Indian Regulatory Requirements - Industrial Pharmacy II B. Pharma 7th semester PDF Notes

Indian Regulatory Requirements


• 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)


To Protect and Promote public health in India.


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 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.


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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