DravyaOS2026 has been a busy year for the Drugs Rules, 1945. Three changes reach the retail counter: one is already law, one has a deadline a year away, and one is still a draft. The headlines haven't always described them accurately, so here is each one in plain terms: what it changes, who it affects, and what, if anything, you need to do.
This is general information about notified and draft rules. Enforcement varies by state, so confirm how a rule applies to your own licence with your State Drugs Control office.
1. Cough syrups leave Schedule K (in force since 9 June 2026)
Schedule K is the list of drugs exempted from parts of the licensing rules. One of its entries let certain household remedies be sold in villages with a population under 1,000 without meeting the full retail licensing conditions. This is the route the restricted licence (Form 20A) was built around. That entry used to read "syrups, lozenges, pills and tablets for cough".
The Drugs (Fifth Amendment) Rules, 2026, effective 9 June 2026, deleted the word "syrups". Lozenges, pills and tablets for cough keep the exemption. Cough syrups no longer do, so they can only be sold through the fully licensed pharmacy system. The government's stated reason is quality: contaminated cough syrups made in India were linked to child deaths abroad from 2022 onwards.
What the headlines got wrong: several reports said every cough syrup now needs a prescription. The amendment doesn't say that. It removes an exemption that let syrups be sold outside a full licence. Whether a particular syrup needs a prescription still depends on what's in it, and many (codeine combinations, for example) were already Schedule H or H1.
What to do:
- On a full retail licence (20/21 or 20B/21B)? Nothing new for you. Keep following the schedule on each product.
- On a restricted licence, or supplying shops that are? Cough syrups are off the list you can sell under it. Clear or return that stock, and talk to your State Drugs Control office about upgrading the licence if syrups matter to your trade.
2. Schedule H2 barcodes spread to four whole categories (from July 2027)
Schedule H2 is not a prescription schedule, despite the name. It's a labelling rule: products on it must carry a barcode or QR code on the pack. Since 1 August 2023 it has covered a list of roughly 300 top-selling brands, which is why you've been seeing QR codes on familiar painkillers and antacids.
G.S.R. 506(E), the Drugs (Seventh Amendment) Rules, 2026, notified on 22 June 2026, adds four entire categories:
- All vaccines for human use: from 1 July 2027
- All narcotic and psychotropic drugs (NDPS): from 1 July 2027
- All anticancer drugs: from 1 July 2027
- All antimicrobials (antibiotics, antifungals, antivirals, antiparasitics): from 1 July 2028
The code carries a unique product identification code, the generic and brand names, the manufacturer, the batch number, manufacturing date and expiry date, and the manufacturing licence number.
What the headlines got wrong: some coverage said chemists must now keep a separate H2 register. The notification puts the obligation on manufacturers, who print the code. It creates no new register or dispensing rule for a retail chemist. Your Schedule H and H1 obligations are exactly what they were.
Why it still matters to you: from mid-2027, most of what you stock in those categories will carry its batch and expiry in a form a scanner can read. Anyone can scan a pack to check whether it's genuine, and customers will. Buy from licensed distributors, keep the invoices, and be wary of short-dated stock offered cheap without a proper bill.
3. CCTV at prescription counters (draft, September 2026)
G.S.R. 791(E), dated 8 September 2026, proposes CCTV at every retail premises that supplies drugs on prescription, which in effect means Schedule H, H1 and X sales, with footage kept for at least three months. Wholesale is excluded. It is a draft: objections are open for 30 days from publication, and nothing takes effect until a final rule names a date.
We've covered it in detail, including the open questions and how to send an objection, in the proposed CCTV rule for medical stores.
What didn't change
None of the three touches the core of what an inspector checks at a retail counter:
- Schedule H: sold only on a prescription.
- Schedule H1: a prescription, plus a register entry with the date, the patient's name, the prescriber's name and address, the drug and the quantity, kept for three years.
- Schedule X: its own stricter register and a copy of the prescription kept.
- Your licence details on the bill, and purchase records that tie every batch back to a licensed supplier.
The three-year H1 register is still where most shops fall short. That's not because anyone skips it deliberately; a field left blank on a busy afternoon is invisible afterwards. The fix is to record the prescriber when you bill, not to backfill a book before an inspection. Our guide to the Schedule H1 prescription register lists every required field.
How we keep this page current
Rules change by Gazette notification, often with little notice at the counter. We'll update this page as each one is notified or takes effect, starting with the final form of the CCTV rule.
The Schedule column on every medicine, and the prescriber on every scheduled bill, kept in step on every counter and phone.
Download DravyaOS for WindowsRelated reading: drug licence and record-keeping rules, and managing batch numbers and expiry dates.