G.S.R. 135(E) – Changes to the Drugs Rules
On February 16, 2026, the Central Drugs Standard Control Organization (CDSCO) rolled out Notification G.S.R. 135(E), bringing some big updates to the Drugs Rules. These changes zero in on raising quality standards, clearing up how drugs are classified, and tightening accountability around wholesale drug licenses.
Here’s what stands out:
1. Expanded Pyrogen / Bacterial Endotoxin Testing (Rule 121A)
CDSCO has replaced Rule 121A, making the testing rules tougher and more inclusive.
Now, every solution for parenteral use—including any water-based solvents—must pass either the Bacterial Endotoxin Test (BET) or the Pyrogen Test. Labs have to follow the latest Indian Pharmacopoeia for these tests. The old rule, which only required pyrogen testing for large-volume parenterals (10 ml or more), is gone. Everything’s covered now.
What does this change? It raises the safety bar across the board and brings testing in line with today’s pharmaceutical standards.
2. Clearer Rules for Prescription-Only Drugs (Schedule H Footnote)
The footnote under Schedule H (which covers prescription-only drugs) just got an important addition.
Drugs listed at Serial No. 15 in Schedule K aren’t part of Schedule H anymore.
Why does this matter? It finally clears up confusion between Schedule H and Schedule K, which makes it easier to know what’s prescription-only and what’s not.
3. New Rules for Wholesale Drug Licenses (Forms 20B, 20BB, 21B, 21BB & 20G)
A. Competent Person Supervision
From now on, anyone selling drugs under these wholesale licenses has to do so under the direct supervision of a “competent person.” This person’s name must be right there on the license:
– Form 20B / 20BB – For drugs other than Schedule C, C(1), and X
– Form 21B / 21BB – For drugs in Schedule C and C(1)
– Form 20G – For Schedule X drugs
B. Reporting Changes
If there’s any change in the named competent person, the license holder has just one month to report it to the licensing authority.
What’s the impact? It puts real responsibility on wholesalers, makes oversight easier, and helps regulators keep track of who’s actually supervising these drug operations.
4. When Did All This Start?
These changes kicked in on February 16, 2026—the day they appeared in the Gazette of India.
Why These Changes Matter
– Safer Drugs: The new testing rules mean better protection for patients and no more outdated loopholes for large-volume drugs.
– Less Confusion: The update to Schedule H finally sorts out overlapping rules and gives everyone a clearer picture of what’s prescription-only.
– More Accountability: Naming and tracking the “competent person” for each license makes it much harder for anyone to dodge responsibility in the wholesale drug business.
