CDSCO - Central Licensing Authority

A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.

1. (CDSCO) presented by: - PRATIBHA M.PHARM DRA Amity University CENTRAL DRUGS STANDARD CONTROL ORGANISATION

2. CONTENTS Introduction Major functions of CDSCO Organization chart Drug approval process Cosmetics SUGAM Pharm Facts

3. INTRODUCTION The Central Drugs Standard Control Organization(CDSCO) is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics .

4. CONTD.. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country. Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi.

5. CONTD.. Ministry responsible : Ministry of Family & Health Welfare. Minister responsible : Dr. Harsh Vardhan Drug Controller General of India : Dr S Eswara Reddy It has six zonal offices , seven sub zonal offices , thirteen Port offices and seven laboratories spread across the country

6. OBJECTIVES VISION : To protect and promote health in India. MISSION : To safeguard and enhance the public health by assuring the safety , efficacy and quality of drugs , cosmetics and medical devices.

7. FUNCTIONS The regulation of manufacture, sale and distribution of Drugs. Approval of New Drugs. Clinical Trials in the country. Control over the quality of imported Drugs. Coordination of the activities of State Drug Control Organizations. Meetings of Drugs Consultative Committee(DCC) and Drugs Technical Advisory Board(DTAB).

8. Contd.. Laying down the standards of drugs. Testing of drugs by Central labs. Monitoring adverse drug reaction. Guidance on Technical matters.

9. CENTRAL LICENSING AUTHORITY Approval of New drugs and clinical trials. Import registration and licensing & approving of blood banks, LVPs, Vaccines, r-DNA products & medical devices. Amendments on D & C Act and Rules. Banning of drugs and cosmetics. Grant of Test license, Personal license. NOCs for Export Testing of New Drugs. Oversight and market surveillance.

10. Zonal Offices Mumbai Kolkata Chennai Ghaziabad Ahmedabad Hyderabad These are involved in GMP audits and inspections of manufacturing units of large volume parenteral , sera, vaccines, and blood products.

11. Sub-Zonal Offices Bengaluru Varanasi Goa Jammu Indore Guwahati Baddi These centers coordinate with State drug control authorities under their jurisdiction for uniform standard of inspection and enforcement .

12. Central Drug Testing Laboratories Central Drug Laboratory, Kolkata Central Drug Testing Laboratory, Mumbai Central Drug Testing Laboratory, Chennai Central Drug Laboratory,Kasauli Regional Drug Testing Laboratory, Chandigarh Regional Drug Testing Laboratory, Guwahati Central Drug Testing Laboratory, Hyderabad

13. Approval of New Drugs New drugs are permitted to be marketed in accordance with the permission granted by DCGI after ensuring that these drugs are: Safe Effective Comply with requirement of schedule Y of D&C rules. Applicant are required to provide technical data in respect of safety and efficacy before these could be permitted to marketed in country.

14. DRUG APPROVAL PROCESS

15. COSMETICS Cosmetic division, CDSCO is responsible : For the Import of Cosmetics in India, the imported cosmetic products required to be registered with CDSCO by giving application in Form 42 to obtain registration certificate in Form 43. The Manufacturer himself/The Authorized agent/any other importer can be an applicant for issuance of Registration certificate for import of cosmetics into India. License will be granted within 6 months.

16. CONTD… The following licenses are required for cosmetic products : License on Form 32 is issued for manufacturer/sale distribute of cosmetics. License on form 32A is issued for loan license for manufacture/sale distribute of cosmetics.(Form 31A)

17. SUGAM – Online Licensing Portal An online licensing portal of CDSCO has been implemented on January 2016 and has been named SUGAM to file application for various services like Application submission, processing and grant of permission for quick delivery of services. Sugam benefits Applicant can apply license under import and registration division to CDSCO Track the status of application Answer back to raise queries Applicant can also upload essential documents for registration, Import license and other related activities.

18. Types of license can apply through SUGAM portal Registration certificate – Form 41 for Drug, Medical Devices, diagnostic kit. Import license – Form 10 for Drug, Medical devices, diagnostic kit. Test licenses for clinical trial BE NOC for Clinical trial / to import or manufacture of new drugs. Registration certificate for cosmetics.

19. PHARM FACTS In INDIA, pharmaceutical market turnover reached Rs 129,015 crore(US$ 18.12 billion)in 2018, growing 9.4% year-on-year and exports revenue was US$17.28 billion in FY18 and US$ 19.14 billion in FY19. Pharmaceutical export from India stood at US$ 17.27 billion in 2017-18, and is expected to grow by 30% to reach US$ 20 billion by the year 2020. India is the largest provider of generic medicines globally. Hyderabad, Mumbai, Bangalore, and Ahmedabad are the major Pharmaceutical hubs of India.

20. THANK YOU