Cdsco- a regulatory overview
- 1. CDSCO Vivekanandan.S, I M.Pharmacy Regulatory Affairs JSS College of Pharmacy, Ooty
- 2. contents • Introduction • Major functions of CDSCO • Organisation chart • Drug approval process • Clinical trial process • Three tier review process • Cosmetics • Medical devices approval • Biologics • Recalls in India • Recent happenings in CDSCO
- 4. Introduction • The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. • CDSCO has six zonal offices, four sub-zonal offices, thirteen port offices and seven laboratories under its control. • Ministry responsible: Ministry of Family & Health Welfare. • Minster responsible : Mr. Jagat Prakash Nadda • Drug Controller General of India: Dr.G.N.Singh
- 5. •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
- 6. • The responsibility entrusted to the CDSCO is enormous, considering the fact that the Indian pharmaceutical industry is currently worth over Rs.1200 billion with a growth rate of 12% for new drugs and 20% for biologicals over the last five years, which is the highest in the world. • It is also the third-largest producer of generic drugs in terms of volume and 14th in terms of value. • India is the second-largest producer of certain generic drugs such as ciprofloxacin, ranitidine, simvastatin, I-ephedrine and chloroquine.
- 7. Pharma Fact-INDIA • Currently there are 10,500 manufacturing units and over 3,000 pharma companies in India • India has been accredited with approximately 1360 CEPs, more than 950 TGA formulations and 600 sites approved by USFDA which is largest in a single country outside USA. • 6 out of top 20 generic companies are from India. • Globally more than 90 per cent of formulations approvals for anti-retroviral , anti-tubercular ARV & anti-malarial ( pre-qualified) have been WHO granted to India. • India is among the top six producers of pharmaceuticals in the world.
- 8. Major functions of CDSCO • Regulatory control over the import of drugs, approval of new drugs and • clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licences as Central Licence Approving Authority is exercised by the CDSCO headquarters.
- 9. Central Licensing Authority • Approval of new drugs and clinical trials • Import Registration and Licensing & approving of Blood Banks, LVPs, Vaccines, r-DNA products & some Medical Devices(CLAA scheme) • Amendment to 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 through Inspectorate of Centre Over and above the State Authority.
- 10. State Licensing Authority • Licensing of Manufacturing Site for Drugs including API and Finished Formulation • Licensing of Establishment for sale or distribution of Drugs • Approval of Drug Testing Laboratories • Monitoring of Quality of Drugs and Cosmetics marketed in the country • Investigation and prosecution in respect of contravention of legal provision • Recall of sub-standard drugs
- 14. • When a company in India wants to manufacture/ import a new drug it has to apply to seek permission from the licensing authority (DCGI) by filing in Form 44 also submitting the data as given in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 • New drug substance discovered in India – start from Phase I Phase III should involve 500 patients , 10-15 centres • New drug substance discovered in other countries –Phase I data need to submit along with application to Licensing Authority • Phase III should involve 100 patients , 3-4 centres
- 15. Clinical trial process • In the past, the regulatory path for clinical trials was fairly simple with a single tier approval process involving review at the Central Drugs Standard Control Organization (CDSCO) office only. Approval timelines ranged between 8 and 12 weeks • In March 2011, CDSCO office constituted 12 New Drug Advisory Committees (NDACs) • Presently, these committees are named as “Subject Expert Committees (SECs).”
- 16. Three tier review process • February 2013, a three-tier review process has been implemented, wherein each clinical trial application is being referred for review to the Technical and Apex Committee
- 17. Cosmetics • Cosmetics Division, Central Drugs Standard Control Organization (CDSCO) is responsible • For the Import of Cosmetics in India, the imported cosmetic products are required to be registered with Central Drugs Standards Control Organization by giving application in Form 42 to obtain Registration certificate in Form 43 • The Manufacturer himself/The Authorized Agent of the Manufacturer/The Subsidiary of the Manufacturer/any other importer can be an applicant for issuance of Registration certificate for import of cosmetics into India • License will be granted within 6months • Fee of 250$ to be paid
- 18. • The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act, 1940. • License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31) • License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A) • SLA will give license to manufacture cosmetics • Fee of 2500 to be paid.
- 19. Medical devices approval (till dec,2017)
- 20. Medical device rules, 2016 • On 17,October.2016 the union health ministry of India published the new medical device rules draft., which will be effective from Jan1, 2018 • The risk based classification for medical devices ranging from Class A low risk (Thermometer, Tongue depressor) Class B low moderate risk (suction equipment, hypodermic needle) Class C high moderate risk(ventilator, bone fixation plate) Class D high risk (heart valves, AICD)
- 21. Biologics Requirements for manufacturer: • NOC for form 29 • Test License • Post Approval Changes • Marketing Authorization • Clinical Trail Permission (Phase 1, 2 & 3) & GCT Requirements for importer: • Registration • Import License • Marketing Authorization • Clinical Trail Permission (Phase 1, 2 & 3) & GCT
- 22. SUGAM –Online licensing portal • An online licensing portal of CDCSO 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 CDCSO • Track the status of application • Answer back to raised queries • Applicant can also upload essential documents for registration, Import license and other related activities
- 23. • SUGAM –Challenges • There is no provision to upload files greater than 10MB file size • Documents need to be split as per each report. Generally companies have information in one single report. For example, Bio-compatibility used to be one topic earlier now it needs to be split into cytotoxicity testing, acute toxicity etc… • There is no provision to upload multiple different files for one heading. Companies can only combine them as one PDF giving the possibility of information getting misplaced.
- 24. • Types of license can apply through SUGAM portal • Registration certificate – Form 41 for Drug • Registration certificate – Form 41 for Medical device • Registration certificate – Form 41 for Diagnostic kit • Import license – Form 10 for Drug • Import license – Form 10 for Medical device • Import license – Form 10 for Diagnostic kit • Test license for clinical trial • BE NOC for clinical trial / to import or manufacture of new drug • Registration certificate for cosmetics • Obtaining permission to conduct GCT will be filed online through SUGAM effected from October 2016
- 25. Recalls in India • Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety.
- 27. Recent happenings in CDSCO • 51ST DCC meeting: DI as DCO, 1:200 for sale outlets, 1:50 for manufacturing units • Vaccine regulatory system , maturity level of 4, maximum as per WHO • 77th DTAB meeting : Plan to extend time period of import of drugs for personal use • Planned to include several steroids under Schedule H like Beclomethasone, Dexamethasone • FDC hearing
- 28. References • www.cdsco.nic.in/ • https://www.cdscoonline.gov.in/ • http://www.pharmainfo.net/reviews/new-drug-approval-process- regulatory-view • Regulatory environment for clinical research: Recent past and expected future • http://www.morulaa.com/cdsco/process-cosmetics-registration-india/ • https://www.emergogroup.com/services/india/india-medical-device- registration • http://www.morulaa.com/cdsco/regulatory-india-medical-device-rules/ • https://cliniexperts.com/india-regulatory-services/biologicals/ • http://www.cdsco.nic.in/writereaddata/Guidlines%20on%20Recall.pdf