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WELCOME          Foreign Regulatory Delegates                  BioAsia-2013                           by             Dr. B...
DRUGS CONTROL ADMINISTRATION, GOVERNMENT OF ANDHRA PRADESH                VENGALRAO NAGAR, HYDERABAD                      ...
DRUGS CONTROL LABORATORY, GOVERNMENT OF ANDHRA PRADESH              VENGALRAO NAGAR, HYDERABAD                            ...
LAWS AND STATUTES ENFORCED    1.   Drugs and Cosmetics Act,1940 and Rules 1945         - To provide safe, efficacious and ...
Brief History Drugs & Cosmetics Act,1940    1919           • Poisons Act    1930           • Dangerous Drugs Act    1931  ...
DRUGS AND COSMETICS ACT-1940      To   Regulate         Import    & Export         Manufacturing    & Testing         ...
Role of Drugs Control Administration  To ensure availability of :     Standard, Safe and Efficacious      medicines     ...
Central Drugs Standard Control Organization           Central Government (Govt. of India)   Central Drugs Standard Contro...
Statutory functions     Lays   Standards of drugs, cosmetics, diagnostics and devices     Brings   about the amendments ...
Other functions      Coordinating the activities of the State Drugs control Organizations to      achieve uniform adminis...
Andhra Pradesh Drugs Control Administration                 State Government (Govt. of A.P) •   Licensing    of    drug   ...
Joint responsibilities of             Central and State Governments        Licensing of:          Large Volume Parentera...
LIST OF SERVICES OFFERED      Provides   Information on Blood Banks      Provides   Information on Banned Drugs      Pr...
Citizen Charter         (Time frame fixed by APDCA)         Licenses Issued:          To be Issued in:        Sales:     ...
Citizen Charter     (Time frame fixed by APDCA)     Certificates Issued:   To be Issued in:      WHO-GMP               45...
NUMBER OF LICENSEES IN THE STATE     a) Pharmacies        (Wholesale and Retail)                    -   50,606     b) Manu...
A.P. PHARMA INDUSTRY     A.P.      occupies a significant position on the World Pharma map.     A.P. is leader in Pharma...
A.P. PHARMA INDUSTRYMFG LICENCES GRANTED BY APDCA              PARTICULARS                    2012-13    Total No. of Manu...
A.P. PHARMA INDUSTRY     Hub   of National Research Centers        Centre   for Cellular & Molecular Biology (CCMB)     ...
Conditions for grant of Mfg. licenses• Technical staff – As specified for individual types  of Drugs Manufactured• Facilit...
Statutory requirements of GMP & GLP• Schedule ‘M’ - GMP requirements for Facility & Materials, Plant &  Equipments of Ster...
Post Licensing Inspection PointsEmphasis on: Compliance on GMP & GLP Validation Stability studies Standard Operating P...
Post Licensing Inspection Points Compliance of GMP & GLP as laid down in  Schedule ‘M’ & ‘L1’ assessed through Periodic  ...
Monitoring of Quality of Drugs Through random sampling at manufacturer’s  premises and from distribution outlets License...
PENAL SECTIONSSECTION 27(a): Adulterated & SpuriousPunishment : In case of death / grievous hurt                    : 10 Y...
PENAL SECTIONSSECTION 27(c): Spurious but not referred in 27(a)Punishment : Not less than 7 years and               fine u...
Penal Sections for CosmeticsSECTION 27-A(i) : Adulterated & SpuriousPunishment      : 3 years and fine Rs 50,000/-SECTION ...
OTHER PENAL SECTIONSSECTION 28 : Non disclosure of the Mfg’s namePUNISHMENT : 1 year and fine up to Rs 20,000/-SECTION 28-...
Monitoring of Quality of Drugs DCA Andhra Pradesh have two separate Drug  Control Laboratories at Hyderabad and  Vijayawa...
Guidelines on Processing of Applications      APDCA: http://dca.ap.nic.in      CDSCO: http://cdsco.nic.in               ...
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Drug Administration GoAP - Shri BL Meena

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Drug Administration GoAP - Shri BL Meena

  1. 1. WELCOME Foreign Regulatory Delegates BioAsia-2013 by Dr. B. L. Meena, I.P.S Director General Drugs Control Administration, Govt. of A.P Email: dgapdca@gmail.com, Ph: 040-23713563, Fax:040-238143601
  2. 2. DRUGS CONTROL ADMINISTRATION, GOVERNMENT OF ANDHRA PRADESH VENGALRAO NAGAR, HYDERABAD 2
  3. 3. DRUGS CONTROL LABORATORY, GOVERNMENT OF ANDHRA PRADESH VENGALRAO NAGAR, HYDERABAD 3
  4. 4. LAWS AND STATUTES ENFORCED 1. Drugs and Cosmetics Act,1940 and Rules 1945 - To provide safe, efficacious and quality medicines. 2. Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 & Rules, 1955 - To prevent cheating etc through false claims and advertisements pertaining to drugs and diseases 3. Drugs (Prices Control) Order, 1995 r/w Essential Commodities Act, 1955. - To make drugs available at the prices fixed by NPPA 4. A.P Narcotic Drugs and Psychotropic Substances Rules, 1986. - Grant of licenses (NDPS-1 & NDPS-2) and transport permits for NDPS drugs (inter and intra state) 5. The Cigarettes and Other Tobacco Products Act, 2003. - Prohibition of Advertisement and Regulation of Trade and Commerce Production and Supply and Distribution relating to tobacco and tobacco products 44
  5. 5. Brief History Drugs & Cosmetics Act,1940 1919 • Poisons Act 1930 • Dangerous Drugs Act 1931 • Drugs Enquiry Committee • Provinces Passed Resolution(Sec.103 of Govt of India Act 1935) 1935 1940 • Drugs & Cosmetics Act 1940 (10th April, 1940)5
  6. 6. DRUGS AND COSMETICS ACT-1940  To Regulate  Import & Export  Manufacturing & Testing  Selling & Distribution Of Drugs & Cosmetics6
  7. 7. Role of Drugs Control Administration To ensure availability of :  Standard, Safe and Efficacious medicines  At reasonable and Fair prices. 7
  8. 8. Central Drugs Standard Control Organization Central Government (Govt. of India) Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare - Headed by the Drugs Controller General India Functions:  Statutory  Other 8
  9. 9. Statutory functions  Lays Standards of drugs, cosmetics, diagnostics and devices  Brings about the amendments to Acts and Rules  Market authorization of new drugs  Regulate Clinical Trials in India  Approve Licenses to manufacture certain categories of drugs as Central License Approving Authority, i.e. for rDNA Products, Vaccines & Sera, Blood Banks, Large Volume Parenterals.  Regulate the standards of imported drugs  Workrelating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC)  Testing of drugs by Central Drugs Labs  Publication of India Pharmacopoeia9
  10. 10. Other functions  Coordinating the activities of the State Drugs control Organizations to achieve uniform administration of the Act  Guidance on technical matters  Participation in the WHO GMP certification scheme  Monitoring adverse drug reactions (ADR)  Conducting training programs for Regulatory officials & Government Analysts  Distribution of quotas of narcotic drugs for use in medicinal formulations  Screeningof drug formulations available in Indian market for irrational combinations.  Evaluation/Screening of applications for granting No Objection Certificates for export of unapproved/banned drugs10
  11. 11. Andhra Pradesh Drugs Control Administration State Government (Govt. of A.P) • Licensing of drug manufacturing and sales establishments • Licensing of drug testing laboratories • Approval of drug formulations for manufacture • Monitoring of quality of Drugs & Cosmetics, manufactured by respective State units and those marketed in the State • Investigation and prosecution in respect of contravention of legal provisions • Administrative actions (SCN, SPO, Suspension, Cancellation) • Pre- and Post-licensing inspection • Certifications: • WHO-GMP, COPP • Free sale11
  12. 12. Joint responsibilities of Central and State Governments  Licensing of:  Large Volume Parenterals  rDNA Products, Vaccines and Sera  Medical Devices  Blood Banks  Public Testing Laboratory12
  13. 13. LIST OF SERVICES OFFERED Provides Information on Blood Banks Provides Information on Banned Drugs Provides Information on Prices of notified drugs Provides Information on drugs about contra-indications, doses etc Redresses Complaints on services of Chemists and Druggists Redresses Complaints on quality and adverse reaction of drugs & cosmetics Issues Drug Licenses13
  14. 14. Citizen Charter (Time frame fixed by APDCA) Licenses Issued: To be Issued in:  Sales: Retail 14 days Wholesale 14 days  Manufacturing: (Includes Loan & Test Licenses) API’s 45 days Formulations 45 days Biological 60 days Cosmetics 45 days Blood Banks 60 days  Testing Laboratories 60 days14
  15. 15. Citizen Charter (Time frame fixed by APDCA) Certificates Issued: To be Issued in: WHO-GMP 45 days GMP 14 days Market Standing 07 days Free Sale 07 days15
  16. 16. NUMBER OF LICENSEES IN THE STATE a) Pharmacies (Wholesale and Retail) - 50,606 b) Manufacturing (Including Cosmetics and Loan licenses) - 1,551 c) Blood Banks - 256 d) Blood Storage Centers - 87 e) Drug Testing Laboratories - 1516
  17. 17. A.P. PHARMA INDUSTRY A.P. occupies a significant position on the World Pharma map. A.P. is leader in Pharmaceuticals exports, including exports to the highly regulated markets such as USA and other European countries.  Producing:  40% of the total Indian Drugs exports (3.5 $ Billions)  45% of Vaccines (Human &Vet) of India 1st in bulk drugs production 3rd in formulations No of USFDA approved units- 26 No of WHO-GMP approved units-184. No of Biological Manufacturing units-1317
  18. 18. A.P. PHARMA INDUSTRYMFG LICENCES GRANTED BY APDCA PARTICULARS 2012-13 Total No. of Manufacturing concerns 1551 existing in the State No. of Basic Drug Units (API) 314 No. of Formulation units 392 No. of Biologicals Manufacturing Units 13 No. of Blood Banks 256 18
  19. 19. A.P. PHARMA INDUSTRY Hub of National Research Centers  Centre for Cellular & Molecular Biology (CCMB)  National Institute of Nutrition (NIN)  Indian Institute of Chemical Technology (IICT)  National Institute of Pharmaceutical Education & Research (NIPER)  National Toxicology Centre  Hyderabad Central University (HCU)19
  20. 20. Conditions for grant of Mfg. licenses• Technical staff – As specified for individual types of Drugs Manufactured• Facilities • Manufacturing • Testing • Storage • Utilities• Quality Assurance Systems 20
  21. 21. Statutory requirements of GMP & GLP• Schedule ‘M’ - GMP requirements for Facility & Materials, Plant & Equipments of Sterile Products, Oral Solids, Oral Liquids, Topical Products, Metered Dosage Inhalers, API’s (Bulk Drugs)• Schedule ‘MII’ - GMP Requirements for Cosmetics• Schedule ‘MIII’ - GMP Requirements for Medical Devices• Schedule ‘LI’ - GLP Requirements of Premises & Equipments• Schedule ’F’-XIIB - GMP Requirements for Blood Banks• Schedule ’F’-XIIC - GMP Requirements for Blood Products 21
  22. 22. Post Licensing Inspection PointsEmphasis on: Compliance on GMP & GLP Validation Stability studies Standard Operating Procedures Exhaustive, elaborate system of documentation Practices followed to avoid mix-up & cross- contamination 22
  23. 23. Post Licensing Inspection Points Compliance of GMP & GLP as laid down in Schedule ‘M’ & ‘L1’ assessed through Periodic Inspections Licensing Authorities empowered to  Direct Compliance  Stop Production Order  Suspend the Licences  Cancel the Licences 23
  24. 24. Monitoring of Quality of Drugs Through random sampling at manufacturer’s premises and from distribution outlets Licensee bound to recall substandard drugs from market Penal action taken by the DCA against defaulters 24
  25. 25. PENAL SECTIONSSECTION 27(a): Adulterated & SpuriousPunishment : In case of death / grievous hurt : 10 YEARS up to life imprisonment. : Fine not less than 10 lakh rupees.SECTION 27(b)(i): Adulterated 27(b)(ii): UnlicensedPunishment : Not the one referred above : 3- 5 years, fine not less than 1 lakh rupees
  26. 26. PENAL SECTIONSSECTION 27(c): Spurious but not referred in 27(a)Punishment : Not less than 7 years and fine up to 3 lakhsSECTION 27(d): Not of standard quality/other contraventions and drugs not referred in Section 27(a)&(b)&(c)Punishment :1-2 years and fine up to 20,000/-
  27. 27. Penal Sections for CosmeticsSECTION 27-A(i) : Adulterated & SpuriousPunishment : 3 years and fine Rs 50,000/-SECTION 27-A(ii): Cosmetics other than referred in Section abovePunishment : 1 year and fine Rs 20,000/-
  28. 28. OTHER PENAL SECTIONSSECTION 28 : Non disclosure of the Mfg’s namePUNISHMENT : 1 year and fine up to Rs 20,000/-SECTION 28-A: Not producing documents and non- disclosure of informationPUNISHMENT : 1 year and fine up to Rs 20,000/-SECTION 28-B: Penalty for manufacture of drugs/cosmetics which are bannedPUNISHMENT : 3 years and fine up to Rs 5,000/-
  29. 29. Monitoring of Quality of Drugs DCA Andhra Pradesh have two separate Drug Control Laboratories at Hyderabad and Vijayawada. The testing capacity of both the laboratories at present is 4,000 samples per annum. If the manufacturer does not agree to the Govt. analyst report the same be challenged and get analysed from Central Drug Laboratory (CDL) 29
  30. 30. Guidelines on Processing of Applications  APDCA: http://dca.ap.nic.in  CDSCO: http://cdsco.nic.in 30
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