Latest trend of pharmaceutical, medical device

regulation, and international cooperation of

India

By: Dr. V. G. Somani

Drugs Controller General (India)

CDSCO, MoFHW, India

2/5/2020 1

Outline of Indian Industry Global Presence of India

Export to different region

Indian Pharmaceutical Industry

Brief profile on Indian Pharmaceutical Industry

Introduction to Drugs and Cosmetics Act and Rules

Recent Amendments

Cooperation with Other Countries

Areas of Cooperation

Advantages of Signing of MoU2/5/2020 2

Global presence Vaccines and bio-pharma products are exported to about

150 countries.

India ranks third in the world providing over 400 APIs.

More than 786 US FDA approved manufacturing facilities

Around 700 EDQM certified facilities for exporting to EU

461 Written Confirmation Certificates

1900 WHO-COPP facilities2/5/2020 3

Exports to Different Regions

S.No Region % of total exports

1 North America 27

2 EU 18

3 Africa 18

4 Middle East 7

5 Asean 6

6 Latin American Countries 6

7 CIS 6

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Indian Pharmaceutical Industry – A ProfileSize of the Industry USD 43 Billion

Export USD 19.5 Billion

Domestic market USD 23.5 Billion

Growth Rate 11-13 %

Imports USD 5 Billion

Exported to More than 180 countries

Volume of Production 3rd Largest in the world

Value of production 14th in the world2/5/2020 5

Indian Pharmaceutical Industry

Type of Manufacturing Unit Number of Units (Approx)

Formulations 4900

Active Pharmaceutical Ingredients 1500

Vaccines 30

Medical Devices 800

Miscellaneous (Surgical dressings, Blood banks, Disinfectants etc)

2850

Other Industry

Cosmetics 2300

Ayurveda, Unani 4800

Homeopathy 1000

Whole sale and Retails 800,000

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Drugs and Cosmetics Act and RulesObjective:

To ensure safety, efficacy and quality of

2/5/2020 7

Drugs

Biologicals

MedicalDevices/IVD

Cosmetics

Veterinary Drugs.

Implementing AuthoritiesDrugs fall under the Concurrent list of the

Constitution

Enforced by both:

Central Government:

Central Drugs Standard Control Organization(CDSCO)

State Governments:

State Drug Licensing Authorities 2/5/2020 8

Drugs and Cosmetics Act and Rules:Central Responsibilities: (CDSCO)

New Drug Approvals Medical Devices (Class C & D) Import of Drugs/Medical Devices/Cosmetics Clinical Trials Standards for Drugs/Cosmetics Amendments to Act and Rules Joint Inspcetion Pharmacovigillance

State Responsibilities: License for Manufacture, Sale and Distribution Monitoring quality of Drugs and Cosmetics Inspection of Manufacturing , Sale and Distribution premises Investigations and Prosecutions

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Recent Amendments

Medical Device Rules, 2017

New Drugs and Clinical Trials Rules, 2019

Draft Schedule M is being upgraded in line with WHO GMP Standard

Draft Cosmetics Rules

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Effective from 01.01.2018

To regulate the Clinical Investigation,Manufacture, Import, Sale and Distributionof the medical devices

Harmonised with the internationalregulatory practices and providecomprehensive legislation for the regulationof Medical Devices

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Medical Device Rules,2017

Medical Device Rules, 2017 Salient Features

Risk based classification

Provisions of Notified Bodies

Quality Management System in line with ISO 13485 has been adopted;

Provisions related to the ‘Essentials Principles of Safety and Performance’ for manufacturers have been specified in the Rules;

Separate provisions for regulation of Clinical Investigation of investigational medical devices (i.e. new devices) have been made at par with international practice.

Provision is made to designate or establish Central Government medical device testing laboratories to verify conformance with the quality standards.

122/5/2020

New Drugs and Clinical Trials Rules Effective from 19.03.2019 New Drugs definition scope has been broadened to

include Phytopharmaceuticals living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts

Waiver to Academic Clinical Trials Provision for Pre and Post-submission meeting

132/5/2020

New Drugs and Clinical Trials Rules Provisions of Accelerated Approval to a new drug for a disease or

condition, taking into account Severity, rarity, or prevalence and the availability or lack of alternative treatments provided that there is a prima facie case of the product being of

meaningful therapeutic benefit over the existing treatment.

Provisions for pre-consultation have been incorporated Orphan drugs intended to treat a condition which affects not

more than five lakh persons in India Separate Provisions for Registration of Ethics Committee for

BA/BE study Marketing Authorization

142/5/2020

New Drugs and Clinical Trials Rules

Reduction in time lines

for approval

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Type of Application Timelines

CT (innovated in India): within 30 working days

CT (if drug is already approved by other country):

within 90 working days

New drug within 90 working days

Processing of Import License 90 working days

If the central licensing authority fails to communicate, the “permission to conduct the clinical trial shall be deemed to have been granted”.

2/5/2020

Salient features of revised Schedule M Pharmaceutical Quality Systems (PQS) is incorporated which is not present in

the current Schedule M.

Quality Risk Management (QRM) is incorporated to evaluate the risk to qualitybased on scientific knowledge with the process and ultimately links to theprotection of the patient.

Change control is incorporated in the revised Schedule M to evaluate allchanges that may affect the production and quality of the product.

Suppliers audit and approval is incorporated.

Stability studies requirements have been elaborated in the revised Schedule M.

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Draft Cosmetics Rules Draft rules for cosmetics published vide GSR 1153 dated

29.11.2018

Comprise of 9 Chapters and 13 Schedules

The concept of establishment and function of Central Cosmetic Laboratory introduced.

Duration of the Import RC is extended from 3 years to 5 years.

Any person can import already registered cosmetic without any further registration just by giving an undertaking under prescribed format at the port of entry.2/5/2020 17

Inspection of foreign manufacturing site by the inspector is introduced for which expense is to bear by RC holder

Verification for the compliance of manufacturing licence is to be done once in two years.

Manufacturing Licence shall remain valid in perpetuity, subject to payment of licence or loan licence retention fee at the end of validity of licence

Separate chapter for procedure of sampling for test or analysis, seizure and report has been introduced.

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Draft Cosmetics Rules

Cooperation with other Countries CDSCO has signed MoU/MoC on cooperation in the field

of regulation of pharmaceuticals with the followingCountries:

1. Japan 2. Russia 3. Sweden

4. Brazil 5. UK 6. Afghanistan

7. Argentina 8. Indonesia 9. Saudi Arabia

A Statement of Intent (SoI) is also signed with USFDA inthe field of regulation of pharmaceuticals.

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Areas of Cooperation The co-operation between the Parties shall take place in the

following areas:

Promoting an understanding between the Parties of eachother's regulatory framework, requirements andprocesses and facilitating future regulatory strengtheninginitiatives for both parties.

Exchange of information and cooperation on GoodLaboratory Practices (GLP), Good Clinical Practices(GCP), Good Manufacturing Practices (GMP) and GoodPharmacovigilance Practices (GPvP).

Recognition of Indian Pharmacopeia

Capacity building in mutually agreed areas2/5/2020 20

Cont.. Exchange of safety information, including

Pharmacovigilance, and adverse events where there is a particular safety concern related to the other party. This includes safety concerns relating to medicines and medical devices

Participation in scientific and practical conferences, symposiums, seminars and forums organized by the Parties.

Coordination at the international fora.

Any other areas of common interest2/5/2020 21

Advantages of Signing of MoU To strengthen the relationship between both countries.

Results in exchange of information and cooperation on GoodLaboratory Practice (GLP), Good Clinical Practice (GCP), GoodManufacturing Practice (GMP) and Good PharmacovigilancePractice (GPvP).

To establish dialogue and cooperation

Help in Exchanging safety information, includingPharmacovigilance, and adverse events where there is a particularsafety concern related to the other party. This includes safetyconcerns relating to medicines and medical devices.

Participation in each other conference and symposiums to learnabout each other regulatory aspects.

2/5/2020 22

Advantages of Signing of MoU To promote the exchange of information.

It promote an understanding between the Parties of each other’sregulatory framework, requirements and processes; and to facilitatefuture regulatory strengthening initiatives for both parties.

Both Parties share comprehensive information about

a) their role in organization, control and supervision of medicinesand cosmetics; and

b) the policies and processes adopted in testing, inspection andacceptance of imported or locally manufactured medicines andcosmetics

To exchange of Best practices between both the countries.

To Participate in scientific meetings, symposia, seminars organizedby other party.2/5/2020 23

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Thank

You 2/5/2020