Indian Regulatory Requirements
Contents
• Introduction
• Central Drug Standard Control Organization (CDSCO)
• State Licensing Authority – Organization,
Responsibilities,
• Certificate of Pharmaceutical Product (COPP),
• Regulatory requirements and approval procedures for New
Drugs.
Learning
objectives
• At the end of this
lecture, student will be able to:
– Explain the Indian regulatory requirements for
registration of drug/new drug/clinical trial/Generics
– Explain the role played by Central Drug Standard Control
Organization (CDSCO)
– Explain the responsibility of State Licensing Authority
Indian
Regulatory Requirements
• Central Drug Standard Control Organization (CDSCO)
• State Licensing Authority – Organization, Responsibilities,
• Certificate of Pharmaceutical Product (COPP),
• Regulatory requirements and approval procedures for New
Drugs.
Central
Drug Standard Control Organization (CDSCO)
• The Central Drugs Standard Control Organisation (CDSCO)
under Directorate General of Health Services, Ministry of Health & Family
Welfare, and Government of India is the National Regulatory Authority (NRA) of
India.
• It’s headquarter is located at New Delhi and also has six
zonal offices, four sub zonal offices, thirteen Port offices and seven
laboratories spread across the country.
• 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
wellbeing of the patients by regulating the drugs and cosmetics
• CDSCO is constantly thriving upon to bring out
transparency, accountability, uniformity in services in order to ensure safety,
efficacy, quality of medical product manufactured, imported, distributed in
India
• Under the D&C Act, CDSCO is responsible for approval
of New Drugs, Conduct of Clinical Trials, laying down standards for Drugs, control
over the quality of imported Drugs & coordination of activities of State Drug
Control Organizations by providing expert advice with a view to bring about
uniformity in the enforcement of the D&C Act.
• Further CDSCO along with state regulators- jointly
responsible for grant of licenses of certain specialized categories of critical
Drugs such as blood, blood products, I. V. Fluids, Vaccine and Sera.
Drugs
Controller General of India [DCGI]
• He/she is a responsible for approval of New Drugs, Medical
devices and Clinical Trials to be conducted in India.
• He is appointed by the central government under the DCGI
the State drug control organization will be functioning.
• The DCGI is advised by the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committed (DCC)
Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the
safety, efficacy and quality of drugs, cosmetics and medical devices.
Organisation Chart
Zonal offices
• Mumbai
• Kolkata
• Chennai
• Ghaziabad
• Ahmedabad
• Hyderabad
These are involved in GMP audits and inspection of
manufacturing units of large volume parental, sera, vaccine and blood products.
Sub-zonal offices
• Chandigarh
• Jammu
• Bengaluru
These centres co-ordinate with state drug control authorities under their jurisdiction for uniform standard of inspection and enforcement.
Central
Drugs Testing Laboratories
• Central Drug Laboratory, Kolkata
• Central Drug Testing Laboratory, Mumbai
• Central Drug Testing Laboratory, Chennai
• Central Drug Laboratory, Kasauli
• Regional Drug Testing Laboratory, Guwahati
• Regional Drug Testing Laboratory, Chandigarh
These laboratories are responsible for quality control of
drugs and cosmetics in the country.
Functions
of CDSCO (At the Center)
• Approval of new drugs and clinical trials.
• Import Registration and Licensing
• Licensing of Blood Banks, LVPs, Vaccines, r-DNA products
and some Medical devices and Diagnostic agents.
• Amendment to D&C Act and Rules.
• Participation in WHO GMP certification schemes.
• Banning of drugs and cosmetics.
• Grant to test license, personal license, NOC’s for export.
• Testing of drugs by Central Labs.
• Publication of Indian Pharmacopoeia.
• Monitoring adverse drug reactions.
• Guidance on Technical matters.
Function of
State Licensing Authorities
• Licensing of drug testing laboratories.
• Approval of drug formulation for manufacture.
• Monitoring of quality of Drugs and cosmetics, manufactured
by respective state and those marketed in the state.
• Investigation and prosecution in respect of contravention
in respect of contravention of legal provisions.
• Administrative actions.
– Pre- and post- licensing inspection.
– Recall of sub-standard drugs.
Responsibilities
of Central authority
• 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
organization.
• Providing expert advice with view of bringing about the
uniformity in the enforcement of the drugs and cosmetics act.
Responsibilities
of State authority
• Manufacturing, sales, distribution of drugs licensing drug
testing laboratories.
• Approving drug formulation for manufacture.
• Carrying pre and post licensing inspection.
• Overseeing the manufacturing process for drugs
manufactured by respective state unites and those marketed in the state.
State Drugs
Control Organisation
Drug
Approval Process
Approval
for New Drugs
New drugs are permitted to be marketed in country in accordance
with the permission granted by DCGI afterensuring that these drugs are
• Safe
• Effective
• Comply with requirement of Schedule Y of the Drug and
Cosmetic rules.
Applicants are required to provide technical data in respect
of safety and efficacy before these could be permitted to be marketed in
country
Definition of new drug also includes fixed dose combination
to be marketed for the first time in India
Clinical
Trials
• Schedule Y of drugs and cosmetics act explain the
guideline for grant of permission for conducting clinical trials in India.
• The protocol for such trials are examined by the office of
DCGI before the permission are granted.
• Office of DCGI also grants permission for conducting
bioequivalence studies.
• Registration of clinical trials has been made mandatory with
centralized clinical trial registry of ICMR with effect from 15th 2009.
• Drug and Cosmetic rules are being amended to make
mandatory the registration of clinical research organizations.
• Drug and Cosmetic act is proposed to be amended to include
a separate chapter on clinical trials.
Drug
Approval Process
When a company in India wants to manufacture / import a new
drug it has to apply to seek permission from the licensing authority by filing
in form 55 also submitting the data as given in schedule y of drug and
cosmetics act 1940 and rules 1945.
New drug substance discovered in India – start from phase I
to phase III should involve 500 patients, 10-15 centres.
New drug substance discovered in other countries – phase I
data data need to submit along with application to licensing authority.
Phase III should involve 100 patients, 3-4 centres.
Clinical
Trial Process
Schedule Y of drugs and cosmetics act explain the guideline
for grant of permission for conducting clinical trials in india.
The protocol for such trails are examined by the office of
DCGI before the permission are granted.
Office of DCGI also grants permission for conducting
bioequivalence studies.
In March 2011, CDSCO office constituted 12 new drug advisory
committees (NDACs).
Presently these committees are named “Subject expert committees” (SECs).
Three Tier
Process
Feb 2013, a three tier process has been implemented, where
in each clinical trial applications is being referred for review to the
technical and apex committee.
Step 1. Review in SEC meeting (if approved moves to step 2)
Step 2. Review by technical Committee (if approved moves to
step 3)
Step 3. Review by APEX Committee (if approved, final
approval granted by DCGI)
Cosmetics
Cosmetics devision, central drug standard control
organization is responsible.
For the import of cosmetics in India, the imported cosmetic
product are required to be registered with CDSCO by giving application in form
42 to obtain registration certificate form 43.
The manufacture himself/ the authorized agents of the
manufacturer / the subsidiary of the manufacturer/ any other importer can be
applicant for issuance of registration certificate for import of cosmetic into
India.
License will be grant within 6 months.
Fees of 250$ to be paid.
The folloing licence are
required for cosmetic product manufacturing and market in india according to
drug and cosmetic act, 1940
Licence on form 32 is issued
for manufacture/sale distribution of cosmetic
Licence on form 32-A is
issued for lone licence manufacturing / sale distribute of cosmetics.
SLA will give licence to
manufacture cosmetics.
Fee of 2500 to be paid
Medical
Devices
On 17, October 2016 the union health ministry of india
published the new medical device rules draft, which will be effective from
January 1, 2018.
The risk based classification for medical device ranging
from
1. Class A low risk (thermometer, tongue depressor)
2. Class B low moderate risk (suction equipment, hypodermic
needle)
3. Class C high moderate risk (ventilator, bone fixation
plate)
4. Class D high risk (heart valves, AICD)
SUGAM-Online
licensing portal
An online licensing portal of CDSCO has been implemented on
Jan. 2016 and has been named SUGAM to file application for varies services like
application submission, processing and grant of permission for quick delivery
of services.
RECALLS
Recall is an action taken to withdraw/ remove the drugs from
distribution or use including corrective action for witch deficiencies are
reported in quality, efficacy and safety.
Class I
Class II
Class III
Types of
Recall
Voluntary Recall
Statutory Recall
Certificate
of Pharmaceutical Product (COPP)
• The Central
Drugs Standard Control
Organization (CDSCO), which is the national
drugs regulatory authority, regulates
the import and
export of the drugs in the country, through the port
offices located in different parts of the country.
• The certificate of pharmaceutical product (CPP or CoPP) is
a certificate issued in the format recommended by the World Health Organization
(WHO).
• The WHO GMP certificate is mandatory in most global
markets for pharmaceutical companies to be able to sell medicines.
• The manufacturer of an exporting country must be licensed
by the regulatory authority of that country and comply with the WHO GMP
guidelines
• The application for grant of WHO GMP Certificate of Pharmaceutical
Product shall be made to respective zonal/sub zonal officers as per the
requirement.
• The COPP will be issued by zonal/sub zonal officers on behalf of Drugs Controller
General (India) after inspection and satisfactory clearance by CDSCO officers
as per WHO – GMP guidelines.
• It is
valid for 3 years from
date of issue
and companies can apply for renewal after that.
• The certificate of a pharmaceutical product (COPP) is
issued under WHO GMP based on guidelines laid down by the health agency and is
aimed at diminishing the risks inherent in pharmaceutical production.
• The certificate helps the regulator ensure that drugs are
consistently produced and are quality controlled before they leave the country.
Documents
required for applying for granting or revalidation of COPPs:
• Application from Manufacturer
• Site Master file (as specified under WHO TRS 823)
• Copy of Manufacturing License
• List of Approved Products
• List of products applied for issuance of COPPs
• List of SOPs and STPs
• Stability Data (3 batches) Accelerated / Real Time
• List of equipment and Instruments
• List of Technical staff, their qualification, experience and
approval status
• Manufacturing Layout Plan
• Process validation for 3 batches of each product
• Schematic diagram of Water system specifying circulation
loop and MOC (Material of Construction)
• Schematic diagram of HVAC system specifying terminal
filter configuration
• Export data of last 2 years in case of revalidation
• Product Summery sheet
Procedure
for accepting the application for Issue of COPP
• Applications forwarded by before 01‐10‐2009 will be considered provided
they should
resubmit the application in
the revised format
with forwarding letter, notarized
product summary sheet and other documents which were not submitted earlier as
per requirement on first come first serve basis.
• All applications received will be scrutinized by CDSCO
Officials after receipt and query letter will be sent to applicant, if any or otherwise
will be considered for inspection.
• Inspection will be
carried out by CDSCO Officers as per WHO GMP guidelines of TRS 823/908 for
non-sterile products, TRS 822/902 for
Sterile Products and other relevant guidelines in
TRS937, TRS 929, TRS 863 etc. as applicable from time to
time.
• Self-appraisal checklist should be filled and submitted to
CDSCO officer before inspection.
• Inspection team verify the checklist at the time of inspection.
• Inspectors brief the inspection findings at the exit meeting
• The report should clearly define deficiencies as per WHO
GMP guidelines.
• Respective
Zonal/ Sub‐Zonal certifying
authority prepare “Review Report” based on review of observations of
check list and written inspection report as per WHO GMP guidelines.
• Firm may reapply, if required after proper compliance
after 5 months from date of rejection
• If the same firm applies after 5 months, scrutiny of such
application should be asked for earlier compliance with documentary evidences
in addition to the usual general requirements for submission of application for
issue of COPP
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