To obtain CDSCO registration in India, you need to make an application online by signing up on the Sugam CDSCO portal. After specifying the registration purpose and entering all the necessary details, you shall submit the registration online. Apply Now With ASC Group for CDSCO and Medical Device Registration.

1. CDSCO Registration Process in India

2. INDEX
Since 1995
01 Understanding CDSCO 02
Purpose of CDSCO
Registration in India
04
Registration Process
03 Benefits of CDSCO
Registration
06 Compliance requirements
in CDSCO Registration in
India
05 Documentation Requirements
07 About Us 08 Our Services 09 Contact Us

3. Since 1995
Understanding CDSCO
• CDSCO, or the Central Drugs Standard Control Organization, is the
national regulatory body for pharmaceuticals and medical devices in
India. It is responsible for ensuring that drugs and devices available in
the Indian market are safe, effective, and of good quality.
• CDSCO operates under the Ministry of Health and Family Welfare and
was established in 1961.CDSCO's primary responsibilities include the
approval of new drugs and medical devices for marketing in India, the
regulation of clinical trials, and the enforcement of drug and device
standards.
• The organization also works closely with other international regulatory
bodies to ensure global harmonization of drug and device regulations.
CDSCO plays a critical role in protecting public health and ensuring
access to safe and effective medicines and devices in India

4. Since 1995
Purpose of CDSCO Registration
in India
Ensure the safety,
efficacy, and
quality of drugs
and medical
devices in the
Indian market.
01
Regulate the
import,
manufacture,
distribution, and
sale of drugs and
medical devices
in the country.
02
Monitor and
control the use
of certain
medications and
medical devices
to safeguard
public health.
03
Maintain a
centralized
database of
approved drugs
and medical
devices to facilitate
easy access and
information
sharing among
stakeholders.
04

5. Since 1995
Benefits of CDSCO Registration
Benefits of CDSCO Registration
• Legal compliance: Companies must be registered with CDSCO to legally market
their products in India.
• Increased consumer confidence: CDSCO registration assures consumers that the
product is safe and effective.
• Access to a growing market: India's pharmaceutical market is expected to reach $55
billion by 2020, providing significant growth opportunities for registered
companies.
Regulatory Framework
CDSCO registration is governed by the Drugs and Cosmetics Act, 1940 and the Rules,
1945. Companies must submit an application to the CDSCO for each product they wish
to register, along with supporting documentation and fees. The CDSCO will review the
application and may request additional information or clarification before granting
registration.

6. Since 1995
Registration Process
• Submit application for registration with CDSCO.
• CDSCO reviews application and may request additional
information or clarification.
• CDSCO conducts inspection of manufacturing facility to ensure
compliance with Good Manufacturing Practices (GMP).
• CDSCO issues registration certificate upon successful completion
of review and inspection.

7. Since 1995
Documentation Requirements
• Product Information: Detailed information about the product,
including its composition, intended use, and dosage form.
• Clinical Trial Data: Results of clinical trials conducted on the
product, including safety and efficacy data.
• Manufacturing Information: Details about the manufacturing
process, including the location of the manufacturing facility and
the quality control procedures in place.
• Stability Data: Information about the stability of the product
over time, including data on its shelf life and storage
requirements.

8. 05
Compliance requirements in
CDSCO Registration in India
Since 1995
Providing evidence of the product's quality, efficacy,
and safety through pre-clinical and clinical trial data,
where applicable.
CDSCO
Registration
Compliance
Meeting Good Manufacturing Practices (GMP) guidelines
for manufacturing facilities and processes.
Compliance with labeling and packaging requirements as
per Indian regulations.
Payment of applicable fees for registration and other
regulatory processes.
Adherence to post-marketing surveillance and reporting
of adverse events.
Regular updates and timely renewals of the registration
as per the specified guidelines.
Submission of detailed information on the drug or medical
device to be registered, including its composition, manufacturing
process, and safety data.

9. ASC Group started in 1995 as a CA firm with a view to offer all accounting and financial services for individuals and corporates under
one roof.
It has a team of more than 300+ people including 120 experts comprising of Chartered Accountants, Company Secretaries, Advocates,
Insolvency Professionals and Management Professionals. Being Registered Office in Delhi, it has several branches in India like Noida,
Gurugram, Mumbai, Bangalore, Chennai and overseas countries with a branch office set up in Singapore and Canada.
ASC Group is offering services through many interlinked entities: Alok Sinhal & Co. (the original Chartered Accountant firm), Themis
and Dike (the legal arm of the ASC group), ASC Consulting Private Limited (catering to multinationals doing business in India), ASC
Consulting Pvt. Ltd. (serving to corporates located in Singapore), ASC Ventures Corp (serving to corporates located in Canada) etc.
Personal
Attention
Practical
Expert
Advice
Positive
Solutions
Singapore
Canada
Delhi
Noida
Gurugram
Mumbai
Bangalore
Chennai
Pune
About us
Since 1995
The Firm’s rich heritage is apparent in the values for which we stand – integrity, reliability & proficiency. It is our considered policy to
provide professional services in a conservative manner with due attention to the security and propriety of the transactions involved.

10. Taxation
01
Risk Advisory &
Assurance
02
Secretarial &
Legal
03 Consulting
04
• International Taxation
• Transfer Pricing
• Expatriate Taxation
• Corporate Income Tax
• Withholding Tax
• Personnel Income tax
• Goods and Service Tax
• Assessment & Tax Litigation
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Engineering
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• Drafting of Agreements / Contracts
• Arbitration & Dispute Resolution
• India Entry & Business Startup
Consulting
• Merger & Acquisition
• Foreign Trade Policy & Free
Trade Agreements
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• SVB & AEO Registration
• Legal Metrology, BIS, FSSAI,
ETA, E-Waste, Plastic Waste
Registration
• Sourcing Solutions
• Outsourcing Services
ACTING AS A CATALYST FOR ALL TYPE OF CLIENT BASE
Business
Conglomerates
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Individuals
Entrepreneurs Family offices MNCs
Services
Since 1995

11. 73, National Park,
Lajpat Nagar IV,
New Delhi - 110024
(India)
P: 011-41729056-57,
41601289
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Phone:
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111 / 116
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wing, Sagar Tech Plaza,
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Since 1995
Locations
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+91 9999043311
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