Understand The Difference Between CDSCO and FSSAI Regulations

Knowing what each of the two regulatory organizations, CDSCO and FSSAI, does becomes relevant while dealing with business opportunities in the healthcare and food sectors in India. Both authorities have different areas of concern, and each has its law which deals with everything in the jurisdiction. 

The Central Drugs Standard Control Organization (CSDCO) supervises the safety & standard of cosmetics and medical devices. Whereas, safety and standards regulations for food are controlled by the FSSAI.  With compliance concerns for stakeholders, the purpose of the article is to help explain the difference between the two regulations.

What Is CDSCO?

The CDSCO is the regulatory body for pharmaceuticals, medical devices, cosmetics, and the import of Ayurvedic products. while FSSAI regulates food safety and standards. The purpose of this article is simply to give differences to allow stakeholders to better understand regulatory compliance.

What Is FSSAI?

The Food and Safety Standards Authority of India is the higher organization that controls the issues related to food safety globally. FASSAI was formed under the Food Safety and Standards Act, 2006.  This act includes many amendments acts, rules, and othertaht address food safety.

CDSCO vs FSSAI Key Differences

Now that we understand what each authority does, let’s dive into the key aspects of the CDSCO vs FSSAI debate.

Aspect	CDSCO	FSSAI
Sector Regulated	Pharmaceuticals and medical devices	Food and food-related products
Governing Act	Drugs and Cosmetics Act, 1940	Food Safety and Standards Act, 2006
Primary Focus	Drug safety, efficacy, and quality	Food safety, hygiene, and nutritional standards
Product Examples	Medicines, vaccines, surgical gloves, stents	Packaged foods, beverages, and dietary supplements
Licensing Authority	CDSCO (for central licensing) and State Drug Controllers	FSSAI (for both central and state levels)
Testing Protocols	Clinical trials, bioequivalence studies	Food testing labs, quality certification
Labeling Standards	Drug composition, usage, and side effects	Nutrition facts, ingredients, allergens

Compliance Requirements For Businesses Under CDSCO and FSSAI

For companies dealing in pharmaceutical products or food, it’s crucial to know the difference between CDSCO and FSSAI compliance. Here are the most important requirements summarized

Overview Of CDSCO Regulations For Medicinal Products And Medical Devices.

• Manufacturing & Import License: Required before manufacturing or importing.
• Product Approval: Required approval is for new products, drugs, and high-risk medical devices.
• Clinical Trials: approval is also necessary to initiate a clinical trial of a new drug.
• Device Classification: Devices are classified by risk (class A-D).
• Regulatory Labels – must contain the dosage, active ingredients, expiry date, and warnings.
• Pharmacovigilance – ADR reporting and monitoring.

FSSAI compliance for food and nutraceuticals.

• FSSAI Licenses/Registration – Based on turnover and/or FSSAI categories of food business.
• Product Approval – Required for nutraceuticals, novel foods, and supplements.
• Labeling Norms – Nutrition facts, allergens, FSSAI logo, etc.
• Food Testing – Food must be tested in NABL-accredited labs. Hygiene – Safety & cleanliness.
• Product Recall & Traceability – Fast & effective removal of hazardous products.

Recent Developments In CDSCO & FSSAI Collaboration

There’s been more focus on better collaboration between CDSCO and FSSAI. Here are some things that have come up:

• Joint Committees: Set up to assess and analyze borderline products.
• Harmonization of Standards: Especially with nutraceuticals and food supplements.
• Digital Portals: For licensing, like the Food Licensing and Registration System (FLRS) and SUGAM, which is CDSCO’s online portal.
• Public Consultations: Relating to the new draft regulations involving both authorities.
• In short, all these initiatives aim to reduce the complexity of regulatory processes and increase efficiency in conducting business around health and food in India.

How Businesses Can Navigate CDSCO vs FSSAI Regulations?

To help businesses deal with the complicated rules of the industry, they might use a sinking fund strategy:

• Hire Regulatory Consultants: Deal with at least two people who know the ins and outs of CDSCO and FSSAI regulations.
• Keep Up-to-Date: Always be aware that Compliance is a moving target.
• Invest in Training: Awareness and education concerning the legal implications for the marketing and legal teams, and R&D for the work being done legally.
• Make Use of Technology: Regulatory tracking, regulatory document management, and audits.
• Don’t Over-Promise: For advertising purposes, do not make therapeutic claims if the drug’s or product’s active substance has not been registered/approved by a CDSCO authority.

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