If It’s Not a CDSCO-Approved Drug, It’s Not Legal. Don’t Risk Your Pharma Brand
- Akshay Gautam
- 2 days ago
- 7 min read
Don’t be fooled by “approved” products without regulatory backing. Your responsibility as a marketer or a pharmaceutical company starts with knowing which new drugs, SNDs, and FDCs are legitimately approved by CDSCO, or risk legal and market fallout.
1. Introduction
The pharmaceutical sector in India is steadily growing, but navigating the regulatory environment is more difficult than locating producers. Although the expansion of pharmaceutical manufacturing makes it possible to contact several affordable manufacturers for product development, it is important to find out if CDSCO has approved a new drug before it is developed and put on the market.
The regulatory gatekeeper for drug safety, effectiveness, and legality in India is the Central Drugs Standard Control Organization (CDSCO). The next steps are determined by CDSCO's approval pathways, regardless of whether the product being developed is a novel molecule, a new formulation, or a combination of known ingredients. Pharma stakeholders can stay informed, competitive, and compliant by using this guide, which provides a clear, structured overview of drug classifications and approval requirements.
The article discusses various drug categories, CDSCO approvals, the kinds of drugs produced and sold in India, and more. The goal is to provide pharmaceutical companies with information about how to prioritize regulatory-approved medications over marketing strategies alone.
2. Regulatory Reality
Amid the rapid transformation of pharma manufacturing, many companies continue to market irrational or unapproved combinations. This often occurs because the manufacturer produces them, but in reality, the manufacturer is not regulating them; CDSCO is. The CDSCO serves as India's National Regulatory Authority (NRA), operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. It is entrusted with the crucial task of regulating the safety, efficacy, and quality of drugs and medical products nationwide.
2.1 Drugs and Cosmetics Act 1940 and Rules, 1945
The authority of the CDSCO derives from the Drug and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945. These laws assign regulatory responsibilities to both state and central regulators for the uniform execution nationwide. These are the crucial pieces of legislation regulating the import, manufacturing, distribution, and sale of drugs and cosmetics. This Act provides the framework, while the Rules detail specific provisions and classification. No matter what manufacturer can make, it does matter that CDSCO has approved it.
3. No blind reliance on manufacturers
Your manufacturer, no matter how reputable, is not the regulator. The mere presence of a product on the market doesn't automatically equate to approval by the Central Drugs Standard Control Organization (CDSCO). This is a crucial distinction, especially if you're charting a course to develop, market, or expand your pharmaceutical portfolio.
3.1 The Immutable Truth: Compliance is Your Responsibility
As the marketing authorization holder, the onus of compliance rests squarely on your shoulders, not the manufacturer's. While manufacturers might present tempting, ready-made compositions or combinations, the simple act of manufacturing does not confer legality or compliance.
If you're building a new pharma brand or strategically expanding your existing portfolio, you absolutely must prioritize regulatory due diligence. Before you take another step forward, remember these non-negotiable actions:
3.2 Verify Regulatory Status: Don't Assume, Confirm
Before committing to any formulation or product, it's imperative to delve into the CDSCO database or consult with a seasoned regulatory expert. Your objective is to confirm the status of the formulation or drug definitively. Is it:
Requiring Special Permission? (Indicating additional hurdles and specific pathways the client will need to navigate.)
3.3 Categorize Your Product: Know Before You Grow
Understanding the regulatory classification of your product is fundamental. This categorization will dictate the approval pathway, required documentation, and timelines. Determine with precision whether your product qualifies as:
A Fixed Dose Combination (FDC): Combining two or more active pharmaceutical ingredients into a single dosage form. These often face stricter scrutiny.
A Subsequent New Drug (SND): A new dosage form, strength, route of administration, or new claim for an already approved drug.
A New Drug: A drug not previously marketed in India, or a new chemical entity. This category typically involves the most rigorous approval process.
3.3.1 Fixed Dose Combination
What it is:
A fixed-dose combination (FDC) is defined as the combination of two or more active pharmaceutical ingredients (APIs) at a fixed ratio in a single dosage form (e.g., one tablet), for a particular indication. FDCs are considered a double-edged sword because a rational FDC can give an increase in patient compliance and a decrease in bill burden and cost-effectiveness; however, at the same time, an irrational combination results in ineffective or increased adverse effects. Under the 2019 Rules, an FDC is explicitly a "New Drug" if it's a first-time combination of approved drugs, or if the ingredient ratio in an existing FDC changes, or new claims are made.
Group 1 FDCs: New drug FDCs require extensive data, similar to any new drug approval.
Group 2 FDCs: Combining existing drugs for the first time with potential interactions requires clinical trial reports, if available internationally, and regulatory status abroad.
Group 3 FDCs: Changing ratios or making new claims for existing FDCs requires rationale and published reports for marketing permission.
Group 4 FDCs: Widely used individual drugs combined for convenience need stability and interaction data, but generally no new animal or human data.
Key Features:
The rationale is paramount: Must demonstrate clear advantages (e.g., enhanced efficacy, reduced side effects, improved patient compliance, reduced resistance) over individual component use.
Categories of FDCs: The approval pathway varies based on whether ingredients are new, already approved but combined for the first time, or existing FDCs with proposed changes/convenience.
Irrational FDCs: Historically, many irrational FDCs were marketed, leading to widespread bans by the CDSCO. Only clinically justified combinations are approved.
Approval Time (Approx.):
Highly variable; new drugs require 3-5+ years for trials, mirroring the new drug’s timeline. CDSCO's review of FDCs of already approved drugs can take 90 days, but overall preparation may extend to 1-2 years.
Rule Reference:
Part of Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, and specific FDC guidelines on the CDSCO website.
Rules Governing Fixed Dose Combinations
Rule 122 D: Permission for FDC import or manufacture.
Rule 122 DA: Mandatory DCG(I) permission for new drug clinical trials.
Rule 122 DAB: Examination of serious adverse events (SAE) with compensation and debarment for non-payment.
Rule 122 DAC: Conditions for clinical trials, including mandatory GCP, Schedule Y, and other regulations; debarment for non-compliance.
Rule 122 DD: Requirements for Ethics Committee registration.
Rule 122 E: Definition of a new drug.
Schedule Y: Detailed guidelines for clinical trials and new drug approval.
FDC Draft Guidelines: Issued by CDSCO.
3.3.2 Subsequent New Drugs
What is it:
A subsequent new drug is one previously approved in India for specific claims, now proposed for marketing with altered or new claims regarding its indication, dosage, form, or administration route. This also applies to drugs approved within the last four years, if proposed for a new indication, dosage form, or administration route.
New indication: Approved for one disease, now for another.
New dosage: New strength (e.g., 10mg to 20mg).
New dosage form: From tablet to suspension.
New route of administration: From oral to injectable.
Modified release form: Immediate release to sustained release.
Key Features:
Requires a strong scientific rationale for the subsequent new drug and often specific studies like bioequivalence (for new dosage forms/strengths) or targeted clinical trials for new indications.
Approval Time (Approx.):
Typically quicker than a completely new drug due to established safety and initial efficacy. Expect a timeline of 6 months to 2 years, influenced by the complexity of the new claim and necessary studies. CDSCO prioritizes expedited review for these applications.
Rule Reference:
Explicitly covered under the definition of "New Drug" (Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019) as a drug already approved but proposed for modified claims.
3.3.3 New Drugs
What it is:
A novel drug molecule has not been widely used in India before, or an existing drug with a proposed new use, administration method, dosage, or dosage form. New drugs always include vaccines, biologics (such as r-DNA products and monoclonal antibodies), stem cell products, and gene therapies.
Key Feature:
Requires extensive data, including comprehensive pre-clinical studies and all phases of clinical trials (Phase I, II, III) conducted in India, unless specific waivers apply for drugs approved in major regulated markets (e.g., US, EU, Japan) with Indian patient data from global trials.
Approval Time (Approx.):
This is the longest process. From initial clinical trial application to marketing approval, it can typically take 3-5 years, often extending to 5-10 years for truly novel molecules requiring full global development and local trials. The clinical trial phases themselves can consume a significant portion of this time (1-3 years per phase, cumulatively).
Rule Reference:
Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019.
3.4 Plan for Approval Timelines & Documentation
Prepare for regulatory timelines
Clinical Data Requirements: You must submit robust clinical trial data (Phase I–III or targeted studies) to establish the safety and efficacy of your drug.
Bioequivalence Studies (if applicable) When modifying dosage forms or strengths, bioequivalence studies are essential to prove therapeutic consistency with the reference product.
Chemistry, Manufacturing, and Control (CMC) Documentation Detailed CMC data ensures the drug's identity, strength, quality, and purity throughout its shelf life and manufacturing process.
Form 44 Submission and Other Regulatory Filings Form 44 is the primary application for CDSCO approval and must be accompanied by supporting data, declarations, and applicable schedules.
4. Insight table
5. Walter Healthcare Execution
Walter Healthcare focuses on building regulatory-ready pharmaceutical brands, not just manufacturing. We guide clients to prioritize compliance and innovation beyond basic formulations and cost, ensuring every product aligns with CDSCO norms from the outset to prevent costly errors and market delays.
Here are five key points:
Regulatory-Ready Brands: We build brands designed for compliance, not just product presence.
Proactive Compliance: Our approach integrates CDSCO norms from the very beginning of formulation development.
Expert Navigation: We proactively guide clients through complex regulatory pathways for FDCs, SNDs, and novel molecules.
Updated Expertise: Our in-house experts stay current with all CDSCO circulars, updates, and bans.
Responsible Innovation: We champion innovation that converges patient safety, regulatory compliance, and business success.
6. Conclusion
In India’s evolving pharmaceutical landscape, navigating regulatory authorities is not just a formality; it’s a strategic imperative. While the market offers a wide range of manufacturing capabilities, true success lies in aligning product development with CDSCO’s regulatory framework. Whether you're launching a new molecule, modifying an existing drug, or combining APIs into a fixed dose, each pathway demands precise understanding, documentation, and timelines. Compliance isn’t optional; it’s the foundation for credibility, market acceptance, and long-term sustainability.
As the marketing authorization holder, the responsibility is yours to ensure your product is not only innovative but also legally viable and ethically sound. The CDSCO provides transparent, accessible guidance; it’s up to you to utilize it effectively. In this tightly regulated arena, knowledge is power, and regulatory diligence is your sharpest competitive edge. At Walter Healthcare, we empower our clients with this knowledge, ensuring they are well-versed in CDSCO regulations before making critical product development decisions.
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