INTRODUCTION + Introduction CDSCO isa licensing auth ority( regulatory agency) for the approval of new drugs proposed to be imported as well as the amount of drugs to be imported + In India, pharmaceuticals are governed by the Drugs and Cosmetics Act and the rules framed to implement the provisions im the Act. + In 1940s the Drugs and Cosmetics Act was passed in order to regulate the ~ import, > manufacture, ~ distribution and sale of drugs im India. * The drug rules were framed in 1945 to give effect to the provisions of the Act.At present the following acts and rules regulate > Manufacture. Export Clinical research of drugs and cosmetics in India: 1. Drugs and Cosmetics Act, 1940 (1) 2. Drugs and Cosmetics Rules, 1945 3. Pharmacy Act, 1948 4. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 5. Medicinal and Toilet Preparations(Excise Duties) Act. 6. 1955 Drugs Price Control) Order, 1955 under Essential Commodities Act, 1955 7. Narcotic Drugs and Psychotropic Substances Act, 1985Regulatory Bodies There are a number of regulatory bodies in India that are involved in the regulation of pharmaceuticals: 1. Drug Cottroller General of India (DCGI) 2. Indian Council of Medical Research (ICMR) 3. Bhabha Atomic Research Centre (BARC) 4. Drugs Consultative Committee (DCC) 5. Central Drugs Laboratory (CDL) 6. Central License Approving Authority (CLAA) 7. Drugs Technical Advisory Board (DTAB) 8. Genetic Engineering Approval Committee (GEAC) 9. Department of Biotechnology (DBT) 10. Atomic Energy Review Board (AERB)In India. the central government, via the Central Drugs Standard Control Organization (CDSCO) under the ministry of Health and Family Welfare, largely works on: developing star@ards and regulatory measures for drugs, diagnostics and devices Playing down regulatory measures by amending acts and rules regulating the market authorisation of new drugs. In its role as the regulator of imported drugs, the CDSCO works with: > The Drugs Technical Advisory Board andthe Drugs Consultative Committee >The Central Drugs Laboratory undertakes testing of such drugs. Other functions of the CDSCO include: 4 The screening of drug fommulations available in the Indian market. Monitoring adverse drug reactions. “Participation in the Worl d Health Organization's good manufacturing practice certification scheme. The screening of applications for granting “no objection certificates’ for export of unapproved or banned drugsCENTRAL DRUGS STANDARD CONTROL ORGANIZATION (@)_ Central Authorities « *Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primatily the concern of the State authorities, + Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. “Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.Central Drugs Standard Control Organization Head quarter islocated at FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the Directorate General of Health Services. Staff details: “+ Drugs Controller General of India Joint Drugs Controller of India Deputy Director General (Drugs) Deputy Director Administration (Drugs) “+ Asst. Drugs Controllers of India “+ Technical Officersfr GRGANTSATIONCHART ————“_S.....CTCCSt:S DIRECTORATE GENERAL OF HEALTH SERVICES CENTRAL DRUGS STANDARD CONTROL ORGANISAITON DRUGS CONTRGEEN GENERAL (INDIA) ¥ + ¥ 7 + ZONAL SUBZONAL | [PORTAIRPORT] [ TABORATORES weap quanren | | cenicesco ence OFFIC) © 4 Jt Drugs Contreler ) Dy Drugs Constrater ‘Asstt. Drags Central (2) ‘Technical Officer ‘Sr. Tech, Asstt. ‘Suppanting Stat 4 + > Dy. Dwg Contec > Asst Drugs Contre 4 > Asi Deg Conéeller () > Avett Dray Centriter () > Technica Officer > Techical Otter > Drug Ihapector 1 Sr Tech. Asstt > Sr. Tech. Att > Sx. Tech, Aen. > Sporting Statt > Suyponting Stat > Supping Stat Radia Baediad Genst —_— Rawaoea, MimbatZONAL OFFICES OF CENTRAL DRUGS STANDARD CONTROL ORGANISATION (CDSCO) The Central Government have established four zonal offices of the Central Drug Standard Control Organisation at Mumbai, Kolkata, Chennai, Ghaziabad. The Zonal Offices work in close collabration with the State Drug Control Administration and assist them in securing uniform enforcement of the Drug Act and other connected legislations, on all India basis Subzonal Office, Ahmedabad Sub-Zonal, HyderabadFUNCTION OFCDSCO Function of CDSCO | Import Registration and Licensing Approval of new drugs and clinical tridls Licensing of Blood Banks, LVPs, Vaccines, r- DNA products & some Medical Devices Amendment to D &C Act and Rule} —___________J Banning of drugs and cosmetic} Grant of Test License, Per sonal License, NOCS > for Export + | “Testing of DrigsAPPROVAL OF NEW DRUG : *The drug approval process varies from one country to another. “In some countries, only a single body regulates the drugs and responsible for all regulatory task such as approval of new drugs. +New drug will not be imported, except under the permission granted by the Licensing Authority, accompanied bya fee of fifty thousand rupees. + The Licensing Authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation will be effective and safe for use in the country, may issue an import permission. + For new drug discovered in other countries Phase I trials are not usually allowed to be initiated in India.Approval for clinical trials + Approval for clinical trials An application to conduct clinical trials in India should be submitted along with the data of chemistry, manufacturing, control and animal studies to DCGI. + The date regarding the trial protocol, investigator's brochures, and informed consent documents should also be attached. + Acopy of the application must be submitted to the ethical committee and the clinical trials are conducted only after approval of DCGI and ethical committee.Approval of Clinical Trials, Import, & Manufacture of New Drugs Requirements and Guidelines - Scheduie Y Permission to import new drag Rule 122 A Permission to manufacture new drug Rule 122 B Rule 122 DA Definition of Clinical trials Rule 122 E Definition of New Drugs™ + New substance having therapeutic dication + Modified or new claims, new route of administration for already approved dr + Fixed Dose CombinationApproval of IN IND Applicant] ===» [Cpsco HQ 4 Examination by New Drug Divi Detailed Review by IND Committeg I Timeline — | ‘Approval Phase I- 90 days Phase II - 45 days Phase III - 60 daysImport, Registration and Licensing ‘Mfg sites and Products are required to be Registered Tssue of Import License in Form 107 104 Rules les related to grant of Registration ‘ertificate and Import License Schedule => [fyfgrmation required for registration of site aud Product Timeline Registration Certificate(RC) and For RC: As per D& C Rules, 9 , . Import License - Valid for 3 years Months ,However in practice, 2 months For Import License 2 -3 weeks As per Rule 24.4(5), there is provision to inspect overseas manufacturing site for ‘which manufacturer ha s to pay 5000 USDRequirements For Import and Registration ¢ Registration of overseas Manufacturing site and Drugs + Registration Certificate issued in form 41 by the Licensing Authority « Import License issued in Form 10 or 10A‘Manufacturer Central Licensing* [CLAA Approval and Grant of License STATE LICENSING AUTHORITY L Toint inspection| by state & central inspectors License Prepared by State Licen sing Authority I ‘Examination of =| report For Biologicals, Large volume parenterals (LVP), Blood bank and blood products & Some Medical DevicesGlobal Clinical Trials + Permission is required from CDSCO for conducting global clinical trials in the country + Phase I for New Drug substance developed outside India is not permitted + So far, approx. 500 permissions have been granted since 2003Advisory Committee. ZRP = Zonal |Centre, Centre (NPAC = National Pharma: Pharmacovigilance Centre, RPC = Regional Pharm /PPC= Peripheral Pharmac A National Pharmacovigilance Programme . — prac PCCentral Drugs Laboratory (CDL) Q The Central Drugs Laboratory. Kolkata is the national statutory laboratory of the Government of India for quality control of Dig and Cosmetics and is established under the Indian Drug & Cosmetics Act, 1940. Q It is the oldest quality control laboratory of the Drug Control Authorities in India. It functions under the administrative control of the Director-General of Health Services in the Ministry of Health and Family Welfare.The functions of the Laboratory include: I. Statutory Functions: (a) Analytical quality control of majority of the imported Drug available in Indian market () Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations. (© Acting as an Appellate authority in matters of disputes relating to quality of Drug. I. Other Funtions: (@) Collection, storage and distribution of Intemational Standard International Reference Preparations of Drug and Pharmaceutical Substances. (&) Preparation of National Reference Standards and maintenance of such Standards. Maintenance of microbial cultures useful in drug analy sis Distribution of Standards and cultures to State Quality Control Laboratories and dug manufacturing establishments,(0) Training of Drag Analysts deputed by State Drug Control Laboratories and other Institutions. (@) Training of World Health Organisation Fellows from abroad on modern methods of Drug Analysis. (©) To advise the Central Drug Control Administration in respect of quality and toxicity of drug awaiting licence. (£) Towork out analytical specifications for preparation of Monographs for the Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India. (g) To undertake analytical research on standardisation and methodology of Drug and cosmetics. (h) Analysis of Cosmetics received as survey samples from Central Drug Standard Control Organisation. @) Quick analysis of life saving Drug on an All-India basis received under National Survey of Quality of Essential Drug Programme from Zonal Offices of Central Drug Standard Control Organisation,Central Drugs Testing Laboratory (CDTL) Chennai Central Drug Testing Laboratory is one of the four National Laboratories in India engaged in the research and analysis of Drug and Cosmetics as per Drug and Cosmetics Act, 1940. Central Drugs Testing Laboratory (CDTL) Mumbai The Central Drugs Testing Laboratory - Mumbai is another national statutory laboratory of the Government of India, functioning under administrative control of the Drug Controller General (India), DGHS, Ministry of Health and Family Welfare. The major functions of the laboratory include: Testing of imported bulk drugs and formulations. ‘The laboratory is notified as Apellate Laboratory for Copper T Intra-Uterine Contraceptive Device and Tubal Rings under the Drugs and Cosmetics Rules, (Medical Stores) & Regional Directors of Department of Family Welfare and procurement and field samples of Oral Contraceptive Pills, Copper T and Tubal Rings referred by the Dept. of Family Welfare.Regional Drugs Testing Laboratory (RDTL) Guwahati The Regional Drugs Testing Laboratory Guwahati is the one of the five National Laboratory of the Govt of India for quality control of Drugs and Cosmetic andis established under the Indian Drugs & Cosmetics Act 1940 functioning under administrative control of the Drags Controller General of India and sub ordinate office under Directorate General of Health Services, Ministry of Health & Family Welfare. The laboratory was set up in the year 2002 for entire North Eastern State including Sikkim and is housed in its own building at Guwahati 1. Statutory Function: a. Analytical quality control of drugs and cosmetic manufactured within the country on behalf of the Central and State Drugs Controller Administration. b. To assists the Central Drugs Standard Control Organization in the testing of Drugs and cosmetic. Regional Drugs Testing Laboratory (RDTL) Chandigarh Regional Drugs testing laboratory, Chandigarh has become operational since November, 2007. Presently the laboratory is testing the drugs at an average of 50 samples per month, primarily to cater the requirements of CDSCO (North Zone). Thelaboratory is in the process of upgradation in infrastructure and manpower in order to increase the testing capacity.Statutory Functions 1. Laying down standards of drugs, cosmetics, diagnostics and devices 2. Layingd own regulatory measures, amendments to Acts and Rules. 3. To regulate market authorization of new drugs. 4. To regulate dinical research in India. 5. To approve licenses to manufacture certain categories of digs as Central Licence Approving Anthoriy ie. for Blood Banks, Large Volume Parenterals and Vaccines & Sera 6. To regulate the standards ofimported drugs. ‘Statutory Functions 1. Licensing of drug mamfactwing and sales ‘establishments 2. Licensing of drug testing kboratories 3. Approval of dmg formulations fr mamifacture. 4. Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state. 5. Investigation and prosecution in respect of contravention of legal provisions. 6. Administrative actions.7. Work relating to the Drugs Technical Advisory Board 7. Pre- and post- licensing inspection (DTAB) and Drugs Consultative Committee (DCC). 8. Testing of drugs by Central Drugs Labs. 8. Recall of sub-standard drugs. 9. Publication o fIndian Pharmacopoeia Other Functions 10. Coordinating the activities of the State Drugs Control Organizations to achieve uniform administration ofthe Act; and policy guidance. 11. Guidance on technical matters. 12. Partidpation in the WHO GMP certification scheme. 13. Monitoring adverse dmg reactions (ADR). 14. Conducting training programmes fr regulatory oficials (& Govt. Analysts 15. Distibution of quotas of narcotic drugs for use inSTATE DRUG CONTROL ORG ANIZATION, *CDSCO joined with state drug control organisation to regulate the import / export drug or medical devices. “The state drug control organization is responsible for ” Licensing drug testing labor atories ” Approving drug formulation for anufacture 5 o Carry out pre & post licensing inspection +? Overseing the manufacturing process for drug manufactured by respective state unit & those marketed in the stateSTRUCTUREAT STATE LEVEL STATE DRUGS CONTROL ORGANISATION | DRUGS CONTROLLER COMMISSIONER DRUGS TESTING LABORATOTY DEPUTY DRUGS CONTROLLER GOVT. ANALYST DRUGS INSPECTOR ANALYST 1 | SUPPORTING STAFF SUPPORTING STAFF Total No. of Drugs Inspectors ~1000 Total No. of Drugs Manufacturers: ~10000 Total No. of Sales Premises : ~ 500000FUNCTIONS OF STATE LICENSING AUTHORITIES [FUNCTIONS OF STATE LICENSING| UTHORITIES Licensing of Manufacturing Site for Drugs inclu: > API and Finished Formulation Licensing of Establishment for sale {distribution of Drugs Approval of Drug Testing Laboratories | lonitoring of quality of drug & cosmetic arketed in the country investigation and prosecution in respect of ‘ontraventiion of legal provision | __, Recall of sub-standard drugsThe CDSCO is conducting an all India survey to assess the extent of availability of spurious drugs in the country by drawing samples from different regions and different strata in the country on the basis of statistical principles provided by the Indian Statistical Institute, HyderabadReferences 1. WWW.cdsco.nic.in 2. WWW.samedanid.com 3. WW in 4. http:/cdsco.nic.in/drugs & cosmetic act pdf