This article deals with the new gazette which talks about OTC Drugs. This article was released on 25th May, 2022. Any objection or suggestion must be given to the Government within 30 days for it to be taken into consideration. 

Draft Rules

  1. (1) These rules may be called the Drugs (…..Amendment) Rules, 2022.
    (2) These rules will be published on the final date of their publication.
  2. These rules will be inserted In the Drugs Rules, 1945, in Schedule K after serial no. 39 

The following drugs to be sold Over-The-Counter (OTC) by retail under the valid license:

  1. Povidone Iodine 5% w/v solution Composition: Povidone Iodine 5% w/v (Antiseptic and disinfectant agent)
  2. Chlorohexidine Mouthwash
  3.  Composition: Chlorohexidine Gluconate 0.2% (For the treatment of gingivitis)
  4. Clotrimazole cream Composition: Clotrimazole 1% w/w cream (Antifungal)
  5. Clotrimazole dusting powder Composition: Clotrimazole 1%w/w powder (Antifungal)
  6. Dextromethorphan Hydrobromide Lozenges (5mg) (Cough)
  7. Diclofenac ointment/cream/gel Each gram of gel contains 10 mg of diclofenac sodium (equivalent to 11.6 mg of diclofenac diethylammonium) (Analgesic)
  8. Diphenhydramine Capsules 25 mg (Antihistamine/Anti Allergic)
  9. Paracetamol tablets 500 mg (Antipyretic)
  10. Sodium Chloride Nasal spray – 0.9% (Nasal Decongestant)
  11. Oxymetazoline nasal solution 0.05% (Nasal Decongestant)
  12. Ketoconazole shampoo 2% w/v (Anti dandruff)
  13. Lactulose solution 10 gm/15ml (Laxative)
  14. Benzoyl peroxide 2.5 w/w (Antibacterial for acne) 
  15. Calamine Lotion (Antiseptic)
  16. Xylometazoline hydrochloride 0.05% w/v (Nasal decongestant)
  17. Bisacodyl tablets 5mg (Laxative)

Extent of Exemptions for the OTC’s mentioned above

The above drugs can be sold as OTC without a prescription from a  Registered Medical Practitioner (RMP), subject to the following conditions, namely:—

  1. The maximum duration of the treatment/dosage should not exceed 5 days 
  2. If the patient’s symptoms do not resolve, the patient should consult a Registered Medical Practitioner.
  3. Pack size should not  exceed the maximum doses recommended for five days.
  4. Each pack should be assisted with a Patient Information Leaflet (PIL).
  5. The indication claimed should be the same as already approved by the Licensing Authority under Rule 21(b) for the categories mentioned. 

To understand the latest regulations on Drugs, Medical Devices, IVD’s and Cosmetics in India, contact Morulaa to know more. You can contact us on admin@morulaa.com or through our website’s contact form.


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