Date: 2017-02-02Category: Extra OrdinaryState: Union GovernmentCountry: India
Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules 1945 was published as required by section 12 and section 33 of the Drugs and Cosmetics Act
**Executive Summary:**
This notification announces the Fourth Amendment to the Drugs and Cosmetics Rules, 1945, as authorized by sections 12 and 33 of the Drugs and Cosmetics Act of 1940. It addresses rules regarding the import of donated drugs by charitable hospitals and extends the validity period for certain forms. The amendments take effect on the date of publication in the Official Gazette, February 2, 2017.
**Key Points / Main Content:**
* **Amendment Title:** Drugs and Cosmetics 4th Amendment Rules, 2017.
* **Effective Date:** Date of publication in the Official Gazette.
* **Insertion of Rule 36A:** Addresses donated drugs by charitable hospitals:
* Small quantities of donated drugs can be imported by charitable hospitals for treating patients free of charge.
* The drugs must not be prohibited for import and must be permitted to be marketed in the country with a residual shelf life of one year or more.
* **Amendment to Rule 45:** Concerns the analysis of drug samples:
* Requires the Government Analyst to test or analyze samples within sixty days of receipt.
* If testing within the specified period is not possible, the Government Analyst must seek an extension from the Government, providing specific reasons for the delay.
* **Amendment to Rule 91:** Extends validity period:
* Substitutes "one year from the date of issue" with "three years from the date of issue."
* **Omission of Rule 124A.**
* **Amendment to Schedule A:** Relates to validity periods in specific forms:
* In Form 11, paragraph 3, "one year" is replaced with "three years."
* In Form 29, paragraph 3, "one year" is replaced with "three years."
**Impact Analysis**
**Drug Manufacturers/Importers:**
* Impact: Must adhere to the revised rules, particularly concerning the shelf life of imported drugs donated to charitable hospitals.
* Action Required: Ensure compliance with the new rules regarding the import and marketing of drugs, particularly concerning shelf life and documentation.
**Charitable Hospitals:**
* Impact: Benefit from the clarification and allowance of importing donated drugs for patient treatment under specified conditions.
* Action Required: Ensure compliance with the conditions outlined for importing and administering donated drugs, including providing treatment free of charge and adhering to shelf life requirements.
**Government Analysts:**
* Impact: Must adhere to the new timelines for testing and analyzing drug samples and seek extensions when necessary.
* Action Required: Comply with the 60-day timeline for sample testing and analysis, and follow the procedure for requesting extensions, including providing specific reasons for delays.
**Regulatory Bodies (e.g., Ministry of Health and Family Welfare):**
* Impact: Responsible for enforcing the amended rules and overseeing compliance.
* Action Required: Update guidelines, monitor compliance, and address any issues arising from the implementation of the amended rules.
Key Entities Referenced
Mayapuri, New Delhi: Location of the Government of India Press.
Drugs and Cosmetics Act, 1940: The primary legislation being amended by the notification.
Drugs and Cosmetics Rules, 1945: The rules which are being amended by this notification under the Drugs and Cosmetics Act, 1940.
Ministry of Health and Family Welfare: The government ministry responsible for the notification and the amendment of the rules.
New Delhi: The location of publication of the notification.
Drugs Technical Advisory Board: Body consulted by the Central Government for amending the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics 4th Amendment Rules, 2017: The title of the amendment rules introduced by this notification.
Government Analyst: Official responsible for testing or analyzing samples, who may seek time extension for testing.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
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No. 80] NEW DELHI, THURSDAY FEBRUARY 2, 2017/MAGHA 13, 1938
(cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण म(cid:7074)ं ालय
((cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण िवभाग)
अिधसचू ना
नई (cid:7408)द(cid:7016)ली, 2 फरवरी, 2017
सा.का.िन. 103(अ).—औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करन े के िलए कितपय
िनयम(cid:7298) का (cid:7079)ा(cid:7272)प औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 12 और धारा 33 क(cid:7409)
अपे(cid:6979)ाऩुसार भारत के राजप(cid:7074), असाधारण, भाग II, खंड 3, उपखंड (i), तारीख 5 जुलाई, 2016 म(cid:7286) (cid:7079)कािशत
भारत सरकार के (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण मं(cid:7074)ालय ((cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण िवभाग) क(cid:7409) अिधसूचना
सं. सा.का.िन. 667(अ), तारीख 5 जुलाई, 2016 (cid:7367)ारा (cid:7079)कािशत (cid:7408)कया गया था िजसके (cid:7367)ारा उन सभी (cid:7390)ि(cid:7334)य(cid:7298) से,
िजनके उनसे (cid:7079)भािवत होने क(cid:7409) संभावना ह,ै उस तारीख से, िजसको उ(cid:7334) अिधसूचना वाले भारत के राजप(cid:7074) क(cid:7409)
(cid:7079)ितयां जनता को उपल(cid:7011)ध करा दी गई थ(cid:7277), प(cid:7289)तालीस (cid:7408)दन क(cid:7409) अविध क(cid:7409) समाि(cid:7385) से पूव(cid:6981) आ(cid:6979)ेप और सुझाव आमंि(cid:7074)त
(cid:7408)कए गए थ;े
और उ(cid:7334) राजप(cid:7074) क(cid:7409) (cid:7079)ितया ं जनता को तारीख 5 जुलाई, 2016 को उपल(cid:7011)ध करा दी गई थ(cid:7277) ।
और के(cid:7008)(cid:7076)ीय सरकार (cid:7367)ारा उ(cid:7334) िनयम(cid:7298) के संबंध म(cid:7286) जनता से (cid:7079)ा(cid:7385) आ(cid:6979)ेप(cid:7298) और सुझाव(cid:7298) पर िवचार (cid:7408)कया
गया ह ै ।
अतः, अब, के(cid:7008)(cid:7076)ीय सरकार, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 12
और धारा 33 के अधीन शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, औषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) से परामश(cid:6981) करने के प(cid:7391)ात्,
औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने के िलए िन(cid:7013) निलिखत िनयम बनाती ह,ै अथा(cid:6981)त:् -
1. (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम औषिध और (cid:7079)साधन साम(cid:7061)ी (चौथा संशोधन) िनयम, 2017 ह ै ।
(2) ये राजप(cid:7074) म(cid:7286) (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
581 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 (िज(cid:7008)ह (cid:7286) इसम(cid:7286) इसके प(cid:7391)ात् उ(cid:7334) िनयम कहा गया ह)ै के िनयम
36 के प(cid:7391)ात् िन(cid:7388)िलिखत िनयम अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त:् -
“36क. पूत (cid:6981) अ(cid:7021)पताल (cid:7367)ारा खच(cid:6981) के िबना औषिधय(cid:7298) का आयात – (1) (cid:7408)कसी पूत(cid:6981) अ(cid:7021)पताल (cid:7367)ारा
उ(cid:7334) अ(cid:7021)पताल म(cid:7286) रोिगय(cid:7298) के उपचार के (cid:7079)योजन के िलए दान(cid:7021)व(cid:7272)प (cid:7079)ा(cid:7385) औषिधय(cid:7298) क(cid:7409) लघु मा(cid:7074)ा का आयात
(cid:7408)कया जा सकेगा बशत(cid:7287) वे औषिधयां रोिगय(cid:7298) को मु(cid:7010)त दी जाए ं ।
(2) एक वष(cid:6981) या उससे अिधक के अविश(cid:7397) शै(cid:7016)फ जीवन वाली औषिधयां दशे म(cid:7286) आयात के िलए
(cid:7079)ितिष(cid:7373) नह(cid:7277) ह(cid:7298)गी और िवपणन के िलए अनु(cid:6980)ात नह(cid:7277) क(cid:7409) जाएगं ी ।” ।
3. उ(cid:7334) िनयम(cid:7298) के िनयम 45 के उपिनयम (1) म(cid:7286), “इन िनयम(cid:7298) के अनुसार (cid:7079)(cid:7021)तुत करेगा” श(cid:7011)द(cid:7298) के (cid:7021)थान पर
िन(cid:7388)िलिखत श(cid:7011)द और पर(cid:7008)तकु रखा जाएगा, अथा(cid:6981)त:् -
“इन िनयम(cid:7298) के अनसु ार नमून े क(cid:7409) (cid:7079)ाि(cid:7385) के साठ (cid:7408)दन क(cid:7409) अविध के भीतर (cid:7079)(cid:7021)तुत करेगा:
पर(cid:7008)तु जहां िविन(cid:7416)द(cid:7397) अविध के भीतर नमनू े का परी(cid:6979)ण या िव(cid:7019) लेषण करना संभव न हो, वहां सरकारी
िव(cid:7019) लेषक ऐसे परी(cid:6979)ण या िव(cid:7019) लेषण म(cid:7286) िवलंब के िविन(cid:7416)द(cid:7397) कारण दते े (cid:7263)ए सरकार से समय बढ़ाए जाने क(cid:7409) ई(cid:7009)सा
करेगा ।”।
4. उ(cid:7334) िनयम(cid:7298) के िनयम 91 म(cid:7286), “जारी करन े क(cid:7409) तारीख स े एक वष”(cid:6981) श(cid:7011)द(cid:7298) के (cid:7021)थान पर “जारी करन े क(cid:7409)
तारीख स े तीन वष”(cid:6981) श(cid:7011)द रखे जाएगं े ।
5. उ(cid:7334) िनयम(cid:7298) के िनयम 124क का लोप (cid:7408)कया जाएगा ।
6. उ(cid:7334) िनयम(cid:7298) क(cid:7409) अनुसचू ी क म(cid:7286),-
(क) (cid:7079)(cid:7272)प 11 के पैरा 3 म,(cid:7286) “एक वष(cid:6981)” श(cid:7011)द(cid:7298) के (cid:7021)थान पर “तीन वष”(cid:6981) श(cid:7011)द रखे जाएगं े;
(ख) (cid:7079)(cid:7272)प 29 के पैरा 3 म(cid:7286) “एक वष(cid:6981)” श(cid:7011)द(cid:7298) के (cid:7021)थान पर “तीन वष”(cid:6981) श(cid:7011)द रखे जाएगं े ।
[फा. सं. ए(cid:6989)स.-1035/288/2015-डीएफ(cid:6989)यूसी]
कु(cid:7008)दन लाल शमा(cid:6981), संयु(cid:7334) सिचव
(cid:7407)ट(cid:7009)पण: मूल िनयम, भारत के राजप(cid:7074) म(cid:7286) अिधसूचना स.ं एफ. 28-10/45-एच (1), तारीख 21 (cid:7408)दस(cid:7013)बर, 1945
(cid:7367)ारा (cid:7079)कािशत (cid:7408)कए गए थे और उनम(cid:7286) अंितम संशोधन अिधसूचना सं. सा.का.िन. 76(अ), तारीख
31 जनवरी, 2017, (cid:7367)ारा (cid:7079)कािशत (cid:7408)कया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd February, 2017
G.S.R. 103(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was
published as required by section 12 and 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. 667 (E), dated the 5th July, 2016, published in the Gazette of India, Extraordinary, Part II, Section 3,
Sub-section (i), dated the 5th July, 2016, inviting objections and suggestions from persons likely to be affected thereby
before the expiry of a period of forty five days from the date on which the copies of the Official Gazette containing the
said notification were made available to the public;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
And whereas copies of the Gazette were made available to the public on 5th July, 2016;
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 section 12 and section 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 and Cosmetics Rules, 1945,
namely:-
1.(cid:32) (1) These rules may be called the Drugs and Cosmetics (4th Amendment) Rules, 2017.
(2) They shall come into force on the date of their publication in the Official Gazette.
2.(cid:32) In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), after rule 36, the following
rule shall be inserted, namely:-
“36A (cid:73)(cid:109)(cid:112)(cid:111)(cid:32)(cid:116)(cid:114)(cid:32)(cid:111)(cid:102)(cid:100)(cid:117)(cid:114)(cid:103)(cid:32)(cid:98)(cid:115)(cid:121)(cid:32)(cid:97)(cid:97)(cid:116)(cid:105)(cid:99)(cid:104)(cid:114)(cid:98)(cid:101)(cid:108)(cid:32)(cid:104)(cid:111)(cid:32)(cid:112)(cid:115)(cid:97)(cid:116)(cid:105)(cid:101)(cid:108)(cid:101)(cid:114)(cid:102)(cid:32)(cid:111)(cid:32)(cid:102)(cid:111)(cid:116)(cid:115)(cid:99) (cid:46)—(1) Small quantity of drugs received in donation by a
charitable hospital for the purpose of treatment of the patients in the said hospital may be imported provided the
drugs are given or administered to the patients free of cost.
(2) The drugs shall not be prohibited for import and permitted to be marketed in the country with residual shelf
life of one year or more.”
3. In the said rules, in rule 45, in sub-rule (1), after the words “in accordance with these rules”, the following words
and the proviso shall be inserted, namely:-
“within a period of sixty days of the receipt of the sample:
Provided that where it is not possible to test or analyse the sample within the specified period, the Government
Analyst shall seek extension of time from the Government giving specific reasons for delay in such testing or
analysis.”;
4. In the said rules, in rule 91, for the words “one year from the date of issue”, the words “three years from the date of
issue” shall be substituted.
5. In the said rules, rule 124A shall be omitted.
6. In the said rules, in Schedule A,
(a)(cid:32) in Form 11, in paragraph 3, for the words, “one year”, the words “three years” shall be substituted;
(b)(cid:32) in Form 29, in paragraph 3, for the words “one year”, the words “three years” shall be substituted.
[F. No. X.-11035/288/2015-DFQC]
K. L. SHARMA, Jt. Secy.
Note: The principal rules were published in the Official Gazette (cid:118)(cid:100)(cid:105)(cid:101) notification number F. 28-10/45-H (1), dated the
21st December, 1945 and last amended (cid:118)(cid:100)(cid:105)(cid:101) notification number G.S.R. 76(E) dated the 31st January, 2017.
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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.