Law and statutory body
Drugs Rules, 1945 (Schedule K, Schedule H1)
GS2 Polity and Governance - Health regulationGS3 EconomyPrelims and Mains
- Why in news
- On 22 May 2026 the Union Health Ministry announced that Pregabalin has been moved from Schedule H to Schedule H1 of the Drugs Rules, 1945, by notification G.S.R. 377(E) dated 13 May 2026.
- What it is
- The Drugs Rules, 1945 are rules made under the Drugs and Cosmetics Act, 1940. They regulate the manufacture, sale and distribution of drugs. Schedule K lists drugs and classes of drugs exempted from certain licensing provisions, while Schedule H1 covers drugs sold only on a prescription with stricter record-keeping.
- Alcohol threshold
- The exemption is removed for formulations with more than 12% v/v ethyl alcohol in quantities above 30 mL.
- Schedule K
- Schedule K exempted items such as tinctures of cardamom, ginger and other aromatic preparations from licensing requirements.
- Schedule H1
- Schedule H1 mandates sale only against a Registered Medical Practitioner's prescription and stricter record-keeping.
- Licensing law
- Such products must now get licences under the Drugs and Cosmetics Act, 1940.
- Reason
- Some formulations have alcohol up to 80-90% v/v, making them prone to misuse for intoxication; some States also sent references.
- Parent Act
- The Drugs Rules, 1945 are framed under the Drugs and Cosmetics Act, 1940.
- Notification
- Pregabalin was brought under Schedule H1 by Gazette Notification G.S.R. 377(E) dated 13 May 2026.
- Change in class
- Pregabalin moves from the existing Schedule H to the stricter Schedule H1.
- Retail record-keeping
- Retailers must keep a separate register of prescriptions and sales.
- Labelling
- Manufacturers must show the Schedule H1 warning label prominently on packs.
- Legal basis
- The Drugs Rules, 1945 are framed under the Drugs and Cosmetics Act, 1940, which also supplies the penalties.
Don’t confuse with Schedule H vs Schedule H1: Schedule H drugs need a prescription; Schedule H1 adds stricter record-keeping of sales.
Don’t confuse with Schedule K vs Schedule H1: Schedule K lists exemptions from licensing; Schedule H1 imposes prescription and record controls.
Don’t confuse with Drugs Rules vs NDPS Act: Schedule H1 sits under the Drugs and Cosmetics law. It is not the same as controlled substances listed under the NDPS Act, 1985.
Laws, judgments and statutory bodies: 30 Prelims questions since 2013 (what the law says, who chairs, legal basis). In Mains, 44 news-triggered questions, most in GS2, asking for provisions and challenges.
Why it matters
- Curbs diversion of medicinal alcohol preparations for intoxication.
- Brings such products into the regulated pharmaceutical supply chain.
- Tighter control on retail sale can curb misuse among youth and illegal trafficking.
- Sale records improve traceability across the supply chain.
Problems
- Enforcement across many retail chemists and record-keeping compliance.
- Balancing availability for genuine therapeutic use against misuse.
- Enforcement across many small retailers and online sellers is uneven.
- Patients with genuine pain or neurological needs should not face access problems.
Way forward
- Strengthen inspection by State drug regulators and audit of sales records.
- Run awareness drives for chemists and consumers.
- Regular inspections by drug controllers and use of digital prescription and sale records.
- Awareness campaigns on misuse, with monitoring of State-level seizure data.
Put in your answer
Regulatory step: Removal of Schedule K exemption shows use of delegated rule-making to tackle misuse of medicines.
Pregabalin reclassification, May 2026: Example of using drug scheduling to tackle misuse of a prescription medicine.
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UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
Prelims practice · Single answer
Ours, not from a UPSC paper
Consider the following statements regarding the recent amendment to the Drugs Rules, 1945: 1. Formulations with more than 12% v/v ethyl alcohol in quantities above 30 mL no longer enjoy the Schedule K licensing exemption. 2. Such formulations have been moved to Schedule H1, which requires sale against a registered medical practitioner's prescription and stricter record-keeping. 3. The Drugs Rules, 1945 are framed under the Narcotic Drugs and Psychotropic Substances Act, 1985. 4. The amendment sets the alcohol threshold at 30% v/v with a quantity limit of 12 mL.
Which of the statements given above are correct?
True or false?
1 of 7
Statements the way Prelims prints them. Say first, then see the fact.
1.Formulations with more than 12% v/v ethyl alcohol in quantities exceeding 30 mL are no longer covered by the Schedule K exemption.
True. The Schedule K exemption is removed above 12% v/v and 30 mL.
2.Such formulations have been moved to Schedule H1 of the Drugs Rules, 1945.
True. They are now under Schedule H1.
3.Schedule H1 allows over-the-counter sale of these products with no record-keeping.
False. Schedule H1 requires sale against a registered medical practitioner's prescription and stricter record-keeping.
4.The affected products must now obtain licences under the Drugs and Cosmetics Act, 1940.
True. Licences are required under the Drugs and Cosmetics Act, 1940.
5.The Drugs Rules, 1945 are framed under the Narcotic Drugs and Psychotropic Substances Act, 1985.
False. They are framed under the Drugs and Cosmetics Act, 1940.
6.Schedule K exempted tinctures such as cardamom and ginger preparations from licensing requirements.
True. Schedule K covered such tinctures and aromatic preparations.
7.The amendment sets the alcohol threshold at 30% v/v, with the 12 mL as the quantity limit.
False. The threshold is 12% v/v alcohol and the quantity limit is 30 mL.
Written by us from the release, not by UPSC; checked by a second model.
Worth revising until Prelims 2028: most news questions come within two years of the event.