Implementation of increase in application fees for grant of various import licences, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations under the provisions of Drugs & Cosmetics Rules,1945

F. No. 18-68/2018-DC Ministry of Health and Family Welfare Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan, Kotla Road, New Delhi Date: OFFICE MEMORANDUM Subject: Implementation of increase in application fees for grant of various import licences, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations under the provisions of Drugs & Cosmetics Rules, 1945-Reg. The Drugs and Cosmetics Rules, 1945 have been amended vide G.S.R.1193(E) dated 12.12.2018 with immediate effect to increase the application fees for grant of various import licences, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations under the Rules. Any application for grant of such import licences, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations as covered under the said amendment received on or after 12.12.2018 shall be accompanied by the increased fees in accordance with the amendment. A copy of the amendment G.S.R.1193(E) dated 12.12.2018 is enclosed. Concerned officers in CDSCO (HQ) and its Zonal, Sub-zonal and Port offices are directed to ensure implementation of the above amendment in the Drugs and Cosmetics Rules, 1945 with effect from 12.12.2018. (Dr. S. Eswara Reddy) Drugs Controller General (India) To 1. All Officers/staff in CDSCO(HQ) 2. All Zonal/Sub-zonal/Port offices of CDSCO 3. Guard file Copy to 1. Indian Drugs/Pharmaceutical Association Forum 2. Website of CDSCOjftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II—[k.M 3—mi&[k.M (i) PART II—Section 3—Sub-section (i) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 883] ubZ fnYyh cq/okj] fnlEcj 12] 2018@vxzgk;.k 21] 1940 No. 883] NEW DELHI, WEDNESDAY, DECEMBER 12, 2018/AGRAHAYANA 21, 1940 (cid:1)(cid:1)(cid:1)(cid:1)वव वव ाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:5)(cid:5) (cid:5)(cid:5) यय यय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)यय यय ााााणणणण मममम(cid:16)(cid:16)ंं(cid:16)(cid:16)ंं ााााललललयययय (((((cid:2)(cid:2)(cid:2)(cid:2)वव वव ाााा(cid:2)(cid:2)(cid:2)(cid:2)(cid:6)(cid:6) (cid:6)(cid:6) यययय औऔऔऔरररर पपपप(cid:11)(cid:11)(cid:11)(cid:11)ररररववववाााारररर कककक(cid:13)(cid:13)(cid:13)(cid:13)यय यय ााााणणणण ििििववववभभभभाााागगगग)))) अअअअििििधधधधससससचचूूचचूू ननननाााा नई (cid:4)द(cid:6)ली, 12 (cid:4)दस(cid:10)ब र, 2018 ससससाााा....ककककाााा....ििििनननन.... 1111111199993333((((अअअअ))))....————औषिध और (cid:17)साधन साम(cid:20)ी िनयम, 1945 का और सशं ोधन करने के िलए कितपय िनयम(cid:22) का (cid:17)ा(cid:24)प, औषिध और (cid:17)साधन साम(cid:20)ी अिधिनयम, 1940 (1940 का 23) क(cid:27) धारा 12 और धारा 33 क(cid:27) अपे(cid:29)ानसु ार भारत के राजप", असाधारण, भाग , खंड 3, उप-खंड (i) 5 अ#टूबर, 2018 म & भारत सरकार के ’ वा’ ) य और प*रवार II क(cid:6)य ाण म"ं ालय (’व ा’) य और प*रवार क(cid:6)य ाण िवभाग) क(cid:27) अिधसूचना स.ं सा.का.िन. 1000(अ), तारीख 5 अ#टूबर, 2018 .ारा (cid:17)कािशत (cid:4)कए गए थ,े िजसम& उन सभी 4 यि5य(cid:22) स,े िजनके उसस े (cid:17)भािवत होने क(cid:27) सभं ावना ह,ै उस तारीख स,े िजसको उ#त अिधसूचना क(cid:27) राजप" क(cid:27) (cid:17)ितयां जनसाधारण को उपल9 ध कराई गई थी, पं:ह (cid:4)दन क(cid:27) अविध के अवसान के पवू ;, आपि= और सझु ाव आंमि"त (cid:4)कए गए थ;े और, राजप" क(cid:27) (cid:17)ितयां जनसाधारण को 10 अ#टूबर, 2018 को उपल9ध हो गई थी; और, उ#त िनयम(cid:22) पर जनसाधारण स े (cid:17)ा? त आपि=य(cid:22) और सुझाव(cid:22) पर के@: ीय सरकार .ारा िवचार कर िलया गया ह;ै अत: अब, के@: ीय सरकार, औषिध और (cid:17)साधन साम(cid:20)ी अिधिनयम, 1940 (1940 का 23) क(cid:27) धारा 12 और धारा 33 .ारा (cid:17)दBत शि5य(cid:22) का (cid:17)योग करते Cए, औषिध तकनीक(cid:27) सलाहकार बोड ; से परामश; करने के पE चात् औषिध और (cid:17)साधन साम(cid:20)ी अिधिनयम, 1945 का और संशोधन करने के िलए िन(cid:10) निलिखत िनयम बनाती ह,ै अथात; :्- 1. (1) इन िनयम(cid:22) का नाम औषिध और (cid:17)साधन साम(cid:20)ी (दसवा ंसंशोधन) िनयम, 2018 ह।ै (2) ये राजप" म &उनके (cid:17)काशन क(cid:27) तारीख को (cid:17)वृBत ह(cid:22)गे। 7286 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 2. औषिध एव ं(cid:17)साधन साम(cid:20)ी िनयम, 1945 (िजसे इसम& इसके पPात् उ5 िनयम कहा गया ह)ै , के िनयम 24 म,& – (क) उप-िनयम (1) म,& - (i) ‘‘एकल औषिध के िलए एक हजार #i, और सौ (cid:24)पए क(cid:27) दर से अित*र5 शु(cid:6)क’’ श9 द(cid:22) के ’थान पर, ‘‘एकल औषिध के िलए दस हजार #i, और एक हजार (cid:24)पए क(cid:27) दर स ेअित*र5 शु(cid:6)क’’ श9द रखे जाय&ग;े (ii) परंतकु म,& ‘‘एक सौ (cid:24)पए’’ श9 द(cid:22) के ’थान पर ‘‘ एक हजार (cid:24)पए’’ श9द रखे जाय&गे; (ख) उप-िनयम (3) म,& ‘‘दो सौ पचास #i, का भुगतान (cid:4)कया जाएगा’’ श9 द(cid:22) के ’थान पर ‘‘लाइस&स म& संशोधन करान ेके िलए एक हजार पांच सौ #i, का भुगतान (cid:4)कया जाएगा या’’ श9द रखे जाय&गे । 3. उ#त िनयम म,& िनयम 24 क म,&- (क) उप-िनयम (3) म,&- (i) खंड (i) म,& ‘‘एक हजार पांच सौ अम*े रक(cid:27) डालर’’ श9 द(cid:22) और अ(cid:29)र(cid:22) के ’थान पर ‘‘दस हजार अम*े रक(cid:27) डालर’’ श9द और अ(cid:29)र रखे जाय&गे; (ii) खंड (ii) और उसके पर@तकु म,& ‘‘एक हजार अम *े रक(cid:27) डालर’’ श9 द(cid:22) और अ(cid:29)र(cid:22) जहां भी आए,ं उनके ’थान पर ‘‘पांच हजार अम*े रक(cid:27) डालर’’ श9द और अ(cid:29)र रख ेजाय&ग;े (ख) उप-िनयम (5) म,& ‘‘पांच हजार अम*ेरक(cid:27) डालर’’ श9 द(cid:22) और अ(cid:29)र(cid:22) के ’थान पर ‘‘पT चीस हजार अमे*रक(cid:27) डालर’’ श9द और अ(cid:29)र रख ेजाय&गे; (ग) उप- िनयम (7) म,& ‘‘तीन सौ अम*े रक(cid:27) डालर या इसके समतु(cid:6) य भारतीय (cid:24)पय(cid:22) का भुगतान (cid:4)कया जाएगा’’, श9द (cid:22) और अ(cid:29)र(cid:22) के ’थान पर ‘‘पंजीकरण (cid:17)माण-प" म& संशोधन कराने के िलए एक हजार आठ सौ अम*े रक(cid:27) डालर या इसके समतु(cid:6)य भारतीय (cid:24)पय(cid:22) का भुगतान (cid:4)कया जाएगा या” श9द और अ(cid:29)र रखे जाय&गे । 4. उ#त िनयम म,& िनयम 34 म,& उप-िनयम (3) म,& ‘‘एकल औषिध के िलए एक सौ #i, तथा पचास #i, का अित*र#त शु(cid:6)क ’’ श9द (cid:22) के ’थान पर ‘‘एकल औषिध के िलए पांच हजार #i, और दो हजार #i, का अित*र# त शु(cid:6)क ’’ श9द रख ेजाय&गे । 5. उ#त िनयम म,& िनयम 34क म,& उप-िनयम (3) म,& ‘‘एकल औषिध के िलए एक सौ #i, तथा पचास #i, का अित*र#त शु(cid:6)क ’’ श9द (cid:22) के ’थान पर ‘‘एकल औषिध के िलए छह सौ #i, तथा तीन सौ #i, का अित*र# त शु(cid:6)क ’’ श9द रखे जाय&गे । 6. उ#त िनयम म,& िनयम 122क म,& उप-िनयम (1) म,& खंड (ख) म,&- (i) ‘‘पचास हजार #i,’’ श9द (cid:22) के ’थान पर ‘‘दो लाख पचास हजार #i, ’’ श9द रख ेजाय&ग;े (ii) पहले परंतकु और दसू रे परंतुक म,& ‘‘पचास हजार #i,’’ श9 द(cid:22) को दोन(cid:22) ’ थान पर, जहां भी आए,ं उनके ’थान पर ‘‘एक लाख (cid:24)पए’’ श9द रखे जाय&गे । 7. उ#त िनयम म,& िनयम 122घ म,& उप-िनयम (1) म,& ‘‘पं:ह हजार #i,’’ श9 द(cid:22) के ’थान पर ‘‘िनयत खरु ाक संयोजन िविनमाण; के िलए आवेदन के मामल े म& पं:ह हजार #i, और िनयत खरु ाक संयोजन के आयात आवेदन के िलए एक लाख (cid:24)पए” श9द रख ेजाय&गे । 8. उ#त िनयम म,& िनयम 129क म,&- क. उप-िनयम (1) म,& ‘‘(cid:17)साधन साम(cid:20)ी के (cid:17)B येक Wांड के िलए दो सौ और पचास अम*े रक(cid:27) डालर या उसके समत(cid:6)ु य भारतीय (cid:24)पए’’ श9द (cid:22) और अ(cid:29)र(cid:22) के ’थान पर “(cid:17)साधन साम(cid:20)ी के (cid:17)B यके Wांड के िलए दो हजार अम*े रक(cid:27) डालर या उसके समतु(cid:6)य भारतीय #i, और (cid:17)B ये क (cid:24)पांतर के िलए पचास अम*े रक(cid:27) डालर का शु(cid:6) क’’ श9द और अ(cid:29)र रखे जाय&गे; ख. उप-िनयम (5) म& ‘‘एक सौ अम*े रक(cid:27) डालर’’ श9 द(cid:22) और अ(cid:29)र(cid:22) के ’थान पर ‘‘पांच सौ अम*े रक(cid:27) डालर’’ श9द और अ(cid:29)र रख ेजाय&गे । [फा. सं. ए#स .11014/32/2018-डीआर] डॉ. मनदीप के भZडारी, संयु#त सिचव¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3 (cid:10)(cid:10)(cid:10)(cid:10)टटटट(cid:19)(cid:19)(cid:19)(cid:19)पप पप णणणण:::: मूल िनयम अिधसूचना सं[य ा एफ.28-10/45-एच (1), तारीख 21 (cid:4)दसंबर, 1945 .ारा भारत के राजप" म & (cid:17)कािशत (cid:4)कए गए थे और अंितम संशोधन अिधसूचना सं[ या सा.का.िन. 1186 (अ), तारीख 7 (cid:4)दसंबर, 2018 .ारा (cid:4)कया गया था । MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare NOTIFICATION New Delhi, the 12th December, 2018 G.S.R. 1193(E).—Whereas the draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required under sections 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. 1000(E), dated the 5th October, 2018 in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of fifteen days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the Gazette were made available to the public on the 10th October, 2018; 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 by 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. (1) These rules may be called the Drugs and Cosmetics (Tenth Amendment) Rules, 2018. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 24,- (a) in sub-rule (1),- (i) for the words “one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees”, the words “ten thousand rupees for a single drug and an additional fee at the rate of one thousand rupees” shall be substituted; (ii) in the proviso, for the words “one hundred rupees”, the words “one thousand rupees” shall be substituted; (b) in sub-rule (3), for the words “two hundred and fifty rupees shall be paid”, the words “one thousand five hundred rupees shall be paid for making amendment in the licence or” shall be substituted. 3. In the said rules, in rule 24A,- (a) in sub-rule (3),- (i) in clause (i), for the words and letters “one thousand and five hundred US dollars”, the words and letters “ten thousand US dollars” shall be substituted; (ii) in clause (ii) and proviso thereto, for the words and letters “one thousand US dollars” wherever they occur, the words and letters “five thousand US dollars” shall be substituted; (b) in sub-rule (5), for the words and letters “five thousand US dollars”, the words and letters “twenty five thousand US dollars” shall be substituted; (c) in sub-rule (7), for the words and letters “three hundred US dollars or its equivalent in Indian rupees shall be paid”, the words and letters “one thousand eight hundred US dollars4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] or its equivalent in Indian rupees shall be paid for making amendment in the registration certificate or” shall be substituted. 4. In the said rules, in rule 34, in sub-rule (3), for the words “one hundred rupees for a single drug and an additional fee of fifty rupees”, the words “five thousand rupees for a single drug and an additional fee of two thousand rupees” shall be substituted. 5. In the said rules, in rule 34A, in sub-rule (3), for the words “one hundred rupees for a single drug and an additional fee of fifty rupees”, the words “six hundred rupees for a single drug and an additional fee of three hundred rupees” shall be substituted. 6. In the said rules, in rule 122A, in sub-rule (1), in clause (b),- (i) for the words “fifty thousand rupees”, the words “two lakh fifty thousand rupees” shall be substituted; (ii) in the first proviso and in the second proviso, for the words “fifteen thousand rupees”, at both the places where they occur, the words “one lakh rupees” shall be substituted. 7. In the said rules, in rule 122D, in sub-rule (1), for the words “fifteen thousand rupees”, the words “fifteen thousand in case of application for manufacture of the fixed dose combinations and one lakh rupees in case of import application of the fixed dose combinations” shall be substituted.. 8. In the said rules, in rule 129A,- (a) in sub-rule (1), for the words and letters, “two hundred and fifty US dollars or its equivalent to Indian rupees for each brand of cosmetic”, the words and letters “two thousand US dollars or its equivalent to Indian rupees for each brand of cosmetic and a fee of fifty US dollars for each variant” shall be substituted; (b) in sub-rule (5), for the words and letters “one hundred US dollars”, the words and letters “five hundred US dollars” shall be substituted. [F. No. X.11014/32/2018-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. 1186(E), dated the 7th December, 2018. 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.