CDSCO Reiterates Mandatory Testing of Pharmaceutical Raw Materials and Finished Formulations in October 2026

The Central Drugs Standard Control Organisation (CDSCO) has called for strict compliance with pharmaceutical drug testing requirements through a communication dated 27 October 2026. Addressed to all State and Union Territory Drug Controllers, the letter emphasises mandatory batch-wise testing of raw materials and finished drug formulations, along with proper vendor qualification.

The direction specifically mentions critical excipients such as propylene glycol, glycerol and sorbitol. Manufacturers must also maintain the required testing records under the applicable Drugs Rules, 1945.

The latest communication reinforces existing legal requirements rather than introducing a new drug testing law.

CDSCO October 2026 Circular at a Glance

The communication was issued by the Directorate General of Health Services through CDSCO and refers to an earlier letter dated 7 October 2025.

The communication asks State and UT Drug Controllers to give the matter top priority and ensure compliance across pharmaceutical manufacturing units under their respective jurisdictions.

Regulatory Framework for Pharmaceutical Raw Material and Finished Drug Testing in India

Pharmaceutical manufacturers in India must follow the applicable provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. These laws regulate drug manufacturing, quality control, licensing, testing and related documentation.

The October 2026 CDSCO communication draws attention to requirements that already form part of the manufacturing licence conditions.

Rule 74(c) of the Drugs Rules, 1945
Rule 74 applies to licences in Form 25 and Form 25F. Under Rule 74(c), the licensee must test each batch or lot of raw material used in manufacturing and each batch of the final product.

Testing must be carried out in the licensee's own laboratory or another laboratory approved by the licensing authority, as permitted under the Rules.

The manufacturer must maintain testing records containing the particulars specified in Schedule U. Rule 74(c) also requires these records to be retained for five years from the date of manufacture.

Rule 78(c)(ii) of the Drugs Rules, 1945
Rule 78 sets out conditions for licences in Form 28, Form 28B and Form 28D.

Rule 78(c)(ii) requires testing of each batch or lot of raw material and each batch of the final product, together with the prescribed testing records.

For record retention, it distinguishes between substances with a fixed potency date and other substances. The relevant provisions prescribe two years from the expiry of the potency date in the former case and five years from manufacture in the latter.

Manufacturers should therefore check their particular licence category rather than apply a single record-retention period to every product.

Schedule U Requirements
Schedule U specifies the particulars to be maintained in manufacturing and analytical records.

It covers details such as raw material receipt, supplier information, batch identification, testing, quality control decisions and other relevant manufacturing records.

The latest CDSCO communication reinforces the importance of maintaining these records alongside the mandatory testing requirements.

What Has CDSCO Reiterated in Its October 2026 Drug Testing Communication?

The letter dated 27 October 2026 focuses on two major responsibilities of pharmaceutical manufacturers: mandatory testing, and proper vendor qualification.

Mandatory Testing of Every Batch of Raw Materials and Finished Formulations
CDSCO has asked State and UT Drug Controllers to ensure that pharmaceutical manufacturers comply with the prescribed batch-wise testing requirements.

This includes testing raw materials used in manufacturing, including critical excipients, and testing each batch of the finished drug product.

A supplier's assurance or documentation alone should not be treated as a replacement for testing required under the applicable licence conditions.

Robust Vendor Qualification and Approved Sourcing
The second direction concerns the selection and qualification of raw material suppliers.

Manufacturers have been instructed to implement robust vendor qualification and source raw materials, and excipients from reliable, approved vendors.

Manufacturers should check whether their suppliers can regularly provide materials that meet the required quality standards.

Both instructions relate to existing quality requirements for manufacturers. The communication does not introduce a separate vendor registration certificate.

CDSCO's October 2026 Instructions Compared with Its October 2025 Communication

CDSCO had issued a similar communication on 7 October 2025.

The 2025 letter referred to reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups. It also highlighted findings from manufacturing inspections and investigations into drugs found to be not of standard quality.

According to that letter, reports had identified instances where manufacturers were not carrying out the required testing of every batch of excipients, inactive ingredients and active pharmaceutical ingredients before their use in manufacturing.

The subsequent communication places renewed emphasis on compliance.

The main point for manufacturers is that the October 2026 letter reinforces existing obligations. It should not be interpreted as introducing mandatory batch testing for the first time.

Who Must Comply with CDSCO's Drug Testing Requirements?

The requirements primarily concern pharmaceutical manufacturers operating under the relevant manufacturing licences.

Businesses that should pay particular attention include:

• Licensed pharmaceutical manufacturers: Companies manufacturing drug formulations must comply with the testing requirements applicable to their products and licences.
• Manufacturers using active pharmaceutical ingredients: Manufacturers must ensure that raw materials used in formulations are tested as required under the applicable rules.
• Manufacturers using pharmaceutical excipients: Businesses using substances such as glycerol, sorbitol and propylene glycol must pay attention to their quality, source and testing.
• Finished formulation manufacturers: Manufacturers producing tablets, capsules, syrups, injections and other drug formulations must carry out the tests prescribed for their products.
• Loan licence manufacturers: Businesses operating under loan licence arrangements must examine the requirements applicable to their own licences and the approved manufacturing facilities they use.

The obligations on manufacturers should not automatically be extended to retailers, distributors or unrelated businesses. Those entities may have separate legal responsibilities depending on their activities.

Mandatory Testing Requirements for Pharmaceutical Raw Materials and Finished Formulations

Testing is an essential part of pharmaceutical manufacturing quality control. It helps determine whether materials and products meet the standards applicable to their intended use.

The Drugs Rules require the relevant licensees to test each batch or lot of raw material used in manufacturing and each finished product batch.

Batch-Wise Testing of Pharmaceutical Raw Materials
Pharmaceutical raw material testing helps establish whether the ingredients received from suppliers meet the prescribed quality specifications.

Manufacturers must arrange the required testing before using raw materials in production.

Testing requirements depend on the material and applicable specifications. They may concern identity, quality, purity or other relevant characteristics.

The manufacturer should also ensure that the material received can be traced to the supplier, batch number and testing records.

A properly maintained raw material control system helps prevent the accidental use of materials that have not received the required quality approval.

Testing of Finished Drug Formulations
Testing responsibilities do not end after raw materials are accepted.

Every batch of finished drug product must also undergo testing in accordance with the applicable requirements.

The tests differ according to the dosage form, product specifications and relevant standards.

For instance, the quality characteristics examined for tablets may differ from those applicable to liquid preparations or injectable medicines.

The purpose is to establish whether the finished batch meets the required standards before it is released for sale or distribution.

Responsibilities of Quality Control Personnel
Quality control personnel play an important role in testing activities, reviewing results and maintaining records.

Depending on the manufacturer's approved procedures and applicable requirements, their responsibilities may include:

• Ensuring that incoming raw material samples are properly identified.
• Coordinating testing against applicable specifications.
• Reviewing analytical reports and results.
• Recording the acceptance or rejection of materials.
• Maintaining appropriate testing documentation.
• Supporting the review of finished product batches before release.

The exact responsibilities must reflect the licence conditions, relevant schedules and approved quality systems of the manufacturing unit.

Testing Requirements for Critical Pharmaceutical Excipients

An excipient is an ingredient used in a pharmaceutical formulation that is not intended to provide the main therapeutic action. Excipients may serve functions such as dissolving ingredients, improving consistency, providing sweetness or helping maintain the stability of a formulation.

Although excipients are often described as inactive ingredients, their quality can directly affect the safety of the finished medicine.

The October 2026 CDSCO communication specifically identifies propylene glycol, glycerol and sorbitol among critical excipients that require attention.

Propylene Glycol Testing Requirements
Propylene glycol is used in certain pharmaceutical preparations as a solvent or formulation ingredient.

Its quality must meet the applicable pharmaceutical specifications before it is used in manufacturing.

Manufacturers should ensure that the relevant batch has undergone the required testing and that its source and analytical records are properly documented.

Glycerol Testing Requirements
Glycerol, also known as glycerin, is used in several pharmaceutical formulations, including certain oral liquid preparations.

The quality and purity of glycerol are important because unsuitable or contaminated material can compromise finished product safety.

Manufacturers must comply with the applicable testing requirements and verify that the material meets the relevant specifications.

Sorbitol Testing Requirements
Sorbitol is commonly used in pharmaceutical preparations for purposes such as sweetening or improving formulation characteristics.

As with other critical excipients, manufacturers must pay attention to its source, quality and required testing before use.

The 2026 letter does not prescribe a new universal analytical method or numerical contaminant limit specifically for these three excipients. Manufacturers must refer to the applicable pharmacopoeial specifications, product requirements and other relevant regulatory directions.

Vendor Qualification Requirements for Pharmaceutical Manufacturers

Vendor qualification is another major area highlighted in the CDSCO communication.

A pharmaceutical manufacturer may purchase ingredients from several suppliers, but the responsibility for using materials that meet applicable quality requirements remains with the manufacturer.

A robust vendor qualification system helps assess whether suppliers are suitable for providing pharmaceutical raw materials and excipients.

Practical areas of review include:

• Supplier Identification and Evaluation: Checking the supplier's identity, relevant business details and suitability to supply the material.
• Material Quality Documentation: Reviewing relevant specifications, analytical information and other supporting quality documents.
• Supplier Performance: Monitoring whether materials consistently meet applicable quality requirements.
• Approved Vendor Records: Maintaining an appropriate system for identifying suppliers approved for procurement.
• Review of Quality Concerns: Examining repeated material failures, documentation gaps or other concerns that may affect supplier suitability.

These elements help manufacturers check the quality of materials supplied to them. The October 2026 communication does not ask manufacturers to obtain separate approval for each raw material supplier through a new national process.

Importantly, vendor qualification does not replace mandatory batch-wise testing.

Manufacturers need both appropriate supplier controls and compliance with the testing obligations applicable to their raw materials.

In-House and Approved Laboratory Testing Requirements

CDSCO's cited provisions allow manufacturers to test their products in their own laboratories or use laboratories approved by the licensing authority.

Testing Through an In-House Laboratory
Manufacturers conducting testing within their own facilities must maintain appropriate laboratory arrangements, personnel and procedures according to the applicable rules and licence conditions.

The laboratory should be capable of performing the relevant tests, and producing reliable analytical records.

Testing Through a Laboratory Approved by the Licensing Authority
The Rules also allow testing through a laboratory approved by the licensing authority, subject to the applicable provisions.

Manufacturers using external laboratory services should verify that the laboratory has the required approval and is suitable for the tests being assigned.

An ordinary commercial testing arrangement should not automatically be assumed to satisfy the regulatory requirement.

Likewise, a laboratory's accreditation status should not be confused with any separate approval required under the Drugs Rules.

The manufacturer remains responsible for meeting its applicable licence conditions.

Drug Testing Records and Documentation Under Schedule U

Testing must be supported by proper documentation.

Schedule U of the Drugs Rules 1945, specifies particulars to be maintained in manufacturing, and analytical records.

For raw materials, Schedule U includes information concerning the date of receipt, invoice number, manufacturer or supplier, batch number, quantity, expiry date where applicable, analytical report and quality control release or rejection.

The records also help trace raw materials to the drug batches in which they were used.

For finished products, the particulars differ according to the drug category and dosage form.

How Long Must Manufacturers Retain Testing Records?
The retention period depends on the applicable licence provision.

Under Rule 74(c), the prescribed testing records are retained for five years from manufacture.

Under Rule 78(c)(ii), the provision distinguishes substances with a fixed potency date, for which records are retained for two years after expiry of that date, from other substances, for which records are retained for five years from manufacture.

Manufacturers should also examine any other applicable record-retention obligations rather than relying on one general period for every document.

Role of State and UT Drug Controllers in Ensuring Compliance

The latest CDSCO communication has been addressed to all State and Union Territory Drug Controllers.

These authorities are responsible for relevant drug licensing and regulatory functions within their jurisdictions, subject to the applicable legal framework.

CDSCO has requested them to direct manufacturers to comply with the prescribed drug testing requirements and implement robust vendor qualification.

The earlier October 2025 letter also referred to monitoring during inspections and informing manufacturers about their responsibilities.

The Drugs Rules allow authorised inspectors to visit manufacturing premises, check testing facilities and review regulatory records.

The October 2026, communication does not set a new inspection schedule or a nationwide deadline for submitting a separate testing declaration.

Impact of CDSCO Drug Testing Requirements on Pharmaceutical Manufacturers

The circular does not introduce an entirely new testing system, but it places renewed attention on whether manufacturers are consistently following their existing legal obligations.

For pharmaceutical businesses, the implications extend across procurement, production, testing and documentation.

• Raw material Procurement: Manufacturers need reliable sources of pharmaceutical ingredients and must ensure that testing requirements are met before materials enter production.
• Quality Control Operations: Laboratories and quality control teams must have suitable arrangements for testing incoming materials and finished drug batches.
• Manufacturing Schedules: Production planning needs to account for required material testing and quality control decisions. Testing gaps may affect the availability of materials for manufacturing.
• Vendor Management: Companies should examine whether their approved supplier arrangements remain suitable for the materials they purchase.
• Documentation and Inspections: Missing test records or incomplete material traceability can make it difficult to demonstrate that the prescribed requirements have been followed.

Risks of Non-Compliance
Failure to comply with applicable drug manufacturing requirements may expose a manufacturer to regulatory action under the Drugs and Cosmetics Act and Rules.

Depending on the established violation and the relevant legal provisions, regulatory consequences can include directions concerning affected drug batches or action relating to manufacturing licences.

For example, Rules 74 and 78 contain provisions concerning withdrawal or recall of batches found not to conform to prescribed standards when the competent authority issues the relevant direction.

The October 2026 communication does not establish a new fixed penalty specifically for failure to follow the instructions in that letter.

Any consequences must be assessed under the applicable law and circumstances of the case.

What Should Pharmaceutical Manufacturers Do Next?

Manufacturers should review their existing arrangements against the applicable testing and licence conditions.

The following checklist can help identify important compliance areas.

• Review manufacturing licence conditions: Identify the legal provisions applicable to the manufacturing unit and the products covered by its licence.
• Check raw material testing procedures: Confirm that the required batch-wise testing is being carried out before raw materials are used in production.
• Review critical excipients: Pay particular attention to propylene glycol, glycerol, sorbitol and other materials whose quality may present significant risks.
• Verify finished product testing: Ensure that finished formulation batches undergo the required testing and quality review before release.
• Examine vendor qualification records: Review approved supplier arrangements, material documentation and supplier performance.
• Check laboratory arrangements: Make sure in-house or external testing facilities meet the applicable requirements and have the necessary approvals.
• Review Schedule U records: Check that all relevant manufacturing and analytical details are properly recorded and maintained.
• Address identified gaps: Investigate missing records, testing deficiencies or supplier concerns and take appropriate corrective action.
• Keep relevant personnel informed: Ensure that procurement, manufacturing and quality control personnel understand their responsibilities.

These review activities should be treated as practical compliance guidance. They do not constitute a new application process introduced by the CDSCO communication.

How Can Corpseed Help with Pharmaceutical Regulatory Compliance?

Pharmaceutical manufacturers may need assistance understanding the licensing conditions, documentation and regulatory procedures applicable to their operations.

Corpseed provides regulatory consulting and licensing-related services for pharmaceutical businesses.

Relevant assistance may include:

• Regulatory Requirement Assessment: Helping businesses identify the regulatory and licensing requirements relevant to their proposed or existing pharmaceutical activities.
• Drug Manufacturing Licence Assistance: Supporting businesses with applicable manufacturing licence documentation and regulatory procedures.
• Compliance Documentation Guidance: Assisting with regulatory documentation requirements within the scope of the relevant consultancy service.
• CDSCO Regulatory Assistance: Providing support for applicable CDSCO registration, licensing or approval processes where required.
• Regulatory Coordination: Helping businesses understand relevant application requirements and communicate with the appropriate authorities during supported regulatory procedures.

Testing itself must be performed through facilities and arrangements that meet the applicable legal requirements. Consultancy assistance does not replace the manufacturer's quality control obligations.

Need support with pharmaceutical regulatory compliance? Contact Corpseed to discuss your licensing requirements and regulatory documentation needs.

Key Takeaways

• CDSCO issued a communication on 27 October 2026 directing strict compliance with existing pharmaceutical raw material and finished product testing requirements.
• Relevant pharmaceutical manufacturers must test every batch or lot of raw materials and every batch of finished drug products under the applicable Drugs Rules.
• Critical excipients, including propylene glycol, glycerol and sorbitol, have been specifically highlighted.
• Manufacturers must implement robust vendor qualification and source raw materials from reliable, approved suppliers.
• The required testing must be carried out through legally appropriate laboratory arrangements, with the prescribed records maintained.
• The latest letter does not introduce a new universal compliance deadline or separate registration certificate.