CDSCO Issues GSR 135(E): Key Amendments to Drugs Rules, 1945 on Rule 121A, Licensing Conditions & Schedule H

CDSCO Issues GSR 135(E): Key Amendments to Drugs Rules, 1945 on Rule 121A, Licensing Conditions & Schedule H

The Central Drugs Standard Control Organisation (CDSCO) has issued an important regulatory update through GSR 135(E) notification dated February 16, 2026, introducing amendments to the Drugs Rules, 1945 under the provisions of the Drugs and Cosmetics Act, 1940.

The Drugs Rules Amendment 2026 brings critical changes relating to Rule 121A (Test for Bacterial Endotoxins–Pyrogens), modifications in Form 20B, Form 20G and Form 21B, and clarification in Schedule H footnote provisions. These amendments aim to strengthen regulatory compliance for pharma manufacturers, distributors, and license holders across India.

The amendments include insertion of specific provisions under Rule 121A, addition of paragraph 3A and condition 2A in Form 20G, insertion of condition 2A in Form 20B, addition of condition 1A in Form 21B, and inclusion of a new entry 6 in the footnote of Schedule H.

Amendment in Rule 121A: Test for Bacterial Endotoxins–Pyrogens

One of the most significant updates in this CDSCO notification 2026 is the substitution of Rule 121A.

Under the revised provision:

• Solutions intended for parenteral administration must comply with the Test for Bacterial Endotoxins.
   
• Where justified and authorized, compliance with the Pyrogen test rule is permitted.
   
• Testing must be conducted as per the current edition of the Indian Pharmacopeia (IP).

The new endotoxin testing requirement in India reinforces patient safety and harmonizes Indian regulations with global pharmacopoeial standards.

Licensing Condition Amendments: Forms 20B, 20G & 21B

Another major part of the GSR 135(E) notification concerns amendments with regard to “Conditions of Licence” under these forms

1. Personal Supervision by Competent Person

Under revised conditions in Form 20B and Form 20G:

• Sale of drugs must be conducted under the personal supervision of a competent person.
   
• The name of the competent person must be specified.

This strengthens accountability in drug distribution license conditions.

2. Mandatory Reporting of Change in Competent Person

A new compliance requirement has been introduced:

• The licensee must report to the licensing authority any change in the competent person within one month of such change.

This regulatory update for drug license holders 2026 increases transparency and ensures active regulatory oversight.

Amendment in Schedule H: Exclusion Clarification

The notification also amends the footnote in Schedule H, clarifying that:

• The class of drugs mentioned at serial number 15 of Schedule K shall not be covered under Schedule H.

This Schedule H amendment 2026 provides clarity regarding drug classification and helps prevent regulatory overlap.

Compliance Implications for Pharma Industry

The impact of GSR 135(E) on pharma industry includes:

• Mandatory Indian Pharmacopeia compliance for endotoxin testing
• Stricter monitoring of competent persons in licensed premises
• Enhanced regulatory compliance for pharma companies
• Clearer classification between Schedule H and Schedule K drugs

Pharma manufacturers, distributors, wholesalers, and compliance officers should review their SOPs to ensure alignment with the Drugs Rules 1945 amendment.

Conclusion

The CDSCO GSR 135(E) notification February 2026 marks an important step in strengthening India's pharmaceutical regulatory framework. With updates to Rule 121A, licensing conditions, and Schedule H provisions, the amendment reinforces quality control, regulatory accountability, and patient safety.

Stakeholders are advised to immediately assess internal compliance systems and implement necessary updates in testing procedures and licensing documentation.

Click here to Access the official guidance document

Note:
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