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:040-23814360
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2. DRUGS CONTROL ADMINISTRATION, GOVERNMENT OF ANDHRA PRADESH
VENGALRAO NAGAR, HYDERABAD
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3. DRUGS CONTROL LABORATORY, GOVERNMENT OF ANDHRA PRADESH
VENGALRAO NAGAR, HYDERABAD
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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
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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)
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6. DRUGS AND COSMETICS ACT-1940
 To Regulate
 Import & Export
 Manufacturing & Testing
 Selling & Distribution
Of
Drugs & Cosmetics
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7. Role of Drugs Control Administration
To ensure availability of :
 Standard, Safe and Efficacious
medicines
 At reasonable and Fair prices.
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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
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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 Pharmacopoeia
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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 drugs
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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 sale
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12. Joint responsibilities of
Central and State Governments
 Licensing of:
 Large Volume Parenterals
 rDNA Products, Vaccines and Sera
 Medical Devices
 Blood Banks
 Public Testing Laboratory
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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 Licenses
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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 days
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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 days
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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 - 15
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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-13
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18. A.P. PHARMA INDUSTRY
MFG 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
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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)
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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
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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
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22. Post Licensing Inspection Points
Emphasis on:
 Compliance on GMP & GLP
 Validation
 Stability studies
 Standard Operating Procedures
 Exhaustive, elaborate system of documentation
 Practices followed to avoid mix-up & cross-
contamination
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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
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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
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25. PENAL SECTIONS
SECTION 27(a): Adulterated & Spurious
Punishment : 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): Unlicensed
Punishment : Not the one referred above
: 3- 5 years, fine not less than 1 lakh rupees

26. PENAL SECTIONS
SECTION 27(c): Spurious but not referred in 27(a)
Punishment : Not less than 7 years and
fine up to 3 lakhs
SECTION 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. Penal Sections for Cosmetics
SECTION 27-A(i) : Adulterated & Spurious
Punishment : 3 years and fine Rs 50,000/-
SECTION 27-A(ii): Cosmetics other than
referred in Section above
Punishment : 1 year and fine Rs 20,000/-

28. OTHER PENAL SECTIONS
SECTION 28 : Non disclosure of the Mfg’s name
PUNISHMENT : 1 year and fine up to Rs 20,000/-
SECTION 28-A: Not producing documents and non-
disclosure of information
PUNISHMENT : 1 year and fine up to Rs 20,000/-
SECTION 28-B: Penalty for manufacture of
drugs/cosmetics which are banned
PUNISHMENT : 3 years and fine up to Rs 5,000/-

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)
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30. Guidelines on Processing of Applications
 APDCA: http://dca.ap.nic.in
 CDSCO: http://cdsco.nic.in
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