया गया था, जिसमें ईन सभी व् यजययों से, जिनके ईससे प्रभाजवत होने की संभावना ह ै ईस तारीख से,
जिसको ईक्त ऄजधसूचना ऄ्त्व्ट करने वाली रािपराल की प्रजतयां िनता को ईपलब् ध करा दी गइ थी, तीस ददनों की
ऄवजध के ऄवसान से पहले अिेप रर सुझाव अंमजरालत दकए गए थे;
रर, ईय रािपराल की प्रजतयां 10 ऄगस्ट्त, 2019 को िनता को ईपलब्ध करा दी गइ थी;
रर, ईक्त जनयमों पर िनता स ेप्रा्त अिेप रर सुझावों पर के् रीय सरकार द्वारा जवचार कर जलया गया ह;ै
ऄत: ऄब, के् रीय सरकार, रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 रर
धारा 33 द्वारा प्रदत् त िजययों का प्रयोग करते ुए, रषजध तकनीकी सलाहकार बोडड स े परामिड करन े के पश् चात,् रषजध
जनयम, 1945 का रर संिोधन करन े के जलए जनम् नजलजखत जनयम बनाती ह,ै ऄथाडत:् ―
367 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
1. (1) आन जनयमों का संजि्त नाम रषजध (संिोधन) जनयम, 2022 ह।ै
(2) य ेजनयम 1 िनवरी, 2023 को प्रवृत होंग े ।
2. रषजध जनयम, 1945 के जनयम 96 म,ें ईप-जनयम (4) के बाद जनम्न जलजखत ईप-जनयम ऄतं ःस्ट्थाजपत दकया िाएगा,
ऄथाडत:् —
"(5) भारत म ें जवजन्मत या अया जतत प्रत् येक सद य भेषि सघं क (प्रपुंि रषजध) के अधान के प्रत् येक स्ट् तर पर
आसके लेबल पर त् विरत प्रजतद या कोड जलखा िाएगा, जिसमें सॉफ् वेयर एप् लीकेिन के साथ पढ़ने योग् य डा ा
या सूचना होगी तादक असानी से ईस पर निर रखी िा सके रर पता लगाया िा सके। आन डा ा या सूचना म ें
जनम्न जलजखत ् यनू तम जवजिज्ट यां िाजमल होंग,े ऄथाडत:—
(i) ऄजद्वतीय ईत् पाद पहचान कोड,
(ii) एपीअइ का नाम,
(iii) ब्ांड का नाम (यदद कोइ हो),
(iv) जवजनमाडता का नाम रर पता,
(v) बैच संख् या,
(vi) बैच का अकार,
(vii) जवजनमाडण की तारीख,
(viii) समाज्त या पुन: िांच की तारीख,
(ix) सीिरयल जिपपग अधान कोड,
(x) जवजनमाडण ऄनुज्ञज्त संख् या या अयात ऄनुज्ञज्त संख् या
(xi) ऄपेजित जवजिष् भंडारण जस्ट्थजत (यदद कोइ हो) । "।
[फा.सं. एक् स.11014/17/2019 – डीअर]
डॉ. मनदीप के भण्डारी, संयुक् त सजचव
ि प्प ण:- मूल जनयम, भारत के रािपराल में ऄजधसूचना संख्यांक एफ.28-10/45-एच (1), तारीख 21 ददसम् बर, 1945 द्वारा
प्रकाजित दकए गए थे रर ऄजधसूचना संख्यांक सा.का.जन. 848(ऄ), तारीख 9 ददसंबर, 2021 द्वारा ऄंजतम बार
संिोजधत दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th January, 2022
G.S.R. 20(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was published as
required under sub-section(1) of section 12 and sub-section(1) of section 33 of the Drugs and Cosmetics Act, 1940
(23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department
of Health and Family Welfare) number G.S.R. 567(E), dated the 8th August, 2019, in the Gazette of India,
Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected
thereby before the expiry of a period of thirty days from the date on which the copies of the Official Gazette
containing the said notification were made available to the public;[भाग II—खण् ड 3(i)] भारत का रािपराल : ऄसाधारण 3
And whereas, copies of the said Official Gazette were made available to the public on the 10th August, 2019;
And whereas, objections and suggestions received from the public on the said rules have been considered by
the Central Government;
Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics
Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby
makes the following rules further to amend the Drugs Rules, 1945, namely:―
1. (1) These rules may be called the Drugs (Amendment) Rules, 2022.
(2) They shall come into force on the first day of January, 2023.
2. In the Drugs Rules, 1945, in rule 96, after sub-rule (4), following sub-rule shall be inserted, namely:—
“(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear
Quick Response code on its label at each level packaging that store data or information readable with
software application to facilitate tracking and tracing. The stored data or information shall include the
following minimum particulars, namely:—
(i) Unique product identification code,
(ii) Name of the API,
(iii) Brand name (if any),
(iv) Name and address of the manufacturer,
(v) Batch no.,
(vi) Batch size,
(vii) Date of manufacturing,
(viii) Date of expiry or retesting,
(ix) Serial shipping container code,
(x) Manufacturing licence no. or import licence no.
(xi) Special storage conditions required (if any).”.
[F.No.X.11014/17/2019 -DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note:— The principal rules were published in the Official Gazette vide notification number F.28-10/45-H (1) dated
21st December, 1945 and last amended vide notification number G.S.R.848(E), dated the 9th December,
2021.
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.