07th September, 2025

The Central Drugs Standard Control Organization (CDSCO) has released an important regulatory update regarding the approval process for combi-pack products—specifically combinations of lyophilized powders for injection or IV infusion with diluents like Sterile Water for Injection (SWFI) or Sodium Chloride Injection, used for reconstitution.

This clarification aims to eliminate regulatory ambiguity, streamline the licensing process, and introduce a structured, tiered framework for approval—offering greater consistency and predictability for manufacturers operating in India’s pharmaceutical space.

🔍 Key Regulatory Update: Structured Pathway for Combi-Pack Approvals

The CDSCO has introduced a structured approval framework for combi-pack products that include lyophilized injections and their corresponding diluents. This new framework will help both central and state regulators identify the appropriate approval process, enhancing compliance timelines and reducing regulatory uncertainty.

  1. Approved Combi-Packs of Lyophilized drugs with Diluent ✅

Criteria:

  • Lyophilized drug product must be approved by CDSCO for over 4 years, and
  • The diluent used in the formulation is the same as listed in the product’s approved prescribing information (PI).

Implication:

  • Such a combi-pack is not classified as a new drug under the New Drugs and Clinical Trials (NDCT) Rules, 2019.
  • The State Licensing Authority (SLA) can directly grant manufacturing/marketing permission.

👉 This pathway significantly reduces regulatory lead time for legacy formulations.

  1. Combi-Pack of Approved Drug but with Different Diluent ⚠️

Criteria:

  • The lyophilized drug product is already approved, but the diluent differs from the one mentioned in the original PI.

Implication:

  • The product will be treated as a New Drug under Rule 2(1)(w) of the NDCT Rules, 2019.
  • Prior New drug approval from CDSCO is mandatory before SLA can issue a manufacturing or marketing license.

🔍 Regulatory teams must carefully assess the diluent being paired to avoid non-compliance.

  1. Other New Drug Combinations 🚨

Criteria:

  • Any product not falling under the above categories and meeting the definition of a New Drug as per the NDCT Rules.

Implication:

  • Requires fresh new drug approval from CDSCO.
  • Only post-CDSCO approval can the SLA proceed with licensing.

🧭 Key Takeaways for Manufacturers and Applicants

With this clarification, CDSCO expects applicants to:

  • Evaluate the approval status of both the lyophilized formulation and the proposed diluent.
  • Identify the correct regulatory category based on CDSCO’s framework.
  • Submit applications accordingly — either to SLA directly or to CDSCO for new drug approval.

For complete details, kindly refer to the official CDSCO circular.

How Vaayath Consulting Supports You:

At Vaayath, we simplify the regulatory process for injectable manufacturers by offering:

  • Regulatory Guidance: Assessing your product’s status and determining the correct approval pathway.
  • Submission Support: Assisting with CDSCO and SLA submissions, ensuring compliance.
  • Documentation Services: Preparing complete and accurate filings to minimize delays.
  • New Drug Application Filing: From submission to granted approval, we handle the entire process.

For more details, Contact us at info@vaayath.com